A127 LEAD EXTENSION by ADVANCED NEUROMODULATION SYSTEMS

The ANS® A127 Lead Extension is designed to be utilized as the lead extension component of a spinal cord stimulation system (SCS) and is indicated for spinal cord stimulation in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

Device Description

The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices: Micronet Axxess™ Lead Model 8000, 8100 and 8200 series Medtronic Pisces Quad® Lead Model 3487 Medtronic Pisces Quad® Plus Lead Model 3888 Medtronic Pisces Quad® Compact Lead Model 3887 Medtronic SpecifyTM Lead Model 3998 Medtronic Resume® II Lead Model 3587A ANS Renew® Receiver Model 3408 ANS Renew® Transmitter Model 3508

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the A127 Lead Extension models. It determines that the device is substantially equivalent to legally marketed predicate devices. This type of document does not contain the detailed study information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or expert qualifications that you've requested.

The letter explicitly states: "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)..."

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets them.

The document primarily focuses on the regulatory determination of substantial equivalence to predicate devices, rather than a detailed technical performance study against pre-defined acceptance criteria for a novel AI/software-as-a-medical-device (SaMD) product. The questions you've asked are typical for the evaluation of AI/ML-based medical devices or diagnostics, which this device (A127 Lead Extension for spinal cord stimulators) is not. It's a hardware component.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Rashmi Moza Regulatory Affairs Specialist Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024

Re: K030461

Trade/Device Name: A127 Lead Extension Models 2341, 2342, 2343 and 2346 Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 11, 2003 Received: February 12, 2003

Dear Ms. Moza:

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. Rashmi Moza

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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

h Mark n Millenn

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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510(k) Number:

Device Name: A127 Lead Extension

Indications for Use:

The A127 Lead Extension Models 2341, 2342, 2343 and 2346 are designed to be used with the following devices:

Micronet Axxess™ Lead Model 8000, 8100 and 8200 series Medtronic Pisces Quad® Lead Model 3487 Medtronic Pisces Quad® Plus Lead Model 3888 Medtronic Pisces Quad® Compact Lead Model 3887 Medtronic SpecifyTM Lead Model 3998 Medtronic Resume® II Lead Model 3587A ANS Renew® Receiver Model 3408 ANS Renew® Transmitter Model 3508

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use y (Per 21 CFR 801.109)

Over-The-Counter Use

h Mark N Milkers
Division Sign-Off

ion of General, Restorative and Neurological Devices

510(k) Number K030461

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).