(7 days)
Not Found
No
The description details standard blood pressure measurement technology using pressure oscillation detection and basic memory functions, with no mention of AI or ML terms or capabilities.
No.
The device is intended for noninvasive measurement of blood pressure and pulse rate, not for treating a condition. It serves as an adjunct to medical management, meaning it aids in monitoring but does not provide therapy itself.
Yes
The device is intended for "noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate" and for use by "patients with labile blood pressure or known hypertension," which indicates its use in diagnosing or monitoring a medical condition.
No
The device description explicitly lists hardware components such as an air pump, electric valve, pushbutton controls, circuitry, LCD display, arm cuff, and carrying case.
Based on the provided information, the DS-1901 system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DS-1901 Function: The DS-1901 system measures blood pressure and pulse rate noninvasively using an arm cuff. It does not analyze samples taken from the body.
The device is a noninvasive medical device used for physiological measurement.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachial artery
Indicated Patient Age Range
age 12 and above.
Intended User / Care Setting
Homecare environment, for measurement, including self-measurement by the patient.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 +81-0279-20-2311
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.
1
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.
2
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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle or bird symbol with three curved lines representing its wings or feathers.
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.
4
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
5
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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