← Product Code [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU) · K063193 # MODIFICATION TO BIOMARC TISSUE MARKER (K063193) _Carbon Medical Technologies, Inc. · NEU · Nov 21, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K063193 ## Device Facts - **Applicant:** Carbon Medical Technologies, Inc. - **Product Code:** [NEU](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU.md) - **Decision Date:** Nov 21, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Intended Use BiomarC Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. ## Device Story BiomarC Tissue Marker is a sterile, nonpyrogenic, single-use implantable device consisting of a pyrolytic carbon-coated zirconium oxide marker. It is designed for placement into soft tissue during open, percutaneous, or endoscopic surgical procedures. The marker provides radiographic visibility on standard X-rays, MRI, and ultrasound, allowing clinicians to identify specific tissue locations for future surgical or diagnostic reference. The device may be used alone or in conjunction with an optional BiomarC Delivery Gel. By providing a permanent, visible landmark, the device assists healthcare providers in accurately locating biopsy or surgical sites, thereby facilitating subsequent clinical interventions. ## Clinical Evidence Bench testing only. ## Technological Characteristics Nonabsorbable pyrolytic carbon-coated zirconium oxide marker. Sterile, single-use, nonpyrogenic. Visible via radiography, MRI, and ultrasound. Optional delivery gel provided. No software or electronic components. ## Regulatory Identification An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - BiomarC Tissue Marker ([K042296](/device/K042296.md)) - Promex Biopsy Site Tissue Marker Device ([K023450](/device/K023450.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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}------------------------------------------------ K063193 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 Page 1 of 2 510(k) Number L063193 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K063193](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEU/K063193) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com