The patient magnet is used to close the reed switch of a pulse generator when held above the reed switch, 1 inch from the generator's surface, and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.

Device Description

The patient magnet is used daily to check that the pulse generator battery is working. When you pass or hold the magnet over the pulse generator, a reed switch inside the pulse generator closes like a gate. When the magnet closes the switch, the normal signal (stimulation) cannot pass, and the pulse generator is temporarily turned OFF. When the magnet is removed, the switch (gate) opens immediately, and the pulse generator is turned back ON and can stimulate again.

The patient magnets are made from Neodymium grade 35 (NdFeB-35) and the entire surface of the magnet is coated with either polypropylene copolymer. The magnet is 1.48 in. x 0.195 in; 50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface. Also supplied with Patient Magnet, are a watchband and a belt-clip that allows that patient to wear the magnet on the wrist like a watch or clipped on belt like a pager for easy deployment.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Cyberonics Patient Magnet:

Acceptance Criteria and Device Performance (Based on Intended Use):

Acceptance Criteria (from Intended Use)	Reported Device Performance
Able to close the reed switch of a pulse generator.	The device description states, "When you pass or hold the magnet over the pulse generator, a reed switch inside the pulse generator closes like a gate."
When held 1 inch from the generator's surface.	The device description states the magnet has a "50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface," which directly relates to its ability to perform its intended function at this distance.
Oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.	The intended use specifies this operational orientation. While not explicitly detailed as a performance outcome, the overall device description suggests it functions as intended under these conditions.

Study Information:

The provided document (K092364) is a 510(k) summary for a Class I medical device (Cyberonics Patient Magnet). For Class I devices, particularly those that are substantially equivalent to existing predicate devices, a formal clinical study with detailed performance metrics and ground truth establishment is typically not required or presented in the 510(k) summary.

The primary method for demonstrating safety and effectiveness for such devices is through substantial equivalence to a predicate device, as highlighted in the document. This relies on demonstrating that the new device has the same intended use and similar technological characteristics (e.g., materials, magnetic properties) as a legally marketed predicate device.

Therefore, many of the specific questions regarding a clinical study (sample size, experts, adjudication, MRMC, standalone performance, ground truth for training/test sets) are not applicable or not detailed in this type of regulatory submission.

Here's how to address the specific points based on the available information:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. The document does not describe a formal clinical test set or study with explicit sample sizes. The claim of performance is based on the device's physical specifications and its substantial equivalence to a predicate device.
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):
- Not Applicable / Not Provided. There is no indication of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No test set or expert assessment is described.
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:
- No. This is not an AI-enabled device. The document describes a simple patient magnet.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device. Performance is inherent to the physical properties of the magnet.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. Ground truth is not established through these means for this type of device. The "ground truth" for this device's function is its physical ability to generate a sufficient magnetic field to close a reed switch as specified.
8. The sample size for the training set:
- Not Applicable / Not Provided. There is no training set for this device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. There is no training set for this device.

Summary of Approach (Implied by 510(k) Summary):

The device's performance regarding its ability to close a reed switch at a specific distance and orientation is a direct consequence of its physical design (material, dimensions, stated magnetic flux density). For a Class I device like a patient magnet, the "proof" it meets acceptance criteria (its intended use) comes from:

Engineering specifications and measurements: The stated "50 gauss (G) minimum magnetic flux density at a distance of 1 inch from its surface" is a key performance metric that demonstrates its capability.
Substantial Equivalence: The primary regulatory pathway for this device, which relies on demonstrating the new device is as safe and effective as a legally marketed predicate device (Pacesetter Systems, Pacemaker Test Magnet - K813153) that performs the same function. This implies that the predicate device has already demonstrated its safety and effectiveness for this function.

In essence, for this specific device, the "study" is the inherent engineering design and the comparison to an already approved equivalent product, rather than a clinical trial or AI validation study.

Summary

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K092364

510(k) SUMMARY

Submitted by:	Karen Stueber, Domestic Regulatory SpecialistCyberonics, Inc.100 Cyberonics Blvd.Houston TX 77058Tel: 281-228-7287 Fax: 281-853-2587Email: karen.stueber@cyberonics.com	NOV - 3 2009
Date of Summary:	July 31, 2009
Trade Name:	Cyberonics Patient Magnet, Models 220-3 & 220-4Cyberonics Block Magnet, Model 220-1Cyberonics Horseshoe Magnet, Model 220-2
Common/Usual Name:	Patient Magnet

Classification Name: Regulation Number: Devices Class: Product Code:

Pacemaker Test Magnet 21 CFR 870.3690 Class I DTG

Intended Use:

The patient magnets shall be able to close the reed switch of a pulse generator when held above the reed switch, 1 inch from the generator's surface and oriented with the magnet's axis parallel to the longitudinal axis of the reed switch.

Predicate Devices:

Pacesetter Systems, Pacemaker Test Magnet (K813153)

Substantial Equivalence:

The Model 220 Patient Magnet is similar with respect to intended use and materials to the above 510(k) cleared predicate device.

Device Description

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, positioned to the right of a circular emblem. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV - 3 2009

Cyberonics, Inc. c/o Ms. Karen B. Stueber Domestic Regulatory Specialist 100 Cyberonics Road Houston, TX 77058

Re: K092364

Trade/Device Name: Model 220, Patient Magnet Regulation Number: 21 CFR 870.3690 Regulation Name: Patient Magnet Regulatory Class: Class I Product Code: DTG Dated: August 03, 2009 Received: August 05, 2009

Dear Ms. Stueber:

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.

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.

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Page 2 - Ms. Karen B. Stueber

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
W. Mac A.

Bram Zuckerman, MD 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): K092364

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	Page 1 of 1
Division of Cardiovascular Devices
510(k) Number	K092364

Regulation Number and Section

§ 870.3690 Pacemaker test magnet.

(a)
Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.