BIOPSY SITE TISSUE MARKER DEVICE

K023450 · Promex, Inc. · NEU · Dec 19, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023450
• Device Name: BIOPSY SITE TISSUE MARKER DEVICE
• Applicant: Promex, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.

Device Story

Biopsy Site Tissue Marker is an implantable device used to radiographically mark the location of a biopsy site. The device is placed by a clinician during or following a biopsy procedure. It serves as a permanent or semi-permanent reference point for future imaging, allowing healthcare providers to accurately locate the biopsy site for follow-up monitoring or subsequent surgical intervention. The marker aids in clinical decision-making by ensuring precise anatomical localization of the previously sampled tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable clip; radiopaque material; designed for radiographic visualization; class II device per 21 CFR 878.4300.

Indications for Use

Indicated for marking the location of a biopsy site in patients undergoing 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 1 9 2002

Food and Drug Administration 200 Corporate Boulevard ckville MD 20850

Mr. Joseph L. Mark Vice President Promex, Inc. 3049 Hudson Street Franklin, Indiana 46131

Re: K023450

Trade/Device Name: Biopsy Site Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NEU Dated: October 9, 2002 Received: October 15, 2002

Dear Mr. Mark :

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);

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## Page 2 - Mr. Joseph L. Mark

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.

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(or 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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510(k) Number (if known):

Device Name:___Tissue Site Marker

Indications For Use:

These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

: Vision 3191-011 Olvision of General, Restorative id Neurological Devices

K023450

(Optional Format 1-2-96)