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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Axxent® Surface Applicator. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing data from a study that establishes acceptance criteria and then proves the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics are not available in this specific document.

Here's a breakdown of what can be extracted and what is not present:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance

Not Available. The document does not describe specific numerical acceptance criteria or performance metrics for the Axxent Surface Applicator itself, beyond stating that its technological characteristics are "the same" as the predicate device. The focus is on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available. No specific test set or clinical study data is presented to evaluate the Axxent Surface Applicator's performance against defined criteria. The substantial equivalence relies on comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Available. Since no specific test set requiring ground truth establishment is described, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Available. As there's no described test set, there's no adjudication method mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable/Not Available. The Axxent Surface Applicator is a physical medical device (brachytherapy applicator) and not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Available. This device is a physical applicator, not an algorithm, so this type of study is not relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Available. No ground truth data is discussed as there is no performance study presented for this device.

8. The sample size for the training set

Not Applicable/Not Available. The device is a physical medical device, not an AI model, so there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable/Not Available. As above, no training set for an AI model is relevant to this device.

Summary of Device Comparison (from the document):

The core of the 510(k) submission is the claim of substantial equivalence to the predicate device.

Predicate Device: Nucletron Valencia Skin Applicator Set (K073107)
Claim of Equivalence: "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."

This document focuses on demonstrating that the new device is functionally identical or very similar to a device that has already been cleared by the FDA, rather than proving its performance against new, specific acceptance criteria through a clinical or performance study.

Summary

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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
ClassificationName:	X-Ray Radiation Therapy System and Accessories90 JAD (per 21 CFR 892.5900)

Predicate Device

Device Name	Premarket Notification
Nucletron Valencia Skin Applicator Set	K073107

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Axxent® Surface Applicator 510(k)

Xoft. Inc. Sunnyvale, California

Device Description

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.

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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.

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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

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Xoft, Inc. Sunnyvale, California

Indications for Use

510(k) Number:

Device Name: Axxent Surface Applicator

Indications for Use:

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

Regulation Number and Section

§ 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.