Medtronic Patient Asistant

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 27, 2015 Medtronic, Inc. c/o Mr. Eric Kalmes Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112 Re: K150117 > Trade/Device Name: Patient Assistant Model PA96000 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II Product Code: DSI Dated: April 21, 2015 Received: April 22, 2015 Dear Mr. Kalmes: 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 {1}------------------------------------------------ Page 2 – Mr. Eric Kalmes CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 531-542 of the Act); 21 CFR 1000-1050. 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) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, FDA Arthell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K150117 Device Name Patient Assistant Model PA96000 #### Indications for Use (Describe) The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal Family of Insertable Cardiac Monitors (ICM) to initiate recording of cardiac event data in the implanted device memory. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 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 Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL 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 Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ | Date Prepared: | 05 February 2015 | |-----------------------|-----------------------------------------------------------------------------------------------------------| | Submitter: | Medtronic, Inc.<br>Cardiac Rhythm Disease Management<br>8200 Coral Sea Street NE<br>Mounds View, MN 55112 | | Contact: | Eric Kalmes<br>Principal Regulatory Affairs Specialist | | Telephone: | (763)526-2809 | | Fax: | (651)367-0603 | | E-mail: | eric.b.kalmes@medtronic.com | | Proprietary Name: | Patient Assistant, Model PA96000 | | Common Name: | Patient Assistant | | Device Classification | Class II, 21 CFR 870.1025, Arrhythmia detector and<br>alarm | | Product Code: | DSI | | Device Predicate: | Patient Assistant Model 9538 - 510(k) K103764 | # 510(k) Summary Complying with 21 CFR 807.92 # Summary of Substantial Equivalence and Predicate Device The intended use, design, materials and performance of the Medtronic Patient Assistant (Model PA96000) are substantially equivalent to the predicate device Patient Assistant Model 9538 (510(k) K103764). This predicate has not been subject to a design-related recall. # Device Description The Patient Assistant is a handheld, battery-operated, radio-frequency device used to communicate with the Reveal Insertable Cardiac Monitors. It utilizes Medtronic's Telemetry B protocol for communication. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor. The Patient Assistant's function is to mark symptomatic episodes in the implanted device memory. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a gray, elongated, rectangular object with rounded corners. There is a rectangular cutout near the top of the object and a loop at the bottom. The object appears to be made of a translucent material, and there is a logo visible near the bottom. Figure 1: Patient Assistant ### Summary of changes Changes were made to the new PA96000 increase patient acceptance by reducing size, improving form factor, and eliminating the need for replaceable batteries. - Reduced size and form factor to allow patients to more easily carry with them. ● - New visual indicator for successful marking of symptom allows confirmation on marking symptoms in addition to the audio tone. - . Non-replaceable battery and no end of life indicator. The Patient Assistant is being designed with sufficient battery capacity to support the entire life of the device. Given the expected use conditions, battery replacements will not be necessary. Batteries are non-replaceable (no removable battery compartment) because the device's longevity is as long or longer as the Reveal implantable and simplifies patient ease of use. ## Indications for Use There are no changes to the Indications for Use. The Indications for Use are provided below: The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal Family of Insertable Cardiac Monitors (ICM) to initiate recording of cardiac event data in the implanted device memory. # Technological Characteristics Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate device referenced. There are no differences between the subject and predicate devices. # Summary of Testing and Performance data All of the proposed changes to the subject Patient Assistant Model PA96000 were fully verified and validated in accordance with design control requirements. Device verification testing was {5}------------------------------------------------ performed to demonstrate