TraceIT™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.

Device Description

TracelT Tissue Marker is a sterile, single use, polymerized polyethylene glycol (PEG) hydrogel that is delivered to mark a surgical location via a needle or cannula. The hydrogel material is visible under MRI, CT, and ultrasound for up to three months after the injection: The material hydrolyzes and is cleared from the body approximately six (6) months after injection.

AI/ML Overview

The provided text is a 510(k) summary for the TraceIT™ Tissue Marker and supporting FDA correspondence. This documentation pertains to a medical device's regulatory clearance based on substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria for an AI/ML diagnostic or prognostic device.

Therefore, the input does not contain the information requested to answer the questions about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details for an AI/ML device.

The document focuses on:

Device Description: A sterile, single-use, polymerized polyethylene glycol (PEG) hydrogel delivered via needle or cannula to radiographically mark soft tissue.
Indication for Use: To radiographically mark soft tissue during a surgical procedure or for future surgical procedures. Intended to mark tissue for at least 3 months after injection.
Visibility: Visible under MRI, CT, and ultrasound for up to three months.
Predicate Devices: BiomarC Tissue Marker (K001807) and Coaptite Tissue Marker (K012955).
Performance Data: States "In vitro and in vivo preclinical tests were performed to verify and validate the safety and effectiveness of TraceIT Tissue Marker and assure substantial equivalence to the predicate devices." However, no specific performance metrics or acceptance criteria are detailed.
Basis for Substantial Equivalence: Based on similar intended use, principle of operation, and technological characteristics to predicate devices.

Conclusion: The provided text does not include the detailed information required for the requested table and study breakdown concerning acceptance criteria and performance data for an AI/ML enabled device. This document is a regulatory submission demonstrating substantial equivalence, not a performance study of a diagnostic AI algorithm.

Summary

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Augmenix, Inc. Supplement 001 to K121964 TracelT Tissue Marker

JAN 2 3 2013

SECTION 5.0:

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information

Submitter's Name:

Address:

Augmenix, Inc

781-902-1613

781-895-3236 ·

November 19, 2012

Tissue Marker

204 Second Avenue Waltham, MA 02451

Telephone:

Fax:

Contact Person:

Date of Preparation

B. Subject Device:
- Trade Name:

Common/Usual Name:

Class:

C. Predicate Device Name(s):
Trade Name(s)

Product Code:

BiomarC Tissue Marker, K001807 Coaptite Tissue Marker, K012955

Eric Ankerud, Executive Vice President

Clinical, Regulatory, Quality

TraceIT™ Tissue Marker

D. Indications for Use:

NEU

E. Device Description

F. Predicate Device(s) Reference

TracelT Tissue Marker was shown to be substantially equivalent in intended use, principle of operation, and technological characteristic to the following previously cleared devices: BiomarC Tissue Marker (K001807) and Coaptite Tissue Marker (K012955)

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K121964

page 2/2

Augmenix, Inc. Supplement 001 to K121964 TraceIT Tissue Marker

ርድስጋሪ መስመር ነው። የጥንተ፡ንጥር ጥናት (ኬሚስትሪ)

G. Performance Data:

In vitro and in vivo preclinical tests were performed to verify and válidate the safety and effectiveness of TracelT Tissue Marker and assure substantial equivalence to the predicate devices.

H. Basis for Determination of Substantial Equivalence

Upon reviewing the safety and efficacy information provided in the submission and comparing intended, principal of operation, and overall technological characteristics, TraceIT Tissue Marker is determined to be substantially equivalent to existing legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, representing the department's mission of protecting the health of all Americans.

Public Health Service

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

Augmenix, Incorporated % Mr. Eric Ankerud Executive Vice President, Clinical, Regulatory, Quality 204 Second Avenue, Lower Level Waltham, Massachusetts 02451

Re: K121964

Trade/Device Name: TraceIt Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: November 19, 2012 Received: November 20, 2012

January 23, 2013

Dear Mr. Ankerud:

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 for association 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 your device is exactive al 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Eric Ankerud

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quand 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 11 you dosite specific ad risboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation entined, 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 I ou may ocain other geticational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Augmenix, Inc. Supplement 001 to K121964 Tracelt Tissue Marker

INDICATION FOR USE STATEMENT SECTION 4.0:

K121964 510(k) Number:

Indication For Use: TraceIT Tissue Marker is indicated for use to radiographically mark soft maleation of OSC. Trucer - noced wfor future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.

× Prescription Use _ (Part 21 CFR 801 SubpartD)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121964

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.