The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232. USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software.

TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.

The intended paient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.

TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, non-invasive blood pressurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions.

A measurement with TONOPORT VI can be combined with other measurements and medical examinations at the patient that a diagnosis about the patient's health condition depends not alone from the measurement of the TONOPORT VI.

Device Description

The TONOPORT VI measures the blood pressure non-invasively and provides the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings. The cuff is borne on the upper arm of the patient and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software. It is intended to get used by physicians (primary care physician, specialists and hospitals).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called TONOPORT VI, a non-invasive blood pressure (NIBP) monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device, TONOPORT V, rather than providing a detailed clinical study for novel performance claims.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/human reader performance, MRMC studies, or training/test set ground truth establishment, is not present in this document. This device is a traditional medical device (NIBP monitor) and not an AI/ML-driven device or an imaging device that would typically undergo such studies.

However, based on the provided document, here's what can be inferred about acceptance criteria for this type of device and the performance demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence and Standards Compliance)

Given that this is a 510(k) submission for a non-invasive blood pressure monitor, the primary acceptance criteria revolve around the device's ability to accurately measure blood pressure and heart rate, meet safety standards, and demonstrate equivalence to a legally marketed predicate device. While explicit "acceptance criteria" tables with numerical targets are not provided in this regulatory letter, they are implicitly met by demonstrating compliance with recognized standards.

Characteristic	Acceptance Criteria (Implicit, based on standards)	Reported Device Performance (Summary from Document)
Measurement Accuracy	Equivalent to predicate device (TONOPORT V); accuracy within established NIBP standards (e.g., ISO 80601-2-30 requirements).	Uses "identical algorithms for the blood pressure measurement like the predicate device TONOPORT V." Compliance with IEC 80601-2-30 is stated as "Pass."
Safety (Electrical, Mechanical, Chemical, Thermal, Radiation)	Compliance with relevant IEC standards for medical electrical equipment.	Compliance with IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 stated as "Pass" for all. Includes improved safety features (additional pressure sensor, two controllers monitoring each other).
Essential Performance	Maintain critical functions under specified conditions.	Compliance with IEC 80601-2-30 stated as "Pass."
Usability	Compliance with usability engineering standards.	Compliance with IEC 60601-1-6 stated as "Pass." Ergonomic design improvements (larger display, smaller size/lower weight) are noted.
Software	Compliance with medical device software lifecycle processes.	Compliance with IEC 62304 stated as "Pass."
Risk Management	Implementation of a risk management process.	Compliance with ISO 14971 (risk analysis) stated as "Pass."
Functional Equivalence	Performs the same intended function as the predicate device.	Measures systolic, diastolic, mean arterial blood pressure and heart rate using the oscillometric method.
Indications for Use	Same as or substantially equivalent to predicate device.	Intended for adults and children (not neonates), upper arm circumference 17-42 cm, prescription use in healthcare setting. Identical to predicate device.
Storage Capacity	Sufficient for intended use.	Records up to 400 blood pressure measurements (predicate: 200). Increased capacity noted.
Connectivity	Ability to transmit data for evaluation.	RS-232, USB 1.1, or USB 2.0 interface (state-of-the-art for clearance times, improved from predicate's serial interface).

Regarding the other specific questions, based on the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a specific clinical "test set" or study with human subjects for performance evaluation (other than, presumably, tests required by the listed standards).
- It explicitly states: "An assessment of clinical data to show safety and performance of the device was not made, because the TONOPORT VI uses identical algorithms for the blood pressure measurement like the predicate device TONOPORT V." This indicates the submission relies on the predicate's established clinical performance and the new device's compliance with electrical and performance standards.
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)
- Not applicable. No expert ground truth establishment for a test set is described, as it's not a diagnostic imaging device or an AI/ML device requiring human expert review for performance evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such adjudication method is described.
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
- No such study was done or described. This device is an NIBP monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device's core function is an "algorithm only" (oscillometric method), the document describes it as a physical device that functions to measure BP. It doesn't detail a "standalone" algorithmic performance study in the context of an AI/ML submission where such a study would test the algorithm's output against ground truth. Its performance is implicitly deemed acceptable by meeting the industry standards (IEC 80601-2-30) for blood pressure measuring systems, which ensures accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For blood pressure monitors, accuracy is typically validated against a reference standard (e.g., invasive arterial blood pressure measurement or auscultation with a trained observer) as part of the standards compliance (IEC 80601-2-30). However, the document does not detail these specific ground truth methodologies or study results, instead relying on compliance with the standard which dictates these.
The sample size for the training set
- Not applicable. This document describes a traditional NIBP device, not an AI/ML device that undergoes "training." The "algorithms" mentioned are established signal processing and measurement algorithms, not machine learning algorithms requiring a distinct training set.
How the ground truth for the training set was established
- Not applicable. See explanation for point 8.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be part of a single, continuous line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2017

