AXXENT RADIATION SHIELD - RIGID

K111299 · Xoft, an Icad Company · JAD · Jul 20, 2011 · Radiology

Device Facts

• Record ID: K111299
• Device Name: AXXENT RADIATION SHIELD - RIGID
• Applicant: Xoft, an Icad Company
• Product Code: JAD · Radiology
• Decision Date: Jul 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2

Indications for Use

Use of the Axxent Radiation Shield - Rigid is indicated in cases in which protection of tissue and/or organs from x-radiation is desired. The Axxent Radiation Shield - Rigid can be used externally and internally, such as during intraoperative radiation therapy (IORT) when the treatment site is exposed surgically.

Device Story

Axxent Radiation Shield - Rigid is a passive accessory for the Axxent Electronic Brachytherapy System; protects healthy tissue/organs from unwanted X-ray radiation during therapy. Device consists of rigid 316L stainless steel pads in circular or ellipsoidal shapes. Used by clinicians in clinical settings, including intraoperative radiation therapy (IORT) where treatment sites are surgically exposed. Shield placed manually over area requiring protection. Attenuates radiation by >99% at 50kVp. Reusable; requires steam sterilization between uses. Benefits patient by minimizing radiation exposure to non-target anatomy.

Clinical Evidence

Bench testing only. Attenuation performance verified to be >99% at 50kVp. Device lifecycle testing confirmed integrity after 50 cycles of cleaning and steam sterilization. Material shedding tests conducted to ensure no particulate release during clinical use.

Technological Characteristics

Fabricated from 316L stainless steel (UNS S31603, ASTM A240/A240M). Rigid pad form factor in circular (3-7 cm diameter) and ellipsoidal (3-12 cm axes) shapes. Passive radiation shielding via physical attenuation. Lead equivalency not less than 0.20 mm at 50 kVp. Reusable; steam sterilization required.

Indications for Use

Indicated for patients requiring protection of tissue or organs from x-radiation during external or internal (intraoperative) radiation therapy.

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

• Photoelectron (now Carl Zeiss Surgical) Photon Radiosurgery System Radiation Shield (K992577)

Submission Summary (Full Text)

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## K111299

# Tab 4

JUL 20 2011

## 510(k) Summary

#### Submitter

Xoft, an iCAD Company Establishment Registration Number: 3005594788 345 Potrero Ave Sunnyvale, CA 94085 Contact Name: Steve Lin Phone Number: [phone] ~Fax Number: [phone] Email: [e-mail] Summary was prepared on May 25, 2011

### Name of Device

| Trade name: | Axxent® Radiation Shield - Rigid |
|-------------------------|--------------------------------------------------------------------------------|
| Common name: | Radiation Shield for Radiation Therapy |
| Classification<br>Name: | X-ray Radiation Therapy System and Accessories<br>90 JAD (per 21 CFR 892.5900) |

#### Predicate Device

| Device Name | Premarket Notification |
|-------------------------------------------------------------------------------------|---------------------------------------------------|
| Photoelectron (now Carl Zeiss Surgical) Photon Radiosurgery System Radiation Shield | Class I, but submitted as an accessory in K992577 |

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#### Device Description

The Axxent Radiation Shield - Rigid is an optional radiation shielding accessory to the Axxent Electronic Brachytherapy System (cleared under K072683) intended to protect tissue and/or organs from unwanted radiation. It is a rigid stainless steel pad placed over the area requiring shielding. It can be used on external patient surfaces, such as skin, as well internally during Intraoperative Radiation Therapy (IORT).

The Axxent Radiation Shield - Rigid is fabricated entirely from 316L stainless steel (UNS S31603, ASTM A240/A240M). The shield is available in circular and ellipsoidal shapes in a range of various sizes.

The Axxent Radiation Shield - Rigid is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use.

#### 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 Radiation Shield - Rigid are the ' same as the Photon Radiosurgery System (PRS) Radiation Shield. The PRS radiation shield is a Class I device that was submitted as an accessory to the PRS under premarket clearance K992577. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device.

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### Substantial Equivalence

| Characteristic | PRS Radiation Shield | Axxent Radiation Shield -<br>Rigid |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Class I, but submitted as<br>an accessory under<br>K992577 | Subject device |
| Indications for Use | Use of the Radiation Shield<br>is indicated in cases in<br>which protection of tissue<br>and/or organs from x-<br>radiation is desired. | Use of the Axxent Radiation<br>Shield - Rigid is indicated in<br>cases in which protection of<br>tissue and/or organs from<br>x-radiation is desired. The<br>Axxent Radiation Shield -<br>Rigid can be used<br>externally and internally,<br>such as during<br>intraoperative radiation<br>therapy (IORT) when the<br>treatment site is exposed<br>surgically. |
| Can be used<br>internally | Yes | Yes |
| Multiple Shapes | Yes, multiple semi-<br>spherical | Yes, available in circular<br>and ellipsoidal shapes |
| Sizes | 1.5 to 5.0cm in diameter | Diameters ranging from 3<br>cm to 7 cm for circular<br>shapes.<br>Minor and major axes<br>ranging from 3 cm to 12 cm<br>for ellipsoidal shapes. |
| Material | Tungsten-filled silicone<br>resin | 316L Stainless Steel (UNS<br>S31603, ASTM<br>A240/A240M) |
| Sterilization | Provided sterile, gamma | Provided non-sterile,<br>required to steam<br>sterilization |
| Lead Equivalency | 0.05mm at 50kVp | Not less than 0.20 mm at<br>50 kVp |
| For Use With | Photoelectron (now Carl<br>Zeiss Surgical) Photon<br>Radiosurgery System | Axxent Electronic<br>Brachytherapy System |

#### Comparison Table of Predicate and Subject Device

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#### Performance Testing

The attenuation of the Axxent Radiation Shield - Rigid is greater than 99% at 50kVp. See Tab 12 for the method used to determine the attenuation.

The Axxent Radiation Shield -- Rigid was tested to withstand at least 50 cycles of cleaning and sterilization according to the instruction in the IFU. See Tab 13 for device lifecycle testing.

The Axxent Radiation Shield -- Rigid device was tested to show that it did not shed material during worst case clinical usage. See Tab14 for material shedding tests conducted on the device.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Steve Lin Director of Regulatory Affairs and Quality Assurance Xoft, an iCAD Company 345 Potrero Avenue SUNNYVALE CA 94085

Re: K111299

Trade/Device Name: Axxent® Radiation Shield - Rigid Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: July 6, 2011 Received: July 7, 2011

JUL 20 2011

#### 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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.

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K111299

Device Name: Axxent® Radiation Shield - Rigid

Indications for Use:

Use of the Axxent Radiation Shield - Rigid is indicated in cases in which protection of tissue and/or organs from x-radiation is desired. The Axxent Radiation Shield - Rigid can be used externally and internally, such as during intraoperative radiation therapy (IORT) when the treatment site is exposed surgically.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Pastel

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Division Sign-Off

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K111299

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