(259 days)
The DMX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis. The SRX Handheld Doppler: Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.
The DMX Doppler provides the clinician with the ability to perform vascular investigations. It is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The DMX hand unit is used with a Doppler or Arterial Photoplethysmography (APPG) probe, selected to suit the nature of the investigation to be performed. The device includes a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. Doppler Mode: The probes emit low energy ultrasonic waves into the body which are reflected back into the probe. The reflected ultrasonic waves contain information about the blood flow, which can be heard as audio sounds from the loudspeaker and waveforms presented on the display. There is a range of compatible Doppler probes; the choice of probe is determined by the type of vascular assessment being performed and depth of vessel. APPG Mode: The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. Dopplex Reporter 5 (DR5) Software Package: The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. The SRX Doppler range is intended to be used by qualified healthcare practitioners for the detection and presentation of the fetal heart rate to assist in the assessment of fetal well-being during pregnancy. Each model is powered from two internal replaceable AA format 1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. The SRX hand unit is used with a choice of either a 2MHz (OP2XS) or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3 have fixed probes (2MHz and 3MHz respectively). All models include a colour liquid crystal display and three soft keys for user input. Doppler audio sounds are reproduced by the integral loudspeaker; the audio level can be adjusted by two buttons. The probes emit low energy ultrasonic waves into the body some of which are reflected back into the probe. The reflected ultrasonic waves contain information about the fetal heart, which can be heard as audio sounds from the loudspeaker and heart rate values presented on the display.
This document describes the Huntleigh Healthcare Ltd DMX/SRX Handheld Doppler and Probes, and its substantial equivalence to predicate devices. It focuses on engineering and performance verification, rather than clinical studies with acceptance criteria in the context of device performance metrics like sensitivity or specificity.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the DMX/SRX Handheld Doppler, especially in comparison to clinical outcomes. Instead, it details various engineering and regulatory compliance testing.
The document states that "The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use." This implies that the acceptance criteria are met if the new device demonstrates similar performance and safety characteristics as the legally marketed predicate devices through the conducted verification and validation tests.
Below is a table summarizing the types of testing performed, which serve as the basis for demonstrating equivalence and meeting "acceptance criteria" in a broad sense for a 510(k) submission:
| Acceptance Criteria Category (Implied) | Reported Device Performance / Testing Conducted |
|---|---|
| Biocompatibility | - Cytotoxicity, Sensitization, Irritation testing per ISO 10993-1:2009 for skin-contacting device (<24 hours). |
| Software Performance | - Software verification and validation testing conducted as per FDA guidance for "moderate" level of concern. |
| Electronic Hardware Performance | - Verification of power, user interface, display, audio, data management, time, and date. |
| Mechanical Performance | - Verification of general, enclosure, physical, environment, labelling, IFU, packaging, durability, and life testing. |
| Electrical Safety | - Compliance with IEC 60601-1:2005 (Third Edition) + A1:2012, IEC 60601-1-11, IEC 60601-1-6, and IEC 60601-2-37. |
| EMC (Electromagnetic Compatibility) | - Compliance with IEC 60601-1-2:2014. |
| Environmental Performance | - Verification of operating and storage temperature, humidity, and atmospheric pressure. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described (biocompatibility, software, hardware, safety, EMC, environmental) refers to engineering and quality assurance testing of the physical device and its software. Therefore, sample sizes for patient data or data provenance are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The submission focuses on substantial equivalence through engineering and regulatory compliance testing, not clinical performance against a ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set requiring adjudication in the clinical sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned as having been performed. The submission is for a handheld Doppler device and focuses on demonstrating substantial equivalence to predicate devices through technical and safety performance, not on AI-assisted interpretation or improvement for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The DMX/SRX Handheld Doppler is a medical device that provides direct physiological measurements (blood flow audio, waveforms, fetal heart rate, APPG pressures for DMX). While it has software and processing capabilities, it is not an "algorithm only" device in the sense of AI software for diagnostic interpretation. Its "performance" is inherently tied to human use (e.g., correctly positioning the probe, interpreting the audio/visual output).
7. Type of Ground Truth Used:
For the specified tests, the "ground truth" would be established by:
- Biocompatibility: Standardized test methods and controls as defined by ISO 10993-1.
- Software Performance: Requirements specifications and expected software behavior.
- Electronic Hardware/Mechanical Performance: Design specifications, engineering drawings, and functional requirements.
