AXXENT SURFACE APPLICATOR, MODEL 710257

K083734 · Xoft, Inc. · JAD · Feb 11, 2009 · Radiology

Device Facts

• Record ID: K083734
• Device Name: AXXENT SURFACE APPLICATOR, MODEL 710257
• Applicant: Xoft, Inc.
• Product Code: JAD · Radiology
• Decision Date: Feb 11, 2009
• 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 Surface Applicator is a component of the Axxent Electronic Brachytherapy System; utilizes miniaturized x-ray source instead of radioactive isotopes. Applicator delivers high-dose rate, low-energy radiation to skin and tissue surfaces; mimics penetration/dose characteristics of Iridium-192. Provided in multiple circular aperture sizes for various lesion sizes; reusable and sterilizable; includes single-use disposable end caps to flatten treatment surface. Used in clinical settings for surface brachytherapy and IORT; operated by healthcare professionals. Output allows precise radiation delivery to target tissue; benefits patient by providing localized radiation therapy without radioactive isotopes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable, sterilizable surface applicator with multiple circular aperture sizes; includes single-use disposable end caps. Functions as part of the Axxent Electronic Brachytherapy System using a miniaturized x-ray source. No software or electronic sensing components described for the applicator itself.

Indications for Use

Indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.

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

• Nucletron Valencia Skin Applicator Set (K073107)

Submission Summary (Full Text)

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KOf373Y

Xoft, Inc. Sunnyvale, California

FEB 1 1 2009

# Tab

# 510(k) Summary

## Submitter

Xoft, Inc. 345 Potrero Ave Sunnyvale, CA 94085 Contact Name: Steve Lin Phone Number: [phone] Fax Number: [phone] [e-mail] Email: Summary was prepared on December 15, 2008

Axxent® Surface Applicator 510(k)

#### Name of Device

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

### Predicate Device

| Device Name | Premarket Notification |
|----------------------------------------|------------------------|
| Nucletron Valencia Skin Applicator Set | K073107 |

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Axxent® Surface Applicator 510(k)

Xoft. Inc. Sunnyvale, California

#### Device Description

The Axxent Surface Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniaturized x-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver high-dose rate, low energy radiation treatment to skin and tissue surfaces. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Surface Applicator is provided in multiple circular aperture sizes to accommodate a range of lesion sizes. The applicators are reusable and sterilizable. Single use disposable end caps are provided to help flatten the treatment surface.

#### 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 Surface Applicator are the same as the Nucletron Valencia Skin Applicator approved in K073107. 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.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The seal is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFR 1 1 2009

Mr. Steve Lin Regulatory Manager Xoft, Inc. 345 Potrero Ave. SUNNYVALE CA 94085

Re: K083734

Trade/Device Name: Axxent® Surface Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-rav radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 15, 2008 Received: December 17, 2008

#### Dear Mr. Lin:

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 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.

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Page 2

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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

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

#### Enclosure

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Xoft, Inc. Sunnyvale, California

## Indications for Use

## 510(k) Number:

Device Name: Axxent Surface Applicator

Indications for Use:

The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.

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)

Helent Remer

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083734 510(k) Number