(287 days)
Not Found
Not Found
No
The summary describes a physical device (needle carrier) for brachytherapy and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a needle carrier for radionuclide seeds, which are therapeutic, but the device itself is for introducing those seeds, not for providing therapy directly.
No
The device is described as a pre-sterilized needle carrier for radionuclide seeds for brachytherapy procedures, which is a therapeutic rather than diagnostic function. It introduces substances into the body for treatment, not to identify or monitor conditions.
No
The intended use describes a "pre-sterilized needle carrier for radionuclide seeds," which is a physical device used in a medical procedure. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a pre-sterilized needle carrier for introducing radionuclide seeds into the body for Brachytherapy procedures. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism, typically on samples like blood, urine, or tissue).
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a device used directly on a patient.
- Anatomical Site: The mention of the transperineal approach and prostate gland further confirms its use within the body.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver a therapeutic agent directly into the body.
N/A
Intended Use / Indications for Use
The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for 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.
Product codes
90 KXK
Device Description
Readi-Load System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transperineal approach in and around the prostate gland.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2003
Mr. Rick Terwilliger Vice President World Wide Medical Technologies 426 Main Street North PO Box 505 WOODBURY CT 06798-0505
Re: K022389
Trade/Device Name: Readi-Load System Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: February 3, 2003 Received: February 5, 2003
Dear Mr. Terwilliger:
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.
1
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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" (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 (800) 638-2041 or (301) 443-6597 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
Page 2
2
EXHIBIT 1
510(k) Number (if known):
K022389
Device Name: Worldwide Medical Technologies Readi-Load System
Indications For Use:
The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
David R. Legmann
(Division Sign-Off) Division of Reproductive and Radio 510(k) Num
(Optional Format 1-2-96)