Active Breathing Coordinator

K151097 · Aktina Medical Corporation · IYE · May 15, 2015 · Radiology

Device Facts

• Record ID: K151097
• Device Name: Active Breathing Coordinator
• Applicant: Aktina Medical Corporation
• Product Code: IYE · Radiology
• Decision Date: May 15, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

The Active Breathing Coordinator (ABC) is a flow-meter-based system used during radiation therapy simulation and delivery. It monitors patient lung volume via an in-line transducer and a patient-controlled pneumatic balloon valve. Patients observe their breathing volume on a computer monitor and are coached to hold their breath at a predefined threshold. During the breath-hold, the device provides status signals to the Elekta Limited Response™ gating interface to enable automated radiation delivery from a linear accelerator (linac), or the therapist may manually control the beam. By immobilizing anatomy through breath-hold, the device reduces radiation dose to surrounding healthy tissues (heart, lung) and allows for smaller tumor target margins. It is used in clinical radiation oncology settings by therapists and patients.

Clinical Evidence

Bench testing only. Hardware verification and validation were performed on the alternative mouthpiece and filter kit (part 12-210). Biocompatibility testing confirmed suitability for surface contact with skin or mucosal membranes for <24 hours. No clinical data provided.

Technological Characteristics

System includes laptop PC, display monitor, and patient respiratory kit (in-line transducer, pneumatic balloon valve). Mouthpiece/filter kit materials include TPE, polycarbonate, polypropylene, and acrylic. Non-conductive plastic construction. Connectivity via electrical interface to linac gating system. Software-based GUI for volume monitoring. Biocompatible for <24h contact.

Indications for Use

Indicated for patients requiring reduced anatomical movement during EBRT for breast, lung, thoracic (esophagus, lymphoma, metastatic), liver, and pancreatic tumors. Facilitates deep inspiration breath-hold (DIBH) for critical organ sparing and tumor target margin reduction. Applicable for linac-based SRS and SRT.

Regulatory Classification

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.

Predicate Devices

• Active Breathing Coordinator (ABC) (K131313)

Reference Devices

• Elekta Limited Response™ gating interface (K123808)

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

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 [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'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 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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <input type="checkbox"/> 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 Name<br>and Address: | Aktina Medical Corporation<br>360 North Route 9 W<br>Congers, New York, 10920<br>Phone: [phone]<br>Fax: [phone]<br>Registration 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

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).

360 North Route 9W Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: [phone] Fax: [phone]

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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: [phone] Fax: [phone] 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 |
|---------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Mouthpiece<br>Material | Polyvinyl Chloride (PVC) with blue<br>colorant | Styrene Block Copolymer/Thermoplastic<br>Elastomer (TPE) with gray colorant |
| Fittings | One elbow and two connectors:<br>polypropylene with blue colorant | One elbow and one connector:<br>polycarbonate with gray colorant |
| Tubing | Polyethylene (natural color) | Polypropylene (natural color) |
| Filter | Housing - Styrene Butadiene with<br>blue colorant<br>Filter - Ethylene-vinyl Acetate (EVA) | Housing - Styrene Acrylonitrile with<br>gray colorant<br>Filter - Acrylic/Polypropylene |
| Nose Clip<br>Pads | Polyethylene foam (blue) | EVA foam (white) |
| Filter Flow<br>Resistance | 1.00 CM H2O@50LPM | 1.5 CM H2O@60LPM. |
| Bacterial<br>Efficiency | 99.99% | >99.999%. |

Congers, NY 10920 USA www.aktina.com 888.433.3380 Tel: [phone] Fax: [phone] North Route 9W