The Axxent® Electronic Brachytherapy System Model 110 XP 1200 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. Only Xoft Axxent Surface Applicators can be used with the Axxent Electronic Brachytherapy System Model 110 XP 1200.

Device Description

The Axxent Electronic Brachytherapy System consists of two primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Catheter/Source). The System is designed to deliver doses of X-ray radiation to tissue in proximity to the applicator using a miniature X-ray tube powered by the Controller.

The Axxent Electronic Brachytherapy System 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 miniature X-ray tube located at the end of a flexible catheter. The Catheter/Source is inserted into a lumen of an appropriate Applicator which are cleared separately under their 510(k). The Axxent Electronic Brachytherapy System Model 110 XP 1200 described in this 510(k) will only be used for surface applications using Xoft Axxent Surface Applicators.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Axxent Electronic Brachytherapy System Model 110 XP 1200. This is a medical device for radiation therapy, not an AI/ML imaging device. Therefore, much of the requested information regarding AI-specific criteria (such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract the acceptance criteria related to the device's performance and the nature of the study conducted to prove it meets those criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are focused on demonstrating that technological changes do not negatively impact the device's fundamental functional, scientific, and performance characteristics, particularly concerning radiation dosage. The device seeks substantial equivalence to its predicate device (Axxent Electronic Brachytherapy System, K122951).

Acceptance Criteria / Performance Aspect	Reported Device Performance (Model 110 XP 1200 vs. Predicate)
Spatial Parameters (Azimuthal and Polar Variation)	Equivalence with the current device.
Depth Dose	Equivalence with the current device.
First and Second Half Value Layers	Agreement between the current x-ray source/catheter and the proposed source/catheter measurement.
Consistency of Spatial Measurements, Depth Dose, and Source/Catheter Spectrum after Extended Use	Consistency demonstrated.
Source/Catheter Output Linearity and Reproducibility	Output is linear as a function of time and reproducible.
Proposed Source/Catheter Longevity	Functions for at least as long as the current source.
Usability in Simulated Clinical Setting	Able to be used in the same manner as the current x-ray source/catheter in a simulated clinical setting.
Clinical Dose Equivalence in Surface Applicator Indication	Clinical dose is identical when using either source/catheter design in the surface applicator indication.

Study Details (as per the document):

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML study. The testing was non-clinical performance data (laboratory testing of the device's physical properties), not based on a "test set" of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance is based on physical measurements of radiation characteristics.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML imaging device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for performance was established through physical measurements and validation testing of the device's characteristics (e.g., spatial parameters, depth dose, half-value layers, output linearity, longevity).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Overall Study Description:

The study referenced is a non-clinical performance assessment conducted to support the substantial equivalence of the Axxent Electronic Brachytherapy System Model 110 XP 1200 to its predicate device. This involved a series of laboratory tests and validation activities focused on the physical and operational characteristics of the device, particularly the changes in the cooling system and anode target. The goal was to confirm that these changes did not alter the fundamental safety and effectiveness of the device, especially concerning radiation delivery. The conclusion from these non-clinical tests was that the clinical dose is identical regardless of whether the proposed or current source/catheter design is used in the surface applicator indication.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

iCAD, Inc. % Mr. John DeLucia VP, Regulatory Affairs, Quality Assurance, Clinical Affairs 98 Spitbrook Road, Suite 100 NASHUA NH 03062

Re: K153570

Trade/Device Name: Axxent Electronic Brachytherapy System Model 110 XP 1200 Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: February 10, 2016 Received: February 11, 2016

Dear Mr. DeLucia:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153570

Device Name

Axxent® Electronic Brachytherapy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
< Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary

510(k) OWNER:

iCAD Inc. 98 Spit Brook Road, Suite 100 Nashua, NH 03062 T: 603- 546-7430 F: 603- 880-3843 Registered Establishment Number: 1225671

MANUFACTURER FACILITY:

Xoft Inc. a Subsidiary of iCAD Inc. 101 Nicholson Lane San Jose, CA 95134 Registered Establishment Number: 3005594788

NAME OF CONTACT:

John A. DeLucia VP, Regulatory Affairs, Clinical Affairs and Quality Assurance

DATE SUMMARY PREPARED AND REVISED: December 11, 2015/February 23, 2016

TRADE NAME: Axxent Electronic Brachytherapy System Model 110 XP 1200

COMMON NAME: Radiation Therapy System

CLASSIFICATION: Class II

CLASSIFICATION NAME: X-ray Radiation Therapy System

CRF CLASSIFICATION: 21 CFR 892.5900

PRODUCT CODE: JAD

{4}------------------------------------------------

510(K) Summary (con't)

Legally Marketed Devices to Which Substantial Equivalence is Claimed

The Axxent Electronic Brachytherapy System is substantially equivalent to the following legally marketed predicate device.

