(319 days)
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Commander Flex devices are home health monitoring tools typically used by patients with diseases such as congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD) asthma and coronary artery disease (CAD). Patients use Commander Flex to collect and send important health information to their health care team to allow a doctor and other health care team members to act before symptoms worsen. Commander Flex devices have a built-in non-invasive blood pressure measurement system that measures systolic and diastolic blood pressure and displays the readings on the Commander Flex panel. In addition to making blood pressure and heart rate measurements, Commander Flex devices store and transmit data from peripheral devices to remote locations. Commander Flex connects to a user's home phone line or cellular network. It has inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff. The display asks health-related questions to obtain objective biometric data such as: weight, blood pressure, glucose, and pulse oximetry. Patients may also answer a series of questions about their current symptoms. The patient can respond Yes or No or select from a list. Commander Flex devices collect data from peripherals and transmit the data using a cellular connection or toll-free telephone number and modelar design of the Commander Flex device allows for selection of the appropriate health monitoring devices for cost-effective patient care. Commander Flex products are for home use. This 510(k) clearance achieves OTC designation for Commander Flex devices. The peripheral devices are used as supplied by the manufacturer. The Commander Flex devices make no interpretation, evaluation, medical judgements or recommendations for treatment. Commander Flex is not used as an emergency response device. Clinical judgment and experience are required to interpret the information transmitted. Commander Flex devices are not intended as a substitute for medical care.
The provided text is a 510(k) summary for the Medtronic Commander Flex device, primarily focusing on its substantial equivalence to previously cleared predicate devices for the purpose of obtaining an Over-The-Counter (OTC) designation. The document does not describe an AI/ML-based device or its performance against acceptance criteria in the context of an AI/ML study.
Therefore, many of the requested elements for describing the acceptance criteria and the study proving the device meets them (such as a table of AI performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for AI) are not applicable to this document as it pertains to a blood pressure measurement system and remote patient monitoring device, not an AI/ML diagnostic tool.
However, based on the provided text, I can infer and extract information relevant to the device's general performance and the studies conducted to demonstrate its capabilities, particularly for the blood pressure measurement component.
Here's an attempt to answer the questions based on the non-AI device described:
1. A table of acceptance criteria and the reported device performance
The document states that the Commander Flex blood pressure algorithm performance meets ANSI/AAMI SP10 and ISO 81060-2 requirements for sphygmomanometers. These standards define the acceptance criteria for blood pressure device accuracy. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly listed in the text, the successful meeting of these recognized standards implies the device's performance reached the established benchmarks.
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10 standards for sphygmomanometers | Met |
| ISO 81060-2 requirements for sphygmomanometers | Met |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 99 human subjects.
- Data Provenance: Not explicitly stated, but clinical testing was performed. Given Medtronic's location (Minneapolis, Minnesota per the document) and FDA submission, it's highly likely the study was conducted in the US. The study appears to be prospective as it involved measuring accuracy with simultaneous measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For blood pressure measurement accuracy studies, the "ground truth" is typically established by trained observers using an auscultatory method (stethoscope).
- Number of Experts/Observers: Not explicitly stated, but it refers to "a trained observer." This might imply multiple trained observers, but the exact count isn't given.
- Qualifications of Experts: Described as "trained observer." Specific qualifications (e.g., years of experience, medical degree, certification) are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The method described is simultaneous blood pressure measurements by the Commander device and a trained observer using the stethoscope auscultatory method. This is a direct comparison, not typically requiring adjudication in the sense of reconciling multiple independent readings like in an imaging study. The "ground truth" is typically the auscultatory reading.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This document describes a non-AI/ML device (a blood pressure monitor and remote patient monitoring system). It is not an MRMC study and does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not contain a discrete "algorithm" in the AI/ML sense that provides a diagnostic output that would be evaluated in a standalone manner like an AI model. However, the blood pressure measurement component does involve an internal algorithm. The clinical data on page 8, "Clinical testing of the Commander Flex blood pressure 2.0 algorithm..." describes an evaluation of this inherent blood pressure measurement algorithm's accuracy compared to a reference standard (auscultation). In that sense, it's an evaluation of the device's automated function, akin to a "standalone" performance for its specific blood pressure task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the blood pressure measurement study was established by simultaneous measurements by a trained observer using the stethoscope auscultatory method. This is considered a gold standard for non-invasive blood pressure measurement studies.
8. The sample size for the training set
Not Applicable. This document does not describe an AI/ML device that would require a separate training set. The device is a traditional medical device (blood pressure monitor and remote patient monitoring system) that has undergone verification and validation testing, not AI model training.
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML training set, there is no ground truth establishment for it mentioned.
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May 15, 2020
Medtronic Care Management Services % Charmaine Sutton Consultant The Tamarack Group - MPLS, LLC 2584 Upton Ave. So Minneapolis, Minnesota 55405
Re: K191745
Trade/Device Name: Commander Flex Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, DRG Dated: April 10, 2020 Received: April 14, 2020
Dear Charmaine Sutton:
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 medical devices and radiation-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,
LT 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) K191745
Device Name
Commander Flex
Indications for Use (Describe)
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k Summary:
Medtronic Commander Flex Series remote patient monitoring device
Date Prepared: May 11, 2020
| Submitter | |
|---|---|
| Applicant: | Medtronic Care Management Services7980 Century BoulevardChanhassen, MN 55317888-243-8881 |
| Contact: | Charmaine Dwyer (Sutton)The Tamarack Group – MPLS, LLCcharmaine.sutton@tgmpls.com |
| Device Information | |
| Trade Name:Model Numbers:Common Name:Classification: | Medtronic Commander FlexCD300, CD300C, CD310, CD315, CD320Remote Patient Monitoring DeviceClass IINoninvasive Blood Pressure Measurement System -21 CFR 870.1130Oximeter – 21 CFR §870.2700Product Codes DXN, DQA, DRG |
Predicate Device(s)
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| Identification | Commander IIIModel CD3xx(Rx) | Tablet CommanderModel TC200/TC210(Rx and OTC) |
| Manufacturer | Cardiocom, LLC(now Medtronic) | Cardiocom LLC(now Medtronic) |
| 510k number | K053303, K091821 | K122285 |
| Regulation number | 21 CFR 870.113021 CFR 870.2700 | 21 CFR 870.2910 |
| ProCode | DXN, DQA | DRG |
Device Description
Commander Flex devices are home health monitoring tools typically used by patients with diseases such as congestive heart failure (CHF), diabetes, chronic obstructive pulmonary disease (COPD) asthma and coronary artery disease (CAD). Patients use Commander Flex to collect and send important health information to their health care team to allow a doctor and other health care team members to act before symptoms worsen.
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Commander Flex devices have a built-in non-invasive blood pressure measurement system that measures systolic and diastolic blood pressure and displays the readings on the Commander Flex panel.
In addition to making blood pressure and heart rate measurements, Commander Flex devices store and transmit data from peripheral devices to remote locations. Commander Flex connects to a user's home phone line or cellular network. It has inputs for peripheral devices such as weight scales, glucose meters, pulse oximeters, thermometers and blood pressure cuff. The display asks health-related questions to obtain objective biometric data such as: weight, blood pressure, glucose, and pulse oximetry. Patients may also answer a series of questions about their current symptoms. The patient can respond Yes or No or select from a list. Commander Flex devices collect data from peripherals and transmit the data using a cellular connection or toll-free telephone number and modelar design of the Commander Flex device allows for selection of the appropriate health monitoring devices for cost-effective patient care.
Commander Flex products are for home use. This 510(k) clearance achieves OTC designation for Commander Flex devices.
The peripheral devices are used as supplied by the manufacturer. The Commander Flex devices make no interpretation, evaluation, medical judgements or recommendations for treatment. Commander Flex is not used as an emergency response device. Clinical judgment and experience are required to interpret the information transmitted. Commander Flex devices are not intended as a substitute for medical care.
Intended Use
The Commander Flex is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry) between the patient, typically at home, and a health care professional at a remote site.
Comparison to Predicate Devices
| Feature | Subject DeviceCommander FlexModel CD300 -CD399with OTC designation | Primary PredicateCommander III, ModelCD300-CD399K091821 & K053303 | Secondary PredicateTablet CommanderModel TC200 -TC299K122285 | Comparison |
|---|---|---|---|---|
| 510(k) Number | K091821 & K053303 | K122285 | -- | |
| Product Code &Classification Name | DXNSystem, Measurement,Blood Pressure, Non-InvasiveDQAOximeter | DXNSystem, Measurement,Blood Pressure, Non-InvasiveDQAOximeter | DRGTransmitters andReceivers, PhysiologicalSignal, Radiofrequency | Same as primary |
| Class | Class II | Class II | Class II | Same |
| Regulation | 21 CFR 870.1130Non-Invasive BloodPressure MeasurementSystem | 21 CFR 870.1130Non-Invasive BloodPressure MeasurementSystem | 21 CFR 870.2910RadiofrequencyPhysiological SignalTransmitter and Receiver | Same as primary |
Regulatory and Intended Use Comparison
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| Feature | Subject DeviceCommander FlexModel CD300 -CD399with OTC designation | Primary PredicateCommander III, ModelCD300-CD399K091821 & K053303 | Secondary PredicateTablet CommanderModel TC200 -TC299K122285 | Comparison |
|---|---|---|---|---|
| 21 CFR 870.2700Oximeter | 21 CFR 870.2700Oximeter | |||
| Intended Users | All three devices are used by home users and health care professionals | Same | ||
| Location of Use | All three devices are used in the home | Same | ||
| Rx/OTC | Rx & OTC | Rx | Rx & OTC | Same as secondary;same Rx as Primary |
| Intended Use | The Commander Flex isfor use by patients tocollect and transmitgeneral healthquestions and patientvital sign data (such asweight, blood pressure,glucose, pulseoximetry) between thepatient, typically athome, and a healthcare professional at aremote site. | The Commander III isfor use by patients tocollect and transmitgeneral healthquestions and patientvital sign data (such asweight, blood pressure,glucose, pulseoximetry, peak flow)between the patient,typically at home, anda health careprofessional at aremote site. | The Tablet Commanderdevice is for use bypatients to collect andtransmit general healthinformation, physiologicalmeasurements and otherdata between themselvesand a caregiver. | Same; all are for useby patients to collectand transmit generalhealth informationbetween themselvesand a healthcareprofessional at aremote monitoringstation |
| All three devices make no interpretation, evaluation, medical judgments, orrecommendations for treatment. Clinical judgment and experience arerequired to check and interpret the information transmitted, and they arenot intended as a substitute for medical care. | Same |
Technological and performance characteristics comparison
| Feature | Subject DeviceCommander FlexModel CD300 -CD399Series with OTCdesignation | Primary PredicateCommander III, ModelCD300-CD399 SeriesK091821 & K053033 | Secondary PredicateTablet CommanderModel TC200 -TC299seriesK122285 | Comparison |
|---|---|---|---|---|
| Basic TechnologyDescription | The Commander Flex is anelectronic device with built-in proprietary software.The Commander Flex alsoincludes an integratedblood pressuremeasurement capability. | The Commander III is anelectronic device withbuilt-in proprietarysoftware.The Commander III alsoincludes an integratedblood pressuremeasurement capability. | The Tablet Commander isa software applicationcapable of running on anyhardware platform thatuses the Androidoperating system. | Same as primary;similar tosecondary |
| All three devices interface with other electronic devices, including 510(k)-cleared orClass I exempt medical devices, using standard wired and wireless protocols tocollect biometric data and communicate that data to a back-end databaseapplication using public communications (phone, cellular or Wi-Fi). All three use thesame proprietary software to query and collect patient data. | Same | |||
| Feature | Subject DeviceCommander FlexModel CD300 -CD399Series with OTCdesignation | Primary PredicateCommander III, ModelCD300-CD399 SeriesK091821 & K053033 | Secondary PredicateTablet CommanderModel TC200 -TC299seriesK122285 | Comparison |
| Device Software | Embedded firmware andpatient database | Embedded firmware andpatient database | Embedded software andpatient database | Same as primary |
| The software hazards for all three are: no data from peripheral, no data transmissionto remote monitoring site, and corrupt data at remote monitoring site. The relatedrisk is low because the patient data is used for trending and not to make immediatetreatment decisions. | Same | |||
| Transmission /communicationmethod | Cellular (networkconnectivity: CDMA orGPRS) or telephone modem(POTS) | Telephone modem(POTS) | Cellular (networkconnectivity: CDMA orGPRS) | |
| Security & Privacy | FIPS 140-2 Level 2 andnative 4G/LTE encryptionfor cellular transmissionsFIPS 140-2 Level 2encryption for POTS (CD320model) | Plain old telephonesystem (POTS) | FIPS Level 140-2 Level 2encryption for WIFItransmissions | Subject deviceadds FIPS 140-2encryption forcellular and POTStransmissions |
| Peripheral deviceinterfaces | RS232 serial portsUSB: 2.0Radio frequencySupports battery chargingof MCMS-approvedperipherals via USBconnection | RS232 serial ports | WIFI: 802.11 b/n/gUSB: 2.0Bluetooth: 3.0Radio frequencySupports battery chargingof MCMS-approvedperipherals via USBconnection | Same aspredicates,collectively |
| All three devices interface with the peripheral medical devices using standardconnections according to protocols established by the manufacturer of theperipheral device. The protocols include checksums with re-transmit and purgeloops for data validation. The list of compatible peripherals will change according tomarket demand, with each new peripheral being validated prior to making claims ofcompatibility. | Same | |||
| Built-inmeasurements | Non-invasive bloodpressure reading usingsmall, medium and largesize cuffs | Non-invasive bloodpressure reading usingsmall, medium and largesize cuffs | None | Same as primary |
| Power supply | All three use an external power supply that converts standard wall 120 volts AC toDC | Same | ||
| Electrical Safety | All three devices are tested to IEC 60601-1,2. The subject device is tested to thecurrent version (2014). | Same | ||
| Communicationscompliance | All three devices comply with FCC Part 68. | Same | ||
| User Interface /Controls | All three communicate with patients using an on-screen LCD display in English,Spanish or both, enlarged font size, voice prompts, user input buttons or keys, quick | Same | ||
| Feature | Subject DeviceCommander FlexModel CD300 -CD399Series with OTCdesignation | Primary PredicateCommander III, ModelCD300-CD399 SeriesK091821 & K053033 | Secondary PredicateTablet CommanderModel TC200 -TC299seriesK122285 | Comparison |
| Start guide, user manuals, voice prompts, and customer support phone line 800 number. | ||||
| physical keypad | physical keypad | virtual keypad /touchscreen | Same as primary | |
| Cleanability | All three are designed to be cleaned using common household cleaning agents. | Same | ||
| Memory | Biometric data collection: all three devices can display past readings. Biometricreview includes weight, blood pressure, glucose, oxygen saturation (and peakflow for the predicate device)Health check/subjective data: for all three devices only a single health check isstored in memory at a given time. If a new health check is taken the new answerswill overwrite the previous answers. Answers are also removed from memory if thedevice successfully transmits a health check to the remote monitoring system.All three devices can read an external memory card. | Nearly identical;the subjectdevice no longersupports a peakflow meter |
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Performance Data
Commander Flex devices are already used and labeled for use in the home, therefore no different or increased risks were identified by the OTC designation. Accordingly, no design changes, including no hardware, software or labeling changes were needed to support the OTC designation.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing conducted on the Commander device showed the device complies with IEC 60601-1-2:2014 Ed.4 Electromagnetic Emissions and Immunity (EMC/EMI) and 80601-2-30 Medical Electrical Equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.
Software verification and validation testing
The software for this device is considered a 'moderate' level of concern, since a failure or latent flaw in the software that controls the blood pressure circuit could directly result in minor injury to the patient or indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," including software risk assessments, software verification testing. A cybersecurity threat assessment report was also provided.
Biomaterial safety information
The patient contact materials in the blood pressure cuff are identical to those in the predicate device, therefore no new biomaterial testing was needed to support substantial equivalence.
K191745
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Human factors engineering information
Reports of usability engineering evaluations of Commander Flex devices, including use error analysis, user interface design analysis, and summative validation were provided. Usability test results show the user interface and user manual are sufficient for lay users to operate the device in a safe and effective manner.
A Use-Related Risk Assessment (URRA) was performed for Commander Flex devices to identify known or foreseeable user actions and identify risk-related use scenarios related to OTC use. The URRA included user profiles, task analysis, use error analysis, user interface design, and summative justification in accordance with FDA 2016 Guidance Applying Human Factors and Usability Engineering to Medical Devices. Commander Flex devices have been home-use devices for over a decade (under an Rx designation). The risk assessment revealed no different or increased risks and no new or additional critical tasks associated with the OTC designation. Therefore, additional Human Factors Validation Testing was deemed not necessary to support the Commander Series OTC designation.
Clinical data
Clinical testing of the Commander Flex blood pressure 2.0 algorithm in 99 human subjects (41% male; small, medium and large cuffs) was performed to measure the accuracy of the blood pressure measurement. Simultaneous blood pressure measurements were made by the Commander device and a trained observer using the stethoscope auscultatory method. The results demonstrate that the Commander blood pressure algorithm performance meets ANSI/AAMI SP10 and ISO 81060-2 requirements for sphygmomanometers.
Summary
Commander devices have always been used in the home. The updated performance evaluations revealed no new information about the safety and effectiveness profile of Commander. Device labeling was updated to reflect current standards. Commander devices with the OTC designation have a safety and effectiveness profile identical to the predicate device.
Conclusion
Commander Flex with the OTC designation has the same regulatory classifications, substantively the same intended use, the same environment of use, the same patient population and the same fundamental technology as the previously cleared Commander III devices. Commander Flex devices have no performance differences when compared to the predicate devices collectively and have been shown to meet all applicable industry standards. There are no new questions of safety or performance compared to the predicate devices. The information supplied demonstrates Commander Flex devices with the OTC designation have substantively the same intended use and the same technological characteristics as the previously cleared Commander III and Tablet Commander devices. Commander Flex devices with the OTC designation are, therefore, substantially equivalent to the legally marketed predicate devices.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).