MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER by MEDTRONIC VASCULAR

Model 3273/3274 Receiver and Model 3629/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.

Device Description

Using a commercially available Medtronic Spinal Cord Stimulation Radiofrequency (RF) Transmitter to provide the appropriate RF signal, the Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will provide an electrical signal to three (3) of the four electrodes (with no signal, or "open", supplied to the fourth electrode). The Model 3273/3274 Receiver, when connected to a commercially available Medtronic quadrapolar lead, will have the ability to reduce the stimulation (voltage) of one of two electrode anodes (related to the cathode), ranging from the programmed stimulation parameter of the other anode to zero. This will allow the physician and patient to customize or balance the stimulation to optimally control pain. The Model 3629/3630 Screener is connected to the (temporary) percutaneous extension of a commercially available lead and to a commercially available Medtronic Model 3210 Transmitter for the screening period. This is the same procedure used with commercially available Medtronic Model 3627 Screener. The Model 3629/3630 Screener is basically a "receiver in a box" (the same circuitry of the Model 3273/3274 Receiver is used), so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener. The Model 3273 or 3274 receiver is implanted subcutaneously, and connected to a quadrapolar stimulation lead. The Model 3629 or 3630 screener is outside the patient, and used for a period of days to deliver pulses from a Model 3210 transmitter to percutaneous wires of a quadrapolar lead.

AI/ML Overview

The provided document, a 510(k) notification for the Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener, focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria. Therefore, several of the requested sections (e.g., sample size, expert qualifications, adjudication method, MRMC study, ground truth for training) are not applicable or cannot be extracted from this document.

However, based on the information provided, here's a breakdown of what can be inferred and what is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Receives appropriate RF signal from Medtronic Spinal Cord Stimulation RF Transmitter	"receive signals transmitted from a Model 3210 transmitter and antenna"	Demonstrated through electrical and functional tests.
Provides electrical signal to three (3) of four electrodes of a quadrapolar lead	"provide an electrical signal to three (3) of the four electrodes (with no signal, or 'open', supplied to the fourth electrode)"	Core function, demonstrated through electrical and functional tests.
Ability to reduce stimulation of one of two electrode anodes (related to the cathode) from programmed parameter to zero	"have the ability to reduce the stimulation (voltage) of one of two electrode anodes (related to the cathode), ranging from the programmed stimulation parameter of the other anode to zero."	Core functionality for customizability, demonstrated through electrical and functional tests.
Satisfactorily delivers electrical pulses to the lead	"perform satisfactorily in this environment by delivering electrical pulses to the lead."	Demonstrated through electrical and functional tests.
Screener replicates stimulation parameters and characteristics of the receiver	"the same circuitry of the Model 3273/3274 Receiver is used, so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener."	Stated as a design principle, implying successful replication through shared circuitry.
Screener performs satisfactorily outside patient with percutaneous wires of a quadrapolar lead	"perform satisfactorily in this environment."	Demonstrated through electrical and functional tests.
Mechanical, physical, and environmental characteristics are identical to predicate devices	"Mechanical, physical and environmental characteristics of these components were not tested, because they should be identical to those of commercially available predicate devices."	Assumed based on substantial equivalence claim; no specific testing reported for these characteristics.

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

Sample Size: The document states, "Sufficient samples were built and tested with electrical and functional tests." However, it does not specify the numerical sample size used for testing either the Model 3273/3274 Receiver or the Model 3629/3630 Screener.
Data Provenance: Not explicitly stated. Given it's a 510(k) for a device manufactured by Medtronic, it's highly likely the testing was conducted internally or by a contracted lab, presumably in the USA where Medtronic is based. The data would be prospective as it involves the testing of newly built devices.

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

This information is not applicable and not provided in the document. The document describes engineering and functional tests, not an assessment requiring expert ground truth in the context of diagnostic or interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used to assess the effectiveness of a diagnostic tool or intervention with and without AI assistance on human readers, which is not the purpose of this 510(k) submission.

