AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS

K964910 · Alpha-Omega Services, Inc. · JAQ · Mar 10, 1997 · Radiology

Device Facts

• Record ID: K964910
• Device Name: AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS
• Applicant: Alpha-Omega Services, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy.

Device Story

Device functions as coupling catheter for remote high dose rate (HDR) afterloading systems; provides enclosed pathway for radionuclide source delivery from afterloader to patient needles or surface applicators. Used in clinical radiation therapy settings; operated by trained medical personnel. Device ensures secure connection between radiation source delivery equipment and patient-applied applicators. Benefits include precise, enclosed guidance of radioactive sources to target treatment sites.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Brachytherapy applicator; coupling catheter. Materials and construction identical to predicate devices. Single-use, non-sterile delivery.

Indications for Use

Indicated for patients requiring radiation therapy via remote high dose rate afterloading systems; provides coupling between afterloader and patient needles or applicators. Contraindicated for reuse; single-use device 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

• Varian Coupling Catheters (K952913)
• Omnitron International System (K881665)

Submission Summary (Full Text)

{0}

510(k) SUBMISSION, AOS UNIVERSAL CONNECTING GUIDE TUBE

MAR 10 1997

K964910

Section 2

Summary & Certification

The following is a Summary & Certification of the AOS Universal Connecting Guide Tube.

I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for a Afterloader Coupling Catheter.

Printed Name Cary Hedgr

Signature

Title Operations Manger/Alt. RSO

Date 11-19-96

Alpha-Omega Services, Inc., 9156 Rose St., Bellflower, CA 90706
1-800-346-7894 Fax [phone]

| CLASSIFICATION NAME: | Brachytherapy Applicators |
| --- | --- |
| COMMON/USUAL NAME: | Afterloader Coupling Catheter |
| PROPRIETARY NAME: | AOS Universal Connecting Guide Tube for Afterloading Systems. |
| CLASSIFICATION: | 21 CFR Part 892.5700, Product Code: 90-JAQ, Class II |
| PERFORMANCE STANDARDS: | No Performance Standards for Brachytherapy Applicators are in effect at this date. |
| PREDICATED DEVICE | Varian Coupling Catheters (K952913) and Omnitron International System (K881665). |
| INDICATIONS | To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. |
| CONTRAINDICATIONS | Single Use Device. Do not re-clean, re-sterilize device. Any reprocessing may result in changes in the physical characteristics of the device. Do |

Section 2, Page 1

November, 1996

SUMMAR-1.DOC 11/18/96

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510(K) SUBMISSION, AOS UNIVERSAL CONNECTING GUIDE TUBE

not counter accepted clinical practice or institution guidelines.

## SUBSTANTIAL EQUIVALENCE

The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.

## CONCLUSIONS

The conclusion drawn from the above is that the AOS Universal Connecting Guide Tube is equivalent in safety and efficacy to its predicate device.

SUMMAR-1.DOC 11/25/96

Section 2, Page 2

November, 1996