SMIT SLEEVE

K052228 · Nucletron Corporation · JAQ · Nov 9, 2005 · Radiology

Device Facts

• Record ID: K052228
• Device Name: SMIT SLEEVE
• Applicant: Nucletron Corporation
• Product Code: JAQ · Radiology
• Decision Date: Nov 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment. The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and the CT/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN Applicators.

Device Story

The Smit Sleeve is a mechanical accessory for Nucletron remote afterloading brachytherapy equipment. It features a flange sutured against the cervix to prevent the intrauterine tube of a gynecological applicator from being inserted too deeply into the uterus. The device remains in the patient between treatment fractions, allowing the intrauterine tube to be re-inserted multiple times without requiring repeated cervical dilation. It is removed following the completion of treatment. The device is used in a clinical setting by healthcare professionals during brachytherapy procedures to facilitate accurate applicator positioning and patient comfort.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical accessory for remote afterloading brachytherapy. Features a flange for cervical positioning. Constructed from implantable materials similar to those used in the predicate Miami Vaginal Applicator Set. Designed for use with Nucletron GYN and CT/MR GYN applicators.

Indications for Use

Indicated for patients undergoing intracavitary brachytherapy procedures requiring the use of Nucletron remote afterloading equipment. Used as an accessory to GYN applicators to prevent excessive insertion depth of the intrauterine tube into the uterus.

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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Nucletron" in bold, black font, next to a square logo. The logo contains a black circle with two white circles on opposite sides. The logo is enclosed in a black square.

#### NUCLETRON B.V.

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

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section

K052228

NOV - 9 2005

# 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: | Smit Sleeve |
|-------------------------|------------------------------------------------------------------|
| 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)

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

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>a for a comments of the country of the county of the<br>Manufacturer | Acres State<br>.<br>Jevice | 510k<br>. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| NUCletron | Annlicator<br>1501051<br>Miami<br>-------------<br>100 - 10 - 100 - 100 - 100<br>annon and a cases of<br>Company of the consideration of the consideration of the contrôleants of the comments of | K953946 |

## Description:

The Nucletron Smit Sleeve as described in this submission is designed as an accessory to the Nucletron remote afterioading equipment and is intended for Intracavitary Brachytherapy procedures.

The Smit Sleeve has a Flange, which is sutured against the cervix. The Smit Sleeve prevents that the Intrauterine Tube of the Gynaecological Applicator is inserted to deep in the Uterus.

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Kojzzzž

The Smit Sleeve is left in the patient between fractions. Between fractions the Intrauterine The of the Gynaecological Applicator can be inserted into the endometrium multiple times without dilating the Cervix. After the treatment the Smit Sleeve is removed.

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

The Smit Sleeve 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 Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.

#### Summary of technological considerations:

The Smit Sleeve is substantially equivalent to the cleared predicate device, Miami Vaginal Applicator Set, 510(k)#: K953946.

TA

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

8th June 2005
Date

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined lines forming a shape reminiscent of a bird or wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the central emblem.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nucletron Corporation % Elizabeth Rosenfeld Administrative Coordinator KEMA Ouality B.V./KEMA Medical 4377 Country Line Road CHALFONT PA 18914

K052228 Re.:

Trade/Device Name: Smit Sleeve Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system. Regulatory Class: II Product Code: JAQ

Dated: November 2, 2005 Received: November 3, 2005

Dear Ms. Rosenfeld:

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 (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, 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 (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 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 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); good manufacturing practice requirements as set forth in the quality systems (OS)

NOV - 9 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated 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), please 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 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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 | K052228 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Smit Sleeve |
| Indications for<br>Use | The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving<br>Nucletron remote afterloading equipment.<br>The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and<br>the CT/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN<br>Applicators. |

## 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

Dana C. Beardon

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