Device Name	Manufacturer	510(k)Reference #	ConcurrenceDate
Axxent Electronic BrachytherapySystem	Xoft	K122951	01/17/2013

Device Description

Intended Use / "Indications for Use"

Summary of Technological Characteristics

The technological characteristics of the Axxent Electronic Brachytherapy System Controller are the same as the Axxent Electronic Brachytherapy Controller cleared in K122951. The table below describes the changes to the proposed Axxent Electronic Brachytherapy Controller.

{5}------------------------------------------------

Characteristic	Proposed Device	Predicate Device	Difference	Comments
Name	Axxent ElectronicBrachytherapySystem	Axxent ElectronicBrachytherapySystem	No Change	NA
Catalog Number	XP 1200	XP 1100	NA	NA
Part number	750-850	750-050	NA	NA
Indications for Use	Same	Same	No Change	NA
Software	Same	Same	No Change	NA
Hardware	Same	Same	No Change	NA
Pump Speed	120 rev/min	60 rev/min	Same pump withresistors removed	Two Resistorsremoved
Cooling Fluid	Galden HT-135	Water	Improve Cooling	Both cooling fluids
Cooling CatheterOuter Material	Polyurethane 75D	HDPE	Longer Life	No Patient Contact
Anode Target	Tungsten Film	Tungsten Film	No Change	NA
Anode TargetThickness	1.5 microns	0.7 microns	IncreasedThickness	Improve efficiencyand life
Connectors onCooling System	Kent QuickConnector	Luer	ImprovedConnector	Prevent newcoolant use witholder AxxentElectronicBrachytherapySystem
Catheter/SourceInterlock	No magnet	Magnet	Interlock notsatisfied	Prevents use innon-surfaceindications

{6}------------------------------------------------

General Safety and Effectiveness Concerns

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis which is used to identify potential hazards. Any potential hazards are controlled via software development, verification and validation testing.

Assessment of Non-Clinical Performance Data

Validation testing was performed and all performance, functional and system requirements were met. A number of non-clinical tests were conducted to support substantial equivalence. These included testing that demonstrated:

Equivalence with the current device for spatial parameters (azimuthal and polar variation) . and depth dose
Equivalence between the current x-ray source/catheter used in the surface applicator and o the proposed source/catheter through measurement of the depth dose
Equivalence through the agreement of the first and second half value layers measured for . the current x-ray source/catheter and the proposed source/catheter
Consistency between spatial measurements, depth dose, and source/catheter spectrum after . extended use of the proposed source/catheter
The source/catheter output is linear as a function of time and reproducible. .
The proposed source/catheter functions for at least as long as the current source .
The proposed source/catheter are able to be used the same manner as the current x-ray . source/catheter in a simulated clinical setting

This data has shown that the clinical dose is identical when using either source/catheter design in the surface applicator indication.

Conclusion

This traditional 510(k) for the Axxent® Electronic Brachytherapy System contains adequate information and data to determine substantial equivalence to the predicate devices.

The Axxent Electronic Brachytherapy System has the same intended use as the previously cleared predicate devices. Both are intended to be used to treat lesions, tumors and conditions in the body where radiation is indications for use for the Axxent Electronic Brachytherapy System remain the same as its last clearance in K122951.

The Axxent Electronic Brachytherapy System has the same fundamental functional, scientific and performance characteristics as the previously cleared predicate device in that both devices are capable of providing radiation delivery through multiple channel applicators. The nonclinical data presented has shown that the clinical dose is identical when using the proposed or

{7}------------------------------------------------

current source/catheter design in the surface applicator indication. There are no new concerns of safety or efficacy with the proposed changes.

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.