(27 days)
Not Found
No
The description details signal processing (smoothing by moving-average) and manual or automatic adjustments based on user settings, but does not mention AI or ML algorithms for respiratory phase detection or gating.
No
The device is described as assisting diagnostic X-ray or radiation therapy systems by gating them based on the patient's respiratory cycle. It does not provide therapy itself, but rather controls other therapeutic or diagnostic devices.
No
Explanation: The device gates other diagnostic X-ray or radiation therapy systems, but it does not diagnose patients itself. Its function is to control when other diagnostic systems operate based on the patient's respiratory cycle.
No
The device description explicitly details hardware components such as respiratory sensors (Load Cell, Laser Sensor, IRP Sensor), an Amp Box, a Sensor Port, a Relay Box, and an LCD Display, in addition to the software application.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used with diagnostic X-ray or radiation therapy systems to gate these devices based on the patient's respiratory cycle. This involves monitoring a physiological process (respiration) in a living patient, not analyzing samples taken from the patient (in vitro).
- Device Description: The description details how the device uses sensors attached to or near the patient to detect respiratory motion. The signal processing and gating functions are all related to this real-time physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Respiratory Gating System AZ-733VI is a medical device used for physiological monitoring and control of other medical devices, not an IVD.
N/A
Intended Use / Indications for Use
Respiratory Gating System AZ-733VI is intended to be used with diagnostic X-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.
Product codes
LHN
Device Description
The Respiratory Gating System AZ-733VI employs a respiratory sensor which can be fixed directly to or near to a patient, and detects the respiratory motion changes according to the type of sensor, the Load Cell (standard component), the Laser Sensor (option component) or the IRP Sensor (option component).
The signal from the sensor is primarily amplified at the Amp Box which is attached to each Respiratory Sensor and sent to the Sensor Port as an analog signal. At the Sensor Port, the analog signal is coarsely adjusted manually, converted to digital signal, smoothed by moving-average method and processed to detect a respiratory phase. Then, as a respiratory information, the respiratory waveform and the respiratory phase are sent to the Application on the Personal Computer via the Relay Box.
The Application performs the fine adjustment of the selected respiratory waveform by the user manually or automatically. The user also sets a Gate signal output condition and selects a mode for the method of generating Gate signal. This Gate signal is output to external equipment (image diagnostic equipment such as a whole body CT equipment, linear accelerator system and radiotherapy equipment) from the Relay Box or the Sensor Port when those respiratory signals reach the preset conditions set by the user. The status of the Gate signal ON and OFF is also displayed on the LCD Display. The Application has a function of managing patient information. This function involves the input, registration, referring, revision and delete of patient information. The Application also provides the function of recording, playback, referring and output by a text file format of respiratory information and Gate signal ON/OFF status as well as Beam signal ON/OFF status.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical Performance Data:
(1) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the AZ-733VI, consisting of standard components and optional components. The system complies with the IEC 60601-1:2012, IEC 60601-1-6:2013, IEC 62366:2007 and IEC 60825-1:2007 standards for safety and the IEC 60601-1-2:2007 standard for EMC.
(2) Software Verification and Validation Testing
Software verification and validation testing were conducted and documented in accordance with the recommendation by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The software for the subject device is considered as a "major" level of concern as well as that of the predicate device, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or user.
Key results: From the nonclinical tests, the subject device is as safe and effective as the predicate device, and performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
AZ-733VI Respiratory Gating System, K160432
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Validity of applying special 510(k): Based on the New 510(k) Paradigm flowchart on the Attachment 1 of "The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" provided by CDRH, validity of applying special 510(k) for the subject device was checked. As the result, it is determined that the modified subject is submitted as special 510(k).
§ 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design 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, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Anzai Medical Co., Ltd. % Ms. Carole Carey President C3-Carey Consultants, LLC 9451 Ellsworth Court FULTON MD 20759
Re: K170719
Trade/Device Name: AZ-733VI Respiratory Gating System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle Radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 8, 2017 Received: March 9, 2017
Dear Ms. Carey:
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. 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) K170719
Device Name
AZ-733VI Respiratory Gating System
Indications for Use (Describe)
Respiratory Gating System AZ-733VI is intended to be used with diagnostic X-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.
