AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Device Facts
| Record ID | K072683 |
|---|---|
| Device Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Applicant | Xoft, Inc. |
| Product Code | JAD · Radiology |
| Decision Date | Feb 29, 2008 |
| Decision | SESU |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5900 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended 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.
Device Story
Axxent Electronic Brachytherapy System delivers high dose rate X-ray radiation to target tissue; system comprises mobile computer-controlled controller, disposable miniature X-ray tube source on flexible cable, and compatible applicator. Source inserts into applicator lumen; controller powers source to deliver radiation. Used in clinical settings by healthcare professionals. Output allows targeted radiation therapy for lesions/tumors. Benefits include localized radiation delivery. Note: Safety/effectiveness for replacing whole breast irradiation in breast cancer treatment not established.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices.
Technological Characteristics
Mobile computer-controlled platform; disposable miniature X-ray tube source; flexible cable delivery; X-ray radiation therapy system (21 CFR 892.5900).
Indications for Use
Indicated for patients requiring high dose rate brachytherapy for treatment of lesions, tumors, and conditions where radiation is indicated. Prescription use only.
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
Related Devices
- K122951 — XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 · Icad, Inc. · Jan 17, 2013
- K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 · Icad, Inc. · Feb 25, 2016
- K050843 — AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM · Xoft, Inc. · Dec 22, 2005
- K083734 — AXXENT SURFACE APPLICATOR, MODEL 710257 · Xoft, Inc. · Feb 11, 2009
- K090914 — AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E · Xoft, Inc. · Jul 16, 2009
Submission Summary (Full Text)
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## FEB 2 9 2008
# 510(k) Summary
K072683
#### Submitter
Xoft, Inc. 49000 Milmont Dr Fremont, CA 94538 Contact Name: Eric Hashemian Phone Number: (510) 580-2913 Fax Number: (510) 668-0962 Email: ehashemian@xoftinc.com Summary was prepared on September 19, 2007.
### Name of Device
| Trade name: | Axxent® Electronic Brachytherapy System |
|----------------------|---------------------------------------------------------------------|
| Common name: | Brachytherapy System |
| Classification name: | X-ray Radiation Therapy System and Accessories<br>(21 CFR 892.5900) |
## Predicate Devices
| Device Name | Premarket<br>Notification |
|--------------------------------------------------------------------------------|---------------------------|
| Axxent® Electronic Brachytherapy System (for<br>Technological Characteristics) | K050843 |
| Varian VariSource 200 HDR Afterloader (Indications for<br>Use only) | K061582 |
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Tab 4
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#### Device Description
The Axxent Electronic Brachytherapy System (System) consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxent-compatible 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
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 Electronic Brachytherapy System are the same as the Axxent Electronic Brachytherapy System cleared in K050843. These devices are equivalent in terms of design, materials, principles of operation and product specifications.
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Tab 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
FEB 2 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Hashemian Director of Regulatory Affairs Xoft, Incorporated 49000 Milmont Drive FREEMONT CA 94538
Re: K072683
Trade/Device Name: Axxent® Electronic Brachytherapy System Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: January 21, 2008 Received: January 25, 2008
Dear Mr. Hashemian:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that successes and use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
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 must be presented within a black box, and the font should be bold and the same size as any surrounding text. The Warning should be the first item in your list of warnings. The safety and effectiveness of this device for use as replacement for whole breast irradiation in the treatment of breast cancer have not been established.
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Page 2 - Mr. Eric Hashemian
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
## 510(k) Number: Ko72683
#### 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, tumors and conditions in or on the body where radiation is indicated.
Prescription Use X (Per 21 CFR 801 subpart D) AND/OR
Over-The Counter Use (Per 21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation
Nancy C. Broadon
Division Sign-Off
Division of Reprodu ctive. Abdominal and Radiological Devices 510(k) Number
