AOS UNIVERSAL CONECTING GUIDE TUBE

K062824 · Alpha-Omega Services, Inc. · JAQ · Jul 3, 2007 · Radiology

Device Facts

• Record ID: K062824
• Device Name: AOS UNIVERSAL CONECTING GUIDE TUBE
• Applicant: Alpha-Omega Services, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

Device Story

AOS Universal Connecting Guide Tube is a 100cm catheter used in radiation therapy; connects remote high dose rate (HDR) afterloader to patient-applied needles or applicators. Distal end features female luer lock for connection to male luer lock accessories. Provides unobstructed pathway for source wire or cable from afterloader to applicator tip. Used in clinical settings by radiation oncology staff. Device ensures enclosed coupling for radionuclide source delivery. Benefits patient by facilitating precise, contained radiation delivery to target sites.

Clinical Evidence

Bench testing only.

Technological Characteristics

100cm catheter; female luer lock distal connection; single-use; sterile; non-electronic; mechanical coupling device.

Indications for Use

Indicated for patients requiring radiation therapy via remote high dose rate afterloader, where the device serves as a coupling conduit for radionuclide sources to be applied into the body or to the body surface. Contraindicated for reuse (single use only).

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

• AOS Universal Connecting Guide Tube (K964910)

Submission Summary (Full Text)

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K062824

# 510(k) Summary AOS Universal Connecting Guide Tube

Alpha-Omega Services, Inc. 9156 Rose Street Bellflower, CA 90706 Tel: [phone] Fax: [phone] Bob A. Robnett July 2006

### DEVICE NAME

AOS Universal Connecting Guide Tube

PROPRIETARY NAME AOS Universal Connecting Guide Tube

COMMON/USUAL NAME Afterloader Coupling Catheter

CLASSIFICATION NAME 21 CFR 892.5700, Product Code: JAQ, Class II

### PREDICATED DEVICES

AOS Universal Connecting Guide Tube, K964910

### DESCRIPTION

Alpha-Omega Services (AOS) Universal Connecting Guide Tube is used to connect any Alpha-Omega applicator accessory with Luer Lock fittings to a High Dose Rate (HDR) Afterloader.

The Alpha-Omega universal Connecting Guide Tube is supplied in the nominal length of 100cm. The distal end is a female luer lock, which is used to connect to the male end of the Luer Lock applicator/accessory or to the Extension Adaptor and Needle combination, providing an un obstructed pathway for the source wire or cable from the Afterloader to the tip of the applicator/accessory.

#### INTENDED USE

The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

#### CONTRAINDICTIONS

Single Use Device

JUL - 3 2007

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## PERFORMANCE STANDARDS

No performance Standards for Brachytherapy Applicators are in effect at this date.

## SUBSTANTIAL EQUIVALENCE

The AOS Universal Connecting Guide Tube are substantial equivalence to the AOS Universal Connecting Guide Tube, K964910. A comparison summary of technological characteristics is Connecting Guide Tube, K964910. A comparison summary of technological characteristics is listed below. See Section 7 Device Description for detailed information.

| NEW DEVICE: | AOS Universal Connecting Guide Tube |
|-------------|----------------------------------------------------------------------------|
| PREDICATE: | AOS Universal Connecting Guide Tube,<br>K964910 |
| DESIGN: | Both the new and predicate device share the<br>same design |
| MATERIAL: | Both the new and predicate device are<br>constructed of the same materials |
| SINGLE USE: | Both the new and predicate device are Single<br>Use Only. |
| STERILE: | New device is sterile. Predicate is non-sterile |

#### Conclusions

The Conclusion drawn from the above is that the AOS Universal Connecting Guide Tube are equivalent in safety and efficacy to their predicate devices.

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Image /page/2/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird with three curved lines forming its wings or body.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## - 3 2007

Mr. Bob A. Robnett Director Regulatory Affairs & Quality Alpha-Omega Services, Inc. 9156 Rose Street P.O. Box 789 BELLFLOWER CA 90706

Re: K062824

Trade/Device Name: AOS Universal Connecting Guide Tube Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 19, 2007 Received: June 20, 2007

#### Dear Mr. Robnett:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "DA" in a bold, sans-serif font in the center. Above the letters, the numbers "1906-2006" are printed in a smaller font. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial". The logo is surrounded by a circular border with small, decorative elements.

comoting Public St

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Enclosure

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 (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.

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 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), 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/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

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# Indications For Use

# 510(k) Number (if known): K.062824

Device Name: AOS Universal Connecting Guide Tube

Indications For Use: The purpose of the AOS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

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

Over-The Counter Use: NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office or Device Evaluation

Nancy Brozdon

(Division Sign-Off)

Division of Reproductive, Abdominal and
Radiological Devices

510(k) Number K062824