ALATUS VAGINAL BALLOON PACKING SYSTEM

K092534 · Radiadyne · JAQ · Dec 7, 2009 · Radiology

Device Facts

• Record ID: K092534
• Device Name: ALATUS VAGINAL BALLOON PACKING SYSTEM
• Applicant: Radiadyne
• Product Code: JAQ · Radiology
• Decision Date: Dec 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2

Indications for Use

The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Device Story

ALATUS Vaginal Balloon Packing System is a non-powered, single-use, disposable positioning device. Components include a polyurethane balloon, catheter tubing, connector, flex tubing, and a 1-way stopcock with a 90-degree turn handle. Used by physicians or physician-directed healthcare professionals in clinical settings (CT, x-ray, or radiation therapy suites). The device is inserted into the vagina to displace and stabilize the vaginal wall and adjacent anatomy, ensuring predictable and reproducible positioning during imaging or radiation treatment. It is placed as a separate procedure prior to the standard exam or treatment. The device is latex-free.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex-free polyurethane balloon; catheter tubing; connector; flex tubing; 1-way stopcock with 90-degree turn handle. Non-powered, manual inflation. Single-use, non-sterile, disposable.

Indications for Use

Indicated for temporary positioning, displacement, and stabilization of the vaginal wall and adjacent structural anatomies during CT, x-ray, or radiation therapy. For use by physicians or physician-directed healthcare professionals. Contraindicated for insertion into the uterine cavity.

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

• Vaginal Applicator Shielded (K001544)
• Vaginal Port Inflatable Speculum (K002912)

Submission Summary (Full Text)

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K092534

## SECTION 5 - 510(k) SUMMARY

# Submission Correspondent

Emergo Group, Inc.

www.emergogroup.com

DEC - 7 2009

Address 1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746

## Phone

[phone]

### Fax

[phone]

## Contact

Stuart R. Goldman

## Submission Sponsor

- Radiadyne 3801 Kirby Suite 710 Houston, TX 77098 Tel: [phone] Fax: [phone]
### www.Radiadyne.com/

### Date Prepared

July 29, 2009

### Trade Name

ALATUS Vaginal Balloon Packing System

## Regulation Name(s)

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Medical charged-particle radiation therapy system (primary) Obstetric-gynecologic general manual instrument (secondary)

#### Requlation Number(s)

892.5050 (primary) 884.4520 (secondary)

### Classification Name(s)

System, planning, radiation therapy treatment (primary) Retractor, vaginal (secondary)

## Product Code(s)

MUJ (primary) HDL (secondary)

### Classification Panel

Radiology (primary) Obstetrics/Gynecology (secondary)

## Regulatory Class

Class II

### Device Description

The ALATUS Vaginal Balloon Packing System is designed as an immobilizer to assist in positioning and displacing the vaginal wall in a more predictable and reproducible location during computed tomography (CT) exams and radiation treatment (RT) therapy. The proposed device is a latex free balloon made from Polyurethane consisting of the following components:

- 1. Balloon
- 2. Catheter tubing
- 3. Connector
- 4. Flex tubing
- 5. 1-way stopcock, 90° turn handle

### Intended Use

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The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

### Predicate Device(s)

1. Mick Radio-Nuclear Instruments, Inc. - Vaginal Applicator Shielded (K001544) 2. Sterilis, Inc. - Vaginal Port Inflatable Speculum (K002912)

### Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the ALATUS Vaginal Balloon Packing System and the predicate devices listed do not raise any questions regarding its safety and effectiveness. The subject device, as designed and manufactured, is as safe and effective as the predicate devices for its intended application; that is, as a temporary vaginal wall positioning device, and therefore is determined to be substantially equivalent to the referenced predicate devices in the context of that application.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with outstretched wings.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD . 20993-0002

Radiadyne % Mr. Stuart R. Goldman Senior Consultant Emergo Group, Inc. 1705 S. Capital of Texas Hwy, Suite 500 AUSTIN TX 78746

## DEC - 7 2009

Re: K092534

Trade/Device Name: ALATUS Vaginal Balloon Packing System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ and IYE Dated: November 20, 2009 Received: November 23, 2009

Dear Mr. Goldman:

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 application (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); medical device reporting (reporting of medical

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Page 2 -

Enclosure

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.html

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE

092534

510(k) Number (if known):

#### Device Name

## ALATUS Vaginal Balloon Packing System

### Indications for Use

The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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