Vienna System

K142597 · Mick Radio-Nuclear Instruments, Inc. · JAQ · Feb 19, 2015 · Radiology

Device Facts

• Record ID: K142597
• Device Name: Vienna System
• Applicant: Mick Radio-Nuclear Instruments, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Feb 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix. The Viema System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. Pre-bent interstital needles are intended to be used with the Vienna System but they are not manufactured by Nfick Radio-Nuclear Instruments, Inc. and are not part of this submission.

Device Story

The Vienna System is an accessory for the Mick CT HDR Tandem/Ring Applicator used in brachytherapy. It consists of perforated Build-Up Caps (5.0mm and 7.5mm) and Needle Collectors (30°, 45°, 60°). The system enables the insertion of up to nine rigid interstitial needles around the ring circumference to achieve asymmetric dose distribution. The clinician attaches the caps and collectors to the existing applicator; the collectors stabilize and organize the needles at the insertion site. The device does not modify the radiation source or after-loader mechanism. It is used in a clinical setting by radiation oncologists or medical physicists to improve treatment precision for uterine and cervical cancer. The system is incompatible with rectal retractors.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Acetal (Build-Up Caps), Titanium (Tandem/Colpostat), PPSU (Needle Collector). Design: Perforated caps with 9-hole array for interstitial needle guidance. Connectivity: Mechanical accessory to existing HDR applicator. Sterilization: Not specified. Energy: Passive mechanical guidance for radioactive sources.

Indications for Use

Indicated for High Dose Rate (HDR) brachytherapy irradiation of the uterus and cervix in patients requiring enhanced dose distribution via interstitial needles.

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

• CT HDR Tandem/Ring Applicator with Rectal Retractor (K030110)
• HDR CT Compatible Tandem/Ring Applicator with 2 Piece Rectal Retractor (K122840)
• Nucletron Vienna Ring CT-MR Applicator (K080934)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2015

Mick Radio-Nuclear Instruments, Inc. % Mr. Chuck Smith Manager, Quality Assurance 521 Homestead Avenue MOUNT VERNON NY 10550

Re: K142597

Trade/Device Name: Vienna System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 9, 2015 Received: January 12, 2015

Dear Mr. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

for

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K142597

Device Name Vienna System

### Indications for Use (Describe)

The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix. The Viema System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. Pre-bent interstital needles are intended to be used with the Vienna System but they are not manufactured by Nfick Radio-Nuclear Instruments, Inc. and are not part of this submission.

### Build-Up Caps

When used with the CT HDR Tandem/Ring Applicator, the Vienna Build-Up Caps enable the introduction of up to nine (9) interstital needles around the circumference of the ring to enhance the standard HDR treatment. The Viema System is not designed to be used with any Rectal Retractor due to the introduction of the interstitial needles.

### Needle Collectors

When used in conjunction with the Vienna Build-Up Caps, the Needle Collectors will maintain and control the positioning of an array of up to nine (9) interstitial needle Collectors are part of the Vienna System ans as such, are not designed to be used with any Rectal Retractor.

The Vienna System is designed to be used as an accessory with the Applicator and this does not alter the indications for use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

[2] Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol on the left, followed by the company name "Eckert & Ziegler" in black text. The symbol is made up of two horizontal bars with an oval in the middle.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

# Traditional 510(k) Summary for compliance with CFR 807.92

September 12, 2014

- 1. General Provisions

| Trade/Proprietary:<br>Name | Vienna System. |
|----------------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name: | Brachytherapy Applicator |
| Classification<br>Name: | Accessory to Remote Controlled Radionuclide Applicator<br>System (21 CFR 892.5700 - Product Code JAQ) |
| Owner<br>Name<br>Address | Mick Radio-Nuclear Instruments,<br>Inc. 521 Homestead Avenue<br>Mount Vernon, New York<br>10550 [phone] |
| Fax<br>Contact Name | [phone]<br>Chuck Smith<br>Manager, Quality Assurance / Regulatory |
| Contact email | Affairs [e-mail] |

- 2. Device Name: Vienna System
#### Name of Predicate Device: 3.

