FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095

K983338 · Nucletron Corp. · JAQ · Apr 20, 1999 · Radiology

Device Facts

• Record ID: K983338
• Device Name: FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: Apr 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nucletron Freiburg Flap Applicator Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for skin surface and intraoperative 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.

Device Story

Freiburg Flap Applicator Set functions as accessory to Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR) for skin surface/intraoperative brachytherapy. Device placed on skin/organ surface and immobilized; radiographic images (CT/MR/planar) determine applicator location for treatment planning. Once planned, applicator connects to afterloading unit via transfer tubes. System performs check cable run to verify path patency/attachment; radioactive source then steps through applicator to deliver prescribed radiation dose. Applicator acts as closed system, preventing source contact with body fluids. Used in clinical settings by healthcare staff; provides physical treatment path for radiation delivery; enables localized dose delivery to target tissue.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Closed-system applicator for brachytherapy; provides physical path for radioactive source. Designed for use with Nucletron mHDR, mHDR-Classic, and mPDR remote afterloading equipment. Incorporates new material compared to predicate. Non-electronic, passive mechanical accessory.

Indications for Use

Indicated for patients requiring skin surface or intraoperative brachytherapy procedures using Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR).

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

• H.A.M. Applicator (K961601)

Submission Summary (Full Text)

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4/20/99

Nucletron Freiburg Flap Applicator Set Date : 18, September 1998

Image /page/0/Picture/3 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 on either side. The black circle is slightly offset, creating a dynamic and modern look. The overall design is clean and professional.

Image /page/0/Picture/4 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '8', '3', '3', '3', and '8'. The digits are written in a cursive style, with some connections between them. The overall appearance suggests that the sequence was written quickly and informally.

### NUCLETRON B.V.

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

Fax [phone]

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<br>Columbia, MD 21046-2133 |
| Contact Person: | Ralph E. Shuping<br>Regulatory Affairs Manager |
| Phone:. | 410-312-4100 |
| Fax: | 410-312-4197 |
| Device Name: | |
| Trade/Proprietary Name: | Freiburg Flap Applicator Set |
| Common/Usual Name: | Remote Afterloading for skin surface and intraoperative<br>brachytherapy applications |

Classification Name:

Accessory to remote afterloader 21 CFR 892.5700, Class II.

#### 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) # |
|--------------------------------|-------------------|----------|
| Mick Radio-Nuclear Instruments | H.A.M. Applicator | K961601 |

#### d. Description

b.

The Nucletron Freiburg Flap Applicator as described in this submission is designed as an accessory to the Nucletron remote aftertoading equipment: mHDR, mHDR-Classic and mPDR, and is intended for skin surface and intraoperative brachytherapy procedures.

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## Nucletron Freiburg Flap Applicator Set Date : 18. September 1998

The Nucletron Freiburg Flap Applicator Set is placed on the skin or organ surface 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-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment catheters and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is 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 the prescribed dose of radiation. When the treatment is complete, the treatment catheters are 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 Freiburg Flap Applicator Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for skin surface and intraoperative 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 Freiburg Flap Applicator Set is substantially equivalent to the predicate device. It combines the functionality, components and design of the predicate device while incorporating a new material.

Johnson Product Manager Title Nucletron BV Veenendaal Netherlands

21-Sept-98

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 1999

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

Re:

K983338 Freiburg Flap Applicator Set Dated: January 18, 1999 Received: January 20, 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 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 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,
Dan Pettit

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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Page_of_of____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Freiburg Flap Applicator Set Device Name :_

Indications For Use:

Nucletron Frieburg Flap Applicator Set is intended for skin surface or intraoperative brachytherapy Nocleares involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and procedures inversing the Nichard Neans of delivering the prescribed radiation dose to the m. Dr. The applicator promos a means 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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K983338 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)