WARNING LETTER
Lexion Medical LLC
MARCS-CMS 613588 —
July 26, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Patrick Spearman
Recipient Title
Owner
Lexion Medical LLC
545 Atwater Circle
Saint Paul
,
MN
55103
United States
pspearman@lexionmedical.com
Issuing Office:
Center for Devices and Radiological Health
United States
July 26, 2021
RE: Adulterated and Misbranded Products, including Products Related to Coronavirus Disease 2019 (COVID-19)
Dear Patrick Spearman:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE Gas Evacuation Cannula (Pneuview XE) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. We also note that the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19
1
in people. As recent as June 22, 2021, FDA reviewed your website, https://www.lexionmedical.com/ and information posted to social media platforms (https://twitter.com/LexionMedical/status/1245400259888582656, https://www.youtube.com/watch?v=NEhxp1fgewA&feature=emb_logo) and determined that the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The AP 50/30 Insufflator, Insuflow Port, and Pneuview XE are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of the product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.
AP 50/30 Insufflator and Insuflow Port
The AP 50/30 Insufflator was cleared under K191780 for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Insuflow Port was also cleared under K191780 for having applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity. However, your firm’s promotion of these devices provides evidence that they are intended for uses such as reduction of cell desiccation, hypothermia, post-operative pain and subcutaneous emphysema, which would constitute major changes or modifications to their intended uses, for which your firm lacks clearance or approval. Any therapeutic, treatment, or prevention effectiveness claims beyond the cleared indication for use constitute a new intended use and requires a premarket submission prior to marketing.
For example, your website, www.Lexion.com, contains the following promotional claims for the AP 50/30 Insufflator and Insuflow Port:
• Under the sections of your website titled, “Gas Delivery” (https://www.lexionmedical.com/gas-delivery) and “Testimonials” (https://www.lexionmedical.com/reviews)
 “Less hypothermia”
 “Less peritoneal damage”
 “Less postoperative pain”
 “Decreased amount of pain medication”
 “Shortened recovery room stay”
 “Less tissue dessication”
• Under the section of your website titled, “Pneumostability” (https://www.lexionmedical.com/pneumostability)“reduce the incidence of subcutaneous emphysema”
There are many factors that may contribute to the health risks listed above. FDA is not aware of evidence demonstrating that the AP 50/30 Insufflator and Insuflow Port are effective in the reduction of these risks. Such promotion of your devices for unsupported and uncleared indications, and statements about demonstrating improved safety outcomes, may lead clinicians to overestimate the performance of the device and minimize the importance of other risk mitigating steps, which may lead to patient harm. If you have data to support these statements, please submit that data to FDA for review. FDA informed your firm in written communications following the submission of 510(k) notifications for a different accessory device that certain claims, such as those listed above, required the submission of clinical data and that literature reviews provided were not adequate to support these indications. The respective submissions were not cleared, were withdrawn, or were cleared without these indications.
Pneuview XE
The Pneuview XE was cleared under K132203 for having applications in thoracic, abdominal, and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization. However, your firm’s promotion of this device provides evidence that it is intended for the elimination of all plume, gases, particles, contaminants, viruses and unsafe negative pressure which would constitute major changes or modifications to its intended use, for which your firm lacks clearance or approval. Any therapeutic, treatment, or prevention effectiveness claims beyond the cleared indication for use constitute a new intended use and requires a premarket submission prior to marketing. For example, the Smoke Evacuation section of your website (https://www.lexionmedical.com/smoke-evacuation) includes the following promotional claims for the Pneuview XE:
• “Eliminate
all
plume, gases, and particles” [emphasis added]
• “…eliminating
all
harmful contaminants associated with combustion, including viral particles” [emphasis added]
• “actively evacuates and removes
all
smoke plume including hazardous gas” [emphasis added]
• “…a patented vacuum break which eliminates the ability of any suction system to pull an unsafe negative pressure on the patient”
The cleared indication for use of this device includes only evacuation of smoke and plume. FDA is not aware of evidence, and no data have been provided in your 510(k), demonstrating that the Pneuview XE is effective in the removal of all harmful gases, vapors, particulates, or viruses. We note that leakage of gases, vapors, and particulates through the cannula when devices are inserted and removed occurs, regardless of filtration within the system. Therefore, statements including the word “all” or any statements implying 100% removal of vapors, gases, particulates, or viruses are misleading. Misleading claims may lead clinicians to overestimate the performance of the device and minimize the importance of other risk mitigating steps. Medical practitioners may also overestimate the amount of protection provided them by use of your device in the operating room (OR), which has the potential to lead to patient and practitioner harm. Additionally, FDA is not aware of evidence, and no data has been submitted in your 510(k), demonstrating that the Pneuview XE is effective in eliminating unsafe negative pressure on the patient. Such promotion of your device for unsupported and uncleared indications may lead to patient harm.