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

Yes, in a sense, a standalone assessment was performed. The device's performance was evaluated through electrical and functional tests without human intervention as part of its operational loop. The tests assessed the device's ability to receive signals, deliver electrical pulses, and modulate stimulation as designed.

7. The Type of Ground Truth Used

The "ground truth" for the functional and electrical tests described was based on engineering specifications and design requirements. The devices were tested against their intended functionality (e.g., receiving signals, delivering pulses, modulating voltage to specific ranges) as defined by Medtronic's design and engineering standards for an RF receiver and screener.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. These are hardware devices, not AI algorithms that require a "training set" in the conventional sense. The "training" of the device is its manufacturing process according to design specifications.

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

This information is not applicable and not provided in the document. As stated above, these are hardware devices, not AI models with a training set and associated ground truth.

Summary

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Medtronic &

eapolis MN 55440-9087 FAX: (612) 572-5078

AUG 22 1097

May 30, 1997

510(k) Notification: Medtronic Model 3273/3274 RF Receiver and Model RE: 3629/3630 Screener

In order to comply with the Safe Medical Devices Act of 1990, these two pages will provide safety and effectiveness information to interested persons.

SUMMARY OF SAFETY AND EFFECTIVENESS

Summary Information

The Model 3272/3274 Receiver is substantially equivalent to the Model 3271/3272 Receiver (K934065), Model 3470 Receiver (K904409A), the Model 3462B RF Receiver (K823130), and other commercially available RF receivers.

The Model 3629/3630 Screener is connected to the (temporary) percutaneous extension of a commercially available lead and to a commercially available Medtronic Model 3210 Transmitter for the screening period. This is the same procedure used with commercially available Medtronic Model 3627 Screener. The Model 3629/3630 Screener is basically a "receiver in a box" (the same circuitry of the Model 3273/3274 Receiver is used), so that the stimulation parameters and characteristics of the Model 3273/3274 Receiver are replicated by the screener.

The Model 3273 or 3274 receiver is implanted subcutaneously, and connected to a quadrapolar stimulation lead. Sufficient samples were built and tested with electrical and functional tests to assure that they will receive signals transmitted from a Model 3210 transmitter and antenna, and perform satisfactorily in this environment by delivering electrical pulses to the lead.

The Model 3629 or 3630 screener is outside the patient, and used for a period of days to deliver pulses from a Model 3210 transmitter to percutaneous wires of a quadrapolar lead. Sufficient samples were built and tested with electrical and functional tests to assure that they will perform satisfactorily in this environment.

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Mechanical, physical and environmental characteristics of these components were not tested, because they should be identical to those of commercially available predicate devices.

The Model 3629/3630 Screener is substantially equivalent to the Model 3625 Screener (K903690B), Model 3627 Screener (K934065), and other commercially available screeners.

Therefore, these devices are substantially equivalent to current Medtronic spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) systems.

Sincerely,

MEDTRONIC, INC. Neurological Division

David Hufchelle

David H. Mueller Regulatory Affairs Manager Neurostimulation Business

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Public Health Service

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AUG 222 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David H. Mueller Requlatory Affairs Manager Neurostimulation Business Medtronic Neuroloqical 800 53rd Avenue NF: Minneapolis, Minnesota 55440

Re: K972043 Trade Name: Model 3273/3274 Receiver and Model 3629/3630 Screener Requlatory Class: II (two) Product Code: 84GZB & 84GZF Dated: May 30, 1997 Received: June 2, 1997

Dear Mr. Mueller:

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 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 against 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.

This letter will allow you to beqin 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

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Page 2 - Mr. David H. Mueller

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 regulation (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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K972043

Device Name: Model 3273/3274 Receiver and Model 3629/3630 Screener

Indications For Use: Model 3273/3274 Receiver and Model 3629/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahan

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

.... Prescription Use X - (Per 21 CFR 801.109) . ... . . ..... OR... Over-The-Counter Use _

Optional Format 1-2-

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Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).