MICK HDR INTERSTITIAL IMPLANT ACCESSORIES

K051423 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Jul 1, 2005 · Radiology

Device Facts

• Record ID: K051423
• Device Name: MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas.

Device Story

Mick HDR Interstitial Implant Accessories consist of needles, catheters, and fixation buttons used as applicators for HDR remote after-loading brachytherapy. The system guides and positions radioactive sealed sources within a treatment volume to provide precise dosimetry and stable delivery. Used in clinical settings by healthcare professionals for treating oral cavity, oropharyngeal, head and neck, and soft tissue cancers. The device facilitates the delivery of radiation therapy by ensuring the radioactive source is accurately placed, enabling effective tumor treatment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System consists of needles, catheters, and fixation buttons. Functions as an applicator for HDR remote after-loading brachytherapy. Materials are identical to predicate devices. No software or electronic components.

Indications for Use

Indicated for the positioning of HDR Remote After-Loader sealed sources for the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck, and soft tissue sarcomas.

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 TP Needle (K890341)
• Afterloading Catheter Set (K811279)
• Interstitial Implant Set (K933400)

Submission Summary (Full Text)

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K051423

## JUL 1 - 2005

# 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 Interstitial Implant Accessories 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 TP Needle | Mick Radio-Nuclear Instruments,<br>Inc. | K890341 |
| Afterloading Catheter Set | Mick Radio-Nuclear Instruments,<br>Inc | K811279 |
| Interstitial Implant Set | Best Medical Industries | K933400 |

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can substantial equivation to thout 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 product can be lawfully marketed without pre-market approval or the the product - can - be - anination 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 Ferrormalice Samularus 101 upplication 514 of the Food, Drug and Cosmetic Act.

#### Intended Use and Device Description 5.

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and The Mick Tibly Interstitude in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas. The design of these systems is the similar to that of the predicate devices listed below.

| Device | Manufacturer | K Number |
|---------------------------|--------------------------------------|----------|
| Mick TP Needle | Mick Radio-Nuclear Instruments, Inc. | K890341 |
| Afterloading Catheter Set | Mick Radio-Nuclear Instruments, Inc | K811279 |
| Interstitial Implant Set | Best Medical Industries | K933400 |

The delivery of radiation therapy via high dose rate Brachytherapy requires the ability to I he deli guide and position the radioactive source under remote control so that the sealed propony garee contained within the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick HDR Interstitial Implant Accessories are designed to act as such.

#### 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 and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 - 2005

Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue MOUNT VERNON NY 10550

Re: K051423 Trade/Device Name: MICK HDR Interstitial Implant Accessories Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ

Dated: May 16, 2005 Received: June 6, 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.

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) I ms letter will anow you to ought thating of substantial equivalence of your device to a legally premarket nothreation: "The Premient of 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 n you desire specific arrive as 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 Alloy, production other general information on your responsibilities under the Act from the 601:57). " For may overnments, 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. Brogdon

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

KOSI423

Device Name: MICK HDR Interstitial Implant Accessories

### Indications for Use:

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation as The Mick HDR Intersitial Implant Recossons (contribution have been developed to function as buttons) presented in the positioning of HDR Remote After-Loader sealed sources in the accessories/applicators for the positioning of ITD's removed and neck and neck and soft tissue sarcomas.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_

or

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

Nancy Brogdon
(Division Sign-Off)

Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
2051423