TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 by BIOCOMFORT DIAGNOSTICS GMBH & CO. KG

The tenso-comfort BPM 105 /BPM 205 is a wrist non-invasive blood pressure device which is intended for use in measuring blood pressure and pulse rate in adult patient population. The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard. The model version BPM 105 is equipped with a radio module to transmit the measurement data to a PC. The device is not intended for neonatal use.

Device Description

The non-invasive wrist blood pressure meter BPM105 and BPM205 determine the arterial blood pressure by means of the oscillometric blood pressure measuring method. With this method the pressure fluctuations are measured, which develop when depressing pulse-cyclic blood pulses in the compressed arteria under the blood pressure cuff put on. The blood pressure apparatus in the model variant BPM105 is equipped with a radio module, with which the transmission of the stored measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the tenso-comfort BPM 105 / 205 device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the tenso-comfort BPM 105 / 205 focus on its measurement accuracy compared to established standards for non-invasive blood pressure devices.

Metric (Acceptance Criteria)	Reported Device Performance
Pressure Accuracy (0 - 300 mmHg)	±3 mmHg
Pulse Accuracy (40 - 199 beats/minute)	±5% of the value

Note: The document explicitly states "The measuring method is an oscillometric blood pressure measurement with automatic sequence and refers to the auscultatory method as the reference standard." This implies that the device's accuracy was compared against auscultatory measurements, which is a standard method for validating blood pressure monitors.

Study Information

The provided 510(k) summary does not include a detailed report of a specific clinical study proving the device meets the acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device, the TaiDoc Clever TD-3018A (K051703), which presumably has already undergone such validation.

The substantial equivalence discussion indicates that the measurement accuracy of the tenso-comfort BPM 105 / 205 is claimed to be equivalent to that of the predicate device.

Given the information provided, many of the requested details about a specific validation study are absent. However, based on what is available, we can infer the following:

Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The document refers to the oscillometric method referring to the auscultatory method as the reference standard, implying such testing would have been done.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For validation against an auscultatory method, it would typically involve trained medical professionals taking blood pressure measurements.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
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 device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The listed accuracy metrics for Pressure and Pulse are for the device's performance directly, without human intervention in the measurement process (beyond operating the device). The device's oscillometric method is an algorithm that directly provides the blood pressure and pulse readings.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for blood pressure measurement is stated as the "auscultatory method as the reference standard." This typically involves measurements taken by trained healthcare professionals using a stethoscope and sphygmomanometer.
The sample size for the training set: Not applicable and not mentioned. This is a measurement device, not an AI model that requires a training set in the conventional sense. The "training" of such a device refers to its design and calibration processes.
How the ground truth for the training set was established: Not applicable for a training set in the context of an AI model. For the device's design and calibration, the reference standard would be the auscultatory method.

In summary, the 510(k) summary primarily demonstrates substantial equivalence to a predicate device by comparing technical specifications and intended use. While it states the device operates under the oscillometric method with reference to the auscultatory standard for accuracy, the specific details of a dedicated clinical validation study for this device (tenso-comfort BPM 105 / 205) are not provided in this document. Such studies would have been performed for the predicate device and the new device would be expected to perform similarly given the equivalence argument.

Summary

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510(k) Summary

The assigned 510(k) number is:

Date Prepared:

Submitter Information:

Official Correspondent:

Mrs. Marion Otto Quality Manager Biocomfort GmbH & Co. KG Phone: +49 7158 98016-48 +49 7158 98016-40 Fax: E-mail: otto@biocomfort.de

Burlington, MA 01803 USA Phone: +1 866 294 8267 E-mail: schill@biocomfort.com

Mr. Dieter Schill

President Biocomfort Inc. 23 Third Avenue

Biocomfort Diagnostics GmbH & Co. KG

Registration Number: 3006493236 Owner Operator Number: 10023755

Ko 81498

Bernhaeuser Strasse 17 73765 Neuhausen a.d.F.

May 19, 2008

Germany

US Agent (Contact):

Device Trade Name: Common Name: Device Classification Name: Product Code: Device Classification No.: Regulatory Status:

Predicate Devices: Device Trade Name: 510(k) Number: Device Classification Name: Product Code: Device Classification No .: Regulatory Status:

Device Description:

tenso-comfort BPM 105 / 205 Blood pressure meter System, Test, Non- invasive Blood Pressure meter, Over The Counter DXN Part 870.1130 Class II

Clever TD-3018A Clever TD-3018A K051703 Blood pressure meter, Over The Counter DXN Part 870.1130 Class II

06 - 510(k) Summary - Page 1 of 3

DEC 1 7 2008

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measured values on a PC is optionally possible (radio interface for PC and software is offered as accessory).

Intended Use:

The device is not intended for neonatal use..

