Resume II Model 3587A and Resume TL Model 3986A are indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs. They are also indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

On-Point Model 3987A is indicated for Peripheral Nerve Stimulation. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

Device Description

Quadripolar implantable neurostimulation surgical leads with in-line connector.

AI/ML Overview

The provided document is a 510(k) summary for Medtronic In-Line Surgical Leads for Neurostimulation. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a clinical study for a novel device might.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy, or clinical outcomes) and then present corresponding device performance values against these criteria. Instead, it asserts substantial equivalence based on technological characteristics and indications for use matching predicate devices, and the results of "testing" which are not detailed.

Therefore, a table of acceptance criteria and reported device performance as typically expected for clinical efficacy/safety outcomes cannot be constructed from this document. The "criteria for acceptance" implicitly are that the technological characteristics and indications for use of the new devices are similar to the predicate devices, and that testing (which is not described in detail) supports their safety and effectiveness.

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 in the document. The document states "Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification," but the details of this data (including sample size, study design, or provenance) are not included in the summary. This appears to be a bench testing type of performance data and does not indicate human clinical trial data.

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 applicable/not provided. The document describes a comparison to predicate devices and general performance testing, not a study involving expert assessment of ground truth in a clinical context.

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

This information is not applicable/not provided. The assessment described is not a clinical study requiring adjudication of ground truth.

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 information is not applicable. This document describes medical device leads, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study related to human readers improving with AI is not relevant.

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

This information is not applicable. This document describes medical device leads, not an algorithm or AI system.

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

This information is not applicable/not provided. The document focuses on demonstrating substantial equivalence through technological characteristics and general performance testing, not on validating accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe a machine learning algorithm or a training set.

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

This information is not applicable/not provided. This document does not describe a machine learning algorithm or a training set.

Summary of what the document does convey regarding "acceptance criteria" and "study":

The "study" described is primarily a substantial equivalence comparison to predicate devices. The implicit "acceptance criteria" for regulatory clearance are that the proposed devices (Medtronic In-Line Surgical Leads) are substantially equivalent to the predicate devices (Resume II 3587A, Resume TL 3986, SymMix 3982, On-Point 3987A) in terms of:

Technological characteristics: The document states, "The technological characteristics of the proposed ILS leads for neurostimulation are substantially equivalent to the noted predicate devices."
Indications for Use: The indications for use for the new devices are explicitly listed and are identical or highly similar to those of the predicate devices.
Performance Data: The document states that "Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification." This performance data is not detailed in the summary, but it would typically consist of bench testing (e.g., mechanical strength, electrical properties, biocompatibility) to ensure the device meets engineering specifications and functions as intended, providing evidence for safety and effectiveness similar to the predicate devices. There is no indication of human clinical study data being used for this 510(k) submission.

In essence, the "study" is a substantiation of equivalence rather than a clinical trial demonstrating efficacy against pre-defined performance metrics.

Summary

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SEP. 11 2003

510(k) Summary Medtronic In-Line Surgical Leads for Neurostimulation (as required by 21 CFR 807.92)

K032561

Submitter Information A.

Submitter's Name:	Medtronic Neurological
Address:	710 Medtronic Parkway NEMinneapolis, Minnesota 55432.5604 U.S.A.
Telephone Number:	763.505.1465
Contact Person:	Lucy Tan
Date Submission Prepared:	August 19, 2003
B. Device Information
Device Trade Name:	In-Line Surgical Leads for Neurostimulation
Common or usual Name:	Spinal Cord Stimulation LeadPeripheral Nerve Stimulation Lead
Classification Name:	Spinal Cord Stimulators (21 CFR Part 882.5880)Peripheral Nerve Stimulators (21 CFR Part882.5870)
Classification Code:	GZB - Spinal Cord StimulatorsGZF - Peripheral Nerve Stimulators
Predicate Device:	Resume II 3587A – K904507Resume TL 3986 - K904507SymMix 3982 - K913993On-Point - K920567
Device Description:	Quadripolar implantable neurostimulation surgicalleads with in-line connector.
Indications for Use:	Resume II Model 3587A and Resume TL Model3986A are indicated for Spinal Cord Stimulationand Peripheral Nerve Stimulation to aid in themanagement of chronic intractable pain of the trunkand/or limbs. The peripheral nerve stimulators areused to stimulate electrically a peripheral nerve inpatients to relieve severe intractable pain.On-Point Model 3987A is indicated for PeripheralNerve Stimulation to aid in the management of

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chronic intractable pain of the trunk and/or limbs. The peripheral nerve stimulators are used to stimulate electrically a peripheral nerve in patients to relieve severe intractable pain.

SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management of chronic intractable pain of the trunk and/or limbs.

Comparison of Required Technological Characteristics C.

The technological characteristics of the proposed ILS leads for neurostimulation are substantially equivalent to the noted predicate devices.

Performance Data D.

Performance data that supports the safety and effectiveness of the ILS leads for neurostimulation are included in this 510(k) premarket notification.

E. Conclusion

Medtronic neurostimulation ILS leads (Resume II 3587A, Resume TL 3986A, SymMix 3982A, and On-Point 3987A) are substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, the identical indications for use and the results of the testing.

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health and Human Services, which is an abstract representation of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

Public Health Service

SEP 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lucy Tan, RAC Senior Regulatory Affairs Specialist Medtronic, Inc. 710 Medtronic Parkway Minneapolis, Minnesota 55432

Re: K032561

Trade/Device Name: Resume II Model 3587A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF

Trade/Device Name: Resume TL Model 3986A Regulation Number: 21 CFR 882.5880 and 21 CFR 882.5870 Regulation Name: Implanted spinal cord stimulator for pain relief and Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZB and GZF

Trade/Device Name: On-Point Model 3987A Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted peripheral nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZF

Trade/Device Name: SymMix Model 3982A Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB

Dated: August 19, 2003 Received: August 20, 2003

Dear Ms. Tan:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

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Page 2 - Ms. Lucy Tan, RAC

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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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); 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. This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

Enclosure

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Indications for Use Statement

Page 1

510(k) Number (if known): K032561

Device Name:	Resume II In-Line Surgical Lead
	Resume TL In-Line Surgical Lead
	SymMix In-Line Surgical Lead
	On-Point In-Line Surgical Lead

Indications for Use:

SymMix Model 3982A is indicated for Spinal Cord Stimulation to aid in the management 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)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K03256/

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).