ULTRACLIP II US

K042341 · Inrad · NEU · Sep 20, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042341
• Device Name: ULTRACLIP II US
• Applicant: Inrad
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Sep 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Ultraclip II US intended use is to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy procedure.

Device Story

Ultraclip II US is an implantable clip designed for marking soft breast tissue at a biopsy site. Used during open surgical or percutaneous breast biopsy procedures. Device provides a permanent marker for the surgical site to assist clinicians in future localization or follow-up. Operated by physicians (surgeons/radiologists) in clinical settings. No complex electronics or software; purely mechanical implantable device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable clip for soft tissue marking. Mechanical design. Materials and specifications not detailed in provided text. Non-electronic, non-software device.

Indications for Use

Indicated for attachment to soft breast tissue at the surgical site during open surgical breast biopsy or percutaneous breast biopsy procedures.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2004

Ms. Melissa Lalomia RA/QA Manager Inrad, Inc. 4375 Donker Court, S.E. Kentwood, Michigan 49512

Re: K042341

Trade/Device Name: Ultraclip® II US Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, GDW Dated: August 25, 2004 Received: August 30, 2004

Dear Ms. Lalomia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 210(x) premained insubstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manation provide Americal Device American be of to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen o the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of general controls provisions of the 1100 libeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) also existing major regulations affecting your device can
may be subject to such additional controls. Existing major and division FD may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the OOG neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri b iboadires or our device complies with other requirements of the Act that I DA has made a acternmalations administered by other Federal agencies. You must of any Federal Statures and regulations daminders but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 807), labeling (21 OFR Part 820); and if applicable, the electronic 10thi in the quality systems (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) This letter will anow you to oegin manical equivalence of your device of your device to a legally premarket notification: "The PDA mining of casion 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 If you desire specific advice for your do rice of other notes note the regulation entitled, and Colliact the Office of Compularse in (est notification" (21CFR Part 807.97). You may obtain Misolanung by telefone to premainto no international the Act from the Division of Small other general intonnational on your response at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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 STATEMENT

K042341

510K Number if Known:

Device Name:

Ultraclip® II US

Indications for Use:

The Ultraclip II US intended use is to attach to soft breast tissue at the The Ultractip II US Intended use is "It unash books" a percutaneous breast
surgical site during an open surgical breast biopsy or a percutaneous breast surgical site dunny an open Surgiour bread. Instruction of the biopsy procedure.

Prescription Use × (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

**510(k) Number** K042341

Special 510K Notification

Inrad Inc. Ultraclip® II US

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