	SE Discussion:
		Substantial EquivalentDevice	Predicate Devices
		Biocomfort tenso-comfort BPM 105/ BPM205	TaiDoc Clever TD-3018A	Discussion of differences
[01]	Indication foruse	The tenso-comfort BPM105 /BPM 205 is a wristnon-invasive bloodpressure device which isintended for use inmeasuring blood pressureand pulse rate in adultpatient population. Themeasuring method is anoscillometric bloodpressure measurementwith automatic sequenceand refers to theauscultatory method asthe reference standard.The model version BPM105 is equipped with aradio module to transmitthe measurement data toa PC.	The Clever TD-3018ABlood Pressure Monitorprovide intended to usenon-invasive measure thesystolic and diastolicblood pressure and pulserate of an adultindividual, over age 18,at home by using a non-invasive technique inwhich an inflatable cuff iswrapped around thewrist. The cuffcircumference is limitedto 5.25"~ 7.75".	The BPM 105 is equippedwith a transmitter to sendthe measuring results to aPC.
[02]	Targetpopulation	Adults,Lay users	AdultsLay users	Equivalent
[03]	Measuringprinciple	Oscillometric method	Oscillometric method	Equivalent
[04]	Type of results	Pressure: mmHgPuls: beats/minute	Pressure: mmHgPuls: beats/minute	Equivalent
[05]	Presentation ofresults	LCD Digital Display	LCD Digital Display	Equivalent
[06]	Measurementrange	Pressure: 0 - 300 mmHgPulse: 40 - 199beats/minute	Pressure: 0 - 300 mmHgPulse: 40 - 199beats/minute	Equivalent
[07]	Measuringaccuracy	Pressure: ±3 mmHgPulse: ±5% of the value	Pressure: ±3 mmHg or2% of readingPulse: ±4% of the reading	In the same area andconsidered equivalent
		Substantial EquivalentDevice	Predicate Devices
		Biocomfort tenso-comfort BPM 105/ BPM205	TaiDoc Clever TD-3018A	Discussion of differences
[08]	Inflation	Automatic inflation	Automatic inflation	Equivalent
[09]	Deflation	Electric Valve	Electric Valve	Equivalent
[10]	Pressurerelease	Automatic exhaust valve	Automatic exhaust valve	Equivalent
[11]	Pressuredetection	Piezo-resistive siliconpressure transducer	Piezo-resistive siliconpressure transducer	Equivalent
[12]	Measuringperiod	App. 30 seconds	App. 20 seconds	Equivalent
[13]	Operationenvironment	10°C - 40°C50°F - 104°F	10°C - 40°C50°F - 104°F	Equivalent
[14]	Storageenvironment	-20°C - 60°C-4°F - 140°F10% - 95% relativehumidity	-20°C - 60°C-4°F - 140°F10% - 95% relativehumidity	Equivalent
[15]	Battery life	App. 300 measurements	App. 200 uses	Improved energymanagement andconsidered equivalent
[16]	Cuff size	135mm - 220mm5 ½ in - 8 ⅜ in	135mm - 195mm5 ¼ in - 7 ¾ in	Slightly larger cuff andconsidered equivalent
[17]	Dimensions	70 x 90 x 26 mm	76 x 64 x 29 mm	Slightly differentdimension due tocorporate design. Thedevices are consideredequivalent.
[18]	Weight	Ca. 140 g (withoutbatteries)	132 g (with batteries)	Equivalent
[19]	Mobility	Hand-held	Hand-held	Equivalent
[20]	MemoryCapability	110 measurements peruser (up to 8 users) withdate and time	352 sets of reading withdate and time	Different number ofmeasurement due to theuser management.It is consideredequivalent.
[21]	Power supply	Two 1.5 alkaline batteriestype AAA/LR03	Two 1.5 alkaline batteriestype AAA/LR03	Equivalent
[22]	Connectivity	Wireless interface with2.4 GHz according toIEEE802.15.4, with 10 mindoor range	None	The model BPM 105provides the option tocommunicate via wirelesstechnology to a PC whichis set up for the interfaceprotocol

06 – 510(k) Summary – Page 2 of 3

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Discussion of the Substantial Equivalence Decision:

The only difference between the BPM 105/205 and the predicate device is the ability to communicate rit only unceless connection. This feature does neither affect nor even represent the measurement of with a r e vireless connection is for the upload of measurement data and the set up of basic device functions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2008

Mr. Dieter Schill President Biocomfort Inc. 23 Third Avenue Burlington, MA 01803

Re: K081498

Trade/Device Name: tenso-comfort BPM 105/205 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: December 12, 2008 Received: December 17, 2008

Dear Mr. Schill:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Dieter Schill

807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

07 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081498

Device Name: tenso-comfort BPM 105 / 205

The device is not intended for neonatal use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please Do not Write Below This Line-Continue on another Page OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
	12/17/08
Division of Cardiovascular Devices
	4081498

510(k) Number

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).