- Electrical Safety/EMC: Relevant IEC standards and their specified limits.
- Environmental Performance: Specified operating and storage conditions and their associated performance limits.
There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for these engineering verification tests.
8. Sample Size for the Training Set:
Not applicable. The DMX/SRX Handheld Doppler is not explicitly described as employing trainable machine learning algorithms. The testing relates to the device's inherent design and functionality, not a model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set for machine learning is indicated.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Huntleigh Healthcare Ltd Steve Monks Quality Manager 35 Portmanmoor Road Cardiff, CF24 5HN United Kingdom
Re: K183574
Trade/Device Name: DMX/SRX Handheld Doppler and Probes Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW, DXO, JOM, JAF, HGL, KNG Dated: August 14, 2019 Received: August 19, 2019
Dear Steve Monks:
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183574
Device Name DMX / SRX Handheld Doppler and Probes
Indications for Use (Describe) The DMX Handheld Doppler:
Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist in diagnosis.
The SRX Handheld Doppler:
Indicated for use by qualified healthcare practitioners in primary, acute and community healthcare environments, for the assessment of fetal heart rate to assist in diagnosis.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary DMX / SRX Handheld Doppler and Probes
| Name & Address: | Huntleigh Healthcare Limited - Diagnostic Products DivisionUnit 35, Portmanmoor RoadCardiffCF24 5HNUnited Kingdom |
|---|---|
| Telephone: | +44 (0)2920 485885 |
| Fax: | +44 (0)2920 492520 |
| Prepared: | July 2019 |
| Contact: | Steve Monks |
Huntleigh Healthcare Limited • Diagnostic Products Division • 35 Portmanmoor Road • Cardiff • CF24 5HN • United Kingdom Tel: +44 (0)29 2048 5885 • Fax: +44 (0)29 2049 2520 • Mail: sales@huntleigh-diagnostics.co.uk • www.huntleigh-diagnostics.com VAT Reg: GB 382 474 630 • Registered No: 942245 England & Wals: Registered Office: ArjoHuntleigh House, Houghton Regis, Bedfordshire, LU5 SXF
AN ARJOHUNTLEIGH COMPANY, MEMBER OF THE GETINGE GROUP
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| Device Name: | DMX / SRX Handheld Doppler and Probes | ||
|---|---|---|---|
| Common Name(DMX / VascularUse) | Cardiovascular Blood Flowmeter / Non-Fetal UltrasonicMonitor / Hydraulic, pneumatic, photoelectric plethysmographs/ Transducer, ultrasonic, obstetric / Blood pressure cuff | ||
| Classification(DMX / VascularUse) | Class | ProductCode | Classification Regulation |
| IIIIIIIIII | DPWJAFJOMHGLDXQ | 870.2100892.1540870.2780884.2960870.1120 | |
| ClassificationName:(DMX / VascularUse) | Flowmeter, Blood, Cardiovascular | ||
| Predicate Devices:(DMX / VascularUse) | MD2 family of Handheld vascular and obstetric Dopplers andprobes (HS range) manufactured by Huntleigh Healthcare(K930200)Vascular Assist manufactured by Huntleigh Healthcare(K002186) | ||
| Indications forUse:(DMX / VascularUse) | Indicated for use by qualified healthcare practitioners in primary,acute and community healthcare environments, for the non-invasive assessment of vascular blood flow to assist indiagnosis. | ||
| Description :(DMX / VascularUse) | The DMX Doppler provides the clinician with the ability toperform vascular investigations. It is powered from two internalreplaceable AA format 1.5 volt alkaline or 1.2 volt NiMHrechargeable batteries. The DMX hand unit is used with aDoppler or Arterial Photoplethysmography (APPG) probe,selected to suit the nature of the investigation to be performed.The device includes a colour liquid crystal display and three softkeys for user input. Doppler audio sounds are reproduced bythe integral loudspeaker; the audio level can be adjusted by twobuttons.Doppler Mode:The probes emit low energy ultrasonic waves into the bodywhich are reflected back into the probe. The reflected ultrasonicwaves contain information about the blood flow, which can beheard as audio sounds from the loudspeaker and waveformspresented on the display. There is a range of compatibleDoppler probes; the choice of probe is determined by the typeof vascular assessment being performed and depth of vessel. |
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APPG Mode:
