Anzai Respiratory Gating System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 22, 2016 Anzai Medical Co. Ltd. % Ms. Carole Carey President C3-Carey Consultants, LLC 9451 Ellsworth Court FULTON MD 20759 Re: K160432 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: February 4, 2016 Received: February 19, 2016 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K160432 Device Name AZ-733VI Respiratory Gating System Indications for Use (Describe) The 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # SECTION 5 # 510(k) Summary | - Table of Contents - | | |-----------------------------------------------------------------------------|---| | 1. Submitter | 1 | | 2. Device | 1 | | 3. Predicate Device | 2 | | 4. Device Description | 2 | | 5. Indications for Use | 2 | | 6. Comparison of Technological Characteristics with the<br>Predicate Device | 3 | | 7. Non-clinical Performance Data | 4 | | 8. Conclusions | 4 | ## 1. Submitter Anzai Medical Co., Ltd. 3-9-15 Nishi-Shinagawa, Shinagawa-ku Tokyo 141-0033, Japan Phone: +81-3-3779-2571 Fax: +81-3-3779-2573 Contact Person Name: Naoya Iwasaki Date Prepared: February 4, 2015 # 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<br>(21 CFR 892.5050) | | Regulatory: | Class II | | Product Code: | LHN | {4}------------------------------------------------ #### 3. Predicate Device AZ-733V Respiratory Gating System, K031385 #### 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 Respiratory Gating System AZ-733VI is identical to the predicate device. {5}------------------------------------------------ #### 6. Comparison of Technological Characteristics with the Predicate Device The subject and the predicate device are based on the following same technological elements: - Load Cell to detect the pressure change caused by the patient abdominal motion . with the use of a strain gage - . Laser Sensor to measure the displacement of the patient abdominal surface with the use of a laser - . Signal processing to convert the analog sensor signal to digital signal, smooth the signal by moving-average method and detect a respiratory information. - Application to adjust the respiratory waveform, set the Gate output condition and . Gate mode, display respiratory waveform and Gate signal, manage patients' information and control the safety parameter. - Interface with external device such as ECG The following technological differences exist between the subject and the predicate device: - Change of system configuration " - Addition of Load Cell amplifier " - . Addition of Laser Sensor type - Increase of the number of Respiratory Sensor connection - Addition of displaying and adjusting function of respiratory waveform to Sensor . Port - . Addition of Wave Monitor - . Change of Gate mode - Addition of Gate Disable Switch . - " Change of Interface Board integration - . Increase of the number of connectable external devices - . Addition of EXGI connectivity - Addition of IRP Sensor to measure the displacement of the patient abdominal . surface with the use of an infrared - . Addition of High-speed Gating mode - Addition of Breath Hold mode " {6}------------------------------------------------ #### 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 60601-1:2005, IEC 60601-1-6:2010, 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 documentations were provided as recommended 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 this device was considered as a "major" level of concern, 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, as effective, and performs as well as or better than the predicate device.