(29 days)
The BiomarC Tissue Marker is in indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
The provided text is a 510(k) summary for the BiomarC Gold Tissue Marker. It explicitly states that the technological characteristics are equivalent to predicate devices and that "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate devices."
However, the summary does not contain the specific information requested regarding acceptance criteria, reported device performance data, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness or standalone studies.
Therefore, I cannot provide a table of acceptance criteria and device performance, or answer the other specific questions about study details from the provided text. The document indicates that bench testing was performed, but it does not detail the results of that testing.
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K07 0436
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ATTACHMENT 5
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
MAR 1 6 2007
| Phone: | 651-653-8512 |
|---|---|
| Fax: | 651-407-1975 |
February 12, 2007 Submitted:
Device Name
| Trade Name: | BiomarC® Gold Tissue Marker |
|---|---|
| Classification Name: | Implantable Clip, 21 CFR 878.4300 |
| Common/Usual Name: | Tissue Marker |
Predicate Device
BiomarC Tissue Marker (K0063193) RadioMed Soft Tissue Marker (K022346)
Indication for Use
BiomarC Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description
BiomarC Gold is a sterile, nonpyrogenic, single use tissue marker consisting of 99.99% metallic gold clearly visible on standard radiographs as well as Magnetic Resonance Imaging (MRI) and ultrasound BiomarC Gold is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a location.
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K070436
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510(k) SUMMARY (CONTINUED)
Technological Characteristics and Performance
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The technological characteristics are equivalent to the predicate devices. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate 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 and Human Services. The logo consists of a stylized eagle or bird-like figure with three flowing ribbons extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carbon Medical Technologies, Inc. % Mr. Robert W. Johnson VP, Regulatory Affairs and Quality Assurance 1290 Hammond Road Saint Paul, Minnesota 55110-5867
MAR 1 6 2007
Re: K070436
Trade/Device Name: BiomarC Gold Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: February 12, 2007 Received: February 15, 2007
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.
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 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.
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Page 2 - Mr. Robert W. Johnson
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,
Fof
Mark N. Muller
Mark N. Melkerson 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
510(k) Number (if known):
Device Name: BiomarC Gold 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)
Poth
(Division Sign-Of-Division of General, Restor attoca and Neurological Levices
510(k) Number
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§ 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.