(80 days)
No
The 510(k) summary describes a physical applicator used in brachytherapy and makes no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is used to treat cancer, which falls under the definition of a therapeutic purpose.
No
Explanation: The device is an applicator used for delivering radiation therapy (brachytherapy) to treat cancer, not for diagnosing it. Its purpose is treatment administration, not diagnosis.
No
The device description clearly states it is an "applicator" and describes its physical placement and components (sleeves, interuterine tubes), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the applicator is designed as an accessory to systems that use a radioactive source to treat cancer. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the delivery of radiation therapy and the requirements for proper visualization, localization, dosimetry, and a stable delivery system for treatment. These are all related to therapy delivery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver radiation for treatment, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.
This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix via the vagina, a wide range of body sites (for the Varisource System and Gammamed System)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR = 8 2002
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
December 30, 2001
1. General Provisions
Common/Usual Name: Remote Controlled Radionuclide Applicator System
Proprietary Name:
HDR Miami Applicator
Applicant Name and Address:
Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550
2. Name of Predicate Devices:
- (1)
| Manufacturer | K Number |
|---|---|
| Nucletron Miami Vaginal Applicator | K953946 |
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
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.
Intended Use and Device Description న్.
The Mick Radio-Nuclear Instruments, Inc. HDR Miami Applicator is intended for use in Brachytherapy. The delivery of intra-cavitary radiation therapy requires not only proper visualization and localization of the applicator within the treatment volume, but precise dosimetry and a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR Miami Applicator meets these requirements.
Biocompatibility 6.
No new issues of biocompataibility 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 8 2002
Re: K020176
Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550
Trade/Device Name: HDR Miami Applicator HDR Brachytherapy Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system
Regulatory Class: II Product Code: 90 JAQ Dated: January 7, 2002 Received: January 18, 2002
Dear Mr. Mick:
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 (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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
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
4
Indications for Use
510(k) Number: To be assigned
KO 20176
Device Name: HDR Miami Applicator
Indications for Use:
This applicator is designed as an accessory to the Varisource System (Varian Associates K952913) and the Gammamed System (K891131/A) which uses a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites. The Miami Applicator is placed in the vicinity of the cervix via the vagina just as described for the predicate device (Nucletron Miami Vaginal Applicator, K953946) and different diameter sleeves and interuterine tubes, can be optimized to best meet the clinical needs of the patient along with minimization of dose to the mucosa.
Prescription Use ✓
Yurid A. Stepanov
(Division Sign Division of Rep and Radiologic 510(k) Numb