← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K110772 # BIOMARC FIDUCIAL MARKER (K110772) _Carbon Medical Technologies, Inc. · IYE · Apr 28, 2011 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K110772 ## Device Facts - **Applicant:** Carbon Medical Technologies, Inc. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Apr 28, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. ## Device Story BiomarC Fiducial Marker is a sterile, pyrolytic carbon-coated zirconium oxide implant. Supplied pre-loaded in a single-use deployment device consisting of a cannula, handle, push rod, plunger, and bone wax retainer. Implanted into soft tissue to serve as a radiopaque reference frame for stereotactic radiosurgery and radiotherapy target localization. Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, CT), ultrasound, and MRI (up to 4.0 Tesla). Used by clinicians to improve target accuracy during radiation therapy planning and delivery. Benefits include precise anatomical marking for tumor localization, facilitating accurate radiation dose delivery to target tissues while sparing surrounding structures. ## Clinical Evidence Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 series, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone), and haemocompatibility. Results confirmed the device is non-toxic, non-sensitizing, non-irritating, non-mutagenic, and non-hemolytic. Visualization performance verified across standard imaging modalities (x-ray, CT, ultrasound, MRI). ## Technological Characteristics Material: Pyrolytic carbon-coated zirconium oxide. Form factor: Discrete marker pre-loaded in a cannula-based deployment device. Energy: Passive radiopaque marker. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 1x10^-6. Biocompatibility: ISO 10993 compliant. ## Regulatory Identification A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories. ## Predicate Devices - Fiducial Markers ([K071614](/device/K071614.md)) - BiomarC Tissue Marker ([K063193](/device/K063193.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}------------------------------------------------ # 510(k) Summary 5 ## 5. 510(k) Summary .APR 2 8 2011 Andrew Adams Director - Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110 Phone: 651-653-8512 Fax: 651-407-1975 Submitted: March 17, 2011 #### Device Name Trade Name: BiomarC Fiducial Marker Accelerator, Linear, Medical, 21 CFR 892.5050 Classification Name: Common/Usual Name: Tissue Marker #### Predicate Devices Fiducial Markers (K071614) BiomarC Tissue Marker (K063193) #### Indication for Use The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. #### Device Description BiomarC Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) at up to 4.0 Tesla field strength. BiomarC Fiducial Marker is supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device. The deployment device consists of a cannula with handle, a push rod with plunger, and bone wax as a marker retaining mechanism. {1}------------------------------------------------ # Technological Characteristics and Performance BiomarC Fiducial Marker is identical to BiomarC Tissue Marker (K063193) except the indications for use have been expanded in accordance with Fiducial Markers (K071614). Biocompatibility and performance testing confirms that the BiomarC Fiducial Marker is substantially equivalent to the Fiducial Markers for the expanded indications for use (Table 5). | Characteristic | Proposed Device | Predicate Device | Predicate Device | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name | BiomarC Fiducial
Marker | Fiducial Markers | BiomarC Tissue Marker | | 510(k) number | K110772 | K071614 | K063193 | | 510(k) holder | Carbon Medical
Technologies, Inc. | Civco Medical Solutions | Carbon Medical
Technologies, Inc | | Indications for use | The BiomarC Fiducial
Markers are intended to
be implanted into the
body to accurately
visualize and constitute
the reference frame for
stereotactic radiosurgery
and radiotherapy target
localization. | The Fiducial Markers
are intended to be
implanted into the body
to accurately visualize
and constitute the
reference frame for
stereotactic radiosurgery
and radiotherapy target
localization.

Specifically, they can be
used in intracranial
diseases as gliomas,
neuromas,
meningiomas,
astroctyomas,
arteriovenous
malformations, and
metastatic carinomas.

Additionally, they can
be used in the body for
treating hepatic,
pancreatic,
retroperitoneal,
paraspinal, skeletal,
prostatic and breast
tumors. | The BiomarC Tissue
Marker is indicated for
use to radiographically
mark soft tissue during a
surgical procedure of for
future surgical
procedures. | | Use | Single use | Single use | Single use | | Sterility | Sterilized by EO with an
SAL of 1x106 | Sterilized by EO with an
SAL of 1x106 | Sterilized by EO with an
SAL of 1x106 | | Pyrogens | Pyrogen free | Unknown | Pyrogen free | | Marker material | Pyrolytic carbon coated
zirconium oxide | Gold | Pyrolytic carbon coated
zirconium oxide | | Device body contact
category | Implant device,
tissue/bone, permanent | Implant device,
tissue/bone, permanent | Implant device, tissue,
permanent | BiomarC Fiducial Marker Premarket Notification 510(k) 5-2 {2}------------------------------------------------ | (Table 5) (continued) | | | | | |-----------------------|--|--|--|--| |-----------------------|--|--|--|--| | Safety | Biocompatibility testing for: | Biocompatibility testing for: | Biocompatibility testing for: | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | | cytotoxicity,
sensitization,
intracutaneous
reactivity,
systemic toxicity,
genotoxicity,
implantation (muscle
and bone), and
haemocompatibility | cytotoxicity,
sensitization,
irritation,
systemic toxicity,
implantation, and
hemolysis | cytotoxicity,
sensitization,
intracutaneous
reactivity,
systemic toxicity,
genotoxicity,
implantation (muscle),
and haemocompatibility | | | has demonstrated that
the BiomarC Fiducial
Marker is: | has demonstrated that
the Fiducial Marker is: | has demonstrated that
the BiomarC Tissue
Marker is: | | | non-toxic (cyto and
systemic),
non-sensitizing,
non-irritating
(intracutaneous and
implantation),
non-mutagenic, and
non-hemolytic | non-cytotoxic,
non-sensitizing,
non-irritating,
non-reacting implanted,
and non-hemolytic | non-toxic (cyto and
systemic),
non-sensitizing,
non-irritating
(intracutaneous and
implantation),
non-mutagenic, and
non-hemolytic | | | per testing in accordance
with the ISO 10993
series. | per testing in accordance
with ISO 10993. | per testing in accordance
with the ISO 10993
series. | | Visualization | Visible on standard
radiographs (x-ray,
mammography,
fluoroscopy, kV, and
CT), ultrasound, and
magnetic resonance
imaging (MRI) | Visible on EPID, film,
kV and CR. | Visible on standard
radiographs (x-ray,
mammography,
fluoroscopy, kV, and
CT), ultrasound, and
magnetic resonance
imaging (MRI) | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Andrew J. Adams Director-Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road SAINT PAUL MN 55110-5867 APR 2 8 2011 Re: K110772 Trade/Device Name: BiomarC Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 17, 2011 Received: March 21, 2011 Dear Mr. Adams: 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding 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 Division of Small Manufacturers, International and Consumer Assistance at its toll me (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours. Mary Patel Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### 4. Indications for Use Statement K110772 510(k) Number (if known): __ Device Name: BiomarC Fiducial Marker Indications for Use: The BiomarC Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mary S Patel --- (Division Sign-Off) SIOK adiningica Office 31 10 Page 1 of ____________________________________________________________________________________________________________________________________________________________________ BiomarC Fiducial Marker Premarket Notification 510(k) 4-1 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K110772](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K110772) **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. 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