BRAUN PRECISION SENSOR PRO, MODEL BP 2590

K012035 · Braun GmbH · DXN · Jul 27, 2001 · Cardiovascular

Device Facts

• Record ID: K012035
• Device Name: BRAUN PRECISION SENSOR PRO, MODEL BP 2590
• Applicant: Braun GmbH
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Braun PrecisionSensor™ Pro (BP2590) is intended to be used for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults in a professional environment.

Device Story

Non-invasive wrist blood pressure monitor; uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Designed for professional medical environments (clinics, hospitals, nursing homes). Operated by healthcare professionals. Device features reconfigured display and memory compared to predicate; utilizes higher-grade Velcro cuff closure for professional durability. Visual indicators include black cuff and silver housing to distinguish from home-use models. Output displayed on monitor for clinician review to assist in hypertension screening and management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarity to the predicate device.

Technological Characteristics

Oscillometric measurement principle. Wrist-worn form factor. Materials include higher-grade Velcro for cuff closure. Device is a standalone monitor. No specific software algorithm class or connectivity standards mentioned.

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adults in professional medical environments (clinics, hospitals, etc.) as part of hypertension screening, monitoring, or management programs supervised by a healthcare provider.

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

• Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor

Submission Summary (Full Text)

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# UUL 2 7 2001

### 510(k) Summary

# Special 510(k) Summary of Safety and Effectiveness

### Company information

Braun GmbH Frankfurter Strasse 145 D-61476 Kronberg Germany

### Device Identification

Trade Name - Braun PrecisionSensor™ Pro (BP2590) Classification Name - Wrist blood pressure monitor Classification - Class II Product Code - 74 DXN

### Predicate Device

Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor.

### Device Description

The PrecisionSensor Pro is a non-invasive wrist blood pressure monitor that measures and displays systolic and diastolic blood pressure, and pulse rate. The values are ascertained by the oscillometric method.

#### Intended Use

The PrecisionSensor™ Pro (BP2590) is intended to be used for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults in a professional environment.

### Intended Patient Population

Adults are the intended patient population to use this device.

# 09 001

KO12035

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### Intended Environment of Use

The intended environment of use is in professional medical environments (e.g., The intonous offices, clinics, nursing homes, hospitals) where blood pressure may be measured.

### Indications for Use

The Braun PrecisionSensor™ Pro (BP2590) wrist blood pressure monitor is indicated for use for the noninvasive measurement of blood pressure (systolic indidiastolic) and pulse rate in adults, in a professional environment. Use may and diaololio, and part of a hypertension screening, monitoring, and/or management program supervised by a healthcare provider.

## Comparison of the Braun PrecisionSensor™ Pro (BP2590) wrist blood onmanson of the Braun PrecisionSensor™ (BP2000 Series) wrist blood pressure monitor.

The basic design, intended use, and indications for use of the Braun PrecisionSensor Pro (BP2590) and the Braun PrecisionSensor™ (BP2000 Series) are similar . The fundamental scientific technology of the modified device has not changed from that of the predicate device.

The primary changes in the modified design of the Braun PrecisionSensor Pro (BP 2590) consist of reconfiguring the display and memory, and using a higher grade of Velcro for the cuff closure to make it robust for use in a professional environment while the predicate device, the Braun PrecisionSensor (BP2000 Series), is indicated for use in a home environment. To visually distinguish the oofessional use blood pressure monitor from the home use monitor, the color of the Velcro cuff was changed from blue to black and the monitor housing was changed from blue or white to silver.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2001

Braun GmbH c/o Mr. Fred Schlador Regulatory Resources, LLC 6183 Paseo Del Norte, Suite 150 Carlsbad, CA 92009

Re: K012035

Trade Name: Braun PrecisionSensor™ Pro, Model BP 2590 Regulatory Number: 21 CFR 870.1130 Regulatory Class: II (two) Product Code: 74 DXN Dated: June 28, 2001 Received: June 29, 2001

Dear Mr. Schlador:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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### Page 2 - Mr. Fred Schaldor

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. The I Drice 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 and If you desire specific active ro first diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 10 millionally, for questions on the promotion and advertising of your device, (201) 594-46. Truchionally, 201 quest at [phone]、Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsive at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

DaKi Teth
L. Lee F. Dill, III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number: K012035

Device Name:

PrecisionSensor™ pro (BP2590) Wrist Blood Pressure Monitor

Indications for Use:

The Braun PrecisionSensor Pro (BP2590) wrist blood pressure monitor is The Braun Procloionsonsoninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a professional use (Systollo and diacters) ane initiated as part of a hypertension screening, environinent: 600 may agement program supervised by a healthcare provider.

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Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109 OR

Over the Counter √

Division of Cardiovascular & Respiratory Devices
510(k) Number K012035

03 002