(127 days)
Not Found
No
The description focuses on the device's function as a communication tool to mark events in an implanted device. There is no mention of AI or ML in the device description, intended use, or performance studies. The testing described is standard device verification and human factors testing, not related to AI/ML model performance.
No
The device's function is to activate data management features and mark symptomatic episodes in an implanted cardiac monitor, not to provide therapy.
No
The Patient Assistant's function is to activate data management features in an implanted cardiac monitor to mark symptomatic episodes, not to diagnose a condition itself.
No
The device description explicitly states it is a "handheld, battery-operated, radio-frequency device" and the performance studies include "Hardware Verification Testing" and "Mechanical Design Verification Testing," indicating it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Patient Assistant's function is to communicate with an implanted cardiac monitor to mark symptomatic episodes. It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is to activate data management features in the implanted device and initiate recording of cardiac event data. This is a data management and event marking function, not a diagnostic test performed on a sample.
The device is a communication tool for an implanted medical device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
unsupervised patient use away from a hospital or clinic.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device verification testing was performed to demonstrate the Patient Assistant Model PA96000 meet established performance criteria to support equivalency to the reference predicate device.
- 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.
- Firmware Verification Testing: Software Level of Concern based on the product Risk Analysis, which includes hardware and software components, the associated hazards and corrective action. The guidance documents Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm dated October 28, 2003, and Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005 were considered. Medtronic concludes the Patient Assistant Model PA96000 software represents a major level of concern. All firmware testing for the PA96000 Patient Assistant was successfully completed.
- 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, no test issues encountered, and 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: A Human Factors Engineering Validation Study of the Patient Assistant (model PA96000) was conducted with 20 participants representative of current ICM patients. 100% of the participants completed the study tasks without any use errors that could result in a hazardous outcome. Participant performance did not reveal any new use errors that could result in a hazardous outcome. 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) is deemed safe and effective for use.
- Biocompatibility Testing: A biological evaluation as guided by the applicable sections of ISO 10993-1:2009/AC: 2010 was performed for the Patient Assistant PA96000. This evaluation 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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)
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3
| Date Prepared: | 05 February 2015 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Contact: | Eric Kalmes |
| 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 |
| 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
Recognition
No. | Summary/Trace Report |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------|
| 1 | EN 55011 (CISPR11)
EMI Emissions Characteristics | | EMC test report |
| 2 | ASTM D4169 – 09
Standard Practice for Performance Testing of
Shipping Containers and Systems | 14-300 | LINQ PA96000 Patient Assistant
Package Test Design Verification
Test Report |
| 3 | EN 45502-1:1997
Active Implantable Medical Devices Part 1:
General Requirements for Safety, Marking and
Information to be Provided by the Manufacturer | | Package and Device Labeling |
| | Standard | FDA
Recognition
No. | Summary/Trace Report |
| | Shall comply to Clause 5.1 only | | |
| 4 | EN ISO 60601-1:2006 / A1:2013
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance | 5-4 | LINQ PA96000 Patient Assistant
Environmental Verification Design
Verification Test Report |
| 5 | IEC 60601-1-2:2014 Class B
Medical electrical equipment Part 1-2: General
requirements for basic safety and essential
performance — Collateral standard:
Electromagnetic compatibility | 5-34 | EMC test report |
| 6 | EN ISO 60601-1-11 2010
Medical electrical equipment Part 1-11: General
requirements for basic safety and essential
performance -Collateral standard: Requirements
for medical electrical equipment and medical
electrical systems used in the home healthcare
environment | 19-6 | LINQ PA96000 Patient Assistant
Environmental Verification Design
Verification Test Report |
| 7 | BS EN ISO 14971:2012
Medical Devices. Application of risk
management to medical devices | 5-40 | Summary Risk Management Report |
| 8 | EN 1041:2008
Information supplied by the manufacturer of
medical devices | | IFU Design Input Requirements |
| 9 | EN 980:2008
Symbols for use in the labeling of medical
devices | | IFU Design Input Requirements |
| 10 | EN ISO 15223-1:2012
Medical devices - Symbols to be used with
medical device labels, labelling and information
to be supplied - Part 1: General requirements -
CORR: July 31, 2012 | 5-91 | IFU Design Input Requirements |
| 11 | EN ISO 60601-1-6 2010
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential
performance — Collateral standard: Usability | 5-85 | LINQ PA96000 Patient Assistant
Human Factors Engineering
Validation Report |
| 12 | ETSI EN 301 489-31 V1.1.1:2005
Electromagnetic compatibility and Radio
spectrum Matters (ERM); Electromagnetic
Compatibility (EMC) standard for radio
equipment and services; Part 31: Specific
conditions for equipment in the 9kHz to 315 kHz
band for Ultra Low Power Active Medical
Implants (ULP-AMI) and related peripheral
devices (ULP-AMI-P) | | EMC testing Report |
| | Standard | FDA
Recognition
No. | Summary/Trace Report |
| 13 | EN 302 195-2 V1.1.1:2004
Electromagnetic compatibility and Radio
spectrum Matters (ERM); Radio equipment in the
frequency range 9 kHz to 315 kHz for Ultra Low
Power Active Medical Implants (ULP-Ami) and
accessories; Part 2: Harmonized EN covering
essential requirements of article 3.2 of the
R&TTE Directive | | EMC testing Report |
| 14 | ISO 1000:1992
SI units and recommendations for the use of their
multiples and of certain other units | | IFU Design Input Requirements |
| 15 | ISO 14708-1:2000
Implants for surgery — Active implantable
medical devices — Part 1: General requirements
for safety, marking and for information to be
provided by the manufacturer | | Package and Device Labeling |
| 16 | ISO 80000-1:2009
Quantities and units - Part 1: General - Technical
Corrigendum 1 | | IFU Design Input Requirements |
| 17 | ISO 8601:2004
Data elements and interchange formats –
Information interchange – Representation of dates
and times | | IFU Design Input Requirements |
| 18 | EN ISO 10993-1:2009/AC:2010
Biological Evaluation of Medical Devices P1
Evaluation and Testing with a Risk Management
Process | 2-156 | Biological Evaluation |
| 19 | JBD No. 185: 2001
National Agency of Sanitary Surveillance
Decision - JBD No. 185, from the 22nd of
October, 2001 | | IFU Design Input Requirements |
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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.