AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES

K062823 · Alpha-Omega Services, Inc. · JAQ · May 29, 2007 · Radiology

Device Facts

• Record ID: K062823
• Device Name: AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
• Applicant: Alpha-Omega Services, Inc.
• Product Code: JAQ · Radiology
• Decision Date: May 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The purpose of AOS Interstitial Templates, Needles, and Accessories is to provide an enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachtherapy).

Device Story

AOS Interstitial Templates, Needles, and Accessories are brachytherapy applicators used to guide radioactive sources into the body or onto the body surface. The system consists of silicone templates with circular hole arrays, template needles, and accessories (e.g., vaginal guide tubes, O-rings, collars). The template is sutured to the patient; needles are inserted through the template holes to the treatment site. Needles may be connected to an HDR afterloader via luer adaptors or used for manual LDR source placement. The device provides a fixed, stable pathway for radiation delivery. Used in clinical settings by radiation oncology staff. The system ensures precise positioning of radioactive sources, facilitating targeted radiation therapy for conditions such as prostate, rectal, or vaginal cancer.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Silicone templates, metal needles. Design: Fixed array template with 1 cm spacing. Connectivity: Compatible with HDR afterloaders via luer adaptors or manual LDR source strands. Sterilization: Sterile (new device). Form factor: Various sizes for prostate, rectal, or vaginal anatomy.

Indications for Use

Indicated for patients requiring brachytherapy, providing an enclosed pathway for the application of radioactive sources into or onto the body. 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 Prostate Template (Preamendment)
• Rectal Template (Preamendment)
• GYN Template (Preamendment)
• AOS Template Needle (Preamendment)
• AOS Template Tip (Preamendment)

Reference Devices

• AOS Implant Tube (Preamendment)
• AOS Implant Needle (Preamendment)
• AOS Retaining Button (Preamendment)
• AOS Universal Connecting Guide Tube (K964910)

Submission Summary (Full Text)

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Kdo28223

# 510(k) Summary AOS Interstitial Templates, Needles & Accessories

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

MAY 2 9 2007

#### DEVICE NAME

AOS Interstitial Templates, Needles & Accessories

#### PROPRIETARY NAME

AOS Interstitial Templates, Needles & Accessories

#### COMMON/USUAL NAME

Interstitial Template

#### CLASSIFICATION

System, Applicator, Radionuclide, Remote-Controlled 21 CFR 892.5700, Product Code: JAQ, Class II

#### PREDICATED DEVICES

AOS Prostate Template, Rectal Template, GYN Template (Preamendment, See Appendix A) AOS Template Needle (Preamendment, See Appendix A) AOS Template Tip (Preamendment, See Appendix A)

#### DESCRIPTION

Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina.

The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources.

Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal

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Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.

Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.

#### INTENDED USE

The purpose of AOS Interstitial Templates, Needles, and Accessories is to provide an enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachtherapy).

#### CONTRAINDICTIONS

Single Use Device

## PERFORMANCE STANDARDS

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

### SUBSTANTIAL EQUIVALENCE

AOS Interstitial Templates, Needles & Accessories are substantial equivalence to the AOS Implant Tube (Preamendment), AOS Implant Needle (Preamendmont), and AOS Retaining Button (Preamendment). A comparison summary of technological characteristics is listed below. See Sections 7 Device Description for detailed information.

| NEW DEVICE: | AOS Interstitial Templates |
|-------------|---------------------------------------------|
| PREDICATE: | AOS Prostate Template, Rectal Template, |
| | GYN Template |
| DESIGN: | Both the new and predicate device share the |
| | same design |
| MATERIAL: | Both the new and predicate device are |
| | constructed of the same materials |

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| SINGLE USE: | Both the new and predicate device are Single Use Only. |
|-------------|-------------------------------------------------------------------------|
| STERILE: | New device is sterile. Predicate is non-sterile |
| NEW DEVICE: | AOS Interstitial Needles |
| PREDICATE: | AOS Template Needles |
| DESIGN: | Both the new and predicate device share the same design |
| MATERIAL: | Both the new and predicate device are constructed of the same materials |
| SINGLE USE: | Both the new and predicate device are Single Use Only. |
| STERILE: | New device is sterile. Predicate is non-sterile |
| NEW DEVICE: | AOS Interstitial Accessories |
| PREDICATE: | AOS Needle Tips |
| DESIGN: | Both the new and predicate device share the same design |
| MATERIAL: | Both the new and predicate device are constructed of the same materials |
| SINGLE USE: | Both the new and predicate device are Single Use Only. |
| STERILE: | New device is sterile. Predicate is non-sterile |

# Conclusions

The Conclusion drawn from the above is that the AOS Interstitial Templates, Needles & Accessories are equivalent in safety and efficacy to their predicate devices.

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure. The logo is black and white and appears to be a scan of a document.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

MAY 2 9 2007

Re: K062823

Trade/Device Name: AOS Interstitial Templates, Needles & Accessories Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: JAQ and KXK Dated: May 1, 2007 Received: May 3, 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/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Rast of activities that I Drivings and that your device complies with other requirements of the Act that I Dri has made a son regulations administered by other Federal agencies. You must of any I carates and registents, including, but not limited to: registration and listing (21 Comply with an the Hot CFR Part 801); good manufacturing practice requirements as set CITY at 807), ademig (21 CENT PET CENT Part 820); and if applicable, the electronic forul in the quality systems (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) This letter will anow you'ls begin inding of substantial equivalence of your device to a legally premarket noticated 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 If you desire specific advise for you 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 (21GI IC I at 607.97). "Tod may obtains of Scharactonal and Consumer Assistance at its toll-free number [phone] or [phone]

on 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

#### Enclosure

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## Indications For Use

510(k) Number (if known): K061823

Device Name: AOS Interstitial Templates, Needles & Accessories

Indications For Use: The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).

### 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

Huberto Leves Led