(114 days)
Not Found
No
The provided text describes a standard electronic brachytherapy system with a controller, source, and applicator. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies mentioned are software system tests, not studies evaluating AI/ML model performance.
Yes
The device is described as treating "lesions, tumors and conditions in or on the body where radiation is indicated," which directly indicates a therapeutic purpose.
No
The device delivers radiation for treatment, it does not diagnose conditions.
No
The device description explicitly states that the system consists of three primary hardware components: the Controller, the Source (a miniature X-ray tube), and an Applicator. This clearly indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "treat lesions, tumors and conditions in or on the body where radiation is indicated." This describes a therapeutic device used directly on a patient, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a system that delivers X-ray radiation to tissue in proximity to an applicator. This is a direct treatment method, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Axxent® Electronic Brachytherapy System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.
Product codes
JAD
Device Description
The Axxent Electronic Brachytherapy System consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller.
The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
in or on the body
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)
Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 122951
510(k) Summary
510(k) OWNER:
JAN 1 7 2013
iCAD Inc. 98 Spit Brook Road, Suite 100 Nashua, NH 03062 T: 603-882-5200 Ext 7945 F: 603- 880-3843 Registered Establishment Number: 1225671
MANUFACTURER FACILITY:
Xoft Inc. a Subsidiary of iCAD Inc. 101 Nicholson Lane San Jose, CA 94134 Registered Establishment Number: 3005594788
NAME OF CONTACT:
John A. DeLucia VP, Regulatory Affairs, Clinical Affairs and Quality Assurance
DATE SUMMARY PREPARED: December 12, 2012
TRADE NAME: Xoft Electronic Brachytherapy System
COMMON NAME: Radiation Therapy System
CLASSIFICATION: Class II
CLASSIFICATION NAME: X-Ray Radiation Therapy System
CRF CLASSIFICATION: 21 CFR 892.5900
PRODUCT CODE: JAD
1
SECTION 6: 510(K) Summary (con't)
Legally Marketed Devices to Which Substantial Equivalence is Claimed
The Axxent Electronic Brachytherapy System Controller is substantially equivalent to the following legally marketed predicate devices. When used with applicators or sources both devices treat lesions, tumors and conditions in or on the body where radiation is indicated.
| Device Name | Manufacturer | 510(k)
Reference # | Concurrence
Date |
|-------------------------------------------|--------------|-----------------------|---------------------|
| Axxent Electronic Brachytherapy
System | Xoft | K072683 | 2/29/08 |
| VariSource 200 HDR Afterloader | Varian | K061582 | 7/25/06 |
Device Description
The Axxent Electronic Brachytherapy System consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller.
The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.
Intended Use / "Indications for Use"
The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.
Image /page/1/Picture/9 description: The image is a warning label. The label warns that the safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The warning sign is inside of a black rectangular box.
2
. Summary of Technological Characteristics
The technological characteristics of the Axxent Electronic Brachytherapy System Controller are the same as the Axxent Electronic Brachytherapy System cleared in K072683, and are similar to the Varian VariSource 200 HDR Afterloader cleared under K061582. These devices are equivalent in terms of design, materials, principles of operation, and product specifications.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis which is used to identify potential hazards. Any potential hazards are controlled via software development, verification and validation testing.
Assessment of Non-Clinical Performance Data
Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met.
Conclusion -
This traditional 510(k) for the Axxent® Electronic Brachytherapy System Controller contains adequate information and data to determine substantial equivalence to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem is a graphic representation of a human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
January 17, 2013
Mr. John DeLucia VP, RA/QA/CA iCAD, Inc. 98 Spitbrook Rad NASHUA NH 03062
Re: K122951
Trade/Device Name: Axxent(R) Electronic Brachytherapy System Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 12, 2013 Received: December 13, 2013
Dear Mr. DeLucia:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
4
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/CDRH/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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122951
Device Name: Axxent® Electronic Brachytherapy System
Indications for Use: The Axxent® Electronic Brachytherapy System is a high dose rate brachytherapy device for use with Axxent Applicators to treat lesions, turnors and conditions in or on the body where radiation is indicated.
WARNING The safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not
been established.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 Diagnostics and Radiological Health (OIR)
Muchel (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K122951 510(k)
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