(43 days)
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No
The provided text describes a brachytherapy needle kit and its intended use, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used for interstitial implantation to treat localized tumors, which is a therapeutic application.
No
Explanation: The device is described as a "Brachytherapy Preloaded Needle Kit" for "interstitial implantation" to treat tumors, indicating it is a therapeutic device, not a diagnostic one. Its purpose is treatment, not diagnosis.
No
The device description clearly indicates 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 clearly describes a device used for interstitial implantation of radioactive sources directly into tumors within the body. This is a therapeutic procedure performed in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed in vitro (outside the body).
The description of the device's function and application falls squarely within the realm of therapeutic medical devices used in vivo, not diagnostic tests performed in vitro.
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 as the sole treatment for tumors or for residual disease after excision of the primary tumor, or for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. Implants are used in conditions where low dose rate (LDR) brachytherapy is prescribed; typical primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix, and prostate, and unresectable tumors.
Product codes
KXK
Device Description
nStrand Implantation Kit
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
head, neck, lung, pancreas, breast, cervix, prostate
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem that resembles a bird with three curved lines forming its body and wings. The emblem is positioned in the center of the circle.
SEP - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Leigh Spotten Director of Quality and Regulatory Affairs North America Scientific, Inc. 20200 Sunburst Avenue CHATSWORTH CA 91311
- Re: K052024 Trade/Device Name: nStrand Implantation Kit Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 25, 2005 Received: August 1, 2005
Dear Ms. 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.
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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin mance.org of substantial equivalence of your device to a legally premarket nothleation: "The I DA mainly or cassification 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 If you desire spective advice for your de room 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 Also, please note the regulation entitle, "hisorized on your responsibilities under the Act from the 807.97). Tou may obtain other general mirenational 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
X052024 510(k) Number (if known):
Device Name: __nStrand 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. interstitlar impramation of soloc tootment for tumors such as those in the head, neck, They are used entifical primally freadinent for lamors or for residual disease
lung, pancreas, breast, cervix and prostate and unresectable turners Prelocated lung, pancteas, breast, cervix and product and answerican Scientific Brachytherapy Preloaded after excision of the primary tamon r use with or at the completion of other treatment Necule Kit miptants are mal 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)
David b. Lyonn
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number
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