(212 days)
The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures.
disposable carrier for seed strands containing radionuclide seeds
This document is a 510(k) clearance letter from the FDA for a medical device called "Worldwide Medical Technologies StrandPort."
Based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria.
The document primarily focuses on:
- Device Name: Worldwide Medical Technologies StrandPort
- Regulation Number: 21 CFR 892.5730
- Regulation Name: Radionuclide brachytherapy source
- Regulatory Class: II
- Product Code: KXK
- Indications For Use: To provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures (transperineal approach for radionuclide seed application in and around the prostate). It is a sterile, single-patient-use product.
- FDA Clearance: The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This allows the company to market the device subject to general controls.
The document does not contain any of the following information requested:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This is a regulatory clearance document, not a detailed technical report of a performance study.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Wayne Richardson Director of Quality, Regulatory Affairs World Wide Medical Technologies 115 Hurley Road OXFORD CT 06478
MAR 0 1 2007
Re: K062214
Trade/Device Name: Worldwide Medical Technologies StrandPort Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: January 24, 2007 Received: January 29, 2007
Dear Mr. Richardson:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy Cbrogdon
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
510(k) Number (if known):
Device Name: Worldwide Medical Technologies StrandPort
Indications For Use:
The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate. This device is a sterile, single patient use product.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮐﮯ OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Torid R. Seaman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 062214
§ 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.