the Patient Assistant Model PA96000 meet established performance criteria to support equivalency to the reference predicate device. The results of the testing indicate that the Medtronic Patient Assistant performs as intended and is safe for its intended use. The following performance data were provided in support of the substantial equivalence determination. - . Hardware Verification Testing - All tests and reviews were executed per the test plan, with no deviations. The results provide verification evidence that requirements in PA96000 Hardware Requirements Specification met the acceptance criteria as set per those requirements. - Firmware Verification Testing -● - Software Level of Concern based on the product Risk Analysis, which includes o hardware and software components, the associated hazards and corrective action. the guidance document Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm dated October 28, 2003, and the guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005. Medtronic concludes the Patient Assistant Model PA96000 software represents a major level of concern. In accordance all documentation was submitted based on level of concern. - o All firmware testing for the PA96000 Patient Assistant was successfully completed. The analysis and testing performed demonstrates the firmware as identified operates per specification. - . Mechanical Design Verification Testing - Mechanical Design Verification has been completed showing the product design output meets its design input requirements. These tests were created based on PA96000 Mechanical Requirements Specification. There were no deviations from the Mechanical Design Verification Plan. There were no test issues encountered. All testing was completed and passed. - . Environmental Verification Testing - The testing performed demonstrates the PA96000 meets its environmental requirements as described in the PA96000 Environmental Verification Test Plan. - . Human Factors Testing - Human factors Engineering Validation Study of the Patient Assistant (model PA96000) was conducted. The 20 participants recruited and tested in the study were representative of current ICM patients. 100% of the participants completed the study tasks without any use errors that could result in a hazardous outcome. - o Participant performance did not reveal any new use errors that could result in a hazardous outcome. - o In addition, 90% of representative users with appropriate training were able to mark a symptomatic event with the Patient Assistant. - Based upon the analysis of the priori goals, the Patient assistant (model PA96000) o is deemed safe and effective for use {6}------------------------------------------------ - Biocompatibility Testing - A biological evaluation as guided by the applicable sections of ISO 10993-1:2009/AC: 2010 that pertain to biological effects has been performed for the Patient Assistant PA96000. This evaluation describes the patient contact of the device and the available biological safety information. This biological evaluation report demonstrates the biological safety of the PA96000 Patient Assistant. - Packaging Verification Testing Package system performance testing was performed . according to ASTM D-4169, Assurance Level 1, and Distribution Cycle 13. The PA96000 Patient Assistant product packaging as outlined in the Package Design Verification Plan, DSN015024, passed all aspects of the package testing and is acceptable for use as intended. - . System Validation - System Validation testing for the PA96000 Patient Assistant project was successfully completed. The analysis and testing performed demonstrates the PA96000 operates per the Design Input Requirement Specification ## Guidance used to Demonstrate Substantial Equivalence Guidance documents used/considered for these device modifications include, but are not limited to, the following: - Draft Guidance Document titled Use of International Standard ISO 10993, Biological ● Evaluation of Medical Devices Part 1: Evaluation and Testing, issued on April 23, 2013 - . Draft Guidance Document titled Design Considerations for Devices Intended for Home Use, issued December 12, 2012 - Radio Frequency Wireless Technology in Medical Devices, issued on August 14, 2013 ● - . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005 - Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm dated . October 28, 2003 # Standards used to Demonstrate Substantial Equivalence The following standards were used to demonstrate substantial equivalence: | | Standard | FDA<br>Recognition<br>No. | Summary/Trace Report | |----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------| | 1 | EN 55011 (CISPR11)<br>EMI Emissions Characteristics | | EMC test report | | 2 | ASTM D4169 – 09<br>Standard Practice for Performance Testing of<br>Shipping Containers and Systems | 14-300 | LINQ PA96000 Patient Assistant<br>Package Test Design Verification<br>Test Report | | 3 | EN 45502-1:1997<br>Active Implantable Medical Devices Part 1:<br>General Requirements for Safety, Marking and<br>Information to be Provided by the Manufacturer | | Package and Device Labeling | | | Standard | FDA<br>Recognition<br>No. | Summary/Trace Report | | | Shall comply to Clause 5.1 only | | | | 4 | EN ISO 60601-1:2006 / A1:2013<br>Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance | 5-4 | LINQ PA96000 Patient Assistant<br>Environmental Verification Design<br>Verification Test Report | | 5 | IEC 60601-1-2:2014 Class B<br>Medical electrical equipment Part 1-2: General<br>requirements for basic safety and essential<br>performance — Collateral standard:<br>Electromagnetic compatibility | 5-34 | EMC test report | | 6 | EN ISO 60601-1-11 2010<br>Medical electrical equipment Part 1-11: General<br>requirements for basic safety and essential<br>performance -Collateral standard: Requirements<br>for medical electrical equipment and medical<br>electrical systems used in the home healthcare<br>environment | 19-6 | LINQ PA96000 Patient Assistant<br>Environmental Verification Design<br>Verification Test Report | | 7 | BS EN ISO 14971:2012<br>Medical Devices. Application of risk<br>management to medical devices | 5-40 | Summary Risk Management Report | | 8 | EN 1041:2008<br>Information supplied by the manufacturer of<br>medical devices | | IFU Design Input Requirements | | 9 | EN 980:2008<br>Symbols for use in the labeling of medical<br>devices | | IFU Design Input Requirements | | 10 | EN ISO 15223-1:2012<br>Medical devices - Symbols to be used with<br>medical device labels, labelling and information<br>to be supplied - Part 1: General requirements -<br>CORR: July 31, 2012 | 5-91 | IFU Design Input Requirements | | 11 | EN ISO 60601-1-6 2010<br>Medical electrical equipment Part 1-6: General<br>requirements for basic safety and essential<br>performance — Collateral standard: Usability | 5-85 | LINQ PA96000 Patient Assistant<br>Human Factors Engineering<br>Validation Report | | 12 | ETSI EN 301 489-31 V1.1.1:2005<br>Electromagnetic compatibility and Radio<br>spectrum Matters (ERM); Electromagnetic<br>Compatibility (EMC) standard for radio<br>equipment and services; Part 31: Specific<br>conditions for equipment in the 9kHz to 315 kHz<br>band for Ultra Low Power Active Medical<br>Implants (ULP-AMI) and related peripheral<br>devices (ULP-AMI-P) | | EMC testing Report | | | Standard | FDA<br>Recognition<br>No. | Summary/Trace Report | | 13 | EN 302 195-2 V1.1.1:2004<br>Electromagnetic compatibility and Radio<br>spectrum Matters (ERM); Radio equipment in the<br>frequency range 9 kHz to 315 kHz for Ultra Low<br>Power Active Medical Implants (ULP-Ami) and<br>accessories; Part 2: Harmonized EN covering<br>essential requirements of article 3.2 of the<br>R&TTE Directive | | EMC testing Report | | 14 | ISO 1000:1992<br>SI units and recommendations for the use of their<br>multiples and of certain other units | | IFU Design Input Requirements | | 15 | ISO 14708-1:2000<br>Implants for surgery — Active implantable<br>medical devices — Part 1: General requirements<br>for safety, marking and for information to be<br>provided by the manufacturer | | Package and Device Labeling | | 16 | ISO 80000-1:2009<br>Quantities and units - Part 1: General - Technical<br>Corrigendum 1 | | IFU Design Input Requirements | | 17 | ISO 8601:2004<br>Data elements and interchange formats –<br>Information interchange – Representation of dates<br>and times | | IFU Design Input Requirements | | 18 | EN ISO 10993-1:2009/AC:2010<br>Biological Evaluation of Medical Devices P1<br>Evaluation and Testing with a Risk Management<br>Process | 2-156 | Biological Evaluation | | 19 | JBD No. 185: 2001<br>National Agency of Sanitary Surveillance<br>Decision - JBD No. 185, from the 22nd of<br>October, 2001 | | IFU Design Input Requirements | {7}------------------------------------------------ {8}------------------------------------------------ ## Conclusion Medtronic has demonstrated that the Patient Assistant described in this submission results in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device. We have provided summary data to demonstrate reasonable assurance of safety and effectiveness of the subject Patient Assistant PA96000 and to demonstrate substantial equivalence to its predicate. As supported by the descriptive information, verification and standards testing, the modified patient assistant is as safe and effective, and performs as well as or better than the predicate device.