The Medtronic Reveal Plus Insertable Loop Recorder is an implantable patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.

Device Description

The Reveal Plus ILR system is designed to record and store electrocardiogram (ECG) during symptomatic events. The system consists of the Model 9526 implanted recorder and the Model 6191 Activator. A Medtronic Model 9790 programmer equipped with a Medtronic Model 9766A radio frequency telemetry head and Model 9809E software is required for programming and retrieving data from the recorder.

The primary new feature of the Reveal Plus ILR is the auto-activation function, which supplements the patient-activated function. Patient activation remains the primary means to capture an event. Patient activation is important to document the patient's ECG when either an arrhythmic or non-arrhythmic event occurs, providing the clinician with a symptom-rhythm correlation. Storage of a patient-activated event with normal sinus rhythm helps the physician to rule out arrhythmic causes. Auto activation may be useful for patients who may be incapable of using the patient Activator or who are otherwise noncompliant.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Reveal Plus Insertable Loop Recorder:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text focuses on the device's substantial equivalence to a predicate device by highlighting similarities and conducting specific tests. It doesn't explicitly state quantitative acceptance criteria in a formal table with corresponding performance metrics for the new features. Instead, it emphasizes passing various in vitro and in vivo tests to demonstrate the device meets design and performance requirements.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of equivalence and successful testing. The primary new feature is "auto-activation."

Acceptance Criteria (Inferred from Study Goals)	Reported Device Performance (Summary)
Mechanical Integrity: Device structure is mechanically sound and robust.	Passed all in vitro requirements. (Mechanical, battery, and package testing not repeated as it uses identical platform to predicate)
Battery Performance: Battery life meets specifications.	Passed all in vitro requirements. (Battery testing not repeated as it uses identical platform to predicate)
Package Integrity: Packaging effectively protects the device and maintains sterility.	Passed all in vitro requirements. (Package testing not repeated as it uses identical platform to predicate; Both package configurations fully validated)
Hybrid Qualification: Electronic components and integrated systems function as intended.	Passed all in vitro requirements (Model 9526 implanted recorder testing).
Electromagnetic Compatibility (EMC): Device operates without interference and is not susceptible to external electromagnetic fields.	Passed all in vitro requirements (Model 9526 implanted recorder testing).
Activator Functionality: Model 6191 Activator functions correctly.	Passed all in vitro requirements (Model 6191 Activator testing).
Auto-activation Feature Functionality: The auto-activation feature correctly identifies and records cardiac events, with acceptable levels of false activations.	Evaluated in a canine study. "False activations were evaluated before and after adjustments to the sensitivity setting." (Implies successful adjustment to meet an acceptable level, though specific metrics are not given).
Biocompatibility: Device materials are not harmful to biological tissues.	Not required for new testing; identical blood-contacting materials as the predicate device.
Sterilization Efficacy: Sterilization process effectively renders the device sterile.	Validated; identical EtO sterilization process to predicate device (Model 9525).
Overall Performance as Intended: Device performs as described in its labeling when used as intended.	"The testing described above provides reasonable assurance that the Reveal Plus ILR system will perform as intended when used in accordance with its labeling."
Substantial Equivalence: The Reveal Plus ILR system is as safe and effective as the predicate Reveal ILR system.	"Medtronic considers the Reveal Plus ILR system to be substantially equivalent to the Reveal ILR system."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (In Vivo): Not explicitly stated as a number of animals, but a "canine study" was performed.
Data Provenance: The study was an "in vivo" test using "canine" subjects. The text does not specify the country of origin, but it is a Medtronic, Inc. product from Minneapolis, MN, USA. The study design appears to be prospective, specifically designed to evaluate the new auto-activation feature.

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

The document does not mention the use of human experts to establish ground truth for the canine study. The evaluation of "false activations" suggests a direct measurement against a predefined criterion for true activation.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study focused on the functional performance of the auto-activation feature in animals, not on human reader performance with or without AI assistance.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, the canine study to evaluate the auto-activation feature can be considered a standalone study for that specific algorithm's performance. The "false activations were evaluated before and after adjustments to the sensitivity setting," indicating an assessment of the algorithm's accuracy in identifying events without human intervention during the event capture process.

7. The Type of Ground Truth Used:

For the canine study evaluating auto-activation: The ground truth appears to be based on physiological events in the canines, against which the device's auto-activation was compared. The "false activations" imply there was a gold standard or a defined truth for what constituted a "true" activation, likely derived from other monitoring equipment or expert observation of the canine's cardiac activity.

8. The Sample Size for the Training Set:

The document does not provide information about a separate training set. This is a premarket notification for a hardware device with a new software feature (auto-activation). While the auto-activation algorithm might have involved internal development and testing, details about training data for a machine learning model are not disclosed, nor is it explicitly indicated that such a model was used. The adjustments to "sensitivity setting" suggest a rule-based or threshold-based algorithm rather than a complex AI model requiring extensive training data in the modern sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided as no specific training set and ground truth establishment method are mentioned. If the "sensitivity setting" was optimized, it would likely have been adjusted based on data from internal development or preliminary testing, where ground truth would have been established by direct observation or more comprehensive physiological monitoring.

