(202 days)
Not Found
No
The summary describes a physical tissue marker and its visibility under various imaging modalities, with no mention of AI or ML for image analysis, processing, or any other function.
No.
The device is described as a marker for soft tissue during surgical procedures, not as a device used to treat a disease or condition. While it aids in surgery, its purpose is identification, not therapy.
No
The device is a tissue marker used to mark soft tissue for radiographic visibility during surgical procedures, not to diagnose a condition or disease.
No
The device description clearly states that the device is a "polymerized polyethylene glycol (PEG) hydrogel" delivered via a needle or cannula, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- TraceIT Tissue Marker Function: The TraceIT Tissue Marker is a physical marker injected into soft tissue during or for future surgical procedures. Its purpose is to make the tissue visible under imaging modalities (MRI, CT, ultrasound). It does not analyze a sample from the body to provide diagnostic information.
The device is a surgical accessory used for localization and visualization, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, and ultrasound
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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:
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
NEU
E. 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.
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)
1
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.
2
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
3
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
4
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