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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic Patient Assistant Model PA96000. It focuses on demonstrating substantial equivalence to a predicate device (Patient Assistant Model 9538 - K103764).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table with corresponding reported device performance metrics. Instead, it describes various verification and validation tests and states that the device "meets established performance criteria" or "performs as intended."

However, we can infer some criteria and reported performance from the "Summary of Testing and Performance data" section:

Acceptance Criteria (Implied)	Reported Device Performance	Study Type/Location in Document
Hardware functions according to specification.	All tests passed. "The results provide verification evidence that requirements in PA96000 Hardware Requirements Specification met the acceptance criteria as set per those requirements."	Hardware Verification Testing (Page 5)
Firmware operates per specification and meets Level of Concern (Major).	All firmware testing successfully completed. "The analysis and testing performed demonstrates the firmware as identified operates per specification."	Firmware Verification Testing (Page 5)
Mechanical design meets input requirements.	All testing passed. "Mechanical Design Verification has been completed showing the product design output meets its design input requirements... All testing was completed and passed."	Mechanical Design Verification Testing (Page 5)
Meets environmental requirements.	All testing passed. "The testing performed demonstrates the PA96000 meets its environmental requirements."	Environmental Verification Testing (Page 5)
Enables users to mark symptomatic events without hazardous use errors.	100% of participants completed tasks without hazardous use errors. "90% of representative users with appropriate training were able to mark a symptomatic event." "Deemed safe and effective for use."	Human Factors Testing (Page 5)
Biologically safe for patient contact.	Biological safety demonstrated. "This biological evaluation report demonstrates the biological safety of the PA96000 Patient Assistant."	Biocompatibility Testing (Page 6)
Packaging integrity meets standards.	All packaging tests passed. "The PA96000 Patient Assistant product packaging... passed all aspects of the package testing and is acceptable for use as intended."	Packaging Verification Testing (Page 6)
Overall system operates per design input requirements.	All system validation testing successfully completed. "The analysis and testing performed demonstrates the PA96000 operates per the Design Input Requirement Specification."	System Validation (Page 6)

2. Sample Sizes Used for the Test Set and Data Provenance

Human Factors Testing:
- Sample Size for Test Set: 20 participants (Page 5).
- Data Provenance: Not explicitly stated, but the study was conducted by Medtronic, Inc. It's likely from a US population, and the nature of the testing suggests it was prospective as participants were recruited for the study.
No other specific sample sizes for test sets (e.g., for hardware, firmware, mechanical, environmental, biocompatibility, packaging, or system validation) are provided in terms of "cases" or "data provenance" as one might expect for a clinical study. These are typically engineering verification tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies described are primarily engineering verification and human factors testing, not clinical studies requiring independent expert ground truth establishment for a diagnostic output. For the human factors study, the "ground truth" would be the successful completion of tasks and lack of use errors, which is assessed by the study design and observers.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for establishing ground truth for diagnostic devices by reconciling differences in expert opinions. This document describes a device primarily focused on communication and data activation, not diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/provided. The device described is a "Patient Assistant" for an Insertable Cardiac Monitor (ICM), intended to "activate the data management features... to initiate recording of cardiac event data." It is not an AI-powered diagnostic tool that assists human readers (e.g., radiologists, cardiologists) in interpreting medical images or signals. Therefore, an MRMC study or AI-assistance improvement metric would not be relevant in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/provided in the context of an "algorithm only" performance as it pertains to AI/diagnostic devices. The Patient Assistant is a physical device that interacts with an ICM; its "performance" is about its functionality (e.g., communication, battery life, mechanical integrity, usability) rather than an isolated algorithm's diagnostic accuracy. The firmware testing could be considered "standalone" in that it verifies the software's performance against specifications, but it's not in the sense of a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the various verification and validation tests:

Hardware, Firmware, Mechanical, Environmental, System Validation: The "ground truth" is adherence to design input requirements and established performance specifications (e.g., "operates per specification," "meets environmental requirements," "meets established performance criteria").
Human Factors Testing: The "ground truth" is successful task completion and the absence of hazardous use errors as determined by observers and predefined criteria of the study design.
Biocompatibility: Adherence to ISO 10993-1 standards for biological safety.
Packaging: Adherence to ASTM D-4169 standards for package integrity.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device described is a hardware patient assistant with firmware, not a machine learning or AI algorithm that requires a "training set" of data for development. The studies mentioned are verification and validation of engineering design and human factors, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the same reasons as point 8.

