(99 days)
The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.
Not Found
I am sorry, but the provided text from the FDA letter regarding the Adjustable Multi-Catheter Source Applicator (K062241) does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The letter is a 510(k) substantial equivalence determination. It primarily:
- Confirms the device is substantially equivalent to a legally marketed predicate device.
- States the device's indications for use.
- Imposes a specific labeling limitation (a "black box warning") about the device's safety and effectiveness not being established for use as a replacement for whole breast irradiation in the treatment of breast cancer. This explicitly indicates a lack of such evidence for this specific use case.
- Outlines general regulatory requirements for the manufacturer.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study proving device performance using the provided text. The document does not contain this type of information.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2007
Mr. Leigh Spotten Director of Ouality and Regulatory Affairs North American Scientific, Inc. 20200 Sunburst Avenue CHATSWORTH CA 91311
Re: K062241
Trade/Device Name: Adjustable Multi-Catheter Source Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 11, 2006 Received: October 12, 2006
Dear Mr. Spotten:
This letter corrects our substantially equivalent letter of November 9, 2006.
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of the Adjustable Multi-Catheter Source Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
The Warning must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings.
{1}------------------------------------------------
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K06224
Device Name: _ Adjustable Multi-Catheter Source Applicator
Indications for Use:
The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062241
Page 1 of 1
Page 12 of 35
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, 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 II.