| The APPG sensor emits low energy infra-red light into the body, some of which is reflected by blood within the tissue back into the sensor. The variation of this reflected light is related to the blood volume within the tissue. The APPG probe is used with an inflatable cuff and sphygmomanometer gauge to measure toe / finger blood pressures. | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Dopplex Reporter 5 (DR5) Software Package: | ||||||||||
| The DR5 software is a medical device data system (MDDS) and is an optional accessory to the dopplex® DMX bidirectional Doppler. It can display bidirectional velocity/time waveforms obtained from various vessels. Data can be archived and a printout can be obtained for patients notes. The DR5 is not a standalone medical device – it can only be used with the DMX Doppler to display, archive and print Doppler waveforms and PPG pressures produced by the DMX. | ||||||||||
| Note: Being an MDDS, the device is exempt from premarket notification and a letter to file against K930200/S2 will be completed, detailing the update in software version, of the already registered Dopplex Reporter Software package. | ||||||||||
| Models:(DMX / VascularUse) | There are two vascular versions:DMX (non-rechargeable version)DMXR (rechargeable version)The DMXR is contained in two different Vascular assessment kits:DMXRABI – Ankle Brachial Index KitDMXRATP – Ankle and Toe Pressure kitThe vascular probes include:VP4XS - 4MHz Vascular Doppler ProbeVP5XS - 5MHz Vascular Doppler ProbeVP8XS - 8MHz Vascular Doppler ProbeEZ8XS - 8MHz Widebeam Vascular Doppler ProbeVP10XS - 10MHz Vascular Doppler ProbePPGA1 - Photoplethysmography Probe | |||||||||
| Common Name(SRX /ObstetricUse) | Fetal ultrasonic Monitor and accessories / Obstetric Ultrasonic Transducer | |||||||||
| Classification(SRX /ObstetricUse) | ClassProduct CodeClassification RegulationIIKNG884.2660IIHGL884.2960 | Class | Product Code | Classification Regulation | II | KNG | 884.2660 | II | HGL | 884.2960 |
| Class | Product Code | Classification Regulation | ||||||||
| II | KNG | 884.2660 | ||||||||
| II | HGL | 884.2960 |
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| ClassificationName:(SRX /ObstetricUse) | Fetal ultrasonic Monitor and accessories |
|---|---|
| Predicate Devices:(SRX /ObstetricUse) | MD2 family of Handheld vascular and obstetric Dopplers andprobes (HS range) manufactured by Huntleigh Healthcare(K930200) |
| Indications forUse:(SRX /ObstetricUse) | Indicated for use by qualified healthcare practitioners in primary,acute and community healthcare environments, for theassessment of fetal heart rate to assist in diagnosis. |
| Description :(SRX /ObstetricUse) | The SRX Doppler range is intended to be used by qualifiedhealthcare practitioners for the detection and presentation of thefetal heart rate to assist in the assessment of fetal well-beingduring pregnancy. |
| Each model is powered from two internal replaceable AA format1.5 volt alkaline or 1.2 volt NiMH rechargeable batteries. TheSRX hand unit is used with a choice of either a 2MHz (OP2XS)or 3MHz (OP3XS) obstetric Doppler probe. The SR2 and SR3have fixed probes (2MHz and 3MHz respectively). | |
| All models include a colour liquid crystal display and three softkeys for user input. Doppler audio sounds are reproduced bythe integral loudspeaker; the audio level can be adjusted by twobuttons. | |
| The probes emit low energy ultrasonic waves into the bodysome of which are reflected back into the probe. The reflectedultrasonic waves contain information about the fetal heart,which can be heard as audio sounds from the loudspeaker andheart rate values presented on the display. | |
| Models:(SRX /ObstetricUse) | There are six obstetric versions: |
| SRX (non-rechargeable version) interchangeable probecapable | |
| SRXR (rechargeable version) interchangeable probe capable | |
| SR2 fixed 2MHz probe (non-rechargeable) | |
| SR2R fixed 2MHz probe (rechargeable) | |
| SR3 fixed 3MHz probe (non-rechargeable) | |
| SR3R fixed 3MHz probe (rechargeable) | |
| The obstetric probes include: | |
| OP2XS – 2MHz Obstetric Doppler Probe | |
| OP3XS – 3MHz Obstetric Doppler Probe | |
| Comparison ofTechnological | Doppler Ultrasound and Infrared Photoplethysmography (PPG)are the technological principles for both the subject and |
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Characteristics with Predicate Devices (DMX — Vascular Use)
predicate devices. It is based on the combination of a handheld 'monitor' and a cable attached Doppler probe or PPG probe, changing the probe changes the functionality of the monitor to the corresponding mode.
