(27 days)
Promex Biopsy Site Tissue Marker Device (k)023450, BiomarC Tissue Marker (k) 032347
Not Found
No
The device description and intended use focus on a physical tissue marker and delivery system, with no mention of AI/ML for image analysis, diagnosis, or any other function.
No.
A therapeutic device is used to treat a disease or condition. This device is used for marking tissue for future identification, which is a diagnostic or procedural aid, not a therapeutic function.
No
The device is used to mark tissue for future procedures or visualization, not to diagnose a condition or disease. Its purpose is localization, not diagnosis.
No
The device description clearly states it is a "delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." This is a direct intervention on the patient's body for marking purposes, not for analyzing samples in vitro (outside the body).
- Device Description: The device is a delivery system for a tissue marker that is placed into soft tissue. This is a surgical/interventional device, not a device used to test biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing blood, urine, tissue samples, or any other biological material in vitro to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically mark a location within the body.
N/A
Intended Use / Indications for Use
The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
NEU, GDW
Device Description
The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs, Magnetic Resonance Imaging (MRI), 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)
Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
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.
Promex Biopsy Site Tissue Marker Device (k)023450, BiomarC Tissue Marker (k) 032347
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.
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K042296
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510(K) SUMMARY
Submitter's Name, Address and Date of Submission
Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
| Phone: | 651-653-8512 |
|---|---|
| Fax: | 651-407-1975 |
August 25, 2004 Submitted:
Device Name
| Trade Name: | BiomarC® Preloaded Tissue Marker Device |
|---|---|
| Classification Name: | Implantable Staple, 21 CFR 878.4750 |
| Implantable Clip, 21 CFR 878.4300 | |
| Common/Usual Name: | Tissue Marker |
Predicate Device
Promex Biopsy Site Tissue Marker Device (k)023450 BiomarC Tissue Marker (k) 032347
Indication for Use
BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
The BiomarC Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use delivery system incorporating the BiomarC tissue marker consisting of a non-absorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. The BiomarC Tissue Marker is delivered either with an obterator or with the BiomarC BiomarC is placed into soft tissue during open, percutaneous, or Delivery Gel. endoscopic procedures to radiographically mark a location.
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KO42296
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510(k) SUMMARY (CONTINUED)
Technological Characteristics and Performance
The technological characteristics are equivalent to the predicate device. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
Public Health Service
SEP 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc, 1290 Hammond Road Saint Paul, Minnesota 55110
Re: K042296
Ro42270
Trade/Device Name: BiomarC® Preloaded Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU, GDW Dated: August 24, 2004 Received: August 24, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegains and the Medical Device Amendments, or to commerce prior to May 20, 1978, the ecordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Costicule Act (71ct) that to not required to the general controls provisions of the Act. The I ou may, dicroro, maries are a Act include requirements for annual registration, listing of general controls provisions of as tice, 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 If your device is enastined (600 a00 royals. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may ou round in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Dris issum that your device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must of any I cochar statutes and regenanents, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements);
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT and 007); ideoining (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Robert W. Johnson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maing of substantial equivalence of your device to a legally prematication. The PDF interessification 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 If you desire spocific acrievier J at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
to 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
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name
BiomarC® Preloaded Tissue Marker Device
Indications for Use
The BiomarC Preloaded Tissue Marker Device is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K042296