(90 days)
No
The description focuses on a physical template and accessories for needle placement in brachytherapy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as supporting the delivery of radiation therapy, which is a treatment for cancer, directly indicating a therapeutic purpose.
No
The device is described as a template and accessories for holding needles for the delivery of radiation therapy (treatment), not for visualizing or localizing the treatment volume or diagnosing a condition.
No
The device description explicitly states it is a "template" and "implant accessories" designed to be attached to the patient and hold needles. This indicates a physical, hardware-based device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an accessory for High Dose Rate (HDR) Brachytherapy systems used for delivering radiation therapy directly to the prostate. It acts as a template and holder for needles used in this treatment.
- Lack of Sample Analysis: There is no mention of the device being used to analyze any biological samples from the patient. Its function is purely related to the physical delivery of radiation.
Therefore, the Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories fall under the category of a therapeutic device or an accessory to a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.
The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading. One common use of high dose rate remote afterloaders is in the treatment of cancer of the The system described in this 510(k) has been developed to work with commercially prostate. available high dose rate remote in the treatment of the Prostate.
Product codes
90 JAO
Device Description
The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K910862, K811280, K933410, K890341, K921886, K961601, K904005
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JAN - 6 2000
493400
Page 1 of 2
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
October 1, 1999
General Provisions 1.
| Common/Usual Name: | Applicator for Remote Controlled Afterloading
Brachytherapy | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------|--|--|--|--|--|
| Proprietary Name: | HDR Contour TP Template and Implant Accessories | | | | | |
| Applicant Name and Address: | Mick Radio-Nuclear Instruments, Inc.
1470 Outlook Avenue
Bronx, New York 10465 | | | | | |
2. Name of Predicate Devices:
- (1)
l
| Device | Manufacturer | K Number |
|---|---|---|
| Template | Best Industries Syed/Neblett Prostate Template | K910862 |
| Template | Mick Radio-Nuclear Instruments, Inc. Flex- | K811280 |
| Needles | Best Industries Flexi-Needle | K933410 |
| Mick Radio-Nuclear Instruments, Inc. Mick 200- | ||
| TP and Mick TP Needle | K890341 | |
| Needle Technologies Seed Implant Needle | K921886 | |
| Mick Radio-Nuclear Instruments, Inc. H.A.M. Applicator | K961601 | |
| Leg | ||
| Support | Huestis Medical Flexi-Board | K904005 |
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "...a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
1
K993480
Page 2082
3. Classification
This device is classified as a class II device according to 21 CFR 892.5700 .
4. Performance Standards
Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
క. Intended Use and Device Description
The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.
6. Biocompatibility
No new issues of biocompatability are raised with regard to this device.
7. Summary of Substantial Equivalence
This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract shapes resembling birds in flight, stacked vertically. The text is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2000
Felix Mick President Mick Radio-Nuclear Instruments, Inc. P.O. Box 99 Bronx, N.Y. 10465
Re:
K993400 HDR Contour TP Template System Dated: October 7, 1999 Received: October 8, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAO
Dear Mr. Mick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 requirements, as set forth in the Quality System Regulation (QS) 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 the Electronic Product 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 questions on the promotion 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
1933400 510(k) Number: To be assigned
Device Name: HDR Contour TP Template and Implant Accessories
Indications for Use:
The use of sealed Radioisotopes to treat tumors within the body has been documented and published since the turn of the century. Modern era Radiation Therapy has developed delivery systems using isotopes of Cesium, Iridium, Iodine, and Gold to name a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. Two common modalities for this are Low Dose Rate and High Dose Rate remote afterloading. One common use of high dose rate remote afterloaders is in the treatment of cancer of the The system described in this 510(k) has been developed to work with commercially prostate. available high dose rate remote in the treatment of the Prostate.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use: | ✓ or Over-The Counter Use: ______ (Per 21 CFR 801.109) |
|---|---|
| ------------------- | ------------------------------------------------------------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993400 |
HDR Contour TP Template and Accessories 510(K)