MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES

K021286 · Nucletron Corp. · JAQ · May 23, 2002 · Radiology

Device Facts

• Record ID: K021286
• Device Name: MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: May 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is 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.

Device Story

The microSelectron HDR-GENIE is an entry-level remote-controlled afterloading system for radiotherapy. It utilizes a radionuclide source to deliver radiation to a patient. The system features three treatment channels and is operated via a PC-based console running dedicated Treatment Console Software. A separate, independent software program on the same console performs radiotherapy treatment planning; plans are transferred to the console software via file transfer. The device is standalone, with LAN connectivity restricted to treatment plan file transfers. It is operated by clinical staff in a radiotherapy setting. By automating the placement of the radionuclide source, the device allows for precise radiation delivery while protecting the operator from radiation exposure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Remote-controlled afterloading system; 3 treatment channels; PC-based operator console; standalone architecture with LAN for file transfer; utilizes existing microSelectron-HDR V2 applicators and transfer tubes.

Indications for Use

Indicated for patients requiring radiation therapy via remote controlled application of a radionuclide source into or onto the body. Prescription use only.

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

• microSelectron-HDR V2 (K953946)

Submission Summary (Full Text)

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K021286
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MAY 2 3 2002 Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002

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NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone [phone] [phone] Fax

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

### Submitter of 510(k):

| Company name: | Nucletron Corporation |
|----------------------|---------------------------------------------------------|
| Registration number: | 1121753 |
| Address: | 7080 Columbia Gateway Drive<br>Columbia, MD 21046-2133 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

### Modified Device Name:

| Trade/Proprietary Name: | microSelectron®HDR - GENIE Afterloading System |
|-------------------------|------------------------------------------------|
| Common/Usual Name: | Remote Controlled Afterloading System |
| Classification Name: | Radiotherapy Device |
| Classification: | Class II |

### Legally Marketed Device(s)

Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

| | . Manufacturer | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| l Nucletron BV<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ' K953946 microSelectron-HDR V2<br>Comments of the first of the property would with the will and the comments of the first of the may be and<br>and the more of the completed of the first to the first and the first for the first and the many and the comments of the comments of the comments of the comments of the comme<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | K953946 |

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K021286
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## Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002 Description:

The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer.

The radiotherapy treatment planning software is covered by a separate 510(k) submission.

Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System.

The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

### Intended use:

The Nucletron microSelectron®HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited:

This device is 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.

## Summary of technological considerations:

The Nucletron microSelectron®HDR - GENIE Afterloading System is substantially equivalent to the cleared predicate device, microSelectron-HDR V2, 510(k)#: K953946.

Signature

10 APRIL 2002
Date

Name: F. van Krieken Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850

## MAY 2 3 2002

Ms. Lisa Dimmick Director Quality Assurance and Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133

Re: K021286

Trade/Device Name: MicroSelectron® HDR - GENIE Afterloading System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system

Regulatory Class: II Product Code: 90 JAQ Dated: April 10, 2002 Received: April 23, 2002

Dear Ms. Dimmick:

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 (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); 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 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 [phone] or [phone] 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

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NUMBER (IF KNOWN): K021286 510 (k)

MICROSELECTRON HDR-GENIE AFTERLOADING SYSTEM DEVICE NAME :

INDICATIONS FOR USE:

The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited.

This device is 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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