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 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.

AI/ML Overview

This document is a 510(k) summary for the Axxent® Electronic Brachytherapy System. 510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria and extensive study data in the way a clinical trial for a new drug or novel high-risk device might.

Based on the provided information, the document does not contain the type of detailed acceptance criteria and study data requested in the prompt. Instead, it focuses on:

Substantial Equivalence: The core of this 510(k) is to demonstrate that the Axxent Electronic Brachytherapy System is substantially equivalent to a previously cleared device (K050843) for technological characteristics and another (K061582) for indications for use.
Technological Characteristics: The summary explicitly states, "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." This means that the device's performance is assumed to meet prior acceptance criteria because its core technology is identical to an already cleared device.
Limitations: The FDA letter (K072683) adds a specific limitation to the device's labeling regarding its use for whole breast irradiation, indicating that its safety and effectiveness for this specific use have not been established. This is a post-submission requirement rather than a set of performance criteria the device had to meet for its general clearance.

Therefore, many of the requested detailed points about acceptance criteria and study design are not present in this type of regulatory document.

However, I can extract the available information and state which points are not covered:

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly detailed as new acceptance criteria the device had to meet for this submission. The device is deemed substantially equivalent in "design, materials, principles of operation and product specifications" to a previously cleared device (K050843).	The Axxent Electronic Brachytherapy System delivers high dose rate X-ray radiation for brachytherapy using an X-ray source and applicator. Performance is assumed to be equivalent to the predicate device K050843.
Specific Limitation/Warning from FDA: Safety and effectiveness as a replacement for whole breast irradiation in the treatment of breast cancer.	Not Established: The FDA explicitly states that the safety and effectiveness for this specific application have not been established, and a warning label is required.

Study Information (Based on available text):

Sample size used for the test set and the data provenance: Not provided. The submission relies on substantial equivalence to predicate devices, not new clinical testing data described here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
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. This is a radiation therapy delivery system, not an AI-based diagnostic or assistive device that would involve human readers or AI assistance in that context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided, as this submission relies on substantial equivalence.
The sample size for the training set: Not provided. This type of device does not typically have a "training set" in the context of an algorithm.
How the ground truth for the training set was established: Not applicable for this type of device and submission.

Summary of what is present:

Identified Device: Axxent® Electronic Brachytherapy System
Intended Use: To deliver high dose rate X-ray radiation for brachytherapy.
Basis for Clearance: Substantial equivalence to predicate devices (K050843 and K061582) in terms of design, materials, principles of operation, and product specifications.
Specific FDA Limitation: The safety and effectiveness of the device as a replacement for whole breast irradiation in the treatment of breast cancer has not been established, and a warning is required.

Summary

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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(21 CFR 892.5900)

Predicate Devices

Device Name	PremarketNotification
Axxent® Electronic Brachytherapy System (forTechnological Characteristics)	K050843
Varian VariSource 200 HDR Afterloader (Indications forUse only)	K061582

Page 1 of 2

Tab 4

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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 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.

Page 2 of 2

Tab 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

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:

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

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.