WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER

K083274 · Biocompatibles, Inc. · KXK · Jan 8, 2009 · Radiology

Device Facts

• Record ID: K083274
• Device Name: WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
• Applicant: Biocompatibles, Inc.
• Product Code: KXK · Radiology
• Decision Date: Jan 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended 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

Device Story

Device consists of radiopaque markers (Anchor Marker, Marker, MarkerStrand) used to provide visual reference points during medical imaging. Markers are placed in soft tissue or organ tissue to delineate anatomic regions or treatment sites for brachytherapy planning and guidance. Device is used by clinicians in a clinical setting. Output is visual identification of markers on imaging modalities, assisting physicians in localizing treatment areas. Benefits include improved accuracy in identifying target anatomy for radiation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque markers for visualization in imaging. Form factors include anchor markers, individual markers, and marker strands. Non-active, passive implantable device.

Indications for Use

Indicated for use in brachytherapy, soft tissue, or organ tissue for radiopaque marking to identify anatomic regions and provide reference positions around a treatment site. Contraindicated for cardiovascular or neurological procedures.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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

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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 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 [phone] or [phone] 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

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## 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 |