(30 days)
No
The summary describes a physical fiducial marker and its delivery system, with no mention of software, algorithms, or any technology related to AI or ML for image analysis or other functions.
No
The device is used for target localization and visualization in radiosurgery and radiotherapy, not for treating a disease or condition itself.
No
The device is a fiducial marker used for visualizing and localizing targets during radiosurgery and radiotherapy. It helps guide treatment but does not diagnose a condition.
No
The device description clearly states it is a physical, implantable gold marker, 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 be "implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization." This describes a device used in vivo (within the living body) for imaging and treatment guidance.
- Device Description: The description confirms it's a physical marker implanted into the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on bodily samples.
Therefore, the BiomarC Gold Fiducial Marker is an implantable medical device used for imaging and treatment guidance, not an IVD.
N/A
Intended Use / Indications for Use
The BiomarC Gold 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.
Product codes
IYE
Device Description
The BiomarC Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI).
Anatomical Site
body
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)
The technological characteristics are equivalent to the predicate devices. A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. A biocompatibility, visibility, and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Gold Fiducial Marker, was substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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ATTACHMENT 4
510(k) SUMMARY
Submitter's Name, Address and Date of Submission
Andrew Adams Director, Regulatory Affairs and Quality Assurance Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
| Phone: | 651-653-8512 |
|---|---|
| Fax: | 651-407-1975 |
Submitted: March 12, 2013
Device Name
| Trade Name: | BiomarC Gold Fiducial Marker | |
|---|---|---|
| Common Name: | Fiducial Marker | |
| Classification Name: | Accelerator, Linear, Medical (21 CFR 892.5050, IYE) |
Predicate Device
BiomarC Fiducial Marker (K110772) Fiducial Markers (K071614) BiomarC Gold Tissue Marker (K070436)
Indication for Use
The BiomarC Gold 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
The BiomarC Gold Fiducial Marker is a sterile, pyrogen free, single patient use, gold discrete marker that is visible on standard radiographs, ultrasound and Magnetic Resonance Imaging (MRI). The marker can be delivered with the preloaded delivery device system or through commercially available, compatible needles chosen by the user.
Technological Characteristics and Performance
The technological characteristics are equivalent to the predicate devices. A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. A biocompatibility, visibility, and sterilization and packaging / shelf life adoption evaluation confirmed that the modified device, BiomarC Gold Fiducial Marker, was substantially equivalent to the predicate devices.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
Carbon Medical Technologies, Inc % Mr. Andrew Adams 1290 Hammond Road Saint Paul, MN 55110
Re: K130678
Trade/Device Name: BiomarC Gold Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: March 12, 2013 Received: March 13, 2013
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. Adams
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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-free number . (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michal FDA Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130678
Device Name:
BiomarC Gold Fiducial Marker
Indications for Use:
The BiomarC Gold 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Mehara Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K130678
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