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.

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.

AI/ML Overview

The provided text describes the UniPulse 400 Defibrillator/Pacemaker Analyzer, a device used to verify the performance of defibrillators. However, it does not include detailed acceptance criteria or a study proving the device meets those criteria in a format directly addressing typical AI/ML device study parameters.

The document discusses performance testing, but focuses on compliance with general safety and EMC standards rather than specific analytical performance metrics and their acceptance thresholds. It also states the device is not an AI/ML product, and thus many of the requested criteria (like ground truth, expert adjudication, MRMC studies) are not applicable.

Here's a breakdown based on the provided text, and where gaps exist because the device is not an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the device was tested to comply with its specifications, but it does not explicitly list quantitative performance acceptance criteria for measuring energy output or pacemaker analysis, nor does it report specific numerical performance results against such criteria. The "Summary of Performance Testing" refers to compliance with safety (Electrical Safety, Electromagnetic Compatibility) and software development standards, not analytical performance accuracy or precision with defined thresholds relevant to a diagnostic AI/ML device.

2. Sample Size for Test Set and Data Provenance

This information is not applicable/provided in the context of an AI/ML test set. The UniPulse 400 is an analyzer for other medical devices, not a diagnostic tool that processes patient data. Performance testing appears to involve laboratory bench testing against standards, not a patient-based test set.

3. Number of Experts for Ground Truth and Qualifications

This is not applicable as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Its performance evaluation would involve comparing its measurements against known, calibrated inputs or reference devices, not expert consensus on medical images or signals.

4. Adjudication Method for Test Set

This is not applicable for the same reasons as (3).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The UniPulse 400 is a measurement device for defibrillators, not an AI-assisted diagnostic tool that aids human readers in interpreting clinical cases. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance Study

While the device's "performance testing" assesses its standalone function, it's not a standalone algorithm in the sense of an AI/ML diagnostic tool. The document states its performance was tested against its predetermined specifications, indicating standalone functionality, but does not provide details of this testing beyond compliance.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/ML diagnostic devices (e.g., pathology, outcomes data) is not applicable here. For the UniPulse 400, "ground truth" would likely involve highly accurate and calibrated reference measurements from specialized lab equipment or known, precise outputs from simulated defibrillator discharges. The document does not specify how the accuracy of these reference measurements was established.

8. Sample Size for Training Set

This is not applicable. The UniPulse 400 is a hardware and software device following traditional engineering principles, not an AI/ML algorithm that is 'trained' on a dataset.

9. How Ground Truth for Training Set was Established

This is not applicable for the same reasons as (8).

Conclusion from the document:

The K182905 510(k) summary for the UniPulse 400 primarily focuses on demonstrating substantial equivalence to a predicate device (Fluke Biomedical Impulse 7000dp Defibrillator Analyzer) by showing similar technological characteristics and compliance with general safety and electromagnetic compatibility (EMC) standards. The "Performance Testing - Bench" section states that the device was tested according to "predetermined specifications" and that the results show compliance, but it does not elaborate on what these specific performance specifications are (e.g., accuracy, precision of energy measurement), nor does it present the numerical results of these tests.

The document is a regulatory clearance for a physical measurement device, not an AI/ML diagnostic algorithm, hence the lack of information pertinent to AI/ML specific study requirements.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K 182905

Device Name

UniPulse 400

Indications for Use (Describe)

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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Submission Date:	October 12, 2018
Submitter:	Rigel Medical, a Seaward Group company15-18 Bracken Hill,South West Industrial Estate,Peterlee, Co. Durham, SR8 2SW,United Kingdom
Submitter Contact:	Rigel Medical, a Seaward Group company15-18 Bracken Hill,South West Industrial Estate,Peterlee, Co. Durham, SR8 2SW,United KingdomName: Jim WallaceRigel Medical, a Seaward Group companyPhone: +44 (0)191 5878724Fax: +44 (0) 191 586 0227Email: JimW@seaward.co.uk
ApplicationCorrespondent:	Bob SteurerPrincipal ConsultantSteurer Consulting Group800 Blue Quail Rd.Keller, TX 76248steurerbob@gmail.com+1 (425) 358-1072
Manufacturing Site:	Rigel Medical, a Seaward Group company15-18 Bracken Hill,South West Industrial Estate,Peterlee, Co. Durham, SR8 2SW,United Kingdom
Trade Name:	UniPulse 400
Common Name:	Defibrillator Analyzer
Classification Name:	Defibrillator Tester

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Primary Classification Regulation: 21 CFR §870.5325

Primary Product Code:

DRL

Substantially Equivalent Devices:

New Device	Predicate 510(k)Number	PredicateManufacturer/Model
Rigel MedicalUniPulse 400 DefibrillatorAnalyzer	K072114	Fluke BiomedicalImpulse 7000dpDefibrillator 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.

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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 –Impulse 7000dp	UniPulse 400
Load resistance	50 ohm	Same
Battery Operation	Internalrechargeable NiMHbatteries with ACadapter	Same
Defibrillatorwaveformcompatibility	Compatible withmono-phasic, bi-phasic, and pulsedwaveforms	Same
Defibrillator TestConnections	Through integratedpaddle connectionplates or you canconnect directlythrough accessorycable.	Same – Connectdirectly throughaccessory cable orpaddle connectionsavailable throughaccessory paddle box
ECG Simulator withArrhythmia outputcapability	Yes	Same
Data download	USB connection toPC	Same
Waveform Display	Through connectedPC	Same, can also showon built-in display
Pacemaker Analysis	Demand andasynchronous test	Same
Pacemaker variable	50 to 1500 ohms in	Different - 50 to 1600
load	50-ohm steps	ohms in 50-ohm steps

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Summary of Performance Testing:

Sterilization andShelf-life	The Rigel Medical UniPulse 400 is not provided sterile. The Rigel MedicalUniPulse 400 does not have a shelf-life.Therefore, this section is not applicable.
Biocompatibility	The Rigel Medical UniPulse 400 does not directly nor indirectly contact thepatient. Therefore, this section is not applicable.
Software Testing	The Rigel Medical UniPulse 400 was designed and developed according to RigelMedical's internal software development process. The Rigel Medical UniPulse400 was tested using verification and validation methods, the results of whichindicate the Rigel Medical UniPulse 400 complies with its specifications.
Electrical Safety	The Rigel Medical UniPulse 400 was tested for performance in accordance withthe following standard:BS EN 61010-1-2010 Safety requirements for electrical equipment formeasurement, control, and laboratory use - Part 1: Generalrequirements, BS EN 61010-2-030:2010 Safety requirements for electrical equipmentfor measurement, control, and laboratory use - Part 2-30 Particularrequirements for testing and measuring circuits Test results indicate the Rigel Medical UniPulse 400 complies with itsspecifications.
ElectromagneticCompatibilityTesting	The Rigel Medical UniPulse 400 was tested for performance in accordance withthe following standard:BS EN 61326-1:2013 Electrical equipment for measurement, control andlaboratory 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 theapplicable standards.
Performance Testing– Bench	The Rigel Medical UniPulse 400 was tested for performance in accordance withits predetermined specifications.
	The results of the performance testing show the Rigel Medical UniPulse 400complies with these specifications.
Conclusion	A comparison of the predicate device and a review of the testing results showsthat the Rigel Medical UniPulse 400 is substantially equivalent to the predicatedevice.

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Regulation Number and Section

§ 870.5325 Defibrillator tester.

(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).