The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

Device Description

The Axxent Cervical Applicator is a component of the Axxent Electronic Brachytherapy System (cleared under K122951) which utilizes a proprietary miniaturized X-ray source and does not require radioactive isotopes. The applicator allows the Axxent HDR X-ray source to deliver high-dose rate, low energy radiation treatment to the uterus, cervix, endometrium and vagina. The Axxent HDR X-ray source mimics the penetration and dose characteristics of Iridium-192.

The Axxent Cervical applicator is provided non-sterile and can be reused. The user must sterilize the device using steam sterilization before each use. An Applicator Clamp is a required accessory to stabilize the Cervical Applicator during radiation treatment.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Axxent® Cervical Applicator, primarily focused on adding MRI compatibility and MR Conditional labeling. It is not an AI/ML device, and therefore, many of the requested criteria related to AI/ML device performance and studies are not applicable.

However, I can extract information related to the acceptance criteria and the study performed for the MRI compatibility of the device, as that is the specific new claim being sought.

Here's the information regarding the MRI compatibility study:

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

Acceptance Criteria (Test Standard)	Reported Device Performance
Magnetically induced displacement force (ASTM F2052)	Results indicated the device meets the criteria for MR Conditional labeling.
Magnetically induced torque (ASTM F2213 as a guide)	Results indicated the device meets the criteria for MR Conditional labeling.
MR image artifact (ASTM F2119)	Results indicated the device meets the criteria for MR Conditional labeling.
Radiofrequency induced heating (ASTM F2182)	Results indicated the device meets the criteria for MR Conditional labeling.

Note: The document states that the results of the testing "indicated that, in accordance with the guidance of relevant ASTM standards, Xoft's Cervical Applicator should be labeled MR Conditional." This implies that the device successfully met the established thresholds and requirements outlined in each ASTM standard for magnetic displacement, torque, artifact, and heating, thereby qualifying for MR Conditional labeling. Specific numerical thresholds or measured values are not provided in this summary.

2. Sample sized used for the test set and the data provenance

Sample size: "Test samples were provided in their final manufactured condition." The exact number of samples tested is not specified, but it implies a sufficient number of devices were used for each test to achieve reliable results as per the ASTM standards.
Data provenance: Not explicitly stated, but given it's a submission to the FDA by a US-based company, the testing was likely conducted in a controlled laboratory environment, presumably in the US. It is a prospective study as tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as this is a device compatibility test, not an AI/ML diagnostic or prognostic study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" here is adherence to engineering standards for MRI safety.

4. Adjudication method for the test set

Not applicable. This involves objective physical measurements and adherence to ASTM standards, not subjective interpretation requiring adjudication among experts.

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. This is not an AI/ML device and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" in this context is established by the ASTM consensus standards (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) for evaluating MRI compatibility. Performance is judged against the objective physical criteria and thresholds defined within these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set.

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

Not applicable. This is not an AI/ML device; there is no training set.

Summary

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a symbolic representation of an eagle above them.

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

September 5, 2014

iCAD, Inc. % Mr. John A. DeLucia Vice President, Regulatory Affairs, Clinical Affairs and Quality Assurance 98 Spit Brook Road, Suite 100 NASHUA NH 03062

Re: K141343

Trade/Device Name: Axxent® Cervical Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: July 24, 2014 Received: July 25, 2014

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 (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'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K141343

Device Name: Axxent® Cervical Applicator

Indications For Use:

Indications for Use: The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Section 5: 510(K) Summary

510(k) OWNER:

iCAD Inc. 98 Spit Brook Road, Suite 100 Nashua, NH 03062 T: 603-882-5200 Ext 7945 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 T: (603) 882-5200 x7945 F: (603) 880-3843 Email: jdelucia@icadmed.com

DATE SUMMARY PREPARED: May 28, 2014

TRADE NAME: Axxent® Cervical Applicator

COMMON NAME: Brachytherapy Cervical Applicator

CLASSIFICATION: Class II

CLASSIFICATION NAME: X-Ray Radiation Therapy System and Accessories

CRF CLASSIFICATION: 21 CFR 892.5900

PRODUCT CODE: JAD

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SECTION 5: 510(K) Summary (con't)

Legally Marketed Device to Which Substantial Equivalence is Claimed

The Axxent Cervical Applicator was originally cleared under K123442. The Axxent Cervical Applicator was found substantially equivalent to the following legally marketed predicate device. In this pre-market clearance submission, iCAD Inc. is seeking clearance for adding MRI compatibility and MR Conditional labeling for which the predicate is also cleared for.

Device Name	Manufacturer	510(k)Reference #	ConcurrenceDate
Mick Radio-NuclearInstruments, Inc. ModifiedHenschke HDR CervixApplicator	Mick Radio-NuclearInstruments, Inc.	K040704	06/18/2004

Device Description

Intended Use / "Indications for Use"

The indications for use have not changed since its clearance under K123442. The Axxent Cervical Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver high dose rate brachytherapy for intracavitary treatment of cancer of the uterus, cervix, endometrium and vagina.

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Summary of Technological Characteristics

The technological characteristics of the Axxent Cervical Applicator have not changed since its clearance under K123442. In this pre-market clearance submission, iCAD Inc. is seeking clearance for adding MRI compatibility and MR Conditional labeling to the Instructions for Use. The Axxent Cervical Applicator is substantially equivalent to the predicate device, Mick Radio-Nuclear Instruments, Inc. Modified Henschke HDR Cervix Applicator, in terms of MR compatibility.

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 through development, verification and validation testing.

Assessment of Non-Clinical Performance Data

A study report was included in this submission which evaluated the Axxent Cervical Applicator for MRI compatibility in 1.5 T and 3 T clinical scanners. Test samples were provided in their final manufactured condition and were evaluated for the following:

1. Magnetically induced displacement force (ASTM F2052)
1. Magnetically induced torque (ASTM F2213 as a guide)
1. MR image artifact (ASTM F2119)
1. Radiofrequency induced heating (ASTM F2182)

The results of the testing indicated that, in accordance with the guidance of relevant ASTM standards, Xoft's Cervical Applicator should be labeled MR Conditional.

Conclusion

This traditional 510(k) for the Axxent® Cervical Applicator contains adequate information and data to determine substantial equivalence to the predicate device.

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.