INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001

K041715 · Nucletron Corp. · JAQ · Mar 24, 2005 · Radiology

Device Facts

• Record ID: K041715
• Device Name: INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
• Applicant: Nucletron Corp.
• Product Code: JAQ · Radiology
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

Device Story

The Intracavitary Mould Applicator Set is a disposable silicone cylinder with eight radial catheters used in intracavitary rectal brachytherapy. It acts as an accessory to the Nucletron microSelectron remote afterloader. The device is inserted into the rectum; X-ray catheters or CT markers are placed within the applicator to facilitate treatment planning via imaging. During treatment, the applicator provides a path for the radioactive source from the afterloader to the target volume. Clinical staff verify proper attachment before use. A check cable run is performed to ensure the path is clear of obstructions. The device is a closed system preventing direct contact between the radioactive source and body tissues. It is removed from the patient after the procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable silicone cylinder with eight radial catheters; closed system for radioactive source delivery; compatible with Nucletron microSelectron afterloader; non-electronic, passive accessory; dimensions/form factor designed for rectal intracavitary use.

Indications for Use

Indicated for patients undergoing intracavitary rectal brachytherapy procedures 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

• Miami Vaginal Applicator Set (K953946)

Reference Devices

• Freiburger Flap

Submission Summary (Full Text)

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KO41715

MAR * 4 7005

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo with a black background and two white circles. The circles are positioned on opposite corners of the square, with a curved line connecting them.

NUCLETRON B.V

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O. Box 930 The Nether ands Phone +31 318 5!57133 [phone] Fax

Department of Health and Human Services Dopartino 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: | 8671 Robert Fulton Drive<br>Columbia, MD 21046 |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick<br>Director Assurance & Regulatory Affairs |

## Modified Device Name:

| Trade/Proprietary Name: | Intracavitary Mould Applicator Set |
|-------------------------|------------------------------------------------------------------|
| Common/Usual Name: | Remote Afterloading for Intracavitary Brachytherapy applications |
| Classification Name: | Remote controlled radionuclide applicator system accessory |
| Classification: | 21Cfr892.5700 Class II |

## Legally Marketed Device(s)

Legally Marketed Device(o)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:

| | Manufacturer: トーム | |
|--------------|-----------------------------------------------------------------|---------|
| | | K953946 |
| Nucletron BV | l Miami Vaqinal Applicator Set | |
| | A Company of Children Comments of Children Comments of Children | |

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#### Description:

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed
ed for The Nucletion intracavitary Mould Application of the equipment and is intended for Intracavitary Brachytherapy procedures.

The device consists of a disposable silicone cylinder, with eight radial placed catheters to the recture The device consists of a unsposable shirts of into the target volume, i.e. the rectum.
surface of the cylinder, which is inserted Intracavitary into the insertion tool and th surface of the cylinder, which inserted introduction of the insertion tool and the I he cylinder is lixated, by using an uppliouted the cathers from kinking during transport. The cylings and filling wires are removed, which protected the catholors in a consisted on the manage the central catheter can be placed.

X-ray catheters or CT markers are inserted into the application. Radiographic X-ray catheters of CT markers are into in the interest the precised to determine the precises lmages, planal limis of transvoros of one of this information is then used for Brachytherapy treatment planning purposes.

The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source The Intracavitary Modio Applicator Git ... The treatment catheter does not control the from coming in contact with body nulles The Cadioactive source. The afterloader
treatment unit, it strictly provides a treatment path for the treatment treatment unit, it strictly provided a treatment.
and the clinical staff verify that the applicator is properly attached prior to treatment.

For the first treatment the Intracavitary Mould Applicator Set is attached to the affection the sherita For the first treatment the intradurities would be applicator is attached, a check cable run is (treatment nead), doing transfer tusator is properly attached and that there are no penormed to ensure that the applicate. In a province of cable run, the radioactive source obstructions, which will interest and the prescribed dose of radiation.

After the treatment the Intracavitary Mould Applicator Set is disconnected from the attached Atler the treatment the miradamary motion is completed the Intracavitary Mould Applicator Set is removed from the patient.

The device uses similar (implantable) materials as in the legally marketed predicate device rited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set.

The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

#### Intended use:

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

The Intracavitary Mould Applicator Set is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.

# Summary of technological considerations:

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The Intracavitary Mould Applicator Set is substantially equivalent to the cleared predicate The Intracavitary Moura Applicator Set, 510(k)#: K953946.

14-6-2004

Name: Frits van Krieken Title: Business Segment Manager Nucietron B.V. Veenendaal, The Netherlands

Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K041715

MAR 2 4 2005

Trade/Device Name: Intracavitary Mould Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ

Dated: March 1, 2005 Received: March 2, 2005

Dear Ms. Dimmick:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in we have reviewed your Security premainter in substantially equivalent (for the indications for use stated in above and have determined the devices is accession interstate commerce prior to the enclosure) to regarly maneled predical Device Amendments, or to devices that have been May 26, 1970, the elactificant date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provinsions of approval application (PMA). You may, therefore, market the do not require approval of a premainer approval spfth Act. The general controls provisions of the Act. device, subject to the general volusions provinces, 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 If your device is classined (see as re) hitional controls. Existing major regulations affecting your Approval), it thay be subject to sublications, 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 r lease oc advised mat 1 Dr. i issues of the see complies with other requirements of the Act or any FDA has made a accemination mad your as a more of the Federal agencies. You must comply with all the rederal statues and regulations administrited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, metading, but not minute requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 Section 510(k)
This in the supportunity of the of a light of sectiol seguinlence of your device This letter will allow you to begin makemig of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence and thi market notification. The FDA Imanig of substantial equilable of your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regarded. (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misorialians of our responsibilities under the Act from the 180 807.97). You may obtain other general mornation on Jour September Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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# Indications for Use Statement

| 510(k)<br>Number | K041715 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name<br>Indications for<br>Use | Intracavitary Mould Applicator Set<br>The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area. |

# 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)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Maurice Hayden

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _