ULTRACLIP II MR

K041201 · Inrad · GDW · Jun 3, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041201
• Device Name: ULTRACLIP II MR
• Applicant: Inrad
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2

Intended Use

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

Device Story

Ultraclip II MR is an implantable device used to mark biopsy sites in soft breast tissue. It is placed during open surgical or percutaneous breast biopsy procedures. The device serves as a radiographic marker, allowing clinicians to identify the biopsy location in subsequent imaging studies. It is intended for use by physicians in clinical settings. The device aids in long-term follow-up and localization of the biopsy site for diagnostic or therapeutic planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable marker/staple for soft tissue. Radiopaque design for visualization. Class II device under 21 CFR 878.4750.

Indications for Use

Indicated for patients undergoing open surgical or percutaneous breast biopsy to radiographically mark the biopsy site.

Regulatory Classification

Identification

An implantable staple is a staple-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

JUN 0 3 2004

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

Re: K041201

Trade/Device Name: Ultraclip® II MR Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 6, 2004 Received: May 7, 2004

Dear Ms. Lalomia:

We have reviewed your Section 510(k) premarket notification of intent to market the indication indication we nave reviewed your becaon 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate for use stated in the encrosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the encentions and 1974, in the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allu Cosmelle Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, ulerclove, market the device, basjon of the manual registration, listing of general controls provisions of the rice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA Illay be subject to suen additional come in the 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be auvised that FDA s issuation of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that I DA has made a decerminations administered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820), and 820), and if applicable, the electronic form 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The FDA miding of basification 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 Patt 801), please If you desire specific advice for your as [phone]. Also, please note the regulation entitled, Colliation of Compilance at (Set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your responsed its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly 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

510K Number if Known:

K041201

Device Name:

Ultraclip® II MR

Indications for Use:

The Ultraclip II MR intended use is to attach to soft breast tissue at the THC Ottractip in Mr. an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

iriàm C. Provost

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

**510(k) Number** K041201

Special 510K Notification

Inrad Inc. Ultraclip® II MR

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