UniPulse

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December 14, 2018 Seaward Group % Robert Steurer Principal Consultant Steurer Consulting Group 800 Blue Ouail Rd Keller, Texas 76248 Re: K182905 Trade/Device Name: UniPulse 400 Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: Class II Product Code: DRL Dated: October 12, 2018 Received: October 16, 2018 ## Dear Robert Steurer: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jessica E. Paulsen -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K 182905 Device Name UniPulse 400 Indications for Use (Describe) The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ | Submission Date: | October 12, 2018 | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Rigel Medical, a Seaward Group company<br>15-18 Bracken Hill,<br>South West Industrial Estate,<br>Peterlee, Co. Durham, SR8 2SW,<br>United Kingdom | | Submitter Contact: | Rigel Medical, a Seaward Group company<br>15-18 Bracken Hill,<br>South West Industrial Estate,<br>Peterlee, Co. Durham, SR8 2SW,<br>United Kingdom<br>Name: Jim Wallace<br>Rigel Medical, a Seaward Group company<br>Phone: +44 (0)191 5878724<br>Fax: +44 (0) 191 586 0227<br>Email: JimW@seaward.co.uk | | Application<br>Correspondent: | Bob Steurer<br>Principal Consultant<br>Steurer Consulting Group<br>800 Blue Quail Rd.<br>Keller, TX 76248<br>steurerbob@gmail.com<br>+1 (425) 358-1072 | | Manufacturing Site: | Rigel Medical, a Seaward Group company<br>15-18 Bracken Hill,<br>South West Industrial Estate,<br>Peterlee, Co. Durham, SR8 2SW,<br>United Kingdom | | Trade Name: | UniPulse 400 | | Common Name: | Defibrillator Analyzer | | Classification Name: | Defibrillator Tester | {4}------------------------------------------------ Primary Classification Regulation: 21 CFR §870.5325 Primary Product Code: DRL ## Substantially Equivalent Devices: | New Device | Predicate 510(k)<br>Number | Predicate<br>Manufacturer/Model | |---------------------------------------------------------|----------------------------|--------------------------------------------------------------| | Rigel Medical<br>UniPulse 400 Defibrillator<br>Analyzer | K072114 | Fluke Biomedical<br>Impulse 7000dp<br>Defibrillator Analyzer | Device Description: The Rigel Medical UniPulse 400 is a portable, rechargeable battery operated (with AC Adapter) defibrillator tester used to determine that a defibrillator and a defibrillator with a transcutaneous pacemaker function perform to their published performance specifications. The UniPulse 400 is connected to a defibrillator output and is used to measure the output energy delivered from the device into a standard resistive test load. It also provides waveform information on its integrated display. For pacemaker testing, a variable load from 50 to 1600 ohms is available in 50-ohm steps. Defibrillator paddles are connected directly to the UniPulse 400 for hands free operation, or to contact plates if using the paddles. When the defibrillator is discharged, the UniPulse 400 will display the energy delivered. Included in the UniPulse 400 is an ECG simulator with normal sinus rhythm and arrhythmia simulation to trigger automated defibrillation. > UniPulse 400 is used by biomedical and/or clinical engineers to verify performance of defibrillators used in their hospital. The UniPulse 400 provides statistical data measured from the device and can communicate to an external Bluetooth printer and a PC / Laptop via Bluetooth and USB. {5}------------------------------------------------ Intended Use: The UniPulse 400 Defibrillator/Pacemaker Analyzer is used to determine that a defibrillator and a defibrillator equipped with transcutaneous pacemaker capability are performing within their performance specifications through the measurement of energy output. The UniPulse 400 is intended to be used in the laboratory environment, outside of the patient care vicinity and is not intended to be used on patients or to test devices while connected to patients. ## Technology Comparison: The Rigel UniPulse 400 employs the same technological characteristics as the predicate device. | Characteristic | Predicate Device –<br>Impulse 7000dp | UniPulse 400 | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Load resistance | 50 ohm | Same | | Battery Operation | Internal<br>rechargeable NiMH<br>batteries with AC<br>adapter | Same | | Defibrillator<br>waveform<br>compatibility | Compatible with<br>mono-phasic, bi-<br>phasic, and pulsed<br>waveforms | Same | | Defibrillator Test<br>Connections | Through integrated<br>paddle connection<br>plates or you can<br>connect directly<br>through accessory<br>cable. | Same – Connect<br>directly through<br>accessory cable or<br>paddle connections<br>available through<br>accessory paddle box | | ECG Simulator with<br>Arrhythmia output<br>capability | Yes | Same | | Data download | USB connection to<br>PC | Same | | Waveform Display | Through connected<br>PC | Same, can also show<br>on built-in display | | Pacemaker Analysis | Demand and<br>asynchronous test | Same | | Pacemaker variable | 50 to 1500 ohms in | Different - 50 to 1600 | | load | 50-ohm steps | ohms in 50-ohm steps | {6}------------------------------------------------ ## Summary of Performance Testing: | Sterilization and<br>Shelf-life | The Rigel Medical UniPulse 400 is not provided sterile. The Rigel Medical<br>UniPulse 400 does not have a shelf-life.<br>Therefore, this section is not applicable. | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | The Rigel Medical UniPulse 400 does not directly nor indirectly contact the<br>patient. Therefore, this section is not applicable. | | Software Testing | The Rigel Medical UniPulse 400 was designed and developed according to Rigel<br>Medical's internal software development process. The Rigel Medical UniPulse<br>400 was tested using verification and validation methods, the results of which<br>indicate the Rigel Medical UniPulse 400 complies with its specifications. | | Electrical Safety | The Rigel Medical UniPulse 400 was tested for performance in accordance with<br>the following standard:<br>BS EN 61010-1-2010 Safety requirements for electrical equipment for<br>measurement, control, and laboratory use - Part 1: General<br>requirements, BS EN 61010-2-030:2010 Safety requirements for electrical equipment<br>for measurement, control, and laboratory use - Part 2-30 Particular<br>requirements for testing and measuring circuits Test results indicate the Rigel Medical UniPulse 400 complies with its<br>specifications. | | Electromagnetic<br>Compatibility<br>Testing | The Rigel Medical UniPulse 400 was tested for performance in accordance with<br>the following standard:<br>BS EN 61326-1:2013 Electrical equipment for measurement, control and<br>laboratory use - EMC requirements - Part 1: General requirements BS EN 61000-3-2:2006+A2:2009 Harmonics BS EN 61000-3-2:2013 Flicker BS EN 61000-4-2:2009 Electrostatic Discharge BS EN 61000-4-2:2006+A2:2010 Radiated Immunity BS EN 61000-4-2:2012 Fast Burst Transients BS EN 61000-4-5:2006 Surge Transients BS EN 61000-4-6:2009 Conducted Immunity BS EN 61000-4-11:2004 Voltage Dips and Short Interruptions CISPR 11/BS EN 55011 Radiated Emissions CISPR 11/BS EN 55011 Conducted Emissions Test results indicate that the Rigel Medical UniPulse 400 complies with the<br>applicable standards. | | Performance Testing<br>– Bench | The Rigel Medical UniPulse 400 was tested for performance in accordance with<br>its predetermined specifications. | | | The results of the performance testing show the Rigel Medical UniPulse 400<br>complies with these specifications. | | Conclusion | A comparison of the predicate device and a review of the testing results shows<br>that the Rigel Medical UniPulse 400 is substantially equivalent to the predicate<br>device. | {7}------------------------------------------------