Summary

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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

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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

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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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Date Prepared:	05 February 2015
Submitter:	Medtronic, Inc.Cardiac Rhythm Disease Management8200 Coral Sea Street NEMounds View, MN 55112
Contact:	Eric KalmesPrincipal 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 andalarm
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

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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:

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

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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

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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	FDARecognitionNo.	Summary/Trace Report
1	EN 55011 (CISPR11)EMI Emissions Characteristics		EMC test report
2	ASTM D4169 – 09Standard Practice for Performance Testing ofShipping Containers and Systems	14-300	LINQ PA96000 Patient AssistantPackage Test Design VerificationTest Report
3	EN 45502-1:1997Active Implantable Medical Devices Part 1:General Requirements for Safety, Marking andInformation to be Provided by the Manufacturer		Package and Device Labeling
	Standard	FDARecognitionNo.	Summary/Trace Report
	Shall comply to Clause 5.1 only
4	EN ISO 60601-1:2006 / A1:2013Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance	5-4	LINQ PA96000 Patient AssistantEnvironmental Verification DesignVerification Test Report
5	IEC 60601-1-2:2014 Class BMedical electrical equipment Part 1-2: Generalrequirements for basic safety and essentialperformance — Collateral standard:Electromagnetic compatibility	5-34	EMC test report
6	EN ISO 60601-1-11 2010Medical electrical equipment Part 1-11: Generalrequirements for basic safety and essentialperformance -Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment	19-6	LINQ PA96000 Patient AssistantEnvironmental Verification DesignVerification Test Report
7	BS EN ISO 14971:2012Medical Devices. Application of riskmanagement to medical devices	5-40	Summary Risk Management Report
8	EN 1041:2008Information supplied by the manufacturer ofmedical devices		IFU Design Input Requirements
9	EN 980:2008Symbols for use in the labeling of medicaldevices		IFU Design Input Requirements
10	EN ISO 15223-1:2012Medical devices - Symbols to be used withmedical device labels, labelling and informationto be supplied - Part 1: General requirements -CORR: July 31, 2012	5-91	IFU Design Input Requirements
11	EN ISO 60601-1-6 2010Medical electrical equipment Part 1-6: Generalrequirements for basic safety and essentialperformance — Collateral standard: Usability	5-85	LINQ PA96000 Patient AssistantHuman Factors EngineeringValidation Report
12	ETSI EN 301 489-31 V1.1.1:2005Electromagnetic compatibility and Radiospectrum Matters (ERM); ElectromagneticCompatibility (EMC) standard for radioequipment and services; Part 31: Specificconditions for equipment in the 9kHz to 315 kHzband for Ultra Low Power Active MedicalImplants (ULP-AMI) and related peripheraldevices (ULP-AMI-P)		EMC testing Report
	Standard	FDARecognitionNo.	Summary/Trace Report
13	EN 302 195-2 V1.1.1:2004Electromagnetic compatibility and Radiospectrum Matters (ERM); Radio equipment in thefrequency range 9 kHz to 315 kHz for Ultra LowPower Active Medical Implants (ULP-Ami) andaccessories; Part 2: Harmonized EN coveringessential requirements of article 3.2 of theR&TTE Directive		EMC testing Report
14	ISO 1000:1992SI units and recommendations for the use of theirmultiples and of certain other units		IFU Design Input Requirements
15	ISO 14708-1:2000Implants for surgery — Active implantablemedical devices — Part 1: General requirementsfor safety, marking and for information to beprovided by the manufacturer		Package and Device Labeling
16	ISO 80000-1:2009Quantities and units - Part 1: General - TechnicalCorrigendum 1		IFU Design Input Requirements
17	ISO 8601:2004Data elements and interchange formats –Information interchange – Representation of datesand times		IFU Design Input Requirements
18	EN ISO 10993-1:2009/AC:2010Biological Evaluation of Medical Devices P1Evaluation and Testing with a Risk ManagementProcess	2-156	Biological Evaluation
19	JBD No. 185: 2001National Agency of Sanitary SurveillanceDecision - JBD No. 185, from the 22nd ofOctober, 2001		IFU Design Input Requirements

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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.

Regulation Number and Section

§ 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.