U-CLIP DEVICE, MODEL NC65

K062057 · Medtronic Vascular · FZP · Aug 2, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062057
• Device Name: U-CLIP DEVICE, MODEL NC65
• Applicant: Medtronic Vascular
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical U-CLIP™ 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; including cardiovascular and coronary artery bypass grafting procedures; including use in cardiovascular and coronary artery bypass grafting procedures.

Device Story

U-CLIP is a self-closing implantable Nitinol clip used for tissue/prosthetic approximation and vascular anastomosis. Device consists of a Nitinol clip constrained in an open position within a stainless steel hypotube. Surgeon places clip at target site; clip is released from a side slot in the hypotube to close. Used in endoscopic and non-endoscopic procedures, including cardiovascular and coronary artery bypass grafting. Facilitates interrupted suture technique. Benefits include precise placement prior to closure. Operated by surgeons in clinical settings.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functional characteristics, including clip strength and deployment angle, met documented product and performance specifications.

Technological Characteristics

Implantable Nitinol clip; stainless steel hypotube delivery system. Self-closing mechanism. Side-slot release design. Non-powered, mechanical device.

Indications for Use

Indicated for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation, attachment, or ligation, and creation of anastomosis in blood vessels, grafts, and tubular structures, including cardiovascular and coronary artery bypass grafting. 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

• Coalescent Surgical U-CLIP (K031623)
• K024366
• K060400
• K023125
• K021407
• K013664
• K012317
• K994160
• K971588

Submission Summary (Full Text)

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AUG 0 2 2006

## 510(k) SUMMARY of Safety and Effectiveness

## Applicant Information: 1.

| Date Prepared: | July 19, 2006 |
|-----------------------------------|-----------------------------------------------------------------------|
| Submitter: | Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NE<br>Minneapolis, MN 55432-5604 |
| Establishment<br>Registration No. | 2135394 |
| Contact Person: | David D. Cox, Ph.D.<br>Senior Principal Regulatory Affairs Specialist |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

## II. Device Information:

| Trade Name: | U-CLIPTM |
|--------------|------------------|
| Common Name: | Implantable clip |

| Classification Name: | Clip, Implantable |
|----------------------|---------------------------|
| Classification: | Class II, 21 CFR 878.4300 |
| Product Code: | FZP |

Coalescent Surgical U-CLIP™ Predicate Device: 510(k) No. K031623, Reg. No. 878.4300; Product Code: FZP

> Device Intended Use: The Surgical U-CLIP™ 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; including cardiovascular and coronary artery bypass grafting procedures; including use in cardiovascular and coronary artery bypass grafting procedures.

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The U-CLIP™ device is a self-closing clip for anastomosis and Device Description: tissue and prosthetic material approximation or attachment tissue and prostheat Thatehar approximation of a applications.
self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after a stainless otoor rijpostared from a slot in the side of the placement. This design allows precise placement of clips prior hypotabo. "This dolly": and interrupted "suture" technique by to closure, and faciliated the device is manufactured with a standard implantable grade of Nitinol.

- The U-CLIP™ Device is intended for endoscopic and non-Intended Use: endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of approximation/attachmont-ensels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Do not use for tubal ligation. Contraindications:

Comparison to

1999 - 1999

:

The U-CLIP™ device is substantially equivalent to the U-CLIP" Predicate Device(s): devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application. The new clip utilizes a different way of constraining and releasing the implantable Nitinol Clip with stainless steel hypotubes, releasing the clip from a slot in the side of the hypotube as opposed to releasing the clip from the end of the hypotube.

Verification and validation testing confirms that functional Test Data: characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. All test data obtained satisfied the documented product and performance specifications.

- Based upon the technical information, intended use, in vitro, in Summary: vivo, and clinical performance information provided in previous vivo, and cimical performanos information "" included in this submission 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 a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of human figures, with three overlapping profiles facing to the right. The figures are depicted with simple, curved lines. Encircling the figures is text that reads "U.S. Department of Health and Human Services, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

Medtronic Cardiac Surgery % David D. Cox, Ph.D. Senior Principal Regulatory Affairs Specialist 7601 Northland Drive Minneapolis, Minnesota 55428-1088

Re: K062057

Trade/Device Name: NC65 U-CLIP Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: July 19, 2006 Received: July 20, 2006

Dear Dr. Cox:

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. Iisting 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 vour 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

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Page 2 - David D. Cox, Ph.D.

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/cdrl/industry/support/index.html.

Sincerely yours,

Herbert Leuner

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

KOG2057 510(k) Number (if known):

NC65 U-CLIP Device Name:

Indications for 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; including use in cardiovascular and coronary artery bypass grafting procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

Herbert Leuner

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number