(72 days)
No
The device is a passive, rigid stainless steel shield and the summary contains no mention of AI or ML.
No
The device is a radiation shield aimed at protecting tissues and organs from unwanted radiation exposure, rather than directly treating a condition or disease.
No
The device is described as a radiation shield intended to protect tissue and organs from x-radiation, not to diagnose a condition.
No
The device description clearly states it is a rigid stainless steel pad, which is a physical hardware component, not software.
Based on the provided information, the Axxent Radiation Shield - Rigid is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to protect tissue and organs from x-radiation during radiation therapy. This is a therapeutic and protective function performed in vivo (within the living body), not a diagnostic test performed in vitro (outside the living body) on biological samples.
- Device Description: The device is a physical shield made of stainless steel. It does not involve the analysis of biological samples or the detection of substances within those samples, which are hallmarks of IVD devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific analytes (e.g., proteins, DNA, antibodies).
- Providing information for diagnosis, monitoring, or screening of diseases.
The Axxent Radiation Shield - Rigid is a medical device used in conjunction with a radiation therapy system for the purpose of shielding, which is a therapeutic/protective intervention, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
JAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue and/or organs (from x-radiation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The attenuation of the Axxent Radiation Shield - Rigid is greater than 99% at 50kVp.
The Axxent Radiation Shield -- Rigid was tested to withstand at least 50 cycles of cleaning and sterilization according to the instruction in the IFU.
The Axxent Radiation Shield -- Rigid device was tested to show that it did not shed material during worst case clinical usage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| Classification | |
| Name: | X-ray Radiation Therapy System and Accessories |
| 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 |
1
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.
2
Substantial Equivalence
| Characteristic | PRS Radiation Shield | Axxent Radiation Shield -
Rigid |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Class I, but submitted as
an accessory under
K992577 | Subject device |
| Indications for Use | Use of the Radiation Shield
is indicated in cases in
which protection of tissue
and/or organs from x-
radiation is desired. | 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. |
| Can be used
internally | Yes | Yes |
| Multiple Shapes | Yes, multiple semi-
spherical | Yes, available in circular
and ellipsoidal shapes |
| Sizes | 1.5 to 5.0cm in diameter | Diameters ranging from 3
cm to 7 cm for circular
shapes.
Minor and major axes
ranging from 3 cm to 12 cm
for ellipsoidal shapes. |
| Material | Tungsten-filled silicone
resin | 316L Stainless Steel (UNS
S31603, ASTM
A240/A240M) |
| Sterilization | Provided sterile, gamma | Provided non-sterile,
required to steam
sterilization |
| Lead Equivalency | 0.05mm at 50kVp | Not less than 0.20 mm at
50 kVp |
| For Use With | Photoelectron (now Carl
Zeiss Surgical) Photon
Radiosurgery System | Axxent Electronic
Brachytherapy System |
Comparison Table of Predicate and Subject Device
3
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.
4
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
5
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
6
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
Division Sign-Off
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111299
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