(145 days)
Empty
No
The description focuses on standard blood pressure monitoring technology and does not mention AI or ML.
No.
The device is strictly for measurement and monitoring, not for treating any condition. Its use is described as an "adjunct to medical management," implying it supports treatment but is not a treatment itself.
Yes
This device measures physiological parameters (blood pressure and pulse rate) and detects irregular pulse rhythm, which provides information used to aid in the diagnosis or treatment of a condition (hypertension, labile blood pressure, irregular pulse rhythm). It is indicated for use by patients with labile blood pressure or known hypertension as an adjunct to medical management.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device measures blood pressure and pulse rate directly from the patient's body using a cuff on the arm. It does not analyze any biological specimens.
The description clearly indicates a non-invasive measurement of physiological parameters, which falls outside the scope of In Vitro Diagnostics.
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 known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
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 LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm 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
self-measurement by the patient, adult patients in a homecare 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
Not Found
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
K07 1384
510(k) Summary
as required by 807.92
1. Company Identification
NIHON SEIMITSU SOKKI CO., LTD. (Nissei) 2508-13 Nakago, Shibukawa, Gunma 377-0293 Japan Tel: +81-279-20-2311 Fax: +81-279-20-2411
2. Official Correspondent
Hideki Tomaru (Mr.) Assistant Manager of International Sales Div.
3. Date of Submission May 16, 2007
- Device Trade name Model DS-1901 Digital Blood Pressure Monitor
5. Common/Usual Name
Blood Pressure Monitor
6. Classification Number
Class II, 74 DXN, 21 CFR 870. 1130 - Cardiovascular Devices Panel
7. Predicate Device
Manufacturer Trade Name .. Model 1901 Digital Blood Pressure Monitor : K050697 510(k) No. . .
8. Description of 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 LCD display of systolic and diastolic blood pressure readings, pulse rate and irregular pulse rhythm 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.
9. Indication 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 known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
10. Technical Characteristics
There is not a difference of intended use and technology characteristic between the subject device and any predicate device (K050697). The reason for 510(K) submission is to include detection and display of irregular pulse rhythm in the Indication for use Statement. This feature is already included in the predicate device. Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are equivalent in the areas of technical characteristics, general functions.
OCT - 9 2007
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1
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Appendix 1: Comparison Table with Predicate Device
| SUBJECT DEVICE | PREDICATE DEVICE: K050697 |
|---|---|
| Indications for use: | Indications for use: |
| Measurement of blood pressure and pulse rate | Measurement of blood pressure and pulse rate |
| adult patients | adult patients |
| Function to detect and display irregular pulse | |
| wave | |
| Method of measurement: | Method of measurement: |
| It is the same as the right | Oscillometric |
| Display of indications: | Display of indications: |
| It is the same as the right | 12-digit LCD: systolic, diastolic, pulse rate, |
| memory data number, 4 status | |
| clock - hour and minute | |
| Error Indications: | Error Indications: |
| It is the same as the right | Four, plus weak battery charge on status |
| indicator | |
| Range of pressure: | Range of pressure: |
| It is the same as the right | 0 to 300 mmHg |
| Range of measuring: | Range of measuring: |
| It is the same as the right | Systolic: 50 to 250 mmHg |
| Diastolic: 40 to 160 mmHg | |
| Pulse rate: 40 to 160 bpm | |
| Accuracy of measurement: | Accuracy of measurement: |
| It is the same as the right | Pressure: + /- 3 mmHg |
| Pulse rate: +/- 5% or reading | |
| Memory: | Memory: |
| It is the same as the right | 30 most recent systolic and diastolic |
| Reading plus average measured time | |
| Inflation: | Inflation: |
| It is the same as the right | Automatic by air pump |
| Deflation: | Deflation: |
| It is the same as the right | None |
| Exhaust: | Exhaust: |
| It is the same as the right | Automatic by EV |
| Operating Temperature and Humidity: | Operating Temperature and Humidity: |
| It is the same as the right | +10℃ to 40℃; 15 to 90% RH |
| Storage Temperature: | Storage Temperature: |
| It is the same as the right | -20℃ to +50℃; 15 to 90% RH |
| Cuff Size: | Cuff Size: |
| It is the same as the right | 142mm×580mm |
| (arm circumference range 230 to 460mm) | |
| Power: | Power: |
| It is the same as the right | 4×1.5-volt "AA" batteries, or 6VDC AC adaptor, |
| consumption 4.0 W (max.) | |
| Weight. Main unit: | Weight. Main unit: |
| It is the same as the right | Approx. 330 grams |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2007
Nihon Seimitsu Sokki Co. Ltd. c/o Mr. Koji Kubo Cosmos Corporation 3F, 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 JