The Medtronic Pisces Z Quad® Model 3890, Pisces Z Quad Compact™ Model 3891, and Pisces Z Quad Plus® Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

Device Description

The function of the Medtronic Mattrix and X-trel® Neurostimulation Systems is accomplished with a power source, extension (for X-trel only) and lead (electrode). The power source generates and controls the stimulation, which is delivered to the spinal cord via electrodes at the end of the lead.

The Models 3890, 3891 and 3892 Leads are lower impedance percutaneous quadripolar, implantable leads. The proximal end provides in-line fourconductor contacts that connect to the Mattrix receiver or Medtronic extension (which connects to the X-trel receiver). The proximal ends and lead bodies of all three leads are identical. Each lead model has four platinum iridium electrodes on the distal end but with variable electrode length and spacing. The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively. A radio-opaque marker band at the tip of the Model 3892 Lead enhances identification when viewed in fluoroscopy. The Models 3890, 3891 and 3892 Leads are available in lengths from 10 cm to 100 cm. The Medtronic Models 3890, 3891, and 3892 Leads are packaged, sterilized, and labeled for single use only (disposable).

AI/ML Overview

This document is a 510(k) premarket notification for Medtronic Models 3890, 3891, and 3892 Leads, which are spinal cord stimulator leads. The information provided heavily focuses on regulatory aspects and substantial equivalence to predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not present in the provided text. The document primarily establishes that the new devices are substantially equivalent to previously cleared devices (Models 3487A, 3887, and 3888 Leads). This substantial equivalence is based on similar design, materials, and intended use.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not present in the provided document. The submission is a 510(k) for substantial equivalence, not a clinical trial report with performance metrics against predefined acceptance criteria. The document states that the electrode spacing and electrode lengths of the new models are "identical to the current Models 3487A, 3887, 3888 Leads, respectively," implying that their performance is expected to be similar to these predicate devices.

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 present. No "test set" in the context of a clinical performance study is described. The 510(k) submission relies on comparison to predicate devices, not on new clinical data demonstrating performance against specific criteria.

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 present. Ground truth for a test set is not discussed as no such performance study is described.

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

This information is not present. Adjudication methods are relevant for studies involving human interpretation or subjective endpoints, which are not described here.

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 present. This device is a medical lead for spinal cord stimulation, not an AI-powered diagnostic tool, so an MRMC study and AI assistance are not applicable.

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

This information is not present. As this is not an algorithm or AI-based device, standalone performance as described is not relevant.

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

This information is not present. No specific ground truth determination is mentioned as a formal performance assessment is not part of this 510(k) submission. Substantial equivalence is based on comparison to existing, legally marketed devices.

8. The sample size for the training set

This information is not present. No training set is described as this is not an AI/machine learning device.

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

This information is not present. No training set or associated ground truth establishment is described.

Summary of available information related to equivalence/performance:

The document focuses on establishing substantial equivalence to predicate devices. The key argument for this equivalence is based on the following:

Identical Electrode Design: "The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively."
Similar Components: "The proximal ends and lead bodies of all three leads are identical."
Intended Use: The indications for use for the new leads are presented as an 'aid in the management of chronic, intractable pain of the trunk and/or limbs,' which is typically consistent with the indications for predicate spinal cord stimulator leads.

Essentially, the "study" that "proves" the device meets any implied "acceptance criteria" (which would be related to safety and effectiveness) is the demonstration of substantial equivalence to predicate devices already on the market and deemed safe and effective. This is the standard pathway for 510(k) clearances. No de novo clinical performance study is described in this document.

Summary

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OCT 3 0 2003

K033016
10F2

510(k) Summary Medtronic Models 3890, 3891, and 3892 Leads

A. General Provisions

Submitter's Name:	Medtronic, Inc.
Submitter's Address:	Sullivan Lake Facility800 53rd Avenue NortheastColumbia Heights, MN 55421
Contact Person:	Pam SchaubPrincipal Regulatory Affairs Specialist
Classification Name:	Implanted Spinal Cord Stimulator for PainRelief21 CFR Section 882.5880
Common or usual Name:	N/A
Proprietary Names:	Pisces Z Quad® Model 3890 Lead,Pisces Z Quad Compact™ Model 3891 Lead,Pisces Z Quad Plus® Model 3892 Lead

B. Name of Predicate Devices

Medtronic Neurological	Models 3487A and 3887 Leads	K923931
Medtronic Neurological	Model 3888 Lead	K923567

C. Device Description

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and commitment to public health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2003

Pam Schaub Principal Regulatory Affairs Specialist 710 Medtronic Parkway NE Minneapolis, Minnesota 55432-5604

Re: K033016

Trade/Device Name: Models 3890, 3891 and 3892 Leads Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: September 25, 2003 Received: September 26, 2003

Dear Ms. Schaub:

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

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Page 2 - Ms. Pam Schaub

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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

fo Mark N Wilkerson

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

510(k) Number (if known):	K033016
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Medtronic Models 3890, 3891, and 3892 Leads Device Name:

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Mark N. Millerson

sion Sign-Off) Division of General, Restorative and Neurological Dev

್ 10(k) Number_

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).