The Active Breathing Coordinator is indicated for use when there is a need to reduce the anatomical movement in the thorax and abdomen caused by breathing and cardiac motion. It is intended for breath-hold (BH) during simulation and delivery of External Beam Radiation Therapy (EBRT) using photons, in single or multiple fractions, administered via static and/or dynamic delivery processes, in any and all areas of the body where such treatment is indicated. It also provides electrical prompts and status information for the Elekta Limited Response™ gating interface when automated gating of the linac is used.

The Active Breathing Coordinator is specifically indicated for:

a. Breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (DIBH) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.
b. Lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by DIBH allows critical organ sparing, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of tumor target margins. Also included is the use of linac-based Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) that may be employed to treat such lesions.
c. Liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.
d. Pancreatic tumors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, enabling potential reduction of tumor target tissue margins. Also included is the use of linacbased SRS and SRT that may be employed to treat such lesions.

Device Description

This Traditional 510(k) describes product enhancements for the Active Breathing Coordinator (ABC). The ABC is a flow meter device that allows radiation therapy patients to graphically observe the volume of air that enters and exits their lungs on a computer monitor. The patients are coached prior to the treatment and instructed to hold their breath when the volume of air entering or exiting their lungs reaches a predefined threshold volume. Accurate and reproducible timing of the breath hold period is aided by a patient controlled balloon valve which is connected to the flow meter device. Radiation is only delivered during the breath hold period. Radiation may be delivered by the therapist manually turning the beam on and off, or automatically by using the Elekta Limited Response™ gating interface (FDA 510(k) clearance number K123808, available separately from Elekta, Ltd., Crawley, UK).

AI/ML Overview

This document describes the Active Breathing Coordinator (ABC), a flow meter device used in radiation therapy to help patients hold their breath, thereby reducing anatomical movement during treatment. The specific enhancements in this 510(k) submission relate to supporting automated gating of the treatment beam from a linear accelerator via the Elekta Ltd. Response linac gating interface.

Here's an analysis of the provided text with respect to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a table of acceptance criteria with numerical performance metrics for the device. Instead, it states that:

"Hardware and software specification testing have been performed on the enhanced ABC to show that the verification, validation and safety requirements have been met."

This general statement indicates that internal testing was conducted, but specific acceptance criteria and their corresponding performance results are not detailed in the public summary. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing quantifiable performance from a clinical study with defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a test set or the provenance (country of origin, retrospective/prospective) of data. The submission relies on demonstrating substantial equivalence to existing predicate devices, implying that extensive new clinical data with a test set was not a primary component of this particular 510(k) application.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a ground truth for a test set. This type of information would typically be part of a clinical performance study, which is not detailed in this 510(k) summary focusing on substantial equivalence.

4. Adjudication Method for the Test Set

Since no test set adjudicated by experts is mentioned, there is no information on any adjudication method (e.g., 2+1, 3+1, none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's technical functionality and its equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone (algorithm only) performance study. The device is a patient monitor with a flow meter and balloon valve, not an AI algorithm that operates independently. The "enhancement" involves an electrical interface for automated linac gating, which is a technical integration rather than a standalone AI performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation, as it doesn't detail a clinical performance study with a defined ground truth. The "ground truth" in this submission is implicitly related to whether the device correctly facilitates breath-hold and interfaces with the linear accelerator as intended, demonstrating equivalence to already cleared devices.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This type of information is relevant for AI/machine learning models, which are not the primary focus of this device. The device is a patient monitoring and control system, not a data-driven diagnostic or predictive algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set is discussed or implied to be part of the device's development, there is no information on how ground truth for a training set was established.

Summary of Device Acceptance:

The acceptance of the Active Breathing Coordinator (ABC) in this 510(k) submission (K131313) is based on demonstrating substantial equivalence to existing predicate devices (Aktina Medical's ABC K003330 and Anzai Medical's AK-733 K031385).

The study that "proves the device meets the acceptance criteria" in this context is the comparison against the predicate devices and internal hardware/software specification testing. The submission states:

"Hardware and software specification testing have been performed on the enhanced ABC to show that the verification, validation and safety requirements have been met."
"This device is similar in design and intended use, technological, physical, and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device."

The core of the "proof" is the argument that the enhanced ABC's technology for "Automatic and Manual Linac Gating" is substantially equivalent to the Anzai AK-733 (K031385), and its updated "Indications for Use" are substantially equivalent to the original ABC (K003330). The FDA's clearance letter confirms this determination of substantial equivalence.

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the enhanced device performs comparably to legally marketed devices for its stated intended use and does not raise new safety or effectiveness concerns, as evidenced by internal verification and validation and the detailed comparison against predicates. No specific quantitative performance metrics or clinical study results are presented in this summary to define "acceptance criteria" in a numerical sense.