Summary

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JAN 2 1 2000

K994331

510(K) SUMMARY

Submitter

Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Contact: Nora K. Hadding, Sr. Product Regulation Manager Telephone: (612) 514-9945 Fax: (612) 514-9954 E-Mail: nora.hadding@medtronic.com

Date Prepared: December 21, 1999

Name of Device

Trade Name: "Reveal® Plus Insertable Loop Recorder" (ILR) System. The system is composed of the Model 9526 implanted recorder and the Model 6191 Activator. The Model 9809E Reveal software, Model 9790 programmer and Model 9766A telemetry head are also part of the system

Common Name: insertable loop recorder

Classification Name: cardiac implantable event recorder (Product Code 74 MXC) (21 CFR 870.2800)

Predicate Device

The predicate device for the Reveal Plus ILR system is the Reveal ILR system.

Device Description

System Description

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Packaging

Two package configurations are available. The Reveal Plus ILR system package contains the implanted recorder, the Activator, the Activator carrying case, the product information manual, and a patient information manual. A replacement Activator is available in the other package configuration. Both package configurations were fully validated.

Intended Use

The Medtronic Model 9526 Reveal Insertable Loop Recorder is an implantable monitoring and recording system designed for diagnostic evaluation of patients who experience transient symptoms that may suggest a cardiac arrhythmia.

Technological Characteristics

The following table outlines the functional similarities between the Reveal Plus ILR system and the Reveal ILR.

Device Feature	Reveal	Reveal Plus
Subcutaneous ECG Recording	Yes	Yes
Pre and Post Event Storage	Yes	Yes
Patient Activation	Yes	Yes
Auto Activation	No	Yes
Total Storage Time	21 or 42 min.*	Same
Maximum Single Event StorageTime	42 min.	42 min. Patient-Activated2 min. Auto-Activated
Storage Modes	4 modes	8 modes
Number of Events	1 or 3	1 or 3 in Patient-Activated mode6 or 14 in Auto-Activated mode
Data Retrieval	Radio-frequency telemetry	Same
Bandwidth	0.85-32 Hz	Same
Sampling Rate	100 Hz	Same
Volume	8 cc	Same
Mass	17 g	Same
Dimensions	61 x 19 x 8 mm	Same

42 min. modes use data compression to increase storage time. Data sampled at 100 Hz is stored to memory at 50 Hz.

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Summary of Studies

The following studies were performed to ensure that the Reveal Plus ILR system meets all of its design and performance requirements.

In Vitro/Bench Testing

Mechanical, battery and package testing were not repeated because Reveal Plus uses a mechanical platform that is identical to the Reveal ILR system. To evaluate other aspects of the Reveal Plus ILR system, the following in vitro testing was completed:

Model 9526 implanted recorder testing (hybrid qualification testing and electromagnetic compatibility testing)

Model 6191 Activator testing.

The Reveal Plus ILR system passed all of the in vitro requirements.

In Vivo Testing

A canine study was performed to evaluate the auto-activation feature prior to human use. The false activations were evaluated before and after adjustments to the sensitivity setting.

Biocompatibility Information

Biocompatibility testing was not required because blood-contacting materials of the Reveal Plus ILR implanted device are the same as the predicate Reveal ILR.

Sterilization Validation

The Model 9526 implanted recorder is sterilized using a 100% Ethylene Oxide (EtO) sterilization process. The sterilization process is identical to that used for the Reveal model 9525 implanted recorder because all materials and packaging are identical to the Reveal ILR.

Conclusion

The testing described above provides reasonable assurance that the Reveal Plus ILR system will perform as intended when used in accordance with its labeling. Additionally, based on similarities in design, materials, in vitro test data and canine in vivo electrical performance, Medtronic considers the Reveal Plus ILR system to be substantially equivalent to the Reveal ILR system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2000

Ms. Nora K. Hadding Medtronic, Inc. 4000 Lexington Avenue North Shoreview, MN 55126-2983

Re : K994331 Reveal® Plus Insertable Loop Recorder System - Model 9526 Implanted Recorder and Model 6191 Patient Activator Requlatory Class: II (two) Product Code: 74 MXC December 21, 1999 Dated: Received: December 23, 1999

Dear Ms. Hadding:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Nora K. Hadding

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

foAuWintuhus fer

Celia M. Witten, Ph.D., M.D Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification for the Reveal Plus ILR System

Indications For Use

K994331

INDICATIONS FOR USE

510(k) Number (if known):	N/A K994331
Device Name:	Reveal® Plus Insertable Loop Recorder
Indications For Use:	The Medtronic Reveal Plus Insertable Loop Recorder is an implantable patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

L.A. Wetherhorn

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number.

Medtronic Confidential

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).