(84 days)
The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
Worldwide Medical Technologies Seed Implant Needle Set
The provided documents are a 510(k) premarket notification letter from the FDA and an "Indications For Use" statement for the "Worldwide Medical Technologies Seed Implant Needle Set." These documents relate to the regulatory clearance of a medical device and do not contain information about acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents.
The documents primarily confirm that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. They do not detail the specific studies or data used to establish device performance against defined criteria.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Gary A. Lamoureux President Worldwide Medical Technologies 125 Main Street North P.O. Box 505 Woodbury, CT 06798-0505
Re: K974118
Worldwide Medical Technologies Seed Implant Needle Set Dated: October 29, 1997 Received: October 31, 1997 Regulatory class: I 21 CFR 892.5650/Procode: 90 IWJ
Dear Mr. Lamoureux:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 requirement, as set forth in the Quality System Regulation (OS) 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 regulation 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 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 question 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 Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". -----
Sincerely yours,
h7liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
510(k) Number (if known):
Device Name: Worldwide Medical Technologies Seed Implant Needle Set
Indications For Use:
The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiologic Devices | |
| 510(k) Number | K974118 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | ----------------------------- | ---- | ---------------------- | ------- |
(Optional Format 1-2-96)
EXHIBIT 1
§ 892.5650 Manual radionuclide applicator system.
(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.