SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30

• K Number: K100847
• Device Name: SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
• Manufacturer: BIOCOMPATIBLES, INC.
• Date Cleared: 2010-05-21 ( 57 days)
• Product Code: KXK
• Regulation Number: 892.5730
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

The WorldWide Medical Technologies Synthetic Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Rrachstherapy procedures.

Device Description

The devices are sterile, single patient use product.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "WorldWide Medical Technologies Synthetic Spacer." It confirms the device's substantial equivalence to a legally marketed predicate device.

However, this document does not contain information about the acceptance criteria, study details, or performance data of the device itself. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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..."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act..."

This indicates that the approval is based on substantial equivalence to an existing device, which is a regulatory pathway, and not necessarily on a new study demonstrating performance against specific acceptance criteria presented in this letter.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, or a separate clinical study report for the device.

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.