(37 days)
Not Found
Not Found
No
The summary describes a physical medical device (brachytherapy needle kit) and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is indicated for interstitial implantation to treat localized tumors, which is a therapeutic intervention.
No
Explanation: The device is a Brachytherapy Preloaded Needle Kit, indicated for interstitial implantation of tumors as a treatment modality, not for diagnosing conditions.
No
The device description is not found, but the intended use clearly describes a "Brachytherapy Preloaded Needle Kit," which is a physical medical device used for interstitial implantation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the interstitial implantation of radioactive sources to treat tumors. This is a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a therapeutic device used in brachytherapy, a form of radiation therapy.
N/A
Intended Use / Indications for Use
The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
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
head, neck, lung, pancreas, breast, cervix and prostate
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle symbol with three flowing lines, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Leigh Spotten Director of Quality and Regulatory Affairs North American Scientific, Inc. 20200 Sunburst Avenue CHATSWORTH CA 91311
APR 2 1 2006
Re: K060679
Trade/Device Name: Surtrak® Implantation Kit Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 14, 2006 Received: March 22, 2006
Dear Mr. Spotten:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a circular logo with the text "1906 2006" at the top and "FDA Centennial" in the middle. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text, but the text is not clear enough to read.
Promoting Public Health
1
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 (OS) 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
2
Indications for Use
510(k) Number (if known):
Device Name: SurTrak Implantation Kit
Indications for Use:
The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
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)
Thari Guadar
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) NumberK060679
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