The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back; .
Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed . Back Syndrome;
. Post Laminectomy Pain;
◆ Unsuccessful Disk Surgery;
. Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
. Peripheral Causalgia;
. Epidural Fibrosis;
Arachnoiditis or Lumbar Adhesive Arachnoiditis; ◆
Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) . or Causalgia; and,
Multiple Back Surgeries .

Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

Device Description

The Model 3875 1 x 8 SC is a test stimulation lead with accessories included in the kit. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and to an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.

AI/ML Overview

The provided text, K062041, is a 510(k) summary for a medical device (Medtronic Model 3875 1 x 8 SC Test Stimulation Lead). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance metrics in the way a diagnostic AI device submission might.

Therefore, many of the requested sections about study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or cannot be extracted from this type of regulatory submission. The document relies on in vitro testing and material equivalence, not clinical performance studies with human subjects.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) because it's for a physical medical device (a neurostimulation lead) and not a diagnostic algorithm. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices through in vitro testing and material composition.

The "performance" is implicitly deemed acceptable if it meets the prior in vitro testing standards of the predicate devices.

Acceptance Criteria Type	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Mechanical/Electrical	Equivalent to predicate devices (Model 3873 & 3874) as demonstrated by previously performed in vitro testing.	Previously performed in vitro testing on the design of Model 3875 1 x 8 SC was deemed sufficient; repeat testing unnecessary.
Sterilization	Utilize the same 100% Ethylene Oxide (EtO) sterilization process as predicate devices and remain STERILE.	The device uses the same 100% EtO sterilization process as predicate devices. Labeled STERILE.
Biocompatibility	Materials are identical to predicate devices and assessed consistent with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."	All materials are identical to predicate devices (Models 3873 and 3874) and were found to be biocompatible and in compliance with ISO 10993-1.
Intended Use	Same as predicate devices.	Intended use and indications are the same as predicate devices.

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

Not applicable for this type of submission. The "test set" here refers to in vitro testing of the device itself (mechanical, electrical properties, etc.), not a clinical dataset of patients. The document does not specify sample sizes for these in vitro tests but refers to prior reports (07TR.020 and NDHF1174-90920). Data provenance is from internal in vitro testing by Medtronic.

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

Not applicable. This device does not have a "ground truth" established by clinical experts in the context of diagnostic accuracy. Its performance is assessed against engineering and material specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the clinical sense for this device's submission. Performance is based on meeting engineering and material standards.

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

Not applicable. This is not an AI or diagnostic imaging device that involves human readers or comparative effectiveness studies of AI assistance.

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

Not applicable. This is a physical neurostimulation lead, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's submission is based on:

Engineering specifications and standards: Ensuring the device meets design requirements for its intended physical function.
Material composition data: Verification that materials are identical to previously approved biocompatible materials used in predicate devices.
Sterilization validation: Confirmation that the sterilization process achieves the required sterility assurance level.

These are not clinical "ground truths" like pathology or expert consensus on patient outcomes/diagnoses.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an algorithm that requires a training set.

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

Not applicable.

Summary

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K062041

Appendix A: 510(K) Summary

Submitter

Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432

AUG 16 2006

Contact:	Paula Cordero, Senior Regulatory Affairs Specialist
Telephone:	(763) 505-0238
Fax:	(763) 505-0258
E-Mail:	paula.cordero@medtronic.com
Date Prepared:	July 18th, 2006

Name of Device

Trade Name:	Medtronic Model 3875 1 x 8 SC Test Stimulation Lead
Common Name:	Neurostimulation Trialing Lead
Classification:	Class II
Product Code:	GZB

Predicate Devices

The predicate devices for the Medtronic Model 3875 1 x 8 SC Test Stimulation Lead are the currently available Model 3873 1 x 8 Test Stimulation Lead and Model 3874 1 x 8 Compact Test Stimulation Lead.

Device Description

Intended Use

The intended use and indications of the modified device, Model 3875 1 x 8 SC Test Stimulation Lead, as described in the labeling, are the same as the intended use and indications for Medtronic's unmodified predicate devices.

The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back;
Image /page/0/Picture/18 description: The image contains the Medtronic logo and the word "Confidential" below it. The Medtronic logo is a stylized image of a person reaching for the sky. The word "Medtronic" is in a bold, sans-serif font. The word "Confidential" is in a smaller, sans-serif font.

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Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to . Failed Back Syndrome:
. Post Laminectomy Pain:
. Unsuccessful Disk Surgery:
Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative . and surgical interventions;
. Peripheral Causalgia;
. Epidural Fibrosis;
Arachnoiditis or Lumbar Adhesive Arachnoiditis; ●
Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy . (RSD) or Causalgia; and,
. Multiple Back Surgeries

Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead Kit is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

Summary of Studies

In Vitro testing on the design of the Model 3875 1 x 8 SC has been previously performed and repeat testing was not deemed necessary to support equivalence to the predicate devices. This is documented for the Model 3875 1 x 8 SC Test. Stimulation Lead in report 07TR.020 and report NDHF1174-90920, which are located in Appendix E and Appendix G respectively, and in the design history file, NDHF1174.

Sterilization

The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead Kit is labeled STERILE. The Model 3875 1 x 8 SC Test Stimulation Lead Kits will be sterilized using the same 100% Ethylene Oxide (EtO) sterilization wrocess as the predicate devices.

Biocompatibility

All materials used in the Model 3875 1 x 8 SC Test Stimulation Lead Kit are identical to the materials used in the predicate devices, Models 3873 and 3874 Test Stimulation Leads, and additional biocompatibility testing was not 50% of necessary for the Model 3875 1 x 8 SC Test Stimulation Lead and accessory components. All device materials / components were assessed for biocompatibility consistent with ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for the predicate devices. All materials were found to be biocompatible and in compliance to ISO 10993-1

Image /page/1/Picture/18 description: The image contains the Medtronic logo, which includes a stylized human figure with outstretched arms. Next to the logo, the word "Medtronic" is written in bold, sans-serif font. Below the company name, the word "Confidential" is written in a smaller, regular font.

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Conclusion

Through data and information presented, as well as similarity to legally marketed devices, Medtronic, Inc. considers the Model 3875 1 x 8 SC Test Stimulation Lead Kit to be substantially equivalent to the legally marketed predicate devices.

Image /page/2/Picture/4 description: The image shows the Medtronic logo with the word "Confidential" underneath. The Medtronic logo consists of a stylized image of a person running with a baton, followed by the word "Medtronic" in bold, sans-serif font. The word "Confidential" is written in a smaller, sans-serif font.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of four stylized human figures connected at the base, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2006

Ms. Paula Cordero Senior Regulatory Affairs Specialist Medtronic, Inc 710 Medtronic Parkway Minneapolis, Minnesota 55604

Re: K062041

Trade/Device Name: Medtronic® 3875 1 × 8 SC Test Stimulation Lead Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: Class II Product Code: GZB Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Cordero

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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Paula Cordero

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Milburn

Mark N. Melkerson 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 ব

510(k) Number (if known): K_06204 |

Device Name: Medtronic® Model 3875 1 x 8 SC Test Stimulation Lead

Indications For Use: The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back; .
Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed . Back Syndrome;
. Post Laminectomy Pain;
◆ Unsuccessful Disk Surgery;
. Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
. Peripheral Causalgia;
. Epidural Fibrosis;
Arachnoiditis or Lumbar Adhesive Arachnoiditis; ◆
Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) . or Causalgia; and,
Multiple Back Surgeries .

Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General. Restorative

Page 1 of 1

Neurological Devices

$\qquad K0(L_{0})(r)$

Confidential

July 2006

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).