PHARMASEED, MODEL BT-125-2

K993701 · Syncor International, Inc. · KXK · Jun 9, 2000 · Radiology

Device Facts

• Record ID: K993701
• Device Name: PHARMASEED, MODEL BT-125-2
• Applicant: Syncor International, Inc.
• Product Code: KXK · Radiology
• Decision Date: Jun 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Syncor Pharmaceuticals' BT-125-2 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor. These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy. Total activity of BT-125-2 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.

Device Story

PharmaSeed BT-125-2 is a brachytherapy seed containing a radioactive source for permanent interstitial implantation. Used in clinical settings by physicians to treat localized, unresectable tumors. Seeds are implanted directly into or in close proximity to tumor tissue. Radiation emission provides localized therapeutic dose to malignant cells. Total activity and placement are determined by clinicians based on tumor volume and prior radiation history using established clinical practice. Benefit includes targeted radiation delivery to tumors while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

No clinical data provided; device relies on established clinical practice for brachytherapy.

Technological Characteristics

Radioactive brachytherapy seed for permanent interstitial implantation. Device delivers ionizing radiation directly to tumor sites. No software or electronic components.

Indications for Use

Indicated for permanent interstitial treatment of localized, unresectable tumors with slow growth rates and low-to-moderate radiosensitivity. Applicable to superficial, intrathoracic, and intraabdominal tumors (e.g., head, neck, lungs, pancreas, prostate), including recurrent or residual tumors post-external radiation therapy.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JUN - 9 2000**

Gary Gilmore President and General Manager Syncor Pharmaceuticals, Inc. 1313 Washington Avenue Golden, CO 80401

Re:

K993701 PharmaSeed Model BT-125-2 Dated: March 24, 2000 Received: March 27, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Gilmore:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have deemined the We have reviewed your Section 510(indication of the enclosure) to legally markets predicate devices
device is substantially equivalent (for the indications for use andreal De device is substantially equivalent (for the enation in the enclosing nicality in the morents, or to devices that maketed in interstate commerce pror to May 26, 1976, the endenters on the morney of the Art Art . You may, therefore,
have been reclassified in accordance with the provision have been reclassified in accordance with the provisions of the Act. The provisions of the Act include of the Act include market the device, subject to the general controls of the Ac. "The general of the reviews of the voluments for and prohibitions against mishanding and adulteration.

lf your device is classified (see above) into either class III (Fremarket Aproval). it may be subject to
r Title Times of Arther Child and Course of Laires and be found in t lf your device is classified (see above) in the class in ( thanks : pperating (remanes . perfected Regulation, Title 21,
such additional controls. Existing major egulations such additional controls. Existing major legite can be rothide Current Got God Manufacturing Practice
Parts 800 to 895. A substantially equipelent delemination (GeMecine C Parts 800 to 895. A substantialiy equiles Onlines Onlines Coner Croundination (21 CFF Pat 820) and requirements, as set forth in the Qualion (QS) in Microsices: Conclul rogundions. Forlue to comply with that, through periodic QS inspections the Food and Internet on the reserved on earnier vour device in the GMP regulation may result in regulation in and the inder canter and the tany on many of the fines any olings on onlines any obligation you might the Federal Register. Please note: this response to your premainer as one and only of the election of the fields of the Federal laws or regulations.

This letter will allow you to begined in your 510(k) pemake notification. The FDA finding of This letter will allow you to begin market predicate in your sreats in the manager. The would be and thus, permits your device to proceed to the market.

If you desire specific advice for your labeling regulation (21 CFR Pat 801 and additionally for guestions on the progri If you desire specific advice for your development (21 cm all a docination on the minimalian in the minimalian and diagnosic devices), please contact the Office of Compliance at (301) 594-483. Also, please note the regulation entiled advertising of your device, please contact to Complainte and processor information on your resonsibilities under the under the "Misbranding by reference to premarket notification' (2/C/F K of .- Ville Spillan Mornaline (800) 63-2041 or [phone]
Act may be obtained from the Division of Small Man Act may be obtained from thp://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

U. Don Stetit.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

K 99370/

Device Name:

PharmaSeed BT-125-2 Brachytherapy Seeds

## Indications for Use:

The intended use of Syncor Pharmaceuticals' BT-125-2 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.

These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.

Total activity of BT-125-2 seeds required for treatment is dependent upon the tumor volume and the radiation history of the site. To calculate the total activity needed, determine the placement of the sources in the tissue, and evaluate the dose distribution achieved, established practice should be followed.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David L. Bergmann

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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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