(63 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not available, and there is no information about performance studies or data sets that would be relevant to AI/ML.
No.
The device provides radiopaque markers for identification of anatomic regions, which serves a diagnostic or localization purpose rather than directly treating a condition.
No
Justification: The device provides radiopaque markers for clearer identification of anatomic regions and reference positions, which aids in treatment planning (e.g., brachytherapy) rather than diagnosing a condition.
No
The device description is not found, but the intended use describes "radiopaque markers" which are physical objects, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Intended Use: The intended use of the World Wide Medical Technologies Anchor Marker and Marker Strand is to provide radiopaque markers within the body for identification of anatomical regions during procedures like brachytherapy. This is an in vivo application (within the living body).
The device is used during a medical procedure to aid in visualization and targeting, not to analyze a sample taken from the body.
N/A
Intended Use / Indications for Use
The World Wide Medical Technologies Anchor Marker and Marker Strand intended use is to, provide radiopaque markers for clearer identification of anatomic regions by providing reference positions around a proposed treatment site.
They are indicated for use in brachytherapy, soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
Product codes
KXK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue or organ tissue
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2009
Mr. Wayne Richardson
Director of Quality, Regulatory Affairs
Biocompatibles, Inc.
Worldwide Medical Technologies
115 Hurley Road
OXFORD CT 06478
Re: K083274
Trade/Device Name: Worldwide Medical Techologies, Anchor Marker, Marker and
MarkerStrand
Regulation Number: 21 CFR 892.5730
Regulation Name: Radionuclide brachytherapy source
Regulatory Class: II
Product Code: KXK
Dated: November 5, 2008
Received: November 6, 2008
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, Dr to 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, if and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 . If and
1
Page 2
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 Ar any Federal statutes and regulations administered by other Federal agencies. You must contributions with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Darp); 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/odrh/industry/support/index.html.
Sincerely vours.
Joque In Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K083274
WorldWide Medical Technologies Anchor Marker Device Name:
WorldWide Medical Technologies Marker Strand
WorldWide Medical Technologies Marker
Indications for Use:
Divi Rac
The World Wide Medical Technologies Anchor Marker and Marker Strand intended use is to, provide radiopaque markers for clearer identification of anatomic regions by providing reference positions around a proposed treatment site.
They are indicated for use in brachytherapy, soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures a
| Prescription Use X (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ____ (21 CFR 807 Subpart C) |
|---|---|---|
| -------------------------------------------------- | -------- | -------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K083274 |