ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068

K983337 · Nucletron Corp. · JAQ · Apr 2, 1999 · Radiology

Device Facts

• Record ID: K983337
• Device Name: ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The Nucletron Rotterdam Nasopharynx Mould Set is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Device Story

The Rotterdam Nasopharynx Mould Set is a brachytherapy applicator accessory for Nucletron remote afterloading systems (mHDR, mHDR-Classic, mPDR). The device is inserted into the patient's mouth and positioned within the nasopharynx cavity using guidance tubes. Once immobilized, treatment catheters are inserted. Clinicians obtain radiographic images (CT, MR, or planar films) to verify applicator location for treatment planning. The applicator connects to the remote afterloading unit via transfer tubes. A check cable run ensures path patency before the radioactive source is stepped through the applicator to deliver the prescribed radiation dose. The device acts as a closed system to prevent radioactive source contact with body fluids. It does not control the treatment unit but provides a physical path for the source. Used in clinical settings by trained medical professionals to facilitate targeted radiation therapy for nasopharyngeal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Brachytherapy applicator accessory; closed system design; utilizes guidance and transfer tubes for connection to remote afterloading equipment (mHDR, mHDR-Classic, mPDR).

Indications for Use

Indicated for patients requiring intracavitary nasopharynx brachytherapy procedures. Used by trained medical professionals to deliver prescribed radiation doses via remote afterloading equipment.

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

• Standard Nasopharyngeal Applicator Set (K953946)

Submission Summary (Full Text)

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4/2/99

Premarket Notification Nucletron Rotterdam Nasopharynx Mould Set Date : 18. September 1998

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font next to a square graphic. The graphic contains a black shape with two white circles inside of it. The black shape is in the center of the square and the white circles are on opposite sides of the shape.

K983337

## 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 Center of Device and Radiological Health Office of Device Evaluation Pre-Market Notification Section

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

## as required by section 807.92(c)

#### Submitter of 510(k) a.

| Company name: | Nucletron Corporation |
|-----------------|-----------------------------|
| Registration # | 1121753 |
| Address: | 7080 Columbia Gateway Drive |
| | Columbia, MD 21046-2133 |
| Contact Person: | Ralph E. Shuping |
| | Regulatory Affairs Manager |
| Phone:. | 410-312-4100 |
| Fax: | 410-312-4197 |

Device Name:

| Trade/Proprietary Name: | Rotterdam Nasopharynx Mould Set |
|-------------------------|-----------------------------------------------|
| Common/Usual Name: | Remote Afterloading Intracavitary Nasopharynx |

Classification Name:

Accessory to remote afterloader 21 CFR 892.5700, Class II.

Brachytherapy Applicator

#### Legally Marketed Predicate Device(s) C.

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

| Manufacturer | Device | 510(k) # |
|--------------|----------------------------------------|----------|
| Nucletron BV | Standard Nasopharyngeal Applicator Set | K953946 |

#### Description d.

b.

The Nucletron Rotterdam Nasopharynx Mould as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures.

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# Premarket Notification

## Nucletron Rotterdam Nasopharynx Mould Set

Date : 18. September 1998

The Nucletron Rotterdam Nasopharynx Mould Set is inserted into the mouth and positioned within the nasopharynx cavity with the assistance of guidance tubes. Once in position, it is immobilized and treatment catheters are inserted. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete. the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient.

The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit: it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.

#### e. Intended use

Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

#### f. Summary of technological considerations

The Nucletron Rotterdam Nasopharynx Mould Set is substantially equivalent to the predicate device. It combines the functionality, components and design of the predicate device while incorporating a new material.

Name: L. A. Johnson Title Product Manager Nucletron BV Veenendaal Netherlands

21-Sept-98

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy base. The logo is rendered in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1999

Ralph E. Shuping, Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Dr. Columbia, MD 21046

Re:

K983337 Nucletron Rotterdam Nasopharynx Mould Set Dated: January 18, 1999 Received: January 19, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ

Dear Dr. Shuping:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 III (Special Controls) or dass 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 Requlations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CART Daniel O. Schultz, M.D.

APT Daniel G. Schultz, M.D. Acting Director. Division of Reproductive. Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Nucletron Rotterdam Nasopharynx Mouid Set Date : 18, September 1998

Image /page/3/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles on either side. The square is outlined in black. The text is aligned to the right of the square.

### NUCLETRON B.V.

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

Department of Health and Human Services Center of Device and Radiological Health Office of Device Evaluation Pre-Market Notification section

## Statement of intended use

Device Name:

Rotterdam Nasopharynx Mould Set

### Intended use

Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

## Prescription use

The Nucletron Rotterdam Nasopharynx Mould Set is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Signature:

2/-Sept-98
Date

Name L. A. Johnson Product Manager Title Nucletron BV Veenendaal Netherlands

Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Dev

510(k) Number K983337

Prescription Use Fer 21 CFR 801.109)