AXXENT FLEXISHIELD MINI

K090417 · Xoft, Inc. · IXI · Jun 23, 2009 · Radiology

Device Facts

• Record ID: K090417
• Device Name: AXXENT FLEXISHIELD MINI
• Applicant: Xoft, Inc.
• Product Code: IXI · Radiology
• Decision Date: Jun 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To shape the beam from a low energy radiation therapy source up to 50kVp.

Device Story

Axxent FlexiShield Mini is a flexible radiation shielding pad used to shape beams from low energy radiation therapy sources (up to 50kVp). The device is placed over patient surfaces or used internally during Intraoperative Radiation Therapy (IORT). It is supplied as a circular pad (12.7 cm diameter, 1 cm thickness) that can be cut by the user to the desired shape. The device acts as a physical barrier to attenuate radiation, protecting non-target tissue. It is non-sterile but steam sterilizable. It is intended for use by clinicians in a radiation therapy setting.

Clinical Evidence

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

Technological Characteristics

Composite material consisting of tungsten and silicone rubber. Circular form factor: 12.7 cm diameter, 1 cm thickness. Flexible, cuttable pad. Steam sterilizable. Non-sterile supply.

Indications for Use

Indicated for shaping radiation therapy beams from low energy sources up to 50kVp for patients undergoing radiation therapy, including external surface applications and internal use during Intraoperative Radiation Therapy (IORT).

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• Arplay Medical Lead Blocks (K010172)

Submission Summary (Full Text)

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のアルバリー

Xoft, Inc Xoft, Inc.

K090417

JUN 2 3 2009

# a ab 510(k) Summary

#### Submitter

| Xoft, Inc. | |
|---------------------|-------------------------------------------|
| 345 Potrero Ave | |
| Sunnyvale, CA 94085 | |
| Contact Name: | Steve Lin |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| | Summary was prepared on February 17, 2009 |

## Name of Device

| Trade name: | Axxent® FlexiShield Mini |
|----------------------|----------------------------------------------------------------------|
| Common name: | Beam Blocks for Radiation Therapy |
| Classification Name: | Radiation Therapy Beam Shaping Block<br>90 IXI (per 21 CFR 892.5710) |

### Predicate Device

| Device Name | Premarket Notification |
|----------------------------|------------------------|
| Arplay Medical Lead Blocks | K010172 |

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#### Device Description

The Axxent FlexiShield Mini is intended to shape the beam from a low energy radiation therapy source up to 50kVp. It is a flexible pad placed over the surface requiring shielding that can be cut by the customer to shape the radiation therapy beam. It can be used on external patient surfaces, as well as internally during Intraoperative Radiation Therapy (IORT).

The Axxent FlexiShield Mini is fabricated from a composite made from tungsten and silicone rubber. The pad is available in a circular shape with a diameter of 12.7 cm and a thickness of 1 cm.

The Axxent FlexiShield Mini is provided non-sterile. The device is steam sterilizable.

#### Intended Use

To shape the beam from a low energy radiation therapy source up to 50kVp.

#### Summary of the Technological Characteristics

The technological characteristics of the Axxent FlexiShield Mini are the same as the Arplay Medical Lead Blocks approved in K010172. 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2009

Mr. Steve Lin Director of Regulatory Affairs and Quality Assurance Xoft, Inc. 345 Potrero Ave. SUNNYVALE CA 94085

Re: K090417

Trade/Device Name: Axxent® FlexiShield Mini Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: June 5. 2009 Received: June 9, 2009

#### 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 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.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/cdrh/industry/support/index.html.

Sincerely yours:

Sincerely yours,

Janine 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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# Indications for Use

510(k) Number: Ko90417

Device Name: Axxent® FlexiShield Mini

Indications for Use:

To shape the beam from a low energy radiation therapy source up to 50kVp.

AND/OR Prescription Use Over-The Counter Use . X (Per 21 CFR 801 subpart D) (Per 21 CFR 801 subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 09041 510(k) Number