HDR IORT SHIELDED APPLICATOR

K052351 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Oct 17, 2005 · Radiology

Device Facts

• Record ID: K052351
• Device Name: HDR IORT SHIELDED APPLICATOR
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.

Device Story

The Mick HDR IORT Shielded Applicator is a mechanical accessory used in high dose rate (HDR) brachytherapy. It provides a stable, reproducible, and predictable geometry for positioning radioactive sources during superficial or intraoperative cancer treatments. The device is used by clinicians in a clinical setting to facilitate precise radiation delivery via remote after-loading systems. It does not contain electronic components or software; it functions as a physical guide for the radioactive source. By ensuring accurate source placement, the device assists the healthcare provider in delivering targeted radiation therapy, potentially improving treatment outcomes for cancer patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical applicator for HDR brachytherapy. Materials and construction are identical to predicate devices. No energy source, software, or electronic components. Designed for manual positioning of radioactive sources.

Indications for Use

Indicated for use as an accessory/applicator for positioning HDR Remote After-Loader sealed sources for superficial or intraoperative radiation therapy in cancer patients.

Regulatory Classification

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.

Predicate Devices

• Mick H.A.M Applicator (K961601)
• Mick Shielded Vaginal Applicator (K001544)
• Mammo Site RTS (K011690 & K030558)

Submission Summary (Full Text)

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# 0C1 ] 7 2005

K05235/

# Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

### May 6, 2005

#### General Provisions 1.

Remote Controlled Radionuclide Applicator System Common/Usual Name:

Mick HDR IORT Shielded Applicator Proprietary Name:

Applicant Name and Address:

Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon. New York 10550

#### Name of Predicate Devices: 2.

(1)

| Device | Manufacturer | K Number |
|----------------------------------|-----------------------------------------|-------------------|
| Mick H.A.M Applicator | Mick Radio-Nuclear Instruments,<br>Inc. | K961601 |
| Mick Shielded Vaginal Applicator | Mick Radio-Nuclear Instruments,<br>Inc | K001544 |
| Mammo Site RTS | Proxima Therapuetics, Inc. | K011690 & K030558 |

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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#### Classification 3.

:

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 5.

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below.

| Device | Manufacturer | K Number |
|-------------------------------------|--------------------------------------|-------------------|
| Mick H.A.M Applicataor | Mick Radio-Nuclear Instruments, Inc. | K961601 |
| Mick Shielded Vaginal<br>Applicator | Mick Radio-Nuclear Instruments, Inc. | K001544 |
| Mammo Site RTS | Proxima Therapuetics, Inc. | K011690 & K030558 |

The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment 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 Mick HDR IORT Shielded Applicator is designed to act as such a device.

#### Biocompatibility 6.

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.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue

MOUNT VERNON NY 10550

Re: K052351 Trade/Device Name: MICK HDR IORT Shielded Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 26, 2005 Received: August 30, 2005

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.

OCT 17 2005

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.

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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.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 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 [phone] or [phone] 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

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### Indications for Use

510(k) Number: To be assigned

K052351

Device Name: MICK HDR IORT Shielded Applicator

Indications for Use:

The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been I he MOR TIDE TOR "Steessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.

Concurrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use: 6

()r

(Per 21 CFR 801.109) Over-The Counter Use: __

- (Ter 21 CFR 801.109)

Nancy Hodgson

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(Division Sign-Off)

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number_