STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE

K983341 · Nucletron Corp. · JAQ · Apr 15, 1999 · Radiology

Device Facts

• Record ID: K983341
• Device Name: STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy. The applicators provide 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.

Device Story

Intracavitary applicator sets (Vaginal, Standard, Ring, Fletcher-Williamson) function as accessories to Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR). Applicators are inserted into body cavities (cervix, endometrium, vagina, rectum) and immobilized. Clinicians obtain radiographic images (CT/MR) to determine applicator location for treatment planning. Once positioned, applicators connect to the afterloading unit via transfer tubes. A check cable verifies path patency before the radioactive source is delivered through the applicator to the treatment site. The system is a closed loop, preventing source contact with body fluids. Applicators do not control the treatment unit; they provide a physical path for radiation delivery. Used in clinical settings by specialized staff.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intracavitary applicators for remote afterloading. Materials modified for CT/MR compatibility. Closed-system design for radioactive source containment. Connects to Nucletron mHDR/mPDR units via transfer tubes. Mechanical device; no software or energy source integral to the applicator itself.

Indications for Use

Indicated for patients requiring intracavitary brachytherapy for gynecological treatment of the cervix, endometrium, vagina, or rectum using Nucletron 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 Applicator Set (K953946)
• Ring Applicator Set (K953946)
• Vaginal Applicator Set (K953946)
• Standard Shielded Applicator Set (K953946)

Submission Summary (Full Text)

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Premarket Notification Nucletron Intracavitary Applicator Sets Date : 18, September 1998

APR 15

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square containing a black circle with two white circles overlapping it. The black circle is positioned diagonally within the square. The overall design is simple and clean, with a focus on the company name.

# NUCLETRON B.V.

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

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

K983341

# 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: b.

| Trade/Proprietary Name: | Vaginal CT/MR Applicator Set, Standard CT/MR Applicator Set, and Ring CT/MR Applicator Set |
|-------------------------|--------------------------------------------------------------------------------------------|
| | Fletcher-Williamson Applicator Set |
| Common/Usual Name: | Intracavitary Remote Afterloading Applicators |
| Classification Name: | Accessory to remote afterloader |
| | 21 CFR 892.5700, Class II. |

# Legally Marketed Predicate Device(s) C.

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

| Manufacturer | Device | 510(k) # |
|--------------|----------------------------------|----------|
| Nucletron BV | Standard Applicator Set | K953946 |
| Nucletron BV | Ring Applicator Set | K953946 |
| Nucletron BV | Vaginal Applicator Set | K953946 |
| Nucletron BV | Standard Shielded Applicator Set | K953946 |

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Premarket Notification Nucletron Intracavitary Applicator Sets Date : 18, September 1998

## Description ರ.

The Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson, as described in this submission are designed as accessories to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy procedures. Standard CT/MR, Ring CT/MR and Fletcher-Williamson Applicator Sets can be used for gynecological treatment of the cervix and endometrium. The Vaginal CT/MR can be used for treatment of the vagina, rectum and endometrium.

The Nucletron Intracavitary Applicator Sets are inserted into the body and immobilized. 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. These 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 are 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

### Intended use e.

Nucletron Intracavitary Applicator Sets: Vaginal CT/MR, Standard CT/MR, Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy. The applicators provide 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 Intracavitary Applicator Sets: Vaginal CT/MR. Standard CT/MR. Ring CT/MR and Fletcher-Williamson are substantially equivalent to the predicate devices. Thev combine the functionality, components and design of the predicate devices while incorporating a new material.

Lu Ann Johnson

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

21-Sept-98

Date

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 1999

Ralph Shuping, Sc.D. Regulatory Affair Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133

Re:

K983341 Vaginal, Standard and Ring CT/MR, & Fletcher-Williamson Applicator Sets Dated: January 22, 1999 Received: January 25, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAO

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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 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,

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

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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Page_of_of____________________________________________________________________________________________________________________________________________________________________

K83341

510(k) Number (if known) :.

Nucletron Intracavitary Applicator Sets: Nuclearon Thru Gouvillary : Spinstant, Ring CT/MR and Fletcher-Williamson Device Name:

Indications For Use:

Nucletron Intracavitary Applicator Sets: Vacinal CT/MR. Standard CT/MR. Ring CT/MR and Fletcher-Williamson are intended for use with the Nucletron remote afterloading equipment, mHDR, mHDR-Classic and mPDR, for intracavitary brachytherapy. The applicators provide 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.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-----------------------------------------------------------------------|---------|-----------------------|
| <div align="center"> <img alt="signature" src="signature.png"/></div> | | |
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | | |
| 510(k) Number | K983341 | |
| Prescription Use_ | OR | Over-The-Counter Use_ |
| (Per 21 CFR 801.109) | | (Optional Format 1- |

(Optional Format 1-2-96)