(44 days)
Not Found
No
The summary describes a physical applicator for radiation therapy and makes no mention of AI or ML technology.
Yes
The device is used for high dose rate (HDR) radiation treatment of cancer, indicating a therapeutic application.
No
The description states that the device is an applicator for high dose rate radiation treatment of cancer, specifically for positioning HDR Remote After-Loader sealed sources. Its function is to facilitate the delivery of radiation therapy for treatment, not for diagnosis.
No
The device description clearly describes a physical applicator designed for positioning radioactive sources, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for positioning radiation sources for the treatment of cancer in the cervix and uterus. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a system for positioning sealed radiation sources for HDR brachytherapy. This is a treatment delivery device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
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.
N/A
Intended Use / Indications for Use
The CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
Product codes
JAQ
Device Description
The CT Compatible F/S/D Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is the similar to that of the predicate devices listed below.
The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The CT Compatible F/S/D Applicator is designed to act as such a device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervix or Uterus
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)
K955844, K913908, K030110, K040704
Reference Device(s)
Not Found
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
OEL 2 2 2006
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
November 2, 2006
1. General Provisions
Common/Usual Name: Remote Controlled Radionuclide Applicator System
CT Compatible F/S/D Applicator Proprietary Name:
Applicant Name and Address:
Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550
2. Name of Predicate Devices:
- (1)
| Device | Manufacturer | K Number |
|---|---|---|
| Applicators for Varian Varisource | ||
| Remote High Dose Rate | ||
| Afterloaders | Varian Associates, Inc. | K955844 |
| OMNITRON Gyn Applicator | ||
| System | OMNITRON Intl, Inc. | K913908 |
| CT HDR Tandem / Ring | ||
| Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, | |
| Inc. | K030110 | |
| HDR Compatible Tandem & | ||
| Ovoid Applicators | Mick Radio-Nuclear Instruments, | |
| Inc. | K040704 |
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.
5. Intended Use and Device Description
The CT Compatible F/S/D Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is the similar to that of the predicate devices listed below.
| Device | Manufacturer | K Number |
|---|---|---|
| Applicators for Varian Varisource | ||
| Remote High Dose Rate | ||
| Afterloaders | Varian Associates, Inc. | K955844 |
| OMNITRON Gyn Applicator | ||
| System | OMNITRON Intl, Inc. | K913908 |
| CT HDR Tandem / Ring | ||
| Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, | |
| Inc. | K030110 | |
| HDR Compatible Tandem & | ||
| Ovoid Applicators | Mick Radio-Nuclear Instruments, | |
| Inc. | K040704 |
The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The CT Compatible F/S/D Applicator is designed to act as such a device.
6. Biocompatibility
No new issues of biocompatibility are raised with regard to this device.
Summary of Substantial Equivalence 7.
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 address for the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned. The image is a close-up of the address, with no other details visible.
DEC 2 2 2006 -
Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550
Re: K063381
Trade/Device Name: CT F/S/D Compatible Applicators Regulation Number: 21 CFR 892.55700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 2, 2006 Received: November 8, 2006
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 (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/2/Picture/9 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906-2006. The letters "FDA" are in the center of the logo in a bold, stylized font. The word "Centennial" is written below the letters "FDA".
Protecting and Promoting Public Health
3
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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 KD6338 I
Device Name: CT Compatible F/S/D Applicators
Indications for Use:
The CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use:_V
Over-The Counter Use: ____ (Per 21 CFR 801.109)
David W. Simpson
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
CT Compatible F/S/D Applicator - 510(K)