(17 days)
The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
The provided text is a 510(k) summary for a medical device called the "[Trade Name] Fiducial Marker." However, it does not contain the specific information required to answer questions 1 through 9 about acceptance criteria and the study that proves the device meets them.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, addressing regulatory requirements like biocompatibility, visibility, MR safety, sterilization, and packaging/shelf-life. It mentions that "A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced," and that "A biocompatibility, visibility, MR safety / compatibility and sterilization and packaging / shelf-life adoption evaluation confirmed that the modified device, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices." This implies that some testing was done to ensure basic device functionality and safety, but it does not detail a study with the kind of acceptance criteria, test set, ground truth establishment, or multi-reader studies typically associated with validating an AI/ML-based medical device.
Therefore, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and performance studies. The document describes a traditional medical device (fiducial marker) clearance process, not one for an AI/ML-driven diagnostic or treatment planning system that would involve such performance metrics validated against a ground truth dataset and human expert comparisons.
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June 10, 2021
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Carbon Medical Technologies Inc. % Mr. Eric Furlich Director - R&D and Regulatory Affairs 1290 Hammond Road ST. PAUL MN 55110
Re: K211590
Trade/Device Name: [Trade Name] Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: May 20, 2021 Received: May 24, 2021
Dear Mr. Furlich:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211590
Device Name [Trade Name] Fiducial Marker
Indications for Use (Describe)
The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY - K211590
Submitter's Name, Address and Date of Submission
Eric Furlich Director - R&D and Regulatory Affairs Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110 Phone: 651-653-8512 Fax: 651-407-1975
Submitted:
Device Name
| Trade Name: | [Trade Name] Fiducial Marker |
|---|---|
| Common Name: | Fiducial Marker |
| Classification Name: | Medical charged-particle radiation therapy system |
| 21 CFR 892.5050 | |
| Product Code: | IYE |
Predicate Device
BiomarC Fiducial Marker (K110772) Preloaded Tissue Marker (K100994)
Indication for Use
The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
Device Description
The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
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, MR safety / compatibility and sterilization and packaging / shelf-life adoption evaluation confirmed that the modified device, [Trade Name] Fiducial Marker, was substantially equivalent to the predicate devices.
§ 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.