MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR

K050697 · Nihon Seimitsu Sokki Co., Ltd. · DXN · Mar 25, 2005 · Cardiovascular

Device Facts

• Record ID: K050697
• Device Name: MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Nihon Seimitsu Sokki Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.

Device Story

Automatic sphygmomanometer for home use by patients; measures systolic/diastolic blood pressure and pulse rate via brachial artery using arm cuff. Device includes air pump for automatic inflation, electric valve, and pressure oscillation sensors. Unlike predicate (deflation-based), this device measures during inflation. Features 'Personal mode' to determine inflation pressure based on historical data; includes arm circumference detection circuit to compensate measurements for 23-43 cm range. Output displayed on LCD; memory stores 30 readings with computed average. Healthcare providers use stored data to monitor hypertension or labile blood pressure trends, aiding clinical management decisions.

Clinical Evidence

Clinical performance and accuracy validated per ANSI/AAMI SP10-2002. Bench testing included electromagnetic compatibility and interference testing per IEC 60601-1-2 and associated IEC 61000 series standards.

Technological Characteristics

Automatic sphygmomanometer; brachial artery oscillometric sensing. Powered by 4 AA batteries or 6V AC adapter. Includes air pump, electric valve, and LCD. Features arm circumference detection circuit for 23-43 cm range. Software-based processing of pressure oscillations. Complies with ANSI/AAMI SP10-2002 and IEC 60601-1-2.

Indications for Use

Indicated for noninvasive measurement of systolic/diastolic blood pressure and pulse rate in adult patients (age 12+). Recommended for home use by patients with labile blood pressure or known hypertension as an adjunct to medical management.

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

• Nissei Model DS-181 Digital Blood Pressure Monitor (K993890)

Submission Summary (Full Text)

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#### SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address & Phone Number: Nihon Seimitsu Sokki., Co., Ltd. (Nissei) 2508-13, Nakago, Komochi-Mura Kitagunma-Gun, Gunma-Ken 377-0293, Japan [phone]

Submission Correspondent:

Lyle Howard Corporation 203 Main Street, 166 Flemington, NJ 08822 USA Attention: Lynette Howard 908-788-4580

Classification Name: Common / Usual Name: Proprietary Name:

Noninvasive Blood Pressure Monitor Blood Pressure Monitor Model DS-1901 Digital Blood Pressure Monitor

Establishment Registration Number: 9610827

Classification: Class II, Reg. # 870.1130, DXN, Cardiovascular Devices Panel

Performance Standards: Sections 898 and 1010 of the Federal Food, Drug and Cosmetic Act

Substantial Equivalence:

The legally marketed device to which substantial equivalence will be demonstrated is the Nissei Model DS-181 Digital Blood Pressure Monitor. This device was cleared for marketing under 510(k) No. K993890, SE decision December 3, 1999.

The subject device is essentially an updating of the predicate device. As can be seen in Appendix S, many of the features and performance specifications are identical. Note particularly that both systems contain a built-in air pump for automatic cuff inflation. have the same measurement accuracy for both blood pressure and pulse rate, are powered by four "AA" batteries, and include an optional AC adaptor.

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The principal differences are that the new DS-1901 includes the circuit detecting arrr circumference and the algorithm revising it to compensate the measurement result and to embody the application of a cuff to arm with circumference of 23 to 43 cm, which the predicate device DS-181 did not and that while the predicate device takes blood pressure measurement during deflation, the subject device takes measurement during inflation. "Personal mode", which determines inflation value from past measurements, is employed with new device. The clock function is also added to the subject device.

Because the difference between the subject device and the predicate device represent functional improvements that have been evaluated through both bench testing and clinical evaluation, it is clear that these changes raise no new questions with respect to either safety or effectiveness.

## Testing conducted or standards applied to assure safety and effectiveness includes but is not limited to:

Clinical Performance and Accuracy: ANSI/AAMI Standard SP10-2002, Electronic or Automated Sphygmomanometers, approved October 28, 2002.

Electromagnetic Compatibility: IEC 60601-1-2, 2001 with test procedures according to IEC 61000-4-2, 2001; IEC 61000-4-3, 2001; IEC 6100-4-4, 2001 with Amendment 1, 2000 and Amendment 2,2001; IEC 6100-4-6, 2001; IEC 61000-4-8, 2001; IEC 61000-4-11. 2001.

Electromagnetic Interference: IEC 60601-1-2, 2001.

#### Description of the new device:

The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of systolic and diastolic blood pressure and pulse rate in adult patients in a homecare environment. Blood pressure is measured in the brachial artery using an arm cuff of the appropriate size. The unit includes an air pump for automatic cuff inflation, an electric valve, pushbutton controls, circuitry to detect and process minute pressure oscillations, an I.CD display of systolic and diastolic blood pressure readings and pulse rate, a wide-ranged arm cuff and a carrying case. The memory circuit stores the thirty most recent readings plus the computed average of the stored readings, which will be retained after power turn-off or battery removal and can be intentionally deleted. The system is powered by four AA-size batteries or, optionally, by a 6V AC adapter.

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### Intended Use:

The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.

### Safety and Efficacy Information:

The DS-1901 Blood Pressure Monitors are well recognized as being safe and effective for the stated intended use. The Nihon DS-1901 Blood Pressure Monitors have the same operating principals and intended uses as the predicate Blood Pressure Monitor systems already in commercial distribution.

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Public Health Service

MAR 2 5 7005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nihon Seimitsu Sokki, Co., Ltd. (Nissei) c/o Dr. J. A. van Vugt KEMA Quality B.V. Utrechtseweg 310, 6812 AR Arnhem P.O. Box 5185, 6802 ED Arnhem THE NETHERLANDS

Re: K050697

K050077
Trade Name: Model DS-1901 Digital Blood Pressure Monitor -Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 17, 2005 Received: March 18, 2005

Dear Dr. van Vugt:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substantially interests a for use stated in the enclosure) the device interest predicate devices marketed in interstate for use stated in the encrosule) to regary manetoe province Amendments, or to commerce prior to May 28, 1776, the enactions of the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of capliation devices that have been recarsined in acceraance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merelore, market the device, beginer is for annual registration, listing of general controls provisions of the Hereas Capital of Childrens against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on Wa may be subject to suell additional combolis of the 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

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Page 2 – Dr. J. A. van Vugt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a backer complies with other requirements of the Act that I DA has made a actorinations administered by other Federal agencies. You must of ally it edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 3 requirements, not, good manufacturing practice requirements as set CFR I art 807), fabeling (21 OF R Part 820); and If applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation control pro herems (we wice as described in your Section 510(k) This letter with anow you to ogin mantoung your and equivalence of your device to a legally premaired notification: The PDA mailing of casting 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 If you desire specific advice ion your as [phone]. Also, please note the regulation entitled, contact the Office of Compunation in (21 m) (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Zimmerman 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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# Indications for Use

510(k) Number (if known):

Model DS-1901 Digital Blood Pressure Monitor Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or know hypertension in a home care environment as an adjunct to medical management.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Ammerman
Division Sign Off

Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_ 050697

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