The device included in this submission are substantially equivalent to the legally marketed predicate devices cited in the following table:

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Image /page/4/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol on the left and the company name "Eckert & Ziegler" on the right. The symbol is made up of a maroon rectangle on top, a maroon oval in the middle, and another maroon rectangle on the bottom. The text is in a simple, sans-serif font.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

| New Device | Predicate Device | Manufacturer | K Number |
|--------------------------------|------------------------------------------------------------------------------|-------------------------------------------|----------|
| Vienna System<br>(Cat. # 0720) | CT HDR Tandem/Ring<br>Applicator with Rectal Retractor | Mick Radio-<br>Nuclear | K030110 |
| | HDR CT Compatible<br>Tandem/Ring Applicator with 2<br>Piece Rectal Retractor | Mick Radio-<br>Nuclear<br>Instruments Inc | K122840 |
| | Nucletron Vienna Ring CT-<br>MR Applicator | Nucletron B. V. | K080934 |

#### 4. Reason for this Traditional 510(k) Premarket Notification

The purpose of this 510(k) submission is to obtain clearance to market a new device that is designed to be used with the Mick CT HDR Tandem/Ring Applicator with Rectal Retractor (Catalog # 0407). The accessories enhance the CT HDR Tandem/Ring Applicator, without changing the intended use of the applicator.

#### 5. Classification

The device is classified as a class II device according to 21 CFR 892.5700.

#### 6. Intended Use and Device Description

The device that is submitted for clearance in this 510(k) is intended to be used with the Mick Radio-Nuclear Instruments, Inc. CT HDR Tandem/Ring Applicator with Rectal Retractor and is intended for use in Brachytherapy. It is indicated for use where high dose rate (HDR) irradiation of the uterus and cervix is an accepted clinical practice. The applicator is designed to be compatible with the sealed sources found in High Dose Rate After-Loaders and does not modify or change the source, source packaging or remote source positioning mechanisms found on these after-loaders.

The use of the Vienna System with the CT HDR Tandem / Ring Applicator does not alter the intended use of the applicator. There are no special controls needed for this device.

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Image /page/5/Picture/0 description: The image contains the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol to the left of the company name. The symbol is made up of a maroon oval shape between two maroon rectangles.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor.

The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems.

Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap. The inserted needles can be clipped to the Needle Collector to provide an easy means of indexing and organizing the needles and to ensure needle stabilization at the insertion site. When used with rigid interstitial needles, it is possible to achieve asymmetric alteration of the dose distribution. Rigid interstitial needles are not supplied by Mick Radio-Nuclear Instruments, Inc. and must be purchased separately.

#### 7. Drawings

Drawings of each of the components of the Vienna System are provided in Vol 9.

#### 8. Manufacturing Process

The Vienna System is manufactured according to Good Manufacturing Practices (GMPs) as defined in 21CFR part 820. The processes used to fabricate these accessories are similar to those used for the predicate device described in this 510(k) notification.

#### 9. Biocompatibility

No new issues of biocompatibility are raised with regard to the use of materials in manufacturing the Vienna System.

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Image /page/6/Picture/0 description: The image contains the logo for Eckert & Ziegler. The logo consists of a maroon-colored symbol to the left of the company name. The symbol is made up of a maroon oval shape between two maroon rectangles.

521 Homestead Ave Mount Vernon, NY 10550 USA www.micknuclear.com

#### 10. Summary of Substantial Equivalence

The Vienna System is similar in design and construction, utilizes the same materials, and has the same intended use and performance characteristics of the predicate devices. The fundamental scientific technology is unchanged from the original predicate devices. No new issues of safety or effectiveness are introduced by using this device. Therefore, Performance Test Results or In vitro Testing / In vivo Testing are not applicable to the Vienna System. By introducing the Vienna Systems, no new issues of safety or effectiveness are raised.

#### 11. Comparison Table

The tables below compare the individual accessory to its predicate device. tables are a comparison of the materials and intended uses of these devices.

| Device / Trade<br>Name | CT HDR<br>Tandem/ Ring<br>Applicator w/<br>Rectal<br>Retractor | Nucletron Vienna<br>Ring CT-MR<br>Applicator | HDR CT<br>Compatible<br>Tandem/ Ring<br>Applicator w/ 2<br>Piece Rectal<br>Retractor | Vienna<br>System |
|-----------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| K Number | K030110 (Mick<br>Radio Nuclear) | K080934<br>(Nucletron) | K122840 (Mick<br>Radio-Nuclear) | To be<br>determined |
| Intended Use | High dose rate<br>Brachytherapy<br>treatment of the<br>uterus and<br>cervix | High dose rate<br>Brachytherapy<br>treatment of the<br>uterus and cervix | High dose rate<br>Brachytherapy<br>treatment of the<br>uterus and cervix | High dose rate<br>Brachytherapy<br>treatment of the<br>uterus and<br>cervix |
| Shielding | No | No | No | No |
| Build-Up Cap<br>Material | Acetal | Acetal | Acetal | Acetal |
| Colpostat /<br>Tandem Mat'I | Titanium | Composite Fiber<br>Tubing | Titanium | Titanium |
| Needle<br>Collector Mat'l | N/A | N/A | N/A | PPSU |

## Vienna System (Catalog # 0720)