(191 days)
The intended use of Syncor Pharmaceuticals' BT-125-1 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "PharmaSeed BT-125-1 Brachytherapy Seeds." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The letter is a regulatory approval document and focuses on:
- Device Name: PharmaSeed BT-125-1 Brachytherapy Seeds
- Applicant: Syncor Pharmaceuticals, Inc.
- Date of Clearance: December 23, 1999
- Regulatory Class: II (21 CFR 892.5730/Procode: 90 KXK)
- Indications for Use: To deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
- Emphasis: Substantial equivalence to predicate devices under the general controls provisions of the Act.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and device performance studies based on the provided text. This type of information would typically be found in the 510(k) submission itself or in a separate clinical study report, neither of which is present here.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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DEC 2 3 1999
Gary Gilmore President and General Manager Syncor Pharmaceuticals, Inc. 1313 Washington Avenue Golden, Colorado 80401
RE:
K992008 PharmaSeed BT-125-1 Brachytherapy Seeds Dated: September 24, 1999 Received: September 30, 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, 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 (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 requiration 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Marufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, 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
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510(k) Number (if known):
K 992008
Device Name:
PharmaSeed BT-125-1 Brachytherapy Seeds
Indications for Use:
The intended use of Syncor Pharmaceuticals' BT-125-1 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor.
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| Prescription Use(Per 21 CFR 801.109) | |
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OR
| Over-The-Counter Use | (Optional Format 1-2-96) |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K992008 |
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Concurrence of CDRH; Office of Device Evaluation (ODE)
§ 892.5730 Radionuclide brachytherapy source.
(a)
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.(b)
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.