PHARMASEED, MODEL BT-125-3

K994018 · Syncor Pharmaceuticals, Inc. · KXK · Jul 17, 2000 · Radiology

Device Facts

• Record ID: K994018
• Device Name: PHARMASEED, MODEL BT-125-3
• Applicant: Syncor Pharmaceuticals, Inc.
• Product Code: KXK · Radiology
• Decision Date: Jul 17, 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-125-3 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 turnors or in residual turnors following completion of a course of external radiation therapy. Total activity of BT-125-3 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 Model BT-125-3 is a brachytherapy seed containing radioactive material for permanent interstitial implantation. Device delivers localized radiation directly to or within tumor tissue; used for treatment of localized, unresectable, slow-growing, low-to-moderate radiosensitivity cancers. Seeds implanted by physicians in clinical settings; placement and total activity determined by tumor volume and radiation history per established clinical practice. Benefit includes targeted radiation delivery to superficial, intrathoracic, or intraabdominal tumors, including recurrent or residual disease, while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Radioactive brachytherapy seeds for permanent interstitial implantation. Technical specifications and material composition not detailed in provided text.

Indications for Use

Indicated for permanent interstitial brachytherapy of localized, unresectable, slow-growing, low-to-moderate radiosensitivity tumors. Applicable to superficial, intrathoracic, and intraabdominal tumors (e.g., head, neck, lung, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2000

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

Re:

K994018 PharmaSeed Model BT-125-3 Dated: April 24, 2000 Received: April 25, 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 determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce procto 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act Include manifor 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in 2011 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

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):

K994018

Device Name:

PharmaSeed BT-125-3 Brachytherapy Seeds

Indications for Use:

The intended use of Syncor Pharmaceuticals' BT-125-3 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 turnors or in residual turnors following completion of a course of external radiation therapy.

Total activity of BT-125-3 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) | |

Division of Reproductive, Abdominal, ENT

(Division Sign-Off)

510(k) Number

and Radiological Devic

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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