Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf10-k102588
Timestamp: 2019-10-17 23:49:36
Document Index: 312135700

Matched Legal Cases: ['art 1', 'arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807']

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medfronicMAR
510(K) SUMMARY Date Prepared: Trade Name of Device: Common Name: Classification: Applicant: March 7, 2011
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Achieve m Mapping Catheter Catheter, electrode recording, or probe, electrode recording Class 11, 21 CFR 870.1220, Electrode Recording Catheter Medtronic Ablation Frontiers 2210 Faraday Avenue, Suite 100 Carlsbad, CA 92008 USA Tel: 760-827-0007 Fax: 760-827-0020 Brenda Clay Regulatory Affairs ProMapTM, ProRhythm LasSOTM, Biosense Webster
Contact Person: Predicate Devices: Device Description:
The AchieveTm diagnostic mapping catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve catheter is a circular ioop with eight evenly spaced electrodes to map electrical conduction within the atrium. The Achieve catheter should only be used with the corresponding electrical cable for Achieve. The Achieve catheter is available with two distal loop diameter sizes described in the following table: Model 990063-015 990063-020 Loop Diameter 15 mm 20 mm
The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal' end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Indications for Use: The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart. Contraindications: The catheter is contraindicated as follows: *For use as an ablation device
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* For use with transeptal sheaths featuring side holes larger than 1.0, mm in diameter * Retrograde approach Electrophysiology studies are contraindicated when the patient's underlying cardiac disease makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a high risk of death, as in the following conditions: &quot; * * * * &quot; &quot; * An active systemic infection Left atrial thrombus Pulmonary vein stents Prosthetic heart valve (tissue or mechanical) Myxoma Interatrial baffle or patch Conditions where the manipulation of the catheter within the heart would be unsafe Acute myocardial infarction
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Technological Characteristics of the Device Compared to the Predicate Device: The Achieve Mapping Catheter uses similar technology, has similar intended use, functions, materials and method of operation as the following predicate device(s): Table 5-1: Characteristic Cornparison Device Achieve Catheter (Subject Device) Intended Use Map intracardiac structures of the heart Indications for Use The Achieve is indicated for multiple electrode electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Achieve Catheter is designed to obtain electru~grams in the atrial regions of the heart, Catheter Body Tubing Diameter Effective Length Number of Electrodes Distal End Shape Loop Diameter Loop Material Delivered through a
ProMap Catheter Map intracardiac structures of the heart The ProRhythm ProMap is to be used for the evaluation of cardiac arrhythmias from endlocardial and intravascular sites. The ProMap coaxial mapping Catheter is typically used in Electrophysiology clinical procedures. Unknown 3F 60 - 125cm 6 Circular Loop 15 to 25mm Nitinol Yes
Lasso Catheter Map intracardiac structures of the heart The LASSO Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The LASSO Catheter is designed to obtain electrograms in the atrial regions of the heart. Pebax 3F 143cm 10 or 20 Circular Loop 15 to 25mm Unknown Yes
Pebax (distal body) Stainless Steel (proximal) 3.317 146cm 8 Circular Loop 15 and 20mm Nitinol insulated with PET (Pebax covered)I Yes
Note: Materials in the predicate devices are not known with certainty. Material equivalence is demonstrated by in vivo performance testsand biocompatibility tests to FDA recognized standards.
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Summary of Studies: In vitro bench testing and in vivo testing have been performed on the device materials and finished devices. Performance, sterilization and biocompatibility testing verified that the Achieve Mapping Catheter performs as designed and is suitable for its intended use. Performance testing included the following: * * * Torquer / Introducer: insertion testing Rotational motion Insertion and retraction with compatible delivery device * Insertion/retraction cycling *Loop rotation *Rotational loading *Electrode cohtact sufficient for mapping *Atraumatic tip * Stiffness / flexibility / buckling *Flexion fatigue *Torque to failure * Simulated use testing *Electrical testing and electrical safety testing (ISO 60601-1:2006) *Tensile testing (ISO 10551-1:2009) *Loop integrity *Connector fatigue *Corrosion resistance (ISO 10555-1:2009)
Biocompatibility testing included the following: &quot; * * * * * * * * Cytotoxicity (1S0 10993-5:2009) Sensitization (150 10993-10:2002, Amend 2006) Intracutaneous reactivity (1S010993-10:2002, Amend 2006)) Systemic toxicity (1S0 10993-11:2006) Pyrogenicity (IS01 0993-11:2006) H-emolysis (ISO 10993-4:2002) Complement activation (ISO 10993-4:2002) Partial thromboplastin time (PPT) (1S0 10993-4:2002) Platelet and leukocyte count (1S0 10993-4:2002)
The Cable has been tested and is considered safe and effective per applicable parts of BS EN 6060 1I-1 (2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). Conclusion: The data presented in this submission demonstrate that the Ablation Frontiers Achieve Mapping Catheter is substantially equivalent to the predicate devices identified in regards to device design, materials, and intended use.
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Food and lDrug Adminisutrtion 10903 Newv Hampshire Avenue Document Contiol Room -W066-G609 Silver Spring, MD 20993-0002
Medtronic Ablation Frontiers c/o Ms. Brenda Clay
2210 Faraday Avenue, Suite 100MAR Carlsbad, CA 92008
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K102588 Trade Name: Achieve Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Class 11 (two) Product Code: DRF Dated: March 11, 2011 Received: March 14, 2011
Dear Ms. Clay: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class 1I (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2 - Ms. Brenda Clay Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CER Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000- 1050. This letter will allow you to begin marketing your device as described in your Section 5 10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (21ICFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3 150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.hitm-l. Sincerelyy
Brain D. ckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT 5 10(K) Number (if known): Device Name: Medtronic
Indications for Use: The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Mapper Catheter is designed to obtain electrograms in the atrial regions of the heart. Prescription Use X (21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)
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Achieve TM Mapping Catheter 5 10(K)