Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical properties and function of a fiducial marker for imaging, with no mention of AI or ML for image analysis, data processing, or any other function.

Therapeutic

No.
The device is used for localizing targets for radiosurgery and radiotherapy, which are therapeutic procedures, but the device itself does not directly provide therapy. It is a marker, not a therapeutic agent or instrument.

Diagnostic

No

This device is a fiducial marker, which is implanted to aid in visualizing and localizing targets for radiosurgery and radiotherapy. It is used for guidance during treatment, not for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical fiducial marker made of zirconium oxide and supplied with a deployment device, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
BiomarC Fiducial Marker Function: The BiomarC Fiducial Marker is designed to be implanted into the body. Its purpose is to be a physical marker visible on various imaging modalities to help guide radiation therapy. It does not analyze any biological samples taken from the body.

Therefore, based on the provided information, the BiomarC Fiducial Marker is a medical device intended for implantation and imaging guidance, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

IYE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT), ultrasound, and Magnetic Resonance Imaging (MRI)

Anatomical Site

implanted into the 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)

Biocompatibility testing for: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, implantation (muscle and bone), and haemocompatibility has demonstrated that the BiomarC Fiducial Marker is: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K071614, K063193

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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.

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