Summary

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510(k) Summary

In Compliance with 21 CFR Section 807.92(c)

General Provisions l.

Device Trade Name:	Active Breathing Coordinator
Common Name:	Patient Monitor
Owner Nameand Address:	Aktina Medical Corporation360 North Route 9 WCongers, New York, 10920Phone: 845-268-0101Fax: 845-268-1700Registration Number: 2436865AUG 07 2013

2. Classification

This device is classified as a class II device according to 21 CFR 892.5050, "Medical chargedparticle radiation therapy system." The product code is IYE.

3. Predicate Devices

1. Active Breathing Coordinator (ABC), 510(k) No. K003330, Aktina Medical Corporation, 360 North Route 9W, Congers, NY 10920
1. Respiratory Gating System, Cat. No. AK-733, 510(k) No. K031385, Anzai Medical Company, Ltd., 3-6-25 Nishi-Shinagawa, Shinagawa-ku, Tokyo 141-0033 Japan

4. Description

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İntended Use ട.

The Active Breathing Coordinator is specifically indicated for:

.a. Breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (DIBH) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.
b. Lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by DIBH allows critical organ sparing, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of tumor target margins. Also included is the use of linac-based Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) that may be employed to treat such lesions.
c. Liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.
d. Pancreatic tumors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, cnabling potential reduction of tumor target tissue margins. Also included is the use of linacbased SRS and SRT that may be employed to treat such lesions.

Technological Characteristics 6.

The cnhanced ABC uses the same technology as its predicate device from Aktina Medical, the ABC K003330, with one exception. The enhanced ABC also supports automated gating of the treatment beam from a linear accelerator that contains the Elekta Ltd. Response linac gating interface option. The enhanced ABC clectrically prompts the Response to interrupt the linac beam and resume it at the appropriate times during the patient's breathing cycle. It also displays status information from the Elekta Response. The technology to support the Elekta Response is the same as the second predicate device listed above, the AK-733 Respiratory Gating System from Anzai Medical Company, Ltd. (K031385), which also electrically

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prompts a linear accelerator to turn the beam on and off at appropriate times during the patient's breathing cycle. The significant technology characteristics of the ABC arc:

a. Laptop personal computer software and external display monitor with graphical user interface.
b. Patient respiratory kit with an in-line transducer and balloon valve for air volume monitoring during patient breathing and lung volume stability during breath hold periods. The balloon valve is controlled pneumatically.

7. Performance Standards and Data

The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product

Hardware and software specification testing have been performed on the enhanced ABC to show that the verification, validation and safety requirements have been met.

Biocompatibility 8.

The patient contact components of the enhanced ABC are identical to the patient contact components of the ABC K003330, except that over-the-counter prism reading glasses may be used in place of a mirror system to allow the patient to see the monitor in a supine position. These components have been shown to be biocompatible for surface devices in contact with a skin or mucosal membrane with a contact duration of less than 24 hours.

9. Summary of Substantial Equivalence

This device is similar in design and intended use, technological, physical, and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

Specifically, the enhancements for the ABC are substantially cquivalent to the predicate devices as follows:

Type ofModification:	ABC(This Application)	Predicate ABCK003330	Predicate Anzai,AK-733, K031385	SubstantiallyEquivalent To:
Technology	Automatic and ManualLinac Gating	Manual Linac Gatingonly	Automatic andManual Linac Gating	Anzai, AK-733,K031385
Update ofIndications	Limit Respiratory-Related Organ Motionwith SpecificIndications	Limit Respiratory-Related Organ Motion	Limit Respiratory-Related OrganMotion	ABC,K003330

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

[Image of the Department of Health and Human Services logo]

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 7, 2013

Aktina Medical Corporation % Mr. Tony Spaccarotella Director, QA/RA 360 North Route 9W CONGERS NY 10920

Re: K131313

Trade/Device Name: Active Breathing Coordinator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 1, 2013 Received: May 9, 2013

Dear Mr. Spaccarotella:

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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Page 2 - Mr. Spaccarotella

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

http://www.fdai.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/deliuit.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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Richard D. O'Hara

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): K131313

Device Name: Active Breathing Coordinator

Indications for Use:

The Active Breathing Coordinator is specifically indicated for:

a. Breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (DIBH) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.
b. Lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by DIBH allows critical organ sparing, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of turnor target margins. Also included is the use of linac-based Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) that may be employed to treat such lesions.
c. Liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.
d. Pancreatic turnors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.

Page 1 of 2

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Indications for Use

510(k) Number (if known): K131313

Device Name: Active Breathing Coordinator

Prescription Use ﮯ۔ (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 CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)_ K131313

Page 2 of 2

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.