Axxent Electronic Brachytherapy System Model 110 XP 1200

K153570 · Icad, Inc. · JAD · Feb 25, 2016 · Radiology

Device Facts

• Record ID: K153570
• Device Name: Axxent Electronic Brachytherapy System Model 110 XP 1200
• Applicant: Icad, Inc.
• Product Code: JAD · Radiology
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Axxent Electronic Brachytherapy System Model 110 XP 1200 is a mobile, computer-controlled platform for high dose rate (HDR) radiation therapy. It utilizes a miniature X-ray tube located at the tip of a flexible catheter/source to deliver X-ray radiation to target tissue. The system is used with Xoft Axxent Surface Applicators to treat lesions, tumors, and conditions where radiation is indicated. The controller manages system operation, including cooling fluid circulation and X-ray source power. Healthcare providers operate the system to deliver precise radiation doses. The device is designed for surface applications, with an interlock mechanism preventing use in non-surface indications. Clinical benefits include localized radiation delivery for tumor/lesion management.

Clinical Evidence

Bench testing only. Non-clinical performance data demonstrated equivalence in spatial parameters (azimuthal and polar variation), depth dose, and half-value layers between the proposed and predicate source/catheter. Testing confirmed output linearity and reproducibility, extended source life, and functional performance in simulated clinical settings. Data shows clinical dose is identical to the predicate when used with surface applicators.

Technological Characteristics

Mobile, computer-controlled X-ray radiation therapy system. Miniature X-ray tube source; Tungsten film anode target (1.5 microns). Cooling system uses Galden HT-135 fluid with Polyurethane 75D cooling catheter. Connectivity via system controller. Software-controlled operation with hardware interlocks for surface-only application. Sterilization/biocompatibility maintained via standard clinical practices for catheter components.

Indications for Use

Indicated for patients requiring high dose rate brachytherapy to treat lesions, tumors, and conditions in or on the body where radiation therapy is indicated, specifically using Xoft Axxent Surface Applicators.

Regulatory Classification

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.

Predicate Devices

• Axxent Electronic Brachytherapy System (K122951)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known) K153570

#### Device Name

Axxent® Electronic Brachytherapy System

#### Indications for Use (Describe)

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.

| 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) |

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## 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

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# 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)<br>Reference # | Concurrence<br>Date |
|--------------------------------------------|--------------|-----------------------|---------------------|
| Axxent Electronic Brachytherapy<br>System | Xoft | K122951 | 01/17/2013 |

#### 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.

## Intended Use / "Indications for Use"

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.

## 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.

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| Characteristic | Proposed Device | Predicate Device | Difference | Comments |
|------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------|
| Name | Axxent Electronic<br>Brachytherapy<br>System | Axxent Electronic<br>Brachytherapy<br>System | 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 with<br>resistors removed | Two Resistors<br>removed |
| Cooling Fluid | Galden HT-135 | Water | Improve Cooling | Both cooling fluids |
| Cooling Catheter<br>Outer Material | Polyurethane 75D | HDPE | Longer Life | No Patient Contact |
| Anode Target | Tungsten Film | Tungsten Film | No Change | NA |
| Anode Target<br>Thickness | 1.5 microns | 0.7 microns | Increased<br>Thickness | Improve efficiency<br>and life |
| Connectors on<br>Cooling System | Kent Quick<br>Connector | Luer | Improved<br>Connector | Prevent new<br>coolant use with<br>older Axxent<br>Electronic<br>Brachytherapy<br>System |
| Catheter/Source<br>Interlock | No magnet | Magnet | Interlock not<br>satisfied | Prevents use in<br>non-surface<br>indications |

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## 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

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