(57 days)
Not Found
No
The summary describes a physical applicator for delivering radiation and does not mention any software or algorithms that would suggest AI/ML.
Yes
The device is used to deliver radiation treatment, which is a therapeutic intervention for skin and tissue surfaces.
No
The device is described as an applicator for delivering radiation treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "component" of a system that utilizes a miniaturized x-ray source and is a physical "applicator" provided in multiple sizes. It also mentions reusable and sterilizable components and disposable end caps, all indicating a hardware device.
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 to skin and tissue surfaces. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a component of a brachytherapy system that uses an x-ray source to deliver radiation. This is a treatment delivery system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
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 treat, not to diagnose.
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 Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.
Product codes (comma separated list FDA assigned to the subject device)
JAD
Device Description
The Axxent Surface Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniaturized x-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver high-dose rate, low energy radiation treatment to skin and tissue surfaces. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Surface Applicator is provided in multiple circular aperture sizes to accommodate a range of lesion sizes. The applicators are reusable and sterilizable. Single use disposable end caps are provided to help flatten the treatment surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin and tissue surfaces, treatment site is exposed surgically
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): 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.
Not Found
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
KOf373Y
Xoft, Inc. Sunnyvale, California
FEB 1 1 2009
Tab
510(k) Summary
Submitter
Xoft, Inc. 345 Potrero Ave Sunnyvale, CA 94085 Contact Name: Steve Lin Phone Number: (408) 419-2341 Fax Number: (408) 419-2301 steve.lin@xoftinc.com Email: Summary was prepared on December 15, 2008
Axxent® Surface Applicator 510(k)
Name of Device
Trade name: | Axxent® Surface Applicator |
---|---|
Common name: | Brachytherapy Surface Applicator |
Classification | |
Name: | X-Ray Radiation Therapy System and Accessories |
90 JAD (per 21 CFR 892.5900) |
Predicate Device
Device Name | Premarket Notification |
---|---|
Nucletron Valencia Skin Applicator Set | K073107 |
1
Axxent® Surface Applicator 510(k)
Xoft. Inc. Sunnyvale, California
Device Description
The Axxent Surface Applicator is a component of the Axxent Electronic Brachytherapy System which utilizes a proprietary miniaturized x-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR Xray Source to deliver high-dose rate, low energy radiation treatment to skin and tissue surfaces. The Axxent HDR X-ray Source mimics the penetration and dose characteristics of Iridium-192 within the treatment target. The Axxent Surface Applicator is provided in multiple circular aperture sizes to accommodate a range of lesion sizes. The applicators are reusable and sterilizable. Single use disposable end caps are provided to help flatten the treatment surface.
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 Surface Applicator are the same as the Nucletron Valencia Skin Applicator approved in K073107. 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.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle symbol. The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFR 1 1 2009
Mr. Steve Lin Regulatory Manager Xoft, Inc. 345 Potrero Ave. SUNNYVALE CA 94085
Re: K083734
Trade/Device Name: Axxent® Surface Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-rav radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 15, 2008 Received: December 17, 2008
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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 os 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
---|---|---|
21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification' (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, 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.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Xoft, Inc. Sunnyvale, California
Indications for Use
510(k) Number:
Device Name: Axxent Surface Applicator
Indications for Use:
The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.
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)
Helent Remer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 083734 510(k) Number