PHARMASEED, MODEL BT-125-1

• K Number: K992008
• Device Name: PHARMASEED, MODEL BT-125-1
• Manufacturer: SYNCOR PHARMACEUTICALS, INC.
• Date Cleared: 1999-12-23 ( 191 days)
• Product Code: KXK
• Regulation Number: 892.5730
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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.