DOPPLER MODE (selected automatically by fitting a Doppler probe):
The subject and the predicate (Huntleigh MD2) are based on the following same technological elements:
- The monitor provides the power to the probe ●
- The monitor and probes have a probe identification (ID) system
- . The monitor provides a Doppler signal audio output via internal loudspeaker or optional headphones
- The monitor performs filtering of the Doppler signal
- . The monitors have LCD displays
- . The monitor displays the Probe frequency
- The monitors are available either with rechargeable or primary batteries
- The monitor provides a graphical battery power level indication
- . The Doppler probes are functionally identical
The following technological differences exist between the subject device and predicate (Huntleigh MD2) device:
- The subject device displays the 'Maximum Frequency' . flowrate waveform for forward and reverse blood flow: the predicate displays flowrate as a bar graph (4 levels in each direction)
- . The subject device can store multiple blood flow waveforms that can be recalled and played back; the predicate does not have this capability.
- The subject device has a 320 x 240 Pixel Colour Graphic ● LCD, whereas the predicate has a fixed character monochrome LCD.
- The subject has a USB interface whereas the predicate has an RS232 interface
- The user controls of the subject device are 'soft keys', ● the function of which is identified by the LCD whereas the predicate has 'fixed' function buttons
- . Audio volume of the subject device is controlled by an up and a down button, whereas the predicate uses a rotary volume control
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APPG MODE (selected automatically by fitting an APPG probe):
The subject device and the predicate (Huntleigh Vascular Assist) are based on the same following technological elements:
- The device can store multiple APPG waveforms and pressures that can be recalled, displayed and 'replayed'.
- The monitor provides the power to the probe ●
- . The monitor and probe have a probe identification (ID) system
- The subject and predicate have colour LCD displays
The following technological differences exist between the subject device and predicate (Huntleigh Vascular Assist) device:
- The subject LCD is smaller than the predicate ●
- The subject can operate on either rechargeable battery or primary battery; the predicate can only operate on rechargeable battery.
- The subject has a USB interface whereas the predicate has an RS232 interface
Comparison of Technological Characteristics with Predicate Devices (SRX - Obstetric Use)
Doppler Ultrasound is the technological principle for both the subject and predicate devices. It is based on the combination of a handheld 'monitor' and a cable attached Doppler probe.
The subject and the predicate (Huntleigh MD2) are based on the following same technological elements:
- The monitor provides the power to the probe ●
- . The monitor and probes have a probe identification (ID) system
- The monitor provides a Doppler signal audio output via ● internal loudspeaker or optional headphones
- The monitor performs filtering of the Doppler signal
- The monitors have LCD displays ●
- The monitor displays the Probe frequency
- . The monitors are available either with rechargeable or primary batteries
- The monitor provides a graphical battery power level indication
- The Doppler probes are functionally identical
The following technological differences exist between the
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| subject device and predicate (Huntleigh MD2) device: | |||||||
|---|---|---|---|---|---|---|---|
| • | The subject device can display fetal heart rate innumerical format and graphically, whereas the predicatecan only display fetal heartrate numerically. | ||||||
| • | The subject device can store multiple fetal heartratetraces that can be recalled, displayed and replayed,which the predicate cannot. | ||||||
| • | The subject device has a 320 x 240 Pixel Colour GraphicLCD, whereas the predicate has a fixed charactermonochrome LCD. | ||||||
| • | The subject device has a USB interface, whereas thepredicate has an RS232 interface | ||||||
| • | The user controls of the subject device are 'soft keys',the function of which is identified by the LCD, whereasthe predicate has 'fixed' function buttons | ||||||
| • | Audio volume of the subject device is controlled by an upand a down button, whereas the predicate uses a rotaryvolume control | ||||||
| SubstantialEquivalence:PerformanceData: | The DMX / SRX Handheld Dopplers and Probes aresubstantially equivalent to the cleared devices Huntleigh MD2and probes (K930200) and Huntleigh Vascular Assist(K002186)Testing to demonstrate substantial equivalence included: | ||||||
| Testing Conducted Discussion Biocompatibility Testing-Cytotoxicity-Sensitization-Irritation The biocompatibility evaluation ofthe device was conducted inaccordance with ISO 10993-1:2009 Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management process. Thesubject device is considered askin contacting device (intact) fora duration of <24 hours. Software PerformanceTesting Software verification andvalidation testing were conductedand documentation was providedas recommended by FDA'sGuidance for Industry and FDAStaff, "Guidance for the Content |
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| Software Contained in MedicalDevices". The software for thisdevice was considered as a"moderate" level of concern as amalfunction or a latent design flawin the software device could leadto an erroneous diagnosis or adelay in the delivery ofappropriate medical care, thatwould likely lead to minor injury. | |
|---|---|
| Electronic HardwarePerformance Testing | Testing provides verification ofelectronic hardware performanceincluding power, user interface,display, audio, data managementand time and date. |
| MechanicalPerformance Testing | Testing provides verification ofmechanical performance includinggeneral, enclosure, physical,environment, labelling, IFU,packaging, durability and lifetesting. |
| Electrical Safety Testing | Electrical safety testing wasconducted on the product by athird party laboratory, UL. Testingconfirms device complies with IEC60601-1:2005 (Third Edition) +A1:2012, IEC 60601-1-11, IEC60601-1-6 and IEC 60601-2-37. |
| EMC Testing | EMC testing was conducted onthe product by a third partylaboratory, UL. Testing confirmsdevice complies with IEC 60601-1-2:2014 |
| EnvironmentalPerformance Testing | Testing provides verification of theoperating and storagetemperature, humidity andatmospheric pressure. |
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| TechnologiesSummary: | The DMX / SRX hand held Dopplers and Probes consist of aninternally powered ‘monitor' with either primary cells orrechargeable (determined as a purchase option), these areused to create the various internal voltages required to drivethe colour 240 x 320 pixel TFT LCD, the microprocessor,analogue electronics, audio amplifier and probe. |
|---|---|
| All versions of the DMX/SRX provide audio representation ofthe Doppler signal via and audio amplifier and internalspeaker, with the ability to connect headphones via a 3.5mmjack socket. | |
| The range of DMX / SRX compatible Huntleigh Dopplerprobes contain all the transmit (piezo transducer excitation)and receive electronics; the output from the probes are twoanalogue signals in phase quadrature which are fed into theDMX / SRX for processing. | |
| The APPG probe includes an optical sensor which contains aninfra red light emitting diode (LED) and photo transistor. TheLED output is modulated at 1 kHz. The phototransistor outputfeeds into an amplifier that is synchronous with the LED drivesignal, which helps to reduce the effect of ambient light. Theamplified signal is bandpass filtered before being fed to themonitor unit. This signal represents relative blood volumechanges, and is not calibrated. | |
| Located inside the APPG module is an air pressuremeasurement sensor which records the instantaneous cuffpressure. The cuff pressure values are presented on theDMX display allowing the user to determine the actual systolicblood pressure. | |
| All versions of the DMX / SRX range have the same internalhardware; the determination whether it is a 'Vascular' DMX orone of the 'Obstetric' SRX, SR2* or SR3* models isdetermined by a single 'link' on the main PCB, and externallabels. | |
| *The SR2 and SR3 models are also determined by havingfixed 'Obstetric' Doppler probes. | |
| The probes used with DMX and SRX models can be easilyinterchanged by the user. | |
| The DMX version is a ‘Vascular' investigation device.Connecting one of a range of vascular Doppler probes setsthe DMX to vascular Doppler mode and connecting the APPGprobe sets the DMX to Photoplethysmography mode. It ispossible to connect an Obstetric Doppler probe to the DMXwhich will provide full obstetric functionality. | |
| The SRX version is an 'Obstetric' investigation device.Connecting either of the available Obstetric Doppler probessets the SRX to Obstetric mode. It is possible to connect avascular Doppler probe which will provide an audio only |
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Doppler output. It is physically possible to connect an APPG probe to the SRX, but the SRX will not recognise the probe and therefore has no effect.
Conclusion: The data detailed within this submission demonstrates that the device is as safe and effective and performs as well as the predicate devices identified in this summary, which are currently marketed for the same intended use. The device hardware, software, mechanical and clinical performance verification demonstrates that it should perform as intended in the specified user conditions.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).