READI-STRAND, MODEL PSSTRAND

• K Number: K022705
• Device Name: READI-STRAND, MODEL PSSTRAND
• Manufacturer: WORLDWIDE MEDICAL TECHNOLOGIES, LLC
• Date Cleared: 2003-06-09 ( 299 days)
• Product Code: KXK
• Regulation Number: 892.5730
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the "Readi-Strand Model PSStrand" device, which is a radionuclide brachytherapy source carrier. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has reviewed Worldwide Medical Technologies, Inc.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the device's indications for use: "to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland."

To answer your specific questions, information regarding acceptance criteria, device performance results, study design details (sample size, data provenance, expert qualifications, adjudication methods, etc.), and ground truth establishment would typically be found in the 510(k) summary submitted by the manufacturer, which is a separate document from this clearance letter.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2003

Mr. Gary Lamoureux Chief Executive Officer Worldwide Medical Technologies, Inc. 426 Main Street North WOODBURY CT 06798-0505

Re: K022705 Trade/Device Name: Readi-Strand Model PSStrand Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 21, 2003 Received: April 2, 2003

Dear Mr. Lamoureux:

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, 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT 1

Labels	Values
510(k) Number (if known):	K 022705

Device Name: Worldwide Medical Technologies Readi-Strand

Indications For Use:

The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

-2-96)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
OR	Over-The-Counter Use ______

(Optional Format 1-)

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

510(k) Number	K022705
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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.