PHARMASEED, MODEL BT-103-1

K992007 · Syncor Pharmaceuticals, Inc. · KXK · Jan 14, 2000 · Radiology

Device Facts

• Record ID: K992007
• Device Name: PHARMASEED, MODEL BT-103-1
• Applicant: Syncor Pharmaceuticals, Inc.
• Product Code: KXK · Radiology
• Decision Date: Jan 14, 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-103-1 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-103-1 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-103-1 are brachytherapy seeds for permanent interstitial radiation therapy. Seeds are implanted directly into or near tumor sites by physicians. Device delivers localized radiation to treat cancer; indicated for slow-growing, low-to-moderate radiosensitivity tumors. Clinical utility includes treatment of localized, unresectable, recurrent, or residual tumors in various anatomical locations (head, neck, lungs, pancreas, prostate). Total activity and placement are determined by clinicians based on tumor volume and radiation history using established clinical practices. Benefits include targeted radiation delivery to tumor tissue while minimizing exposure to surrounding healthy structures.

Clinical Evidence

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

Technological Characteristics

Permanent interstitial brachytherapy seeds. Radioactive source encapsulated for implantation. Dimensions and material specifications are consistent with established brachytherapy standards for localized radiation delivery.

Indications for Use

Indicated for permanent interstitial brachytherapy 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, 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head facing to the left. The eagle is composed of three curved lines, giving it a modern and abstract look.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2000

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

Re:

K992007 PharmaSeed BT-103-1 Brachytherapy Seeds Dated: October 20, 1999 Received: October 21, 1999 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 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). You may, therefore, 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 III (Special Controls) or dass 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 the Electronic Product 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 vitro 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"(21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

510(k) Number (if known):

K992007

Device Name:

PharmaSeed BT-103-1 Brachytherapy Seeds

## Indications for Use:

The intended use of Syncor Pharmaceuticals' BT-103-1 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-103-1 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) | |
|---------------------------------------|--|
| OR | |
| Over-The-Counter Use | |

| (Division Sign-Off) | |
|--------------------------------------------------------------------|--|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |

| 510(k) Number | K992007 |
|---------------|---------|
|---------------|---------|

| Revised 10/20/99 | |
|--------------------------|--|
| 2-1 | |
| (Optional Format 1-2-96) | |