MICROSELECTRON HDR V2, MODEL 105.999

K092804 · Nucletron Corp. · JAQ · Oct 8, 2009 · Radiology

Device Facts

• Record ID: K092804
• Device Name: MICROSELECTRON HDR V2, MODEL 105.999
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: Oct 8, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

Device Story

MicroSelectron HDR Version 2 is a remote afterloading system for high dose rate (HDR) brachytherapy. It utilizes a single iridium-192 radioactive source to deliver radiation doses. The device operates via a workstation where treatment data is either entered or imported from a treatment planning system. It is used by clinicians to perform radiation therapy in clinical settings. The primary modification from the predicate is an increase in maximum source strength from 10 Ci to 12 Ci, allowing for higher dose rate delivery. The system enables precise, remote-controlled application of radiation to target tissues, minimizing radiation exposure to medical staff while providing therapeutic benefits to patients requiring localized radiation treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Remote-controlled radionuclide applicator system; utilizes iridium-192 radioactive source; maximum source strength 12 Ci (approx. 48,000 μGy.m²/h); workstation-based control; interfaces with external treatment planning systems.

Indications for Use

Indicated for patients requiring radiation therapy via remote-controlled radionuclide source application, including interstitial, intracavitary, intraluminal, bronchial, endovascular, intra-operative, or surface body applications.

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 Version 2 (K953946)

Reference Devices

• microSelectron_V3 (K061354)

Submission Summary (Full Text)

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Korssoy

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

## OCT - 8 2009

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

#### Submitter of 510(k):

Company name: Registration number: Address:

Phone: Fax: Correspondent:

Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Elaina Colby Manager Quality Assurance & Regulatory Affairs

#### Modified Device Name:

| Trade/Proprietary Name: | MicroSelectron HDR Version 2 |
|-------------------------|--------------------------------------------------|
| Common/Usual Name: | Afterloader |
| Classification Name: | Remote controlled radionuclide applicator system |
| Classification: | 21Cfr892.5700 Class II |
| Product Code | JAQ |

#### Legally Marketed Device(s)

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

| | . Manufacturer Same Calif. Device La Device La 200 10 510 K) 1 | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------|
| Nucletron BV<br>Comments of the control of the later the large of the comments of the comments of the comments of the contribution of the comments of the contribution of the contribution of | MicroSelectron HDR Version 2 | K953946 |

#### Description:

The microSelectron-HDR is a remote afterloading system for high dose rate brachytherapy treatment using a single iridium-192 radioactive source.

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The MicroSelectron-HDR delivers a radiation dose distribution conforming to treatment data, r he Miorooolouren . Alle workstation or imported from a treatment planning system.

The modifications to the cleared device k953946 are:

- Increase of maximum source strength for treatment of patients from 10 Ci (aprox. 40.000 . μGy.m²/h) to 12Ci (aprox. 48.000 μGy.m²/h).
#### Intended use:

The modified device has the same intended use as the legally marketed predicate device cited:

The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

### Summary of technological considerations:

MicroSelectron HDR Version 2 is substantially equivalent to the previously cleared device (K953946) and to the microSelectron_V3 (K061354).

Name: John Lapre

Aug 28, 2009
Date

Title: Vice President R&D Nucletron BAV. Veenendaal, The Netherlands

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Elaina M. Colby Manager, Quality Assurance & Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133

OCT = 8 2009

Re: K092804

Trade/Device Name: MicroSelectron HDR Version 2 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAO Dated: September 10, 2009 Received: September 11, 2009

Dear Ms. Colby:

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. Iisting 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 mav 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 of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 i of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting 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 Statement

MicroSelectron HDR Version 2

510(k) Number

K092804

Device Name

Indications for Use

The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number.