(59 days)
Not Found
No
The summary describes a device for measuring defibrillator output and does not mention any AI or ML capabilities.
No
The device is a tester for defibrillators, used to ensure they meet performance specifications, and is explicitly stated as "not intended to be used on patients or to test devices while connected to patients."
No
This device is a defibrillator/pacemaker analyzer used to test defibrillators and pacemakers, not to diagnose a patient's medical condition. It's explicitly stated that it's "not intended to be used on patients."
No
The device description explicitly states it is a "portable, rechargeable battery operated (with AC Adapter) defibrillator tester" and includes physical components like an integrated display, connections for defibrillator paddles, and a variable load. It is a hardware device with integrated software.
Based on the provided information, the UniPulse 400 Defibrillator/Pacemaker Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to test the performance of defibrillators and pacemakers. It is used in a laboratory environment, outside of patient care, and is not intended to be used on patients or to test devices connected to patients.
- Device Description: The description reinforces that it's a tester for medical equipment, measuring energy output and providing waveform information. It's used by biomedical and clinical engineers to verify the performance of defibrillators.
- Lack of Biological Sample Interaction: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The UniPulse 400 does not interact with any biological samples.
The UniPulse 400 is a medical device accessory or test equipment used to ensure the proper functioning of other medical devices (defibrillators and pacemakers). It does not provide diagnostic information about a patient's health based on in vitro examination of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
DRL
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.
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
Used by biomedical and/or clinical engineers in the laboratory environment, outside of the patient care vicinity.
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)
- Software Testing: The Rigel Medical UniPulse 400 was designed and developed according to Rigel Medical's internal software development process. The Rigel Medical UniPulse 400 was tested using verification and validation methods, the results of which indicate the Rigel Medical UniPulse 400 complies with its specifications.
- Electrical Safety: The Rigel Medical UniPulse 400 was tested for performance in accordance with the following standard: BS EN 61010-1-2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements, BS EN 61010-2-030:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-30 Particular requirements for testing and measuring circuits Test results indicate the Rigel Medical UniPulse 400 complies with its specifications.
- Electromagnetic Compatibility Testing: The Rigel Medical UniPulse 400 was tested for performance in accordance with the following standard: BS EN 61326-1:2013 Electrical equipment for measurement, control and 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 applicable standards.
- Performance Testing – Bench: The Rigel Medical UniPulse 400 was tested for performance in accordance with its predetermined specifications. The results of the performance testing show the Rigel Medical UniPulse 400 complies with these specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Submission Date: | October 12, 2018 |
|---|---|
| Submitter: | Rigel Medical, a Seaward Group company |
| 15-18 Bracken Hill, | |
| South West Industrial Estate, | |
| Peterlee, Co. Durham, SR8 2SW, | |
| United Kingdom | |
| Submitter Contact: | Rigel Medical, a Seaward Group company |
| 15-18 Bracken Hill, | |
| South West Industrial Estate, | |
| Peterlee, Co. Durham, SR8 2SW, | |
| United Kingdom | |
| Name: Jim Wallace | |
| Rigel Medical, a Seaward Group company | |
| Phone: +44 (0)191 5878724 | |
| Fax: +44 (0) 191 586 0227 | |
| Email: JimW@seaward.co.uk | |
| Application | |
| Correspondent: | Bob Steurer |
| Principal Consultant | |
| Steurer Consulting Group | |
| 800 Blue Quail Rd. | |
| Keller, TX 76248 | |
| steurerbob@gmail.com | |
| +1 (425) 358-1072 | |
| Manufacturing Site: | Rigel Medical, a Seaward Group company |
| 15-18 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 |
4
Primary Classification Regulation: 21 CFR §870.5325
Primary Product Code:
DRL
Substantially Equivalent Devices:
| New Device | Predicate 510(k)
Number | Predicate
Manufacturer/Model |
|---------------------------------------------------------|----------------------------|--------------------------------------------------------------|
| Rigel Medical
UniPulse 400 Defibrillator
Analyzer | K072114 | Fluke Biomedical
Impulse 7000dp
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 –
Impulse 7000dp | UniPulse 400 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Load resistance | 50 ohm | Same |
| Battery Operation | Internal
rechargeable NiMH
batteries with AC
adapter | Same |
| Defibrillator
waveform
compatibility | Compatible with
mono-phasic, bi-
phasic, and pulsed
waveforms | Same |
| Defibrillator Test
Connections | Through integrated
paddle connection
plates or you can
connect directly
through accessory
cable. | Same – Connect
directly through
accessory cable or
paddle connections
available through
accessory paddle box |
| ECG Simulator with
Arrhythmia output
capability | Yes | Same |
| Data download | USB connection to
PC | Same |
| Waveform Display | Through connected
PC | Same, can also show
on built-in display |
| Pacemaker Analysis | Demand and
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
Shelf-life | The Rigel Medical UniPulse 400 is not provided sterile. The Rigel Medical
UniPulse 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 the
patient. Therefore, this section is not applicable. |
| Software Testing | The Rigel Medical UniPulse 400 was designed and developed according to Rigel
Medical's internal software development process. The Rigel Medical UniPulse
400 was tested using verification and validation methods, the results of which
indicate the Rigel Medical UniPulse 400 complies with its specifications. |
| Electrical Safety | The Rigel Medical UniPulse 400 was tested for performance in accordance with
the following standard:
BS EN 61010-1-2010 Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1: General
requirements, BS EN 61010-2-030:2010 Safety requirements for electrical equipment
for measurement, control, and laboratory use - Part 2-30 Particular
requirements for testing and measuring circuits Test results indicate the Rigel Medical UniPulse 400 complies with its
specifications. |
| Electromagnetic
Compatibility
Testing | The Rigel Medical UniPulse 400 was tested for performance in accordance with
the following standard:
BS EN 61326-1:2013 Electrical equipment for measurement, control and
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
applicable standards. |
| Performance Testing
– Bench | The Rigel Medical UniPulse 400 was tested for performance in accordance with
its predetermined specifications. |
| | The results of the performance testing show the Rigel Medical UniPulse 400
complies with these specifications. |
| Conclusion | A comparison of the predicate device and a review of the testing results shows
that the Rigel Medical UniPulse 400 is substantially equivalent to the predicate
device. |
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