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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Axxent® Radiation Shield - Rigid, focusing on acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance Study for Axxent® Radiation Shield - Rigid

This 510(k) summary (K111299) describes the Axxent® Radiation Shield - Rigid, an accessory for the Axxent Electronic Brachytherapy System. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for performance in a tabular format with corresponding "reported device performance." Instead, it highlights key performance characteristics tested against general safety and effectiveness principles and comparison to the predicate device. However, based on the Performance Testing section and the comparison table, we can infer the following:

Acceptance Criterion (Inferred)	Reported Device Performance
Radiation Attenuation (at 50kVp)	Greater than 99%
Durability (Cleaning & Sterilization Cycles)	Withstands at least 50 cycles
Material Shedding	Did not shed material during worst-case clinical usage
Lead Equivalency (for comparison to predicate)	Not less than 0.20 mm at 50 kVp

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes for each performance test (attenuation, durability, material shedding). It mentions "the Axxent Radiation Shield - Rigid" in singular, implying representative samples were used for testing.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for device clearance, the testing would be prospective, conducted by the manufacturer, Xoft, an iCAD Company, located in Sunnyvale, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis for diagnostics). For a physical medical device like a radiation shield, "ground truth" is established through objective physical measurements and engineering tests using calibrated equipment and standard methodologies, not through expert consensus in the traditional sense. Therefore, this section is not applicable in the context of this device's performance testing.

4. Adjudication Method for the Test Set

As explained above, since the performance tests are based on objective physical measurements and engineering tests, an adjudication method (like 2+1, 3+1) involving human experts for disagreement resolution is not applicable. The results are quantitative and determined by the test equipment and procedures.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is primarily used for diagnostic devices involving physician interpretation of images, where the goal is to assess the impact of AI on clinical decision-making. The Axxent® Radiation Shield - Rigid is a passive device designed for physical shielding, not for data interpretation or diagnostic assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (algorithm only) was not done. This is also not applicable as the device is a physical radiation shield and does not involve any algorithms or artificial intelligence.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Axxent® Radiation Shield - Rigid was established through objective physical measurements and engineering tests:

Radiation Attenuation: Measured using appropriate radiation detection equipment to determine the percentage of X-ray beam blocked. The method is referenced as "See Tab 12."
Durability: Inferred to be through repeated cleaning and sterilization cycles, followed by inspection for degradation, as described by "See Tab 13 for device lifecycle testing."
Material Shedding: Confirmed through "material shedding tests conducted on the device," referenced as "See Tab 14."
Lead Equivalency: Calculated or measured based on the material's properties (316L Stainless Steel) and its attenuation characteristics.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve any machine learning algorithms requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

Summary

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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: (408) 419-2341 ~Fax Number: (408) 419-2301 Email: steve.lin@xoftinc.com Summary was prepared on May 25, 2011

Name of Device

Trade name:	Axxent® Radiation Shield - Rigid
Common name:	Radiation Shield for Radiation Therapy
ClassificationName:	X-ray Radiation Therapy System and Accessories90 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 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 -Rigid
510(k) Number	Class I, but submitted asan accessory underK992577	Subject device
Indications for Use	Use of the Radiation Shieldis indicated in cases inwhich protection of tissueand/or organs from x-radiation is desired.	Use of the Axxent RadiationShield - Rigid is indicated incases in which protection oftissue and/or organs fromx-radiation is desired. TheAxxent Radiation Shield -Rigid can be usedexternally and internally,such as duringintraoperative radiationtherapy (IORT) when thetreatment site is exposedsurgically.
Can be usedinternally	Yes	Yes
Multiple Shapes	Yes, multiple semi-spherical	Yes, available in circularand ellipsoidal shapes
Sizes	1.5 to 5.0cm in diameter	Diameters ranging from 3cm to 7 cm for circularshapes.Minor and major axesranging from 3 cm to 12 cmfor ellipsoidal shapes.
Material	Tungsten-filled siliconeresin	316L Stainless Steel (UNSS31603, ASTMA240/A240M)
Sterilization	Provided sterile, gamma	Provided non-sterile,required to steamsterilization
Lead Equivalency	0.05mm at 50kVp	Not less than 0.20 mm at50 kVp
For Use With	Photoelectron (now CarlZeiss Surgical) PhotonRadiosurgery System	Axxent ElectronicBrachytherapy 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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:

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

Division Sign-Off

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

510K K111299

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Regulation Number and Section

§ 892.5900 X-ray radiation therapy system.

(a)
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.(b)
Classification. Class II.