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Timestamp: 2019-10-14 18:29:25
Document Index: 15186047

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803', 'art21', 'art 1', 'art 1', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

June 17, Skanray Technologies Pvt Ltd. c/o Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland PDF
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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD June 17, 2015 Skanray Technologies Pvt Ltd. c/o Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland Re: Trade/Device Name: Star 90 Regulation Number: 21 CFR Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: May 12, 2015 Received: May 14, 2015 Dear Ms. Yolanda Smith, We have reviewed your Section 510(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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
2 Page 2 - Ms. Yolanda Smith related adverse events) (21 CFR 803); 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 of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Sincerely yours, Enclosure forbram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3 510(k) Number (if known) Device Name STAR90 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No Expiration Date: January See PRA Statement below. Page 1 of 1 Indications for Use (Describe) The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient s vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2), IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, IBP, EtCO2 and FiCO2 readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. Type of Use (Select one or both, as applicable) X Prescription Use (Part21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperw ork Reduction Act of *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions. search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperw ork Reduction Act (PRA) Staff "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (1114) Page 1 of 1 PSC Publishmg Services(301} EF 1
4 510(k) Summary (As Per 21 CFR ) Page 1 of 4 SPONSOR Company Name: Skanray Technologies PVt Ltd Healthcare Division Company Address: Skanray Technologies PVT Ltd. No , Hebbal Industrial Area, Mysore, KA India Telephone: Fax: Contact Person: Hema Singh Summary Prepared September 5, 2014 Trade Name: Star 90 Common/Usual Name: Patient Monitoring System Classification Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Product Code: MWI Device Class: Class II Regulation Number: 21 CFR Predicate Device Company Product 510(k) # Larsen & Toubro Ltd Star 55 K08073 Philips medizin Systeme Boeblingen Philips Intellivue patient Monitor K Device Description The STAR 90 Multi Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons. Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include: ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC DC section of the ER2T lie in the interface card.
5 Page 2 of 4 SpO2: This module is inbuilt inside the monitor on the interface card, but there is an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body. NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non invasively measure the systolic and diastolic blood pressure. CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module. Indications for Use The STAR 90 Multi Parameter Patient Monitoring System is intended to monitor a single adult, pediatric or neonatal patient s vital signs at the bedside or during intra hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 5 lead / 12 lead), Spo2, Respiration, Temperature and Capnography (CO2), IBP. It can also display the numeric values of HR/PR, SpO2, RR, Non Invasive Blood Pressure (Systolic, Diastolic and Mean). Temperature, IBP, EtCO2 and FiCO2 readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. Summary of Technological Characteristics Star 90 is designed and developed with reference to our previous 510K cleared product Star55 with same product code as Star90 MWI. These 2 products are same in terms of: ECG, Respiration, Temperature, IBP, NIBP,
6 Page 3 of 4 SpO2 and CO2 Display type Alarm systems Thermal recorder / printer Equipment classification, applicable standards Star90 is compared with MP70 for advanced features that are included in the Star 90 and include: Communication with external equipment including analog and system outputs Display size and resolution. Differences between Star 90 and Star 55 The differences between the two devices includes advanced features that include: Number of waveform traces displayed Waveform display options / selections The inclusion of the advanced features have been validated and verified to ensure that the new features do not impact performance and the safety and efficacy of the device. Non Clinical Testing Electrical and EMC Testing for the Star 90 included the following IEC EMC Test Report IEC Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC Medical electrical equipment Part 1 6: General requirements for basic safety and essential performance Collateral standard: Usability IEC Medical electrical equipment Part 1 8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC Medical electrical equipment Part 2 27: Particular performance of electrocardiographic monitoring equipment IEC Medical electrical equipment Part 2 30: Particular performance of automatic cycling non invasive blood pressure monitoring equipment.
7 IEC IEC ISO ISO ISO Page 4 of 4 Medical electrical equipment Part 2 34: Particular performance of invasive blood pressure monitoring equipment. Medical electrical equipment Part 2 49: Particular performance of multifunction patient monitoring equipment Medical electrical equipment Part 2 55: Particular performance of respiratory gas monitors Medical electrical equipment Part 2 56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Medical electrical equipment Part 2 61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment Additional Performance Testing: ANSI/AAMI EC 13 Cardiac Monitors, Heart rate Meter and Alarms ANSI/SSMI SP10 Manual, Electronic or Automated Sphygmomanometers IEC Medical device software software life cycle processes (Software/Informatics) ISO Application of risk management to medical devices Substantial Equivalence The Star 90 is substantially equivalent to the predicate device in Indications for Use, Materials and Design. Safety and performance testing was performed and Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices.
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