U-CLIP DEVICE

K062821 · Medtronic Neurosurgery · FZP · Dec 19, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062821
• Device Name: U-CLIP DEVICE
• Applicant: Medtronic Neurosurgery
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.

Device Story

U-CLIP is a self-closing implantable clip used for dura mater and prosthetic material approximation or attachment in neurosurgical procedures. Device consists of Nitinol wire coil surrounding Nitinol wire core, connected to surgical needles via flexible members. Design allows precise clip placement prior to closure; facilitates interrupted suture technique; eliminates knot tying. Used in endoscopic and non-endoscopic neurosurgery; operated by neurosurgeons. Provides mechanical tissue approximation equivalent to traditional non-absorbable sutures.

Clinical Evidence

In vivo testing confirmed the U-CLIP device is comparable to standard non-absorbable suture for dura approximation applications.

Technological Characteristics

Implantable clip manufactured from standard implantable grade Nitinol. Self-closing mechanism utilizing Nitinol wire coil and core. Dimensions/form factor include flexible members connected to surgical needles. Mechanical device; no energy source or software.

Indications for Use

Indicated for dura mater and prosthetic material approximation, attachment, or ligation during neurosurgical procedures. Contraindicated for tubal ligation.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• U-CLIP™ Device (K062057)
• U-CLIP™ Device (K053252)
• U-CLIP™ Device (K013664)

Reference Devices

• Ethicon, Polypropylene, PRONOVA Nonasbsorbable Suture (K001625)
• Surgilon/Polyamide Nonabsorbable Surgical Suture (K981582)

Submission Summary (Full Text)

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2006

## 5. 510(k) Summary

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Establishment Registration Number: | 2021898 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Address of Manufacturer: | Medtronic Neurosurgery<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] Phone<br>[phone] Facsimile |
| Contact Person: | Jeffrey Henderson |
| Date: | September 19, 2006 |
| Trade or Proprietary Name: | U-CLIPTM Device |

Common usual or Classification Name: Clip, Implantable 21CFR878.4300 (FZP)

Description: The U-CLIP™ Device is a self-closing clip for dura mater and prosthetic material approximation or attachment applications. The U-CLIP™ consists of a self-closing Nitinol clip connected to surgical needles via flexible members. The U-CLIP™ includes a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.

Intended Use: The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.

Contraindications: Do not use for tubal ligation.

Predicate Device Identification: The U-CLIP™ Device is substantially equivalent to the following predicate device:

- U-CLIP™ Device K062057, K053252, K013664 .
The predicate devices intended for tissue approximation have been cleared for neurological applications include:

- Ethicon, Polypropylene, PRONOVA Nonasbsorbable Suture K001625 .
- Surgilon/Polyamide Nonabsorbable Surgical Suture K981582 .

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Predicate Device Intended Use: The U-CLIP™ Device is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures.

K062821

Comparison to Predicate Device: Medtronic Neurosurgery submits that the device design, fabrication, packaging, specifications, and the fundamental scientific technology of the U-CLIP™ device is identical to the U-CLIP™ (K062057, K053252, and K013664). The specific neurosurgical indication is substantially equivalent to the Ethicon PRONOVA Nonabsorbable Suture (K001625) and the Surgilon/Polyamide Nonabsorbable Surgical Suture (K981582).

Test Data: In vivo testing confirmed that the U-CLIP Device is comparable to the predicate, standard non-absorbable suture, for dura approximation application.

Summary: Based upon the product technical information, intended use, in vitro, in vivo, and clinical performance information provided in this and previous pre-market notifications, the U-CLIP Device has been shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Neurosurgery % Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500

DEC 1 9 2006

Re: K062821

Trade/Device Name: U-CLIP™ Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 19, 2006 Received: November 8, 2006

Dear Mr. Henderson:

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 -- Mr. Jeffrey Henderson

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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours

Pur Pato V
Mark N. Melkerson

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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## 4. Indications for Use Statement

510(k) Number (if known): K062821

Device Name: U-CLIP™ Device

Indications for Use:

The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.

Prescription Use V (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, and Neurological Devices

510(k) Number. *K062821*