(92 days)
No
The summary describes a physical applicator for brachytherapy, focusing on its mechanical design and function in delivering radiation. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is described as an applicator for the "intracavitary treatment of cancer of the vagina and cervix," which clearly indicates a therapeutic purpose.
No
The device is an applicator used for delivering radiation therapy (brachytherapy) to cancer of the vagina and cervix. Its function is to position radioactive sources for treatment, not to diagnose a condition.
No
The device description explicitly states it is a physical applicator (Tandem and Ovoid Applicators) used in HDR Brachytherapy, which is a hardware component for delivering radiation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intracavitary treatment of cancer of the vagina and cervix" using "Remote After-Loader sealed sources." This describes a therapeutic device used for delivering radiation therapy directly to a tumor site within the body.
- Device Description: The description focuses on the physical design and function of applicators used to position radioactive sources for brachytherapy. It discusses linking to an HDR unit, positioning sealed sources, dosimetry, and stable delivery. These are all characteristics of a therapeutic radiation delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
Therefore, this device falls under the category of a therapeutic medical device, specifically for delivering radiation therapy, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371).
The applicators presented in this 510(k) notification have been developed to function as remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371). The design of these systems is the similar to that of the predicate devices listed below.
The delivery of radiation therapy to cervix via high dose rate Brachytherapy requires the ability to properly link the applicator to the HDR unit so that the radioactive source can be remotely positioned in the applicator along with the ability to properly localize the sealed sources at the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR compatible Tandem and Ovoid Applicators are designed to act as such a device and utilize the same design as previously cleared for other applicators manufactured by Mick Radio-Nuclear Instruments (Vaginal Applicator Set, Shielded, K001544, HDR Tandem/Ring Applicator with Rectal Retractor, K011657).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina and cervix
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.
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JUN 1 8 2004
Page 1 of 2
K040704
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
March 15, 2004
General Provisions 1.
| Common/Usual Name: | Remote Controlled Radionuclide Applicator System: |
|---|---|
| Proprietary Name: | Modified Henschke HDR Cervix Applicator |
| Hilaris/Nori HDR Cervix Applicator |
Applicant Name and Address:
Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, New York 10550
2. Name of Predicate Devices:
- (1)
| Model and Manufacturer | K Number |
|---|---|
| Henschke Applicator; Mick Radio-Nuclear Instruments, Inc. | K871217 |
| Hilaris/Nori Applicator; Mick Radio-Nuclear Instruments, Inc. | K891377 |
| Cervix Applicator; Varian Medical Systems, Inc. | K033371 |
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).
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Page 2 of 2
K040704
3. Classification
This device is classified as a class II device according to 21 CFR 892.5700 .
Performance Standards 4.
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 ડ.
The Mick Radio-Nuclear Instruments, Inc. HDR compatible Tandem and Ovoid Applicators are intended for use in HDR Brachytherapy as described for the predicate device (Cervix Applicator, Varian Medical Systems, K033371). The design of these systems is the similar to that of the predicate devices listed below.
| Predicate Device | Manufacturer | K Number |
|---|---|---|
| Henschke Applicator | Mick Radio-Nuclear Instruments, Inc. | K871217 |
| Hilaris/Nori Applicator | Mick Radio-Nuclear Instruments, Inc. | K891377 |
The delivery of radiation therapy to cervix via high dose rate Brachytherapy requires the ability to properly link the applicator to the HDR unit so that the radioactive source can be remotely positioned in the applicator along with the ability to properly localize the sealed sources at the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear HDR compatible Tandem and Ovoid Applicators are designed to act as such a device and utilize the same design as previously cleared for other applicators manufactured by Mick Radio-Nuclear Instruments (Vaginal Applicator Set, Shielded, K001544, HDR Tandem/Ring Applicator with Rectal Retractor, K011657).
6. Biocompatibility
No new issues of biocompatibility 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Eorporate Boulevard Rockville MD 20850
JUN 1 8 2004
Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550
Re: K040704 Trade/Device Name: HDR Compatible Tandem and Ovoid Applicators Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: March 15, 2004 Received: March 22, 2004
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 ar.d adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 that is a regulations 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.
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Page 2
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 the 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" (21CFR Part 807.97) you may obtain. 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 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
4
Indications for Use
510(k) Number: To be assigned K040704
Device Name: HDR Compatible Tandem and Ovoid Applicators
Indications for Use:
The applicators presented in this 510(k) notification have been developed to function as The applicators presonted in this 310(t), hemote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | ✓ |
|---|---|
| ------------------- | --- |
Over-The Counter Use: ____ (Per 21 CFR 801.109)
tion Use: V or
Daniel R. Gleason
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K04070
HDR Compatible Tandem and Ovoid Applicators - 510(k)