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 cardian 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 rradiated 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.

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 Special 510(k) describes the addition of an alternative mouthpiece and filter kit (Aktina Part Number: 12-210) for the Active Breathing Coordinator (ABC). There is no change to the intended use or indications for use with this modification.

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 is a 510(k) premarket notification for the "Active Breathing Coordinator" device, specifically for an alternative mouthpiece and filter kit. It aims to demonstrate substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results similar to what would be found in a detailed study report. However, it mentions specific performance characteristics for the filter kit and states that "Hardware specification testing has been performed ... to show that the verification, validation and safety requirements have been met."

Based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the stated performance of the new component:

Acceptance Criteria (Implied)	Reported Device Performance (Alternative Mouthpiece and Filter Kit)
Biocompatibility for patient contact (surface, < 24 hours).	Shown to be biocompatible.
Filter Flow Resistance (comparable to predicate)	1.5 CM H2O @ 60LPM
Bacterial Efficiency (comparable to predicate)	>99.999%
Maintenance of intended use and indications for use	No change to intended use or indications for use.
Similarity in technological characteristics to predicate	Uses identical technology; alternative mouthpiece and filter kit share the same technology.
Verification, validation, and safety requirements met	Hardware specification testing performed to show requirements met.

Note: The predicate device had a Filter Flow Resistance of "1.00 CM H2O@50LPM" and Bacterial Efficiency of "99.99%". The alternative kit's filter flow resistance is slightly higher at a higher flow rate, and its bacterial efficiency is marginally better. The document implies these differences are acceptable and do not raise new safety or effectiveness concerns.

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

The document focuses on a modification to an existing device (an alternative mouthpiece and filter kit). It mentions "Hardware specification testing has been performed" but does not specify any sample sizes for this testing, nor does it detail the provenance (country of origin, retrospective/prospective) of any data beyond stating that performance characteristics were measured for the new components. This type of submission (Special 510(k)) usually relies on demonstrating that the change does not impact the safety and effectiveness established for the original device.

There is no mention of a clinical "test set" in the context of patient data for the device's overall function.

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

This information is not provided in the document. The submission is a Special 510(k) for a device modification, focusing on engineering and material equivalence rather than clinical performance requiring expert ground truth for interpretation (e.g., image analysis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described clinical "test set" and no mention of expert adjudication.

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

An MRMC study was not relevant and therefore not done for this submission. The "Active Breathing Coordinator" is a patient monitoring and breath-hold device for radiation therapy, not an AI-assisted diagnostic imaging device that would involve human "readers" interpreting images with or without AI assistance.

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

This concept is not applicable to the Active Breathing Coordinator device. The device is hardware-based, with software controlling patient monitoring and breath-hold instructions. It is designed to be used in conjunction with radiation therapy equipment and requires a human operator (therapist) to coach the patient and deliver radiation. There is no "algorithm only" performance that would be evaluated in a standalone manner without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the specific aspect of this submission (the alternative mouthpiece and filter kit), the "ground truth" used for evaluation relates to engineering specifications, material science, and biocompatibility standards. This involves testing materials against established biocompatibility guidelines and measuring physical properties like flow resistance and bacterial efficiency, comparing them to the predicate device and relevant standards. There is no mention of clinical "ground truth" like pathology or outcomes data for this specific modification.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is not an AI/ML model that requires a "training set" in the conventional sense. The submission is for a hardware modification, and its performance is evaluated based on engineering tests and comparisons to a predicate device.

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

This information is not applicable and therefore not provided for the same reasons as #8.

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure.

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

May 15, 2015

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

Re: K151097

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: April 23, 2015 Received: April 24, 2015

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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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

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151097

Device Name Active Breathing Coordinator

Indications for Use (Describe)

The Active Breathing Coordinator is specifically indicated for:

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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Image /page/3/Picture/0 description: The image contains the logo for Aktina Medical. The word "AKTINA" is in a bold, brown font. To the right of "AKTINA" is the word "MEDICAL" in a smaller, gray font.

510(k) Summary

In Compliance with 21 CFR Section 807.92(c)

1. General Provisions

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: 243686-

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 Device

Active Breathing Coordinator (ABC), 510(k) No. K131313, Aktina Medical Corporation, 360 North Route 9W, Congers, NY 10920

4. Description

360 North Route 9W Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700

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AKTINA MEDICAL

5. Intended Use

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:

Breast tumors, including total and partial breast irradiation techniques, where a. 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.
Liver tumors, where immobilized anatomy provides critical organ sparing, including ﻥ 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 linac-based SRS and SRT that may be employed to treat such lesions.

6. Technological Characteristics

The ABC with the alternative mouthpiece and filter kit uses identical technology compared to the predicate device from Aktina Medical, ABC K131313. The alternative mouthpiece and filter kit and the predicate mouthpiece and filter kit also share the same technology. Both are assembled and attached at the filter section to the in-line transducer and both are made of nonconductive plastic materials. As with the predicate device, the significant technology characteristics of the ABC with the alternative mouthpiece and filter kit, part number 12-210, are:

a. Laptop personal computer software and external display monitor with graphical user interface.
Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700 360 North Route 9W

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Image /page/5/Picture/0 description: The image shows the logo for Aktina Medical. The word "AKTINA" is in a bold, brown font. To the right of "AKTINA" is the word "MEDICAL" in a smaller, gray font.

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 specification testing has been performed on the alternative ABC mouthpiece and filter kit, part number 12-210, to show that the verification, validation and safety requirements have been met.

Biocompatibility 8.

The patient contact components of the ABC with the alternative mouthpiece and filter kit, part number 12-210, are similar to the patient contact components of the predicate device, ABC K131313. The patient contact components of the alternative 12-210 kit 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, intended use, technological, physical and performance characteristics to the predicate device. No new issues of safety or effectiveness are introduced by using this device.

10. Summary of Alternative Mouthpiece and Filter Kit Material and Design Differences

Aspect	Predicate Mouthpiece and Filter Kit	Aktina Mouthpiece and Filter Kit
MouthpieceMaterial	Polyvinyl Chloride (PVC) with bluecolorant	Styrene Block Copolymer/ThermoplasticElastomer (TPE) with gray colorant
Fittings	One elbow and two connectors:polypropylene with blue colorant	One elbow and one connector:polycarbonate with gray colorant
Tubing	Polyethylene (natural color)	Polypropylene (natural color)
Filter	Housing - Styrene Butadiene withblue colorantFilter - Ethylene-vinyl Acetate (EVA)	Housing - Styrene Acrylonitrile withgray colorantFilter - Acrylic/Polypropylene
Nose ClipPads	Polyethylene foam (blue)	EVA foam (white)
Filter FlowResistance	1.00 CM H2O@50LPM	1.5 CM H2O@60LPM.
BacterialEfficiency	99.99%	>99.999%.

Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: 845.268.0101 Fax: 845.268.1700 360 North Route 9W

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.