(15 days)
Not Found
No
The device description mentions "fuzzy logic" for regulating cuff pressure, which is a form of control system, not typically considered AI/ML in the context of modern machine learning algorithms. There are no mentions of AI, ML, DNN, or any related concepts in the provided text.
No.
The device is used for noninvasive measurement of blood pressure and heart rate, which is for diagnostic purposes, not for treating a condition or disease.
No.
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. This device measures blood pressure and heart rate, which are vital signs, but it does not interpret these measurements to diagnose a specific medical condition. It's for monitoring, not for diagnosing.
No
The device description explicitly lists hardware components such as an air pump, circuitry, a deflation-rate control valve, an LCD display, and an arm cuff.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the noninvasive measurement of blood pressure and heart rate. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device description details a sphygmomanometer that uses the oscillometric method to measure blood pressure from the brachial artery. This is a physical measurement process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the body). IVDs are designed to examine these samples to provide information about a person's health.
Therefore, the Nissei Model DS-1862 is a medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DS-1862 Digital Blood pressure Monitor is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. age 18 and above. The product is rccommended for use by patients capable of understanding written and/or oral directions in a home care environment.
Product codes (comma separated list FDA assigned to the subject device)
DXN, 74 DXN
Device Description
The Nissei Model DS-1862 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of. measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations; an electromagnetic deflation-rate control valve, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff. Operation: If occlusion of the systolic pulse is not achieved by initial pressurization, cuff pressure is automatically increased incrementally until a proper systolic measurement can be obtained. The device employs a pressure measurement algorithm designed to detect, filter, process, and store pressure readings. An eitor message is presented whenever improper measurement procedures might result in inaccurate readings. If cuff pressure starts to exceed 330 mmHg, cuff pressure is exhausted automatically and an error signal is presented. . Power: The Model DS-1862 is powered by four AA-size batteries. Power is shut down automatically if the unit remains idle for a period of approximately three minutes. An optional AC adaptor is also available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brachial artery in the arm
Indicated Patient Age Range
age 18 and above
Intended User / Care Setting
patients capable of understanding written and/or oral directions in a home care environment.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench and user testing indicate that the new device is as safe and effective as the predicate device.
After analyzing both bench and clinical testing data, it is the conclusion of Nissci that the "DS-1862" Digital Blood Pressure Monitor is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±3 mm Hg (cuff press.), ±5% of reading (pulse rate)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
EXHIBIT 2
510K Summary Nihon Seimitsu Sokki Co. Ltd (Nissei) 2508-13 Nakago, Komochi-Mura, Kitagunma-Gun, Gunma-Ken 377-0293, Tokyo, Japan Phone: +81-0279-20-2311 Fax: +81-0279-20-2411 Contact: I. Ishii, Chief Engineer
-
- Identification of the device Proprietary-Trade Name: Model DS-1862 Digital Blood Pressure Monitor Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Noninvasive Blood Pressure Measurement System
-
- Equivalent legally marketed devices This product is similar in function and design to predicate Nihon Seimitsu Sokki Co., Ltd. (Nissei) DS-181, K993890
-
- Indications for Use (intended use). The DS-1862 Digital Blood pressure Monitor is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients, i.e. age 18 and above. The product is rccommended for use by patients capable of understanding written and/or oral directions in a home care environment.
-
- Description of the Device The Nissei Model DS-1862 is an automatic sphygmomanometer intended for measurement, including self-measurement by the patient, of blood pressure and heart rate. The method of operation is the oscillometric method and the site of. measurement is the brachial artery in the arm. The system is microprocessor controlled and includes an air pump for automatic inflation; fuzzy logic to regulate opening cuff pressure, circuitry to detect and process minute pressure oscillations; an electromagnetic deflation-rate control valve, an eleven-digit LCD display of systolic and diastolic pressure readings and heart rate; a memory function that stores the thirty most recent measurement results for two patients plus the computed average of the stored readings; error displays, a standard arm cuff, and an optional large arm cuff. Operation: If occlusion of the systolic pulse is not achieved by initial pressurization, cuff pressure is automatically increased incrementally until a proper systolic measurement can be obtained. The device employs a pressure measurement algorithm designed to detect, filter, process, and store pressure readings. An eitor message is presented whenever improper measurement procedures might result in inaccurate readings. If cuff pressure starts to exceed 330 mmHg, cuff pressure is exhausted automatically and an error signal is presented. . Power: The Model DS-1862 is powered by four AA-size batteries. Power is shut down automatically if the unit remains idle for a period of approximately three minutes. An optional AC adaptor is also available.
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K040309
page 2 of 2
Safety and Effectiveness, comparison to predicate device 5.
The results of bench and user testing indicate that the new device is as safe and effective as the predicate device.
| Designation | Nihon Seimitsu Sokki Co., Ltd.
(Nissei) DS-181, K993890 | Nihon Seimitsu Sokki Co., Ltd.
(Nissei ) DS-1862 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Operating Principle | Oscillometric method | SAME |
| Indication for use | For the noninvasive
measurement of systolic and
diastolic blood pressure and
determination of heart rate in
adult patients, i.e. age 18 and
above. | SAME |
| Display | 7 Digit LCD | 11 Digit LCD |
| Measurement Range | Sys 50-250 mm Hg (cuff press.)
Dia 40 to 180 mm Hg
Pulse rate 40 to 160 pulse/min | SAME |
| Accuracy | ±3 mm Hg (cuff press.)
±5% of reading (pulse rate) | SAME |
| Cuff arm
circumference | 230 to 320 mm | 170 to 350 mm |
| Power supply | Four AA size batteries | SAME |
| External dimensions | 160mm W x 100mm D x 52mm H | 163mm W x 180mm D x 83mm H |
| Memory | 7 Measurement results,
Computation of the average of
stored data. | 30 Measurement results x 2,
Computation of the average of
stored data. |
| Weight | 265 g. w/o batteries | 420 g. w/o batteries |
6. Comparison matrix - new vs. Predicate device
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of Nissci that the "DS-1862" Digital Blood Pressure Monitor is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2004
Nihon Seimitsu Sokki Co. Ltd. c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O.Box 7007 Deerfield, IL 60015
K040309 Re:
Trade Name: Digital Blood Pressure Monitor, Model DS-1862 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: February 03, 2004 Received: February 09, 2004
Dear Mr. Kamm:
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 for too mated in the 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.
3
Page 2 -- Mr. Daniel Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read on as made a determination that your device complics with other requirements of the Act that I Drines intel to and regulations administered by other Federal agencies. You must or any I odotal blacked and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set SI It rate 877) stuces (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. product raction comror provide in (seting your device as described in your Section 510(k) I his letter will anow you to ought maing of substantial equivalence of your device to a legally premarket notification "The stassification 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 Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational 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,
some R. Williner
O Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Nissei Model DS-1862 Blood Pressure Monitor
For the noninvasive measurement of systolic and diastolic blood Indications For Use: Indications I of '000' - 1 viration of heart rate in adult patients, i.e. age 18 and above, in a pl essure and the december of understanding the inderstanding the instructions for use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
the contraction of the control of the country
Orang 2_lodine 1
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K04030 G
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