(235 days)
None
No
The summary describes a physical applicator and radiation source, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is intended to deliver X-ray radiation for brachytherapy to treat conditions in the vagina and rectum, which is a therapeutic intervention.
No
This device is an electronic brachytherapy system and applicator, which delivers radiation treatment, rather than performing diagnosis.
No
The device description clearly states it is a physical applicator and a component of a larger hardware system (Axxent Electronic Brachytherapy System) that delivers radiation. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver radiation therapy for brachytherapy, specifically in the vagina and rectum. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a component of a system that delivers X-ray radiation. It's a physical applicator used to direct radiation to a specific anatomical site.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver treatment, not to perform such analysis.
N/A
Intended Use / Indications for Use
The Axxent Electronic Brachytherapy System is intended to deliver high dose rate X-ray radiation for brachytherapy.
The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.
Product codes
JAD
Device Description
The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina and rectum
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the word "Xoft" in a bold, sans-serif font. Below the word "Xoft" is the alphanumeric string "K072616" in a handwritten style. The text is black against a white background.
510(k) Summary
Submitter
Xoft, Inc. 49000 Milmont Dr Fremont, CA 94538 Contact Name: Eric Hashemian Phone Number: (510) 580-2900 Fax Number: (510) 668-0962 Email: ehashemian@xoftinc.com Summary was prepared on September 13, 2007
Name of Device
| Trade name: | Axxent® Vaginal Applicator Set |
|---|---|
| Common name: | Brachytherapy Vaginal Applicator |
| Classification | |
| Name: | X-Ray Radiation Therapy System and Accessories |
| 90 JAD (per 21 CFR 892.5900) |
Predicate Device
| Device Name | Premarket
Notification |
|------------------------------------------------------------------------------------|---------------------------|
| Varian Intracavitary Brachytherapy Applicators
Vaginal Applicator Set #11-00414 | K033371 |
Page 1 of 2
Tab 4
1
Device Description
The Axxent Vaginal Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniature X-ray source and does not require radioactive isotopes. Each applicator provides a channel for the Axxent HDR X-ray Source-2.2 to deliver high-dose rate, low energy radiation treatment. The source mimics the penetration and dose characteristics of Iridium 192 within the target volume. The Axxent Vaginal Applicators are available in 4 different sizes. The applicators are reusable and sterilizable. An Applicator Clamp and Base Plate are provided as a required accessory to stabilize the Vaginal Applicator during radiation treatment.
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 Vaginal Applicator are the same as the device approved in K033371. The device is substantially equivalent in terms of design, materials, principles of operation, and product specification to the predicate device. A comparison table is available in Tab 8.
Tab 4
Image /page/1/Picture/8 description: The image shows the word "Xoft" in a bold, sans-serif font. The letters are all connected and in black. The word is slightly slanted to the right.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY - 9 2008
Mr. Eric Hashemian Director of Regulatory Affairs Xoft, Inc. 345 Potrero Avenue SUNNYVALE CA 94085
Rc: K072616
Trade/Device Name: Axxent® Vaginal Appicator Set Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: March 27, 2008 Received: March 31, 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 arior 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 either class II (Special Controls) or class III (Premarket 11 your do roo be subject to such additional controls. Existing major regulations affecting your Apple rary, it ifaly of other of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text that is difficult to read due to the image quality.
Protesting and Promoting Public Health
3
Page 2
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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Xoft, Inc. Fremont, California
Indications for Use
510(k) Number:
Device Name: Axxent® Vaginal Applicator
Indications for Use:
The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.
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 (ODE)
Lora Northing
(Division Sign Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number