(32 days)
Not Found
No
The description focuses on a physical tissue marker and its visibility on imaging modalities, with no mention of AI/ML for image analysis, diagnosis, or any other function.
No.
The device is used to radiographically mark soft tissue during a surgical procedure or for future surgical procedures, it does not provide therapy.
No
Explanation: The device is a tissue marker used to radiographically mark a location for future surgical procedures or during a surgical procedure, not to diagnose a condition.
No
The device description explicitly states it is a physical tissue marker made of pyrolytic carbon coated zirconium oxide, which is a hardware component.
No, 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 outside of the body (in vitro) to provide information about a patient's health.
- BiomarC Function: The BiomarC Tissue Marker is a physical object placed inside the body (in vivo) to mark a location in soft tissue for future imaging or surgical procedures. It does not analyze a sample from the body to diagnose or provide information about a disease or condition.
The description clearly states its purpose is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures," which is a physical marking function, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or 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) 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
Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
063193/51
ATTACHMENT 5
510(K) SUMMARY
Submitter's Name, Address and Date of Submission
NOV 2 1 2006
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 |
October 18, 2006 Submitted:
Device Name
| Trade Name: | BiomarC® Tissue Marker |
|---|---|
| Classification Name: | Implantable Staple, 21 CFR 878.4750 |
| Implantable Clip, 21 CFR 878.4300 |
Tissue Marker Common/Usual Name:
Predicate Device
BiomarC Tissue Marker (K042296) Promex Biopsy Site Tissue Marker Device (K023450)
Indication for Use
BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
BiomarC is a sterile, nonpyrogenic, single use tissue marker consisting of a nonabsorbable pyrolytic carbon coated zirconium oxide marker that is clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound. BiomarC is provided alone or with the BiomarC Delivery Gel. BiomarC is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
1
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.
2
Public Health Service
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carbon Medical Tecnologies, Inc. % Mr. Robert W. Johnson Vice President, Regulatory Affairs and Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110-5867
Re: K063193
Trade/Device Name: BiomarC Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulation Class: II Product Code: NEU Dated: October 30, 2006 Received: November 1, 2006
Dear Mr. Johnson:
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.
NOV 2 1 2006
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); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Robert W. Johnson
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
for Pete O
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
11
Indications for Use
510(k) Number (if known): K063193
Device Name: BiomarC Tissue Marker
Indications for Use:
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number L063193