STELLAR FIDUCIAL MARKER, MODEL GFMIA

K092041 · Stellar Medical, LLC · IYE · Oct 2, 2009 · Radiology

Device Facts

• Record ID: K092041
• Device Name: STELLAR FIDUCIAL MARKER, MODEL GFMIA
• Applicant: Stellar Medical, LLC
• Product Code: IYE · Radiology
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The needles are used for interstitial placement of gold fiducial markers. Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.

Device Story

Device consists of solid gold marker pre-loaded into 17 or 18 gauge brachytherapy needle; needle pre-plugged with bone wax. Used by clinicians for interstitial implantation of markers into patient tissue. Once implanted, markers act as radiopaque localization targets for IMRT and IGRT radiation therapy planning and delivery. Markers improve precision of radiation targeting; benefit patient by potentially increasing accuracy of dose delivery to tumor while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Solid gold fiducial markers; 17 or 18 gauge stainless steel brachytherapy needles; bone wax plug; ethylene oxide sterilization.

Indications for Use

Indicated for interstitial placement of gold fiducial markers to serve as localization targets for patients undergoing IMRT and IGRT radiation therapy.

Regulatory Classification

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

• Device Fiducial Markers (K071614)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Stellar Medical. The logo features a five-pointed star to the left of the word "Stellar" in a bold, sans-serif font. The word "Medical" is written in a similar font, but it is not bolded.

Cleveland Ave. uite 403 Ft. Myers, FL 33907 Phone: [phone] Fax: [phone]

OCT - 2 2009

K092041

510 (k) SUMMARY (as required by 807.92(c))

Stellar Medical LLC 10970 S. Cleveland Ave., Suite 403 Fort Myers, FL 33907 USA Phone: [phone] [phone] Fax:

Contact Person:

Submitter of 510(k):

Date of Summary:

Trade Name:

Common Name:

Classification:

Classification Name:

Predicate Devices:

Device Description:

Intended Use:

Indications for Use:

Substantial Equivalence:

Spencer Leete

July 2, 2009

Stellar Fiducial Marker

Fiducial Marker

Class II (21 CFR 892.5050, Product Code IYE)

Medical charged-particle radiation therapy system

Device Fiducial Markers 510(k) # K071614

The Stellar Fiducial Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of a solid gold marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax. The packaged needles are sterilized via ethylene oxide.

The needles are used for interstitial placement of fiducial markers. Once implanted, the fiducial markers serve as localization devices for the purpose of radiation therapy.

The needles are used for interstitial placement of gold fiducial markers. Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.

The Stellar Fiducial Markers are compared to the CIVCO Medical Solutions Fiducial Marker.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

## 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

Stellar Medical, LLC % Mr. Benjamin Roedell Owner Quality Medical Device Consulting . 12738 Buckhorn Dr. HUDSON FL 34669

OCT - 2 2009

Re: K092041

Trade/Device Name: Stellar Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 2, 2009 Received: July 15, 2009

Dear Mr. Roedell:

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 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092041

Device Name: Stellar Fiducial Marker

The needles are used for interstitial placement of gold fiducial markers. Indications for Use: Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

UNN

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number