TraceIT Tissue Marker - 3mL

K151998 · Augmenix, Inc. · NEU · Aug 19, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151998
• Device Name: TraceIT Tissue Marker - 3mL
• Applicant: Augmenix, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Aug 19, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The TraceIT Tissue Marker is intended to be used to radiographically mark tissue for future medical procedures.

Device Story

TraceIT Tissue Marker is an implantable device used to mark soft tissue sites for future radiographic localization. The marker is implanted into the target tissue by a clinician. Once in place, it provides a radiopaque reference point visible under standard imaging modalities (e.g., CT, X-ray). This allows physicians to accurately identify the previously treated or biopsied site during follow-up procedures or radiation therapy planning. The device facilitates precise targeting, potentially improving clinical outcomes by ensuring accurate anatomical correlation over time.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implantable tissue marker; radiopaque material; designed for visualization under radiographic imaging (CT/X-ray).

Indications for Use

Indicated for radiographic marking of soft tissue in patients undergoing medical procedures requiring future localization of the site.

Regulatory Classification

Identification

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

Predicate Devices

• Visicoil Linear Marker (K062666)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2015

Augmenix Incorporated Mr. Noel Rolon Vice President Regulatory Affairs and Quality Systems 204 Second Avenue, Lower Level Waltham, Massachusetts 02451

Re: K151998

Trade/Device Name: TraceIT Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: July 17, 2015 Received: July 20, 2015

Dear Mr. Rolon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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