U-CLIP DEVICE, MODEL NC65 by MEDTRONIC VASCULAR

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.

Device Description

The U-CLIP™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The device is a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. This design allows precise placement of clips prior to closure, and facilitates the device is manufactured with a standard implantable grade of Nitinol.

AI/ML Overview

Here's an analysis of the provided text regarding the U-CLIP™ device, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the specific quantitative acceptance criteria are not explicitly detailed. However, the qualitative performance objective was "substantially equivalent" to predicate devices.

Acceptance Criteria (Qualitative)	Reported Device Performance (Qualitative)
Functional characteristics substantially equivalent to predicate device	"Verification and validation testing confirms that functional 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."
Substantially equivalent in terms of materials, use, and application to predicate devices	"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."

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

The document does not explicitly state the specific sample size used for the test set. It mentions "Verification and validation testing" which included "in vitro, in vivo, and clinical performance information." However, details on the number of clips tested or the number of subjects (for in vivo/clinical) are absent.

The data provenance is described as "in vitro, in vivo, and clinical performance information provided in previous vivo, and cimical performanos information." This suggests a mix of laboratory testing, animal studies, and potentially human clinical data, but the geographic origin of this data is not specified. It's described as "provided in previous... included in this submission," implying it was accumulated over time and presented for this submission. The nature of the studies (retrospective/prospective) is also not specified.

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

This information is not provided in the document. The text focuses on the device's substantial equivalence to predicate devices and its functional performance, rather than an expert-driven ground truth assessment for a specific medical condition.

4. Adjudication Method for the Test Set

This information is not provided in the document. The testing described (clip strength, deployment angle, in vitro/in vivo/clinical performance) doesn't inherently suggest an adjudication process for subjective assessments, but rather objective measurements and functional evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The U-CLIP™ is a physical surgical implant (a self-closing clip), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and not provided. As explained above, the U-CLIP™ is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the functional performance specifications for the clip (e.g., clip strength, deployment angle) and the established safety and efficacy profile of the predicate devices for achieving tissue approximation/ligation. The testing aimed to demonstrate that the new U-CLIP™ met its own specifications and performed comparably to already-approved devices, suggesting the "ground truth" was a combination of engineering specifications and the historical performance of predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to a specific diagnostic task.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As the U-CLIP™ is a physical medical device, not an AI or machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, but not the training of a model on a dataset.

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

This information is not applicable and not provided for the same reasons mentioned in point 8.

Summary

{0}------------------------------------------------

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, NEMinneapolis, MN 55432-5604
EstablishmentRegistration No.	2135394
Contact Person:	David D. Cox, Ph.D.Senior Principal Regulatory Affairs Specialist
Telephone Number:	(763) 391-9251
Fax Number:	(763) 391-9279

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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

{4}------------------------------------------------

Indications for Use

KOG2057 510(k) Number (if known):

NC65 U-CLIP Device Name:

Indications for Use:

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

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.