(132 days)
Not Found
Not Found
No
The 510(k) summary describes a brachytherapy source, a physical device for delivering radiation. There is no mention of software, image processing, AI, ML, or any data-driven components typically associated with AI/ML medical devices.
Yes
The device is described as being "intended to deliver radiation... for therapy of malignant lesions," which clearly indicates a therapeutic purpose.
No
The device is described as a brachytherapy source intended to deliver radiation for therapy, not for diagnosis.
No
The device description clearly identifies it as a physical brachytherapy source, which is a hardware component used to deliver radiation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "therapy of malignant lesions" by delivering radiation. This is a therapeutic application, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of such specimens.
The device described is a therapeutic medical device used for brachytherapy.
N/A
Intended Use / Indications for Use
The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant lesions.
Product codes
KXK
Device Description
I-125 Radionuclide Brachytherapy Source Model MED3631-A
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 a logo for the Department of Health and Human Services. The logo features a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH &" is arranged in a semi-circle around the left side of the logo. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1997
L. Michael Cutrer President, North American Scientific 7435 Greenbush Avenue North Hollywood, CA 91605
Re: K972271 I-125 Radionuclide Brachytherapy Source Model MED3631-A Dated: September 12, 1997 Received: September 15, 1997 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK
Dear Mr. Cutrer:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the including 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,
William 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
Image /page/1/Picture/0 description: The image shows the logo for North American Scientific. The logo consists of a stylized "N" on the left, followed by the words "NORTH AMERICAN" in large, bold letters. Below that, the word "SCIENTIFIC" is written in a smaller, pixelated font.
INDICATIONS FOR USE STATEMENT
501 (k) Number (If know) :
Not Applicable
Device Name :
Indications For Use :
I-125 Radionuclide Brachytherapy Source Model MED3631-A
The North American Scientific Corporation's I-125 Radionuclide Brachytherapy Source Model MED3631-A is a device intended to deliver radiation by interstitial intracavity or surface application for therapy of malignant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . lesions.
Signature
Signature
L. Michael Cutrer Printed Name
President Title
June 9, 1997 Date
David A. Lessem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)