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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510(k) Summary
| - Table of Contents - | |
|---|---|
| 1. Submitter | |
| 2. Device | |
| 3. Predicate Device | |
| 4. Device Description | |
| 5. Indications for Use | |
| 6. Comparison of Technological Characteristics with the | |
| Predicate Device | |
| 7 . Non-clinical Performance Data | |
| 8. Conclusions | |
| 9. Validity of applying special 510(k) |
1. Submitter
Anzai Medical Co., Ltd. 3-9-15 Nishi-Shinagawa, Shinagawa-ku Tokyo 141-0033, Japan
Phone: +81-3-3779-1611 Fax: +81-3-3779-6606
Contact Person Name: Naoya Iwasaki
Date Prepared: March 8, 2017
2. Device
| Name of Device: | AZ-733VI Respiratory Gating System |
|---|---|
| Common or User Name: | Respiratory Gating System |
| Classification Name: | Medical Charged-Particle Radiation Therapy System |
| (21 CFR 892.5050) |
4
| Regulatory: | Class II |
|---|---|
| Product Code: | LHN |
3. Predicate Device
AZ-733VI Respiratory Gating System, K160432
4. Device Description
The Respiratory Gating System AZ-733VI employs a respiratory sensor which can be fixed directly to or near to a patient, and detects the respiratory motion changes according to the type of sensor, the Load Cell (standard component), the Laser Sensor (option component) or the IRP Sensor (option component).
The signal from the sensor is primarily amplified at the Amp Box which is attached to each Respiratory Sensor and sent to the Sensor Port as an analog signal. At the Sensor Port, the analog signal is coarsely adjusted manually, converted to digital signal, smoothed by moving-average method and processed to detect a respiratory phase. Then, as a respiratory information, the respiratory waveform and the respiratory phase are sent to the Application on the Personal Computer via the Relay Box.
The Application performs the fine adjustment of the selected respiratory waveform by the user manually or automatically. The user also sets a Gate signal output condition and selects a mode for the method of generating Gate signal. This Gate signal is output to external equipment (image diagnostic equipment such as a whole body CT equipment, linear accelerator system and radiotherapy equipment) from the Relay Box or the Sensor Port when those respiratory signals reach the preset conditions set by the user. The status of the Gate signal ON and OFF is also displayed on the LCD Display. The Application has a function of managing patient information. This function involves the input, registration, referring, revision and delete of patient information. The Application also provides the function of recording, playback, referring and output by a text file format of respiratory information and Gate signal ON/OFF status as well as Beam signal ON/OFF status.
5. Indications for Use
The Respiratory Gating System AZ-733VI is intended to be used with diagnostic xray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.
The Indications for Use statement for the modified device is identical to the predicate
5
device.
6. Comparison of Technological Characteristics with the Predicate Device
The subject device and the predicate device are based on the same technological elements except for the following:
- . Addition of ABLE which utilizes wireless Bluetooth technology
7. Non-clinical Performance Data
The following performance data ware provided in support of the substantial equivalence determination.
-
(1) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the AZ-733VI, consisting of standard components and optional components. The system complies with the IEC 60601-1:2012, IEC 60601-1-6:2013, IEC 62366:2007 and IEC 60825-1:2007 standards for safety and the IEC 60601-1-2:2007 standard for EMC. -
(2) Software Verification and Validation Testing
Software verification and validation testing were conducted and documented in accordance with the recommendation by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The software for the subject device is considered as a "major" level of concern as well as that of the predicate device, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or user.
8. Conclusions
From the nonclinical tests, the subject device is as safe and effective as the predicate device, and performs as well as or better than the predicate device.
9. Validity of applying special 510(k)
Based on the New 510(k) Paradigm flowchart on the Attachment 1 of "The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" provided by CDRH, validity of applying special 510(k) for the subject device was checked.
As the result, it is determined that the modified subject is submitted as special 510(k).