AXXENT VAGINAL APPLICATOR

K072616 · Xoft, Inc. · JAD · May 9, 2008 · Radiology

Device Facts

• Record ID: K072616
• Device Name: AXXENT VAGINAL APPLICATOR
• Applicant: Xoft, Inc.
• Product Code: JAD · Radiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy.

Device Story

Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System; utilizes a miniature X-ray source to deliver high-dose rate, low-energy radiation; eliminates need for radioactive isotopes; mimics penetration and dose characteristics of Iridium-192. Applicator provides a channel for the Axxent HDR X-ray Source-2.2; available in 4 sizes; reusable and sterilizable. System includes an Applicator Clamp and Base Plate to stabilize the applicator during treatment. Used in clinical settings for brachytherapy; operated by healthcare professionals. Output is radiation dose delivered to target volume; assists clinicians in localized cancer treatment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

Reusable, sterilizable vaginal applicators available in 4 sizes. Includes applicator clamp and base plate for stabilization. Functions as a delivery channel for the Axxent HDR X-ray Source-2.2. Operates as part of an electronic brachytherapy system using a miniature X-ray source rather than radioactive isotopes.

Indications for Use

Indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.

Regulatory Classification

Identification

An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Varian Intracavitary Brachytherapy Applicators Vaginal Applicator Set #11-00414 (K033371)

Submission Summary (Full Text)

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# 510(k) Summary

# Submitter

Xoft, Inc. 49000 Milmont Dr Fremont, CA 94538 Contact Name: Eric Hashemian Phone Number: [phone] Fax Number: [phone] Email: [e-mail] Summary was prepared on September 13, 2007

# Name of Device

| Trade name: | Axxent® Vaginal Applicator Set |
|-------------------------|--------------------------------------------------------------------------------|
| Common name: | Brachytherapy Vaginal Applicator |
| Classification<br>Name: | X-Ray Radiation Therapy System and Accessories<br>90 JAD (per 21 CFR 892.5900) |

# Predicate Device

| Device Name | Premarket<br>Notification |
|------------------------------------------------------------------------------------|---------------------------|
| Varian Intracavitary Brachytherapy Applicators<br>Vaginal Applicator Set #11-00414 | K033371 |

Page 1 of 2

Tab 4

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# Device Description

The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.

### Intended Use

The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy.

# Summary of the Technological Characteristics

The technological characteristics of the Axxent Vaginal Applicator are the same as the device approved in K033371. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device. A comparison table is available in Tab 8.

Tab 4

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

**MAY - 9 2008**

Mr. Eric Hashemian Director of Regulatory Affairs Xoft, Inc. 345 Potrero Avenue SUNNYVALE CA 94085

Rc: K072616

Trade/Device Name: Axxent® Vaginal Appicator Set Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: March 27, 2008 Received: March 31, 2008

Dear Mr. Hashemian:

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 arior 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 11 your do roo be subject to such additional controls. Existing major regulations affecting your Apple rary, it ifaly of other 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 circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text that is difficult to read due to the image quality.

Protesting and Promoting Public Health

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

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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Xoft, Inc. Fremont, California

# Indications for Use

510(k) Number:

K072616

Device Name: Axxent® Vaginal Applicator

Indications for Use:

The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.

Prescription Use X (Per 21 CFR 801 subpart D)

AND/OR

Over-The Counter Use (Per 21 CFR 801 subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lora Northing
(Division Sign Off)

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