The Pneuview XE is further misbranded under § 502(a) of the Act, 21 U.S.C. § 352(a), because there are statements on your website and social media sites that, under 21 CFR § 801.6, constitute false or misleading representations with respect to another device. Specifically, the information makes misleading comparisons between your device, a one-way insufflator, and competing devices, two-way insufflators. For example, relevant pictures, illustrations, videos, literature, and written/verbal statements include the following:
• A picture of smoke venting out of the patient into the OR in the two-way insufflator and a picture showing that all the smoke is vented outside the OR by one-way insufflator on your website page titled, “What Technology Is Used In Your OR?” (https://www.lexionmedical.com/youror). This information is misleading in that it fails to recognize the smoke reduction characteristics contained in two-way insufflators.
• Stating, with respect to two-way insufflators, that, “Smoke particulates and some gases are removed however toxic [gas] is vented into the OR” on your website page titled, “What Technology Is Used In Your OR?” (https://www.lexionmedical.com/youror). This information is misleading in that it minimizes the smoke reduction characteristics contained in two-way insufflators.
• Stating that the recirculating system of two-way insufflators “[c]ycles contaminated gases through insufflator potentially increasing the risk of cross contamination and build-up of toxic gas”, under the section on your website titled, “What Technology Is Used In Your OR?” (https://www.lexionmedical.com/youror). This information is misleading in that it fails to recognize that both one-way and two-way systems carry these risks and contain filtration capabilities to mitigate these risks.
• Referencing a limited selection of journal articles about competing devices under the section on your website titled, “Resources”
2
(https://www.lexionmedical.com/insights) and “Testimonials” (https://www.lexionmedical.com/reviews). This information is misleading in that it may cause medical practitioners to overestimate the type of protection provided to their patients by use of your device in the OR.
• Stating in videos and literature on social media platforms, including YouTube, that there is “constant venting of gas into the atmosphere” which increases the risk of cross-contamination and colonization of pathogens in two-way insufflators and referencing a limited selection of journal articles, as described above. This information is misleading in that it mischaracterizes two-way devices by failing to recognize their smoke reduction characteristics.
We are not aware of any new data supporting such claims. Such claims are false or misleading because data do not demonstrate that the Pneuview XE is superior to other insufflator devices. These comparisons may mislead consumers about the effectiveness of the Pneuview XE by implying less effectiveness of other devices. Misleading information may lead clinicians to overestimate the performance of the device and minimize the importance of other risk mitigating steps, which may lead to practitioner and patient harm. These claims therefore constitute misleading representations with respect to another device. If you do have data demonstrating that Pneuview XE is more effective than other insufflation devices, please provide that information to the agency.
Additionally, the FDA has observed that your website currently offers the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE for sale in the United States as being intended to mitigate, prevent, treat, diagnose or cure COVID-19
3
in people. Promoting these devices as an effective prevention method against COVID-19 constitutes a major change or modification to its intended use, for which your firm lacks clearance or approval, and requires premarket submission prior to marketing. For example, in videos under the sections on your website titled, “COVID-19” (https://www.lexionmedical.com/covid-19) and “Testimonials,” (https://www.lexionmedical.com/reviews) several statements are made about how your devices provide safety against COVID-19. Some of those statements include the following:
• The video titled, “How Does Lexion Compare with other Insufflation Systems for COVID-19?” provides a testimonial that states in part:
 “This COVID crisis has brought a lot of focus on how we work in the operating room and particularly the risks to us and our patients that could come from some of the laparoscopic insufflation devices [used]…to perform procedures.” (minute 0:23)
 In the context of COVID-19, the video goes on to compare two-way systems, and how they remove “a lot of raw gas out of the patient and straight into the room…dumping the gas back into the OR room and the OR atmosphere… [potentially] contaminating the device itself [leading to contamination] into the patient or the next patient.” (minute 2:32) to traditional one-way systems and leakage of gas that “escape[s] through any variety of ways” (minute 2:45)
 The video clip then describes the advantages of the AP 50/30 Insufflator which include, “The Lexion is a valved system [that has] minimal spillage of gas out of the port and into the [OR] room during the procedure.” (minute 6:03)
 The video concludes that “[a] lot of the different surgical societies have been making recommendations in the midst of this COVID crisis about ways we can try to protect ourselves and those we work with, and … [based on those recommendations] the Lexion AP 50 seems to checks all those boxes for us.” (minute 6:50) [https://www.lexionmedical.com/covid-19].
