(265 days)
The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
The safety and effectiveness of the Axxent Electronic Brachytherapy System as a I he salely and chectryedies of the ristion in the treatment of breast cancer has not been established.
The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source.
The Controller is a mobile platform that is responsible for the overall operation of the device. The radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of the appropriately-sized Balloon Applicator. The System is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical marqins following lumpectomy for breast cancer.
The Axxent Electronic Brachytherapy System does not utilize a radioactive isotope, or require an HDR isotope afterloader, and thus does not require the heavily-shielded treatment rooms necessary for the delivery of isotope-based HDR brachytherapy.
The provided text is a 510(k) Summary for the Axxent Electronic Brachytherapy System (K050843), focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The 510(k) summary primarily addresses:
- Device Name: Axxent™ Electronic Brachytherapy System
- Predicate Devices: Photoelectron Corporation Photon Radiosurgery System (PRS), Varian VariSource Remote Afterloader, Proxima Therapeutics MammoSite Radiation Therapy System (RTS).
- Device Description: Three components - Controller, Balloon Applicators-BR, and X-ray Source. It describes its function as delivering X-ray radiation directly to the excised tumor bed for intracavitary or interstitial radiation following lumpectomy for breast cancer, without using a radioactive isotope.
- Intended Use: To provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
- Technological Characteristics: Claims similarity and equivalence to predicate devices in design, materials, principles of operation, product specifications, and sterilization.
- Summary of Equivalence: Argues substantial equivalence to predicate devices based on design, materials, function, and intended use.
- FDA Communication: Includes a letter from the FDA stating the determination of substantial equivalence and a critical warning that “The safety and effectiveness of the Axxent Electronic Brachytherapy System as a sole or adjunctive form of breast irradiation in the treatment of breast cancer has not been established.” This warning was required to be presented in a black box in the device's labeling.
In summary, this 510(k) submission is a regulatory document focused on demonstrating substantial equivalence to already cleared devices, not on providing a study with acceptance criteria and performance data as you've requested for an AI/ML device. The device described is a physical medical device (X-ray radiation therapy system), not an AI/ML system, which would require different types of performance evaluation.
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DEC 2 2 2005
ll. 510(k) Summary
A. Name of Device
| Trade name: | Axxent™ Electronic Brachytherapy System |
|---|---|
| Common name: | X-Ray Radiation Therapy System |
| Classificationname: | X-Ray Radiation Therapy System and Accessories(21 CFR 892.5900) |
B. Predicate devices
| Device Name | PremarketNotification (Date) |
|---|---|
| Photoelectron Corporation Photon RadiosurgerySystem (PRS) and Spherical Applicators | K992577(09/23/1999) |
| Varian VariSource Remote Afterloader | K945383(02/15/1995) |
| Proxima Therapeutics MammoSite RadiationTherapy System (RTS) | K011690(05/06/2002) |
| Proxima Therapeutics MammoSite RadiationTherapy System (RTS) | K030558(05/21/2003) |
| Proxima Therapeutics MammoSite RadiationTherapy System (RTS) | K032067(02/10/2004) |
C. Device description
The three components of the Axxent Electronic Brachytherapy System include the Controller, Balloon Applicators-BR and X-ray Source.
The Controller is a mobile platform that is responsible for the overall operation of the device. The radiation is delivered by a disposable, microminiature X-ray source located at the end of a flexible cable. The X-ray source at the distal tip of the cable is inserted into the central lumen of the appropriately-sized Balloon Applicator. The System is designed to deliver doses of X-ray radiation directly to the excised tumor bed when the physician desires to deliver intracavitary or interstitial radiation to the surgical marqins following lumpectomy for breast cancer.
The Axxent Electronic Brachytherapy System does not utilize a radioactive isotope, or require an HDR isotope afterloader, and thus does not require the
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heavily-shielded treatment rooms necessary for the delivery of isotope-based HDR brachytherapy.
010842
D. Intended use
The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
E. Technological characteristics
The technological characteristics of the Axxent Electronic Brachytherapy System are very similar to those of the predicate devices. These devices are equivalent in terms of design, materials, principles of operation, product specifications and sterilization.
F. Summary
The Axxent Controller has the same operating features as the VariSource afterloader in that both are software-controlled devices that control the placement and delivery of high dose rate brachytherapy sources. The Axxent Balloon Applicator-BR is substantially equivalent to the RTS devices in design, materials and intended use. The Axxent HDR X-ray Source 2.2 is substantially equivalent to the PRS Source in that the fundamental characteristics of the two devices are the same; they both generate x-rays of up to 50 keV energy for radiation therapy inside the body using similar technology and materials.
Thus by virtue of design, materials, function and intended use, the Axxent Electronic Brachytherapy System is substantially equivalent to devices legally marketed in the United States.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three wing-like shapes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
Kathy O'Shaughnessy, Ph.D. Vice President, Regulatory/Clinical/QA Xoft, Inc. 49000 Milmont Drive FREMONT CA 94538
Re: K050843
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: December 2, 2005 Received: December 5, 2005
Dear Dr. O'Shaughnessy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosure) to regally the enactment date of the Medical Device Amendments, or to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, ue rices that have boon rocksomey, therefore, market the device, subject to the general controls and Costient Act (rich). "Tod may, are stescribed below. The general controls provisions of the provisions of the Ace and the minute are tration, 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 The Office of Dorted Lraintended use not identified in the proposed labeling and that such 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 r he sareey and 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 The warning mast of p. The warning should be the first item in your list of warning.
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Page 2 - Dr. O'Shaughnessy
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Flease note that the above mooning memore 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 The FDA Initing of substantial equiralized or your device and permits your device to the device results in a Classification for your device as described in your Section Inarket. "This letter will anon-you to svigation 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), If your device is classified (300 above) in the existing major regulations affecting your device can be it may be subject to additional controlling may and 800 to 898. In addition, FDA may found in the Code of I cattar resgueening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri 3 issuance or was evice complies with other requirements of the Act that I Dri has made a deceminations administered by other Federal agencies. You must of any I coular statures and regulations and limited to: registration and listing (21 compry with an the Act 3 requirements, methods, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 801), good maxat 820); and if applicable, the electronic (200), 1959 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your II you desire specific information acount the Office of Compliance at (240) 276-0100. Also, device (21 CF RT an 001), product or Misbranding by reference to premarket notification' (21 prease note the regulation onlined, "Thise mater on your responsibilities under the CIN Fatt 607.77): 10a may other of the mational, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nutan MD for
Bea Tillman, Ph.D., M.P.A. Donr Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050843
Device Name: Axxent Electronic Brachytherapy System
FDA Indications For Use:
The Xoft Axxent Electronic Brachytherapy System is intended to provide brachytherapy when The Not Axxon Diooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
The safety and effectiveness of the Axxent Electronic Brachytherapy System as a I he salely and chectryedies of the ristion in the treatment of breast cancer has not been established.
ジ Prescription Use (Part 21 CFR 801 Subpart D) AND
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 Device Evaluation (ODE)
Jerold G. Seggern
(Division Sign-off)
Division of A. oductive, Abdominal, and Radiologia Levices 510(k) Namber
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§ 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.