The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.

Device Description

The PA97000 Patient Assistant (hereinafter referred to as PA97000) is a hand-held, battery operated, Bluetooth Low Energy (BLE) device used by patients to mark symptoms in the memory of their implantable device, as illustrated in Figure 1: Image of PA97000. It is intended for unsupervised use away from a hospital or clinic.

AI/ML Overview

The provided text is a summary of the 510(k) submission for the Medtronic Patient Assistant Model PA97000. It describes the device, its intended use, and the testing performed to support its substantial equivalence to a predicate device. However, it does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

The information primarily focuses on design verification and validation, rather than a study with a test set, ground truth, or expert adjudication for determining performance against clinical acceptance criteria.

Therefore, I cannot fulfill all parts of your request as the specific information is not present in the provided text.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document in the format requested (specific performance metrics against acceptance criteria). The text states that "Device verification testing was performed to demonstrate the PA97000 meets established performance criteria" but does not detail what those criteria are or the quantitative results against them. The listed tests are primarily engineering design verification and validation.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The text mentions "extensive testing" and "design verification testing" but does not specify sample sizes for any test sets that would typically be used for evaluating clinical or analytical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided. As there's no mention of a clinical or analytical performance study with a test set requiring ground truth, there's no information about experts or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided for the same reasons as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this device. The Patient Assistant Model PA97000 is a hardware device (a hand-held, battery-operated device) that initiates recording of cardiac event data. It is not an AI-based diagnostic tool, nor does it involve "human readers" in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable to this device. It is a physical device, not an algorithm, and its function involves user interaction (a patient pressing a button) to mark symptoms. While it operates "unsupervised" in terms of clinical oversight, it's not an "algorithm-only" performance in the sense of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. No clinical or analytical ground truth is mentioned in the context of performance evaluation, as the focus is on engineering verification.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

This information is not provided for the same reason as above.

Summary of Device and Testing (from the text):

The device under review is the Medtronic Patient Assistant Model PA97000.

Device Purpose: The PA97000 is a hand-held, battery-operated device that allows patients to mark symptoms in the memory of their implanted cardiac device (an Insertable Cardiac Monitor). It provides feedback to the user about searching for the implanted device and successful symptom marking.

Study Type and Goal (as described): The submission aimed to demonstrate substantial equivalence to the predicate device, Patient Assistant Model PA96000. This was supported by "design verification testing" and "hazard analysis." The primary change from the predicate was an update in the communication protocol from Telemetry B to Bluetooth Low Energy (BTLE).

Tests Performed (Design Verification and Validation):

Safety Design Verification
EMC Design Verification
Environmental Design Verification
Mechanical Design Verification
Firmware Design Verification
Packaging Design Verification
Security Design Validation
System Design Validation
Human Factors Testing
Biocompatibility

Conclusion of the Submission: The intended use, design, materials, and performance of the PA97000 are substantially equivalent to the predicate PA96000, supported by thorough hazard analysis and extensive testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic, Inc Cheryl Swanson Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K190574

Trade/Device Name: Patient Assistant Model PA97000 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI Dated: August 21, 2019 Received: August 22, 2019

Dear Cheryl Swanson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190574

Device Name Patient Assistant Model 97000

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) SUMMARY

The following table provides background information regarding this Traditional 510(k) submission:

Date Prepared:	March 1, 2019
510(k) Owner / Address:	Medtronic, Inc.Cardiac Rhythm and Heart Failure8200 Coral Sea Street NEMounds View, MN 55112
Contact Person:	Cheryl SwansonSenior Principal Regulatory Affairs Specialistcheryl.swanson@medtronic.comOffice: (763) 514-0088Cell: (651) 242-3506Secondary Contact:Ryan CalabreseSenior Regulatory Affairs Directorryan.s.calabrese@medtronic.comOffice: (763) 526-3515
Submission Type:	Traditional 510(k)
Device Trade Name:	Patient Assistant, Model 97000
Device Common Name:	Patient Assistant
Product Code and ClassificationRegulation Name:	DSI: Arrhythmia Detector and Alarm21 CFR 870.1025Class II
Predicate Devices:	K150177

Device Description

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Image /page/4/Picture/0 description: The image shows a gray Medtronic device with a white button. There are two small lights on the top of the device, one green and one blue. The word "Medtronic" is printed on the bottom right of the device. The device has a hole at the bottom.

Figure 1: Image of PA97000

Device Purpose

The PA97000 Patient Assistant provides three key functions for the user:

1. Activates the data management feature in an insertable cardiac device to initiate recording of cardiac event data in the implanted device memory. The stored episodes are used by the clinician to correlate the patient's cardiac rhythm with their symptoms.
1. Provides feedback to the user that the PA97000 is searching for the implanted device.
1. Provides feedback to the user that the PA97000 has marked a symptom in the implanted device memory.

Indications for Use

The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of an Insertable Cardiac Monitor. The Patient is intended for unsupervised patient use away from a hospital or clinic.

Summary of Changes

The primary changes from the Patient Assistant Model PA96000 to the PA97000 are as follows:

1. Update the communication protocol from Telemetry B to Bluetooth Low Energy (BTLE)
1. Update the Indications for Use to state the PA97000 can be used with the an Insertable Cardiac Monitor that the subject device is tested with.

Technological Characteristics

The PA97000 operates identically to the PA96000. The only difference is the communication protocol used by PA97000 is Bluetooth LE rather than Telemetry B that is used by the predicate device. Analysis of the change confirms it does not raise new questions of safety or effectiveness. This conclusion is supported by a thorough hazard analysis and extensive testing.

Summary of Testing and Performance Data

The proposed changes to the PA97000 were fully verified and validated in accordance with design control requirements. Device verification testing was performed to demonstrate the

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PA97000 meets established performance criteria and supports substantial equivalency to the Patient Assistant Model PA96000.

The following performance data were provided in support of the substantial equivalence determination.

Safety Design Verification
EMC Design Verification
Environmental Design Verification ●
Mechanical Design Verification ●
Firmware Design Verification
Packaging Design Verification
Security Design Validation ●
. System Design Validation
Human Factors Testing
Biocompatibility

Conclusion

The intended use, design, materials and performance of the PA97000 are substantially equivalent to the predicate Patient Assistant Model PA96000. This is supported by a thorough hazard analysis and extensive testing.

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.