(21 days)
No
The device description focuses on a flow meter and patient-controlled valve for breath-hold, with no mention of AI or ML for data analysis, prediction, or control. The modification is simply an alternative mouthpiece and filter kit.
No.
The device is used to reduce anatomical movement during radiation therapy, which is a treatment modality, rather than providing therapy itself. It facilitates the delivery of radiation therapy by helping patients hold their breath, but it is not a therapeutic device in and of itself.
No
The Active Breathing Coordinator is described as a flow meter device that helps reduce anatomical movement during radiation therapy by enabling breath-hold. It monitors the volume of air and provides feedback to the patient and therapist for controlled radiation delivery. Its primary function is a control mechanism during treatment, not to diagnose a medical condition.
No
The device description explicitly states it is a "flow meter device" and mentions a "patient controlled balloon valve which is connected to the flow meter device," indicating the presence of physical hardware components beyond just software. The performance studies also mention "Hardware specification testing."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Active Breathing Coordinator is a flow meter device that helps patients control their breathing during radiation therapy. It measures air volume entering and exiting the lungs and aids in breath-hold techniques.
- Intended Use: The intended use is to reduce anatomical movement during radiation therapy by facilitating breath-hold, not to analyze biological specimens for diagnostic purposes.
- Device Description: The description focuses on the mechanical and functional aspects of the device related to airflow measurement and breath-hold control.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic claims, or typical IVD components or processes.
Therefore, the Active Breathing Coordinator falls under the category of a therapeutic or supportive device used in conjunction with radiation therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
IYE
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax and abdomen, Breast, Lung, Liver, Pancreatic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Filter Flow Resistance: 1.5 CM H2O@60LPM.
Bacterial Efficiency: >99.999%.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 (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 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) | |
|---|---|
| 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 Name | |
| and Address: | Aktina Medical Corporation |
| 360 North Route 9 W | |
| Congers, New York, 10920 | |
| Phone: 845-268-0101 | |
| Fax: 845-268-1700 | |
| 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: 845.268.0101 Fax: 845.268.1700
4
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 |
|---|---|---|
| Mouthpiece | ||
| Material | Polyvinyl Chloride (PVC) with blue | |
| colorant | Styrene Block Copolymer/Thermoplastic | |
| Elastomer (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 with | |
| blue colorant | ||
| Filter - Ethylene-vinyl Acetate (EVA) | Housing - Styrene Acrylonitrile with | |
| gray colorant | ||
| Filter - Acrylic/Polypropylene | ||
| Nose Clip | ||
| Pads | Polyethylene foam (blue) | EVA foam (white) |
| Filter Flow | ||
| Resistance | 1.00 CM H2O@50LPM | 1.5 CM H2O@60LPM. |
| Bacterial | ||
| Efficiency | 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