• In the video titled, “Why this Oncology GYN Robotic Surgeon switched to the Lexion System,” the testimonial states, “…but lately, mainly due to COVID-19… I’m using the system by Lexion which to me is the safest and best system out there… It’s just so much safer with the current climate… I would just hate to have a patient who turns COVID-19 positive.” (minute 0:23)
Taken together, the statements exemplified above imply that traditional one-way insufflators and two-way insufflators potentially contaminate the OR or lead to contamination to other patients, whereas, the AP 50/30 Insufflator and accessories are recommended for and may be used to mitigate and/or prevent the spread of COVID-19. FDA is not aware of evidence demonstrating that the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE are effective in the reduction of the spread of COVID-19. If you have data to support these statements, please submit that data to FDA for review.
In combination with information displayed on your COVID-19 webpage, as well as other areas of your website, as referenced above, where your firm claims that these devices can remove viral particles, these statements and information indicate that the AP 50/30 Insufflator and its accessories are intended for use to protect OR staff or patients against COVID-19. Such promotion of your device for unsupported and uncleared indications may cause medical practitioners to overestimate the type of protection provided them and their patients by use of your device in the OR, which has the potential to lead to patient and practitioner harm.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
4
In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.
5
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described herein, you sell a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved, uncleared, and unauthorized product for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
For more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices
.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the Act. This list can be found at
https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products
. Once you have taken actions to address the sale of unapproved, uncleared, and unauthorized product(s) for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
FDA requests that Lexion Medical LLC immediately cease activities that result in the misbranding or adulteration of the AP 50/30 Insufflator, Insuflow Port, and Pneuview XE, such as the commercial distribution of the device for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product(s) as safe and/or effective for indications outside the cleared indications, including for COVID-19-related uses, for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that adulterate or misbrand the product(s) in violation of the Act. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Note, there are two response time frames specified.
Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov
describing the specific steps you have taken to address the COVID-19 related violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. For all other claims, please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Please include documentation of any corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, please state the reason for the delay and the time within which these activities will be completed. Your firm’s responses should be comprehensive and address all violations included in this Warning Letter. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the Act, please provide us with your reasoning and any supporting information for our consideration.
Your firm’s response to address all other violations, should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, Rm 3572, 10903 New Hampshire Ave, Silver Spring, Maryland 20993 or emailed to CDRHWarningLetterResponses@fda.hhs.gov.
Please refer to the identification numbers CMS 613588 and CPT2001060 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Jason Roberts, Ph.D., Assistant Director for the Gynecological and Surgical Devices Team, at Jason.Roberts@fda.hhs.gov.
Finally, this letter is not meant to be an all-inclusive list of the violations that exist in connection with the product(s) at your firm or in your promotional materials including your website. It is your firm’s responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. Failure to adequately address any violations may result in legal action, including without limitation, seizure and injunction.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC
Shelly Amann, Owner
Lexion Medical LLC
545 Atwater Circle
Saint Paul, MN 55103
samann@lexionmedical.com
______________________
1
As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
While earlier journal articles dated 2009 -2013 cite some cases of subcutaneous emphysema with AirSeal, later articles show no significant difference in subcutaneous emphysema for AirSeal and standard CO2 insufflator. The 2020 Feng et al article even notes a significantly lesser risk of subcutaneous emphysema with the AirSeal at 12mmHg and the transperitoneal approach. Feng TS, Heulitt G, Islam A, Porter JR. Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial [published online ahead of print, 2020 Jul 6].
J Robot Surg
.
3
As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
4
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed),
available
at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
5
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
Content current as of:
08/03/2021
Regulated Product(s)
Medical Devices