The Ball 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 such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

Device Description

The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for the Cosman Ball Fiducial Markers. It states that the device is "substantially equivalent" to a predicate device (CIVCO MEDICAL SOLUTIONS, Fiducial Markers) and is "safe and effective for indicated intended use." However, it does not contain the specific information requested regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, training sets, or data provenance.
Information on the number or qualifications of experts used for ground truth.
Adjudication methods.
Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
Information on standalone algorithm performance.
The type of ground truth used (e.g., pathology, outcomes data).
How ground truth for any training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not a detailed performance study report. The core of its argument for safety and effectiveness is simply that it has similar physical and technical characteristics to the predicate device.

Summary

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K 1.0 113)

JUN 1 7 2010

510(k) Summary

Applicant / Manufacturer: Cosman Medical, Inc. 76 Cambridge St., Burlington MA 01803. USA Tel. 781-272-6561, Fax 781-272-6563

Fiducial Markers

April 19, 2010

CFR 892.5050.

system Product Code: IYE

Contact Person:

Louis Falcone, Director of RA LFalcone@cosmanmedical.com

Registration Number: 3004867882

Date Prepared: April 19, 2010

Trade Names:

Dated:

Common Name:

Classification:

Performance Standard:

No applicable performance standards have been issued under section 514 or under section 513(b) of the Food, Drug, and Cosmetic Act.

CIVCO MEDICAL SOLUTIONS、Fiducial Markers

Class II, Medical charged-particle radiation therapy

COSMAN MEDICAL Ball Fiducial Markers

Predicate Device:

-- (K071614)

Intended Use:

Comparison to Predicate:

The Cosman Ball Fiducial Markers have been compared to previously 510(k) cleared devices with respect to intended use and technological characteristics. The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices. The technical characteristic comparison chart provided in this 510(k)

Cosman Ball Fiducial Markers 510(k) Page 3

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notification shows that the Cosman Ball Fiducial Markers are substantially equivalent to the CIVCO MEDICAL SOLUTIONS, Fiducial Markers predicate device and are safe and effective for indicated intended use.

Safety and Effectiveness: The comparison to the predicate device demonstrates that the Cosman Ball Fiducial Markers are safe and effective and are substantially equivalent to the CIVCO MEDICAL SOLUTIONS Fiducial Markers predicate device.

Submitted By:

Name: Louis Falcone

Louis Idue
Signature

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is stylized with three distinct lines forming the body and wings.

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

JUN 1 7 2010

Mr. Louis Falcone Director of RA Cosman Medical, Inc. 76 Cambridge Street BURLINGTON MA 01803

Re: K101131

Trade/Device Name: Cosman Ball Fiducial Markers Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 12, 2010 Received: April 22, 2010

Dear Mr. Falcone:

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

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 logal y 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 Viro Diagnostic Device Evaluation and Safety at (30) 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 the first nic (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amed J. H.

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K (0113)

Device Name: Cosman Ball Fiducial Markers

Indications For Use:

"The Ball 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 such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.

Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors."

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (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) Page 1 of

510K

(Division Sign-Off) Division of Radiological Devi Office of In Vitro Diagnostic Device Evalua

Cosman Ball Fiducial Markers 510(k) · Page 2

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.