TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205

K081498 · Biocomfort Diagnostics GmbH & Co. KG · DXN · Dec 17, 2008 · Cardiovascular

Device Facts

• Record ID: K081498
• Device Name: TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
• Applicant: Biocomfort Diagnostics GmbH & Co. KG
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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 Story

Wrist-worn oscillometric blood pressure monitor; measures pressure fluctuations in compressed artery via inflatable cuff; piezo-resistive silicon pressure transducer detects signals; automatic inflation/deflation via electric valve; displays systolic/diastolic pressure (mmHg) and pulse (bpm) on LCD. BPM 105 model includes 2.4 GHz wireless radio module (IEEE 802.15.4) for data transmission to PC. Used by lay users in home/clinic settings. Output allows users to track blood pressure trends over time; aids in monitoring cardiovascular health.

Clinical Evidence

Bench testing only. Device performance compared to auscultatory reference standard. Accuracy specifications: Pressure ±3 mmHg, Pulse ±5%.

Technological Characteristics

Wrist-worn oscillometric monitor; piezo-resistive silicon pressure transducer; automatic inflation/deflation; 2.4 GHz wireless interface (IEEE 802.15.4) for BPM 105; powered by two 1.5V AAA alkaline batteries; LCD display.

Indications for Use

Indicated for non-invasive measurement of blood pressure and pulse rate in adults. Not for neonatal use.

Regulatory Classification

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.

Predicate Devices

• Clever TD-3018A (K051703)

Submission Summary (Full Text)

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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: [phone] [phone] Fax: E-mail: [e-mail]

Burlington, MA 01803 USA Phone: [phone] E-mail: [e-mail]

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

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

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 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..

| | SE Discussion: | | | |
|------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Substantial Equivalent<br>Device | Predicate Devices | |
| | | Biocomfort tenso-<br>comfort BPM 105/ BPM<br>205 | TaiDoc Clever TD-3018A | Discussion of differences |
| [01] | Indication for<br>use | The tenso-comfort BPM<br>105 /BPM 205 is a wrist<br>non-invasive blood<br>pressure device which is<br>intended for use in<br>measuring blood pressure<br>and pulse rate in adult<br>patient population. The<br>measuring method is an<br>oscillometric blood<br>pressure measurement<br>with automatic sequence<br>and refers to the<br>auscultatory method as<br>the reference standard.<br>The model version BPM<br>105 is equipped with a<br>radio module to transmit<br>the measurement data to<br>a PC. | The Clever TD-3018A<br>Blood Pressure Monitor<br>provide intended to use<br>non-invasive measure the<br>systolic and diastolic<br>blood pressure and pulse<br>rate of an adult<br>individual, over age 18,<br>at home by using a non-<br>invasive technique in<br>which an inflatable cuff is<br>wrapped around the<br>wrist. The cuff<br>circumference is limited<br>to 5.25"~ 7.75". | The BPM 105 is equipped<br>with a transmitter to send<br>the measuring results to a<br>PC. |
| [02] | Target<br>population | Adults,<br>Lay users | Adults<br>Lay users | Equivalent |
| [03] | Measuring<br>principle | Oscillometric method | Oscillometric method | Equivalent |
| [04] | Type of results | Pressure: mmHg<br>Puls: beats/minute | Pressure: mmHg<br>Puls: beats/minute | Equivalent |
| [05] | Presentation of<br>results | LCD Digital Display | LCD Digital Display | Equivalent |
| [06] | Measurement<br>range | Pressure: 0 - 300 mmHg<br>Pulse: 40 - 199<br>beats/minute | Pressure: 0 - 300 mmHg<br>Pulse: 40 - 199<br>beats/minute | Equivalent |
| [07] | Measuring<br>accuracy | Pressure: ±3 mmHg<br>Pulse: ±5% of the value | Pressure: ±3 mmHg or<br>2% of reading<br>Pulse: ±4% of the reading | In the same area and<br>considered equivalent |
| | | Substantial Equivalent<br>Device | Predicate Devices | |
| | | Biocomfort tenso-<br>comfort BPM 105/ BPM<br>205 | TaiDoc Clever TD-3018A | Discussion of differences |
| [08] | Inflation | Automatic inflation | Automatic inflation | Equivalent |
| [09] | Deflation | Electric Valve | Electric Valve | Equivalent |
| [10] | Pressure<br>release | Automatic exhaust valve | Automatic exhaust valve | Equivalent |
| [11] | Pressure<br>detection | Piezo-resistive silicon<br>pressure transducer | Piezo-resistive silicon<br>pressure transducer | Equivalent |
| [12] | Measuring<br>period | App. 30 seconds | App. 20 seconds | Equivalent |
| [13] | Operation<br>environment | 10°C - 40°C<br>50°F - 104°F | 10°C - 40°C<br>50°F - 104°F | Equivalent |
| [14] | Storage<br>environment | -20°C - 60°C<br>-4°F - 140°F<br>10% - 95% relative<br>humidity | -20°C - 60°C<br>-4°F - 140°F<br>10% - 95% relative<br>humidity | Equivalent |
| [15] | Battery life | App. 300 measurements | App. 200 uses | Improved energy<br>management and<br>considered equivalent |
| [16] | Cuff size | 135mm - 220mm<br>5 ½ in - 8 ⅜ in | 135mm - 195mm<br>5 ¼ in - 7 ¾ in | Slightly larger cuff and<br>considered equivalent |
| [17] | Dimensions | 70 x 90 x 26 mm | 76 x 64 x 29 mm | Slightly different<br>dimension due to<br>corporate design. The<br>devices are considered<br>equivalent. |
| [18] | Weight | Ca. 140 g (without<br>batteries) | 132 g (with batteries) | Equivalent |
| [19] | Mobility | Hand-held | Hand-held | Equivalent |
| [20] | Memory<br>Capability | 110 measurements per<br>user (up to 8 users) with<br>date and time | 352 sets of reading with<br>date and time | Different number of<br>measurement due to the<br>user management.<br>It is considered<br>equivalent. |
| [21] | Power supply | Two 1.5 alkaline batteries<br>type AAA/LR03 | Two 1.5 alkaline batteries<br>type AAA/LR03 | Equivalent |
| [22] | Connectivity | Wireless interface with<br>2.4 GHz according to<br>IEEE802.15.4, with 10 m<br>indoor range | None | The model BPM 105<br>provides the option to<br>communicate via wireless<br>technology to a PC which<br>is set up for the interface<br>protocol |

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 [phone]. 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 [phone] or [phone] 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 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.

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