ULTRACLIP II WING AND ULTRACLIP II COIL by INRAD

The intended use of the Ultraclip II WING and Ultraclip II COIL is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance metrics of the device (Ultraclip® II WING, Ultraclip® II COIL).

The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It confirms that the device can be marketed but does not include the detailed study results or acceptance criteria that would typically be found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inrad, Inc. % Ms. Melissa Lalomia Manager, Regulatory Affairs and Ouality Assurance 4375 Donker Court S.E. Kentwood, Michigan 49512

JAN 3 0 2007

Re: K063238

Trade/Device Name: Ultraclip® II WING, Ultraclip® II COIL Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU, GDW Dated: December 20, 2006 Received: December 22, 2006

Dear Ms. Lalomia:

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 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.

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Page 2 -- Ms. Melissa Lalomia

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/cdrh/industry/support/index.html.

Sincerely yours,

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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K063238
Page 1 of 1

INDICATIONS FOR USE STATEMENT

510K Number if Known:

KO63238

Device Name:

Ultraclip® II WING Ultraclip® II COIL

Indications for Use:

Prescription Use ✗

Over-The-Counter Use

(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Division of General, Restoral and Neurological Devices

V063238

510(k) Number

Special 510K Notification

Inrad Inc. Ultraclip® II WING Inrad Inc. Ultraclip® II COIL

CONFIDENTIAL

Page 22

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.