PAR Medizintechnik GmbH & Co. KG Thomas Fischer Sachsendamm 6 10829 Berlin Germany

Re: K170966

Trade/Device Name: TONOPORT VI Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 12, 2017 Received: May 15, 2017

Dear Thomas Fischer:

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. 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 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrenner

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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Statement of Indications for Use 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170966

Device Name TONOPORT VI

Indications for Use (Describe)

TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.

The intended paient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Special 510(k) TONOPORT VI

5 510(k) Summary

Table 2: Submitter information
Submitter:	PAR Medizintechnik GmbH & Co. KGSachsendamm 610829 BerlinGermany
Contact person:	Mr. Thomas FischerResearch and development departmentPAR Medizintechnik GmbH & Co. KGE-mail: info@par-berlin.comPhone: +49 30 235070 10Fax: +49 30 2138542
Date:	March 29th, 2017

Table 3: Device information

Table 3: Device information
Device:	Trade name:	TONOPORT VI
	Common name:	Non-Invasive Blood-Pressure Monitor
	Classification name:	Non-invasive blood pressure measurementsystem(21 CFR 870.1130, Product Code DXN,Class II)
	Legally markeddevice:	Device name:	TONOPORT V
		510(k) number:	K012647

Device Description 5.1

Table 4: Device description

Device functions:	The TONOPORT VI measures the blood pressure non-invasively andprovides the systolic, diastolic, mean arterial blood pressure and theheart rate of human beings. The cuff is borne on the upper arm of thepatient and an electrical pump in the device generates the pressure inthe cuff. The TONOPRT VI is powered by two AA size batteries(alkaline or rechargeable NiMH batteries). The device records up to400 blood pressure measurements at predefined intervals. In order toassess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation orarchiving purposes by analysis software. It is intended to get used byphysicians (primary care physician, specialists and hospitals).
-------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device functions:

The TONOPORT VI measures the blood pressure non-invasively andprovides the systolic, diastolic, mean arterial blood pressure and theheart rate of human beings. The cuff is borne on the upper arm of thepatient and an electrical pump in the device generates the pressure inthe cuff. The TONOPRT VI is powered by two AA size batteries(alkaline or rechargeable NiMH batteries). The device records up to400 blood pressure measurements at predefined intervals. In order toassess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation orarchiving purposes by analysis software. It is intended to get used byphysicians (primary care physician, specialists and hospitals).

-------------------

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PAR MedizintechnikGmbH & Co. KG		Special 510(k) TONOPORT VI
Basic scientificconcept:	The blood pressure is measured by the oscillometric method. Thecriteria for this method are the pressure pulsations superimposedwith every systole on the air pressure in the cuff. In order to measurethe blood pressure, a blood pressure cuff wrapped around the upperarm needs to be inflated and subsequently deflated.
Device design:	The TONOPORT VI is a small-sized, light weighted and portableNIBP monitor with an easy to read display.
Used materials:	Polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) for thecase and plastic foil for the labels of the device. Tested biocompatiblematerials (Nylon and PVC) are used for the cuffs.
Physicalproperties:	Size: width: 73.0 mm / height: 27.0 mm / depth: 108.0 mm
	Weight: under 190 g, incl. batteries
	Connectors: cuff, USB and RS-232 connector

5.2 Indications for Use

The TONOPORT VI is a small-size, lightweight, portable, non-invasive blood pressure (NIBP) monitor for ambulatory measurement of the blood pressure by the oscillometric method. The cuff is borne on the upper arm and an electrical pump in the device generates the pressure in the cuff. The TONOPRT VI is powered by two AA size batteries (alkaline or rechargeable NiMH batteries). The device records up to 400 blood pressure measurements at predefined intervals. In order to assess the measurements, the stored data can be transmitted via a RS-232, USB 1.1 or USB 2.0 interface to a PC for further evaluation or archiving purposes by analysis software.

TONOPORT VI is intended to be used for measuring the systolic, diastolic, mean arterial blood pressure and the heart rate of human beings.

The intended patient populations are adults and children (but not neonates) with a circumference of the upper arm in the range of 17 to 42 cm.

TONOPORT VI is a prescription device in health care medicine and is intended for use following consultation and instruction by a physician (family doctor, specialist or hospital). It can be used, if the physical condition of the patient allows an automatic, noninvasive blood pressure measurement. Preparation and application of the TONOPORT VI is done by medically trained staff. The patient does not operate with the TONOPORT VI

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by himself. TONOPORT VI is not intended to be used in intensive care medicine or for alarming of life-threatening conditions.

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AR Medizintechni
GmbH & Co. KG

oecial 510(k) TONOPORT

Comparison of the TONOPORT VI and the predicate dev 5.3

The TONOPORT VI is substantially equivalent and employs the same functional technology as the predicate device TONOPORT

Table 5: Device compariso

Characteristic	Subject deviceTONOPORT VI	Primary predicate deviceTONOPORT V (510(k) -No.: K012647)	Explanation of thedifferences
Product code	DXN	DXN	Identical
Classificationnumber	21 CFR 870.1130	21 CFR 870.1130	Identical
Common name	Non-Invasive Blood-Pressure Monitor	Non-Invasive Blood-Pressure Monitor	Identical
Class	Class II	Class II	Identical
Intended use	The TONOPORT VI measures and storesthe blood pressure data (systolic pressure,diastolic pressure and heart rate) at humanbeings. The blood pressure can bemeasured several times at the physician orup to 400 times during a long-termmonitoring with one set of fully chargedbatteries. Medically trained staff has toapply the device and the physician has toanalyze the results. The patient does notoperate with the TONOPORT VI byhimself. The stored data can betransmitted to a PC based application viaserial interface for analysis andevaluation.	The TONOPORT V measures and storesthe blood pressure data (systolic pressure,diastolic pressure and heart rate) at humanbeings. The blood pressure can bemeasured several times at the physician orup to 200 times during a long-termmonitoring with one set of fully chargedbatteries. Medically trained staff has toapply the device and the physician has toanalyze the results. The patient does notoperate with the device by himself. Thestored data can be printed directly on aprinter and/or transmitted to a PC-basedapplication via serial interface for analysisand evaluation.	EquivalentThe storage capacity isincreased and thetransmission interfaces arestate of the art for theclearance times. Thesechanges are documentedand do not influence theindications for use.
PAR MedizintechnikGmbH & Co. KG	Special 510(k) TONOPORT VI
Characteristic	Subject deviceTONOPORT VI	Primary predicate deviceTONOPORT V (510(k) -No.: K012647)	Explanation of thedifferences
Indications for use	Target population:Adults and children, but not neonatesAnatomical site:Upper arm (see section 0)Where used:In hospital and at home (following consultation and instruction by a physician)	Target population:Adults and children, but not neonatesAnatomical site:Upper armWhere used:In hospital and at home (following consultation and instruction by a physician)	Identical
Design	New and good looking ergonomic designof the case and the user interface	Functional design of the case and the userinterface	EquivalentThe changes of the caseergonomics and the userinterface that enhance theoperator's and patient'sconvenience aredocumented and are notrelevant for theindications for use.
PAR MedizintechnikGmbH & Co. KG		Special 510(k) TONOPORT VI
Characteristic	Subject deviceTONOPORT VI	Primary predicate deviceTONOPORT V (510(k) -No.: K012647)	Explanation of thedifferences
Display	27.0 mm x 58.0 mm(width to height)Image: [display]	30.0 mm x 10.5 mm(width to height)Image: [display]	EquivalentThe change of theergonomics of the userinterface into a clear andeasy to read display thatincreases the safety of thedevice and enhance theconvenience aredocumented.
Dimensions andweight	Smaller with lower weight compared toTONOPORT V	Small size and low weight	EquivalentThe changes indimensional specificationsare documented, do notaffect the indications foruse and enhance theoperator's and patient'sconvenience.
Width	73.0 mm	80.0 mm	Identical
Height	27.0 mm	27.0 mm
Depth	108.0 mm	100.0 mm
Weight	Approximately 190 g with batteries	Approximately 199 g with batteries
Communication	Measurement settings of the device andthe read out of the stored data can be donevia serial interface	Measurement settings of the device andthe read out of the stored data can be donevia serial interface	Identical
Event marking	By pressing the START STOP Button	By pressing the START STOP Button	Identical
Energy source	Powered by two AA size batteries(alkaline or NiMH batteries).	Powered by two AA size batteries(alkaline or NiMH batteries).	Identical
GmbH & Co. KG	Characteristic	Subject deviceTONOPORT VI	Primary predicate deviceTONOPORT V (510(k) -No.: K012647)	Explanation of thedifferences
	Storage capacity	Up to 400 measurements	Up to 200 measurements	EquivalentThe evaluation of user needs showed that morestorage capacity is need.The change is documentedand do not influence theindications for use.
	Measuring method	Oscillometric measuring method duringdeflation of the cuff	Oscillometric measuring method duringdeflation of the cuff	Identical
	Measuring range	60 to 260 mmHg40 to 220 mmHg35 to 240 min-1systolic pressurediastolic pressurepulse rate (HR)	60 to 260 mmHg40 to 220 mmHg35 to 240 min-1systolic pressurediastolic pressurepulse rate (HR)	Identical
	Max cuff pressure	300 mmHg	300 mmHg	Identical
	Materials	PC and ABS for the case and plastic foilfor the labels of the device. Biocompatiblematerials are used for the applied parts(cuff).	PC for the case and plastic foil for thelabels of the device. Biocompatiblematerials are used for the applied parts(cuff).	EquivalentThe change of the materialformulation to increasethe durability of thedevice is documented. Thechanged materials are notin contact with the bodyof the patient.

5-4

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ecial 510(k) TONOPORT VI - Doc.-Rev. E from June 14th, 201

K170966
Page 5 of 9

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AR Medizintechni

Special 510(k) TONOPORT VI

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AR Medizintechnil
GmbH & Co. KG

pecial 510(k) TONOPORT VR

	Characteristic	Subject deviceTONOPORT VI		Primary predicate deviceTONOPORT V (510(k) -No.: K012647)		Explanation of thedifferences
EnvironmentalconditionsforOperation	Temperature	+5 to +40 °C		+10 to +40 °C	Temperature	Equivalent
	Humidity	15 to 93 %	Atmospheric pressure	30 to 75 %	Humidity	The environmentalconditions are changed
	Atmospheric pressure	700 to 1060 hPa		700 to 1060 hPa	Atmospheric pressure	according to the
Environmentalconditionsfortransport andstorage	Temperature	-25 to +70 °C		-20 to +70 °C	Temperature	requirements of the
	Humidity	10 to 93 %		10 to 90 %	Humidity	standards IEC 80601-2-30and 60601-1-11. These
	Atmospheric pressure	500 to 1060 hPa		500 to 1060 hPa	Atmospheric pressure	changes do not affect theindications for use.
Safety	Increased safety	An additional pressure sensor and apressure release valve are added.Two controllers (main and supervisorcontroller) that monitor each other and thesafety related components are used.		Standard safetyOne pressure sensor and one valve for thedeflation of the cuff are used.One controller (main controller) is used.		EquivalentThe improvement of thesafety properties of thedevice is documented.
Sterilization	Not applicable	Not applicable		Not applicable		Identical
Expiration date	Not applicable	Not applicable		Not applicable		Identical

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Summary of performance testing 5.4

Characteristic	Standard/Test/FDA Guidance	Result
Safety (electrical,mechanical, chemical,thermal and radiation) andessential performance	IEC 60601-1IEC 60601-1-11IEC 80601-2-30	PassPassPass
Usability	IEC 60601-1-6	Pass
Software	IEC 62304	Pass
Risk Management
Risk analysis	ISO 14971	Pass

Table 6: Performance testing to demonstrate equivalence

The TONOPORT VI complies with the voluntary and mandatory standards. The following quality assurance measures were applied to the development of the TONOPORT VI to ensure that design inputs, safety requirements, new features, preexisting requirements were met and re-tested:

Requirements specification review
o Software and hardware testing
Safety testing
Environmental testing
Final verification and validation
o Compliance with performance standards

An assessment of clinical data to show safety and performance of the device was not made, because the TONOPORT VI uses identical algorithms for the blood pressure measurement like the predicate device TONOPORT V. Consequently the form FDA-3674 'Certification of compliance with requirements of ClinicalTrails.gov data bank' is not completed and submitted.

5.5 Conclusion

The TONOPORT VI is substantially equivalent to the TONOPORT V with respect to the indications for use and the basic scientific concept.

Regulation Number and Section

§ 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).