The Medtronic Twist Lock Anchor, Part Number 103953 or Model 3550TLA, is indicated as an alternate anchor accessory for use with Spinal Cord Stimulation (SCS) Systems for the treatment of chronic intractable pain of the trunk or limbs. The Twist Lock Anchor is only for use with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads with an outside diameter of 1.27 mm. All other uses are contraindicated.

Device Description

The Medtronic Twist Lock Anchor is an implantable device. It is used with Spinal Cord Stimulation (SCS) systems for the treatment of chronic intractable pain of the trunk or limbs. The anchor is assembled from three parts: the driver and the shell which are made of polysulfone, and a stainless steel pin which is press fitted into the shell. The compression created by the fit of the driver within the shell grips the lead body outer jacket. The Medtronic Twist Lock Anchor can be used only with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads that require anchor sleeve and that have an outside diameter of 1.27 mm.

AI/ML Overview

The provided document describes the Medtronic Twist Lock Anchor, an implantable device used with Spinal Cord Stimulation (SCS) systems. The study presented is for the purpose of demonstrating substantial equivalence to a predicate device, as required for a 510(k) Pre-market Notification, rather than proving a novel device meets specific performance acceptance criteria from a clinical trial. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study details, training set size) is not applicable or not provided in this specific type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the "Twist Lock Anchor" in the format of a table as it's a submission for substantial equivalence to a predicate device, not a de novo device requiring new performance benchmarks. Instead, it aims to show equivalence in key performance aspects to an existing device. The performance is described qualitatively as "equivalent" or "substantially equivalent" to the predicate.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Function	Equivalent to the current silicone rubber anchor	Same function as the current silicone rubber anchor
Intended Use	Equivalent to the current silicone rubber anchor	Same intended use as the current silicone rubber anchor
Gripping Method	Equivalent to the current silicone rubber anchor (compression based)	Grips using compression, equivalent to silicone rubber anchor
Gripping Strength	Substantially equivalent to the current silicone rubber anchor	Breakaway load equivalent to the current silicone rubber anchor
Flex Characteristics	Equivalent to the lead body gripped by the current silicone anchor	Lead body while gripped has equivalent flex characteristics
Tissue Securement	Equivalent to the current silicone rubber anchor (sutures)	Secured by sutures, same as current silicone rubber anchor

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

The document mentions "Flex testing" and "Pull testing" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated but would typically be generated in-house by Medtronic as part of their device development and testing. It represents retrospective engineering test data, not prospective clinical data from specific countries.

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

This information is not applicable as the "test set" here refers to engineering performance tests (flex and pull testing) on the device itself, not a diagnostic or clinical test where expert ground truth would be established from patient data.

4. Adjudication Method for the Test Set

This is not applicable for engineering performance tests. Adjudication methods (like 2+1) are typically used for clinical endpoints or diagnostic interpretations involving human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in this document. This submission focuses on demonstrating substantial equivalence of a physical medical device (an anchor) rather than evaluating the diagnostic or interpretive accuracy of an AI algorithm in a clinical setting with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is an implantable mechanical anchor, not an algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for the performance tests (flex and pull) would be the measured physical properties and mechanical performance of the device under test conditions, directly compared to the measured performance of the predicate device. It's based on engineering specifications and test protocols, not expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

This is not applicable. The device is a mechanical anchor, not a machine learning algorithm that requires a "training set."

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

This is not applicable as there is no training set for a mechanical device.

Summary

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Medtronic &

FFB - 6 199

Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 800-328-0810 (612) 572-5078

SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTER I.

Name and Address;

Medtronic, Inc. 830 53rd Avenue N.E. Minneapolis, MN 55421

Contact Person:

Lisa L. Pritchard

October 8, 1997

Establishment Registration Number: 2182207

II. DEVICE NAME

Device Common or Usual Name:

Date of Summary Preparation:

Device Trade Name

Device Classification Name:

Lead Accessory (Anchor) for Implanted Spinal Cord

Stimulation

Medtronic Twist Lock Anchor

Implanted Spinal Cord Stimulator for Pain Relief (21 CFR 882.5880)

III. PREDICATE DEVICE

Medtronic Lead Anchor Accessory Model 3550-01

IV. DEVICE DESCRIPTION

The Medtronic Twist Lock Anchor is an implantable device. It is used with Spinal Cord Stimulation (SCS) systems for the treatment of chronic intractable pain of the trunk or limbs.

The anchor is assembled from three parts: the driver and the shell which are made of polysulfone, and a stainless steel pin which is press fitted into the shell. The compression created by the fit of the driver within the shell grips the lead body outer jacket.

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Image /page/1/Picture/0 description: The image shows the word "Medtronic" in bold, black font. To the right of the word is a logo of a square with a design inside. The design inside the square is a diamond shape with a smaller diamond shape inside of it.

ત્તર

Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078

The Medtronic Twist Lock Anchor can be used only with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads that require anchor sleeve and that have an outside diameter of 1.27 mm.

INDICATIONS FOR USE V.

The Medtronic Twist Lock Anchor is indicated as an alternate anchor accessory for use with Spinal Cord Stimulation (SCS) Systems for the treatment of chronic intractable pain of the trunk or limbs. The Twist Lock Anchor can be used only with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads with an outside diameter of 1.27 mm. All other uses are contraindicated.

VI. COMPARISON TO PREDICATE DEVICES

Function and Intended Use તે.

The Medtronic Twist Lock Anchor has the same function and intended use as the current silicone rubber anchor. The Medtronic Twist Lock Anchor and the current silicone rubber anchor are indicated for use as alternate spinal cord stimulation lead accessories for use in the treatment of chronic intractable pain of the trunk or limbs. Both are used with spinal cord stimulation leads with an outer diameter of 1.27 mm.

Gripping Method and Strength b.

Both the current silicone rubber anchor and the Twist Lock Anchor grip using compression. The gripping strength of the current silicone rubber anchor and the Twist Lock Anchor are substantially equivalent.

Recommended Anatomical Placement and Anchoring Site C.

Both the current silicone rubber anchor and the Medtronic Twist Lock Anchor are placed as close as possible to where the lead emerges from the deep fascia. Both have a recommended anchoring site of the supraspinous ligament or deep fascia.

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Medtronic Neurological 800 53rd Avenue NE P.O. Box 1250 Minneapolis, MN 55440-9087 (612) 572-5000 1-800-328-0810 FAX: (612) 572-5078

d. Tissue Securement

The current silicone rubber anchor and the Medtronic Twist Lock Anchor are secured by sutures.

Performance Testing e.

Medtronic, Inc. has provided descriptive data on the test plan and test results for the Twist Lock Anchor. These data support that the function and characteristics of the device are suitable for its intended use.

Flex testing was performed which demonstrated that the lead body, while gripped by the anchor, has equivalent flex characteristics as the lead body gripped by the current silicone anchor.

Pull testing was performed that demonstrated the breakaway load of the Twist Lock Anchor is equivalent to the current silicone rubber anchor.

In summary, Medtronic, Inc. has provided information within the 510(k) Premarket Notification to indicate that the Twist Lock anchor is safe and effective for its intended use as an alternate neurological lead accessory in the treatment of chronic intractable pain of the trunk and limbs. Additionally, the Twist Lock Anchor has been shown to be comparable in terms of intended use and technological characteristics to the silicone rubber anchor currently in commercial distribution. The data and information provided within the 510(k) Premarket Notification adequately support that the Twist Lock Anchor is substantially equivalent to the silicone rubber anchor currently in commercial distribution.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Ms. Lisa L. Pritchard ·Senior Product Regulation Manager Medtronic, Inc. 800 53rd Avenue NE P.O. Box 1250 55440-9087 Minneapolis, Minnesota

K972906 Re: Medtronic Twist Lock Anchor [Part 103963, or Model 3550TLA] Regulatory Class: II Product Code: GZB December 30, 1997 Dated: Received: December 31, 1997

Dear Ms. Pritchard:

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, Drug, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

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This letter will allow you to begin 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 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) 594-4659. 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 ene rogalation Chousen, (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,

Celia M. Witten, Ph.D.

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

Enclosure

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510(k) Number (if known)

Twist Lock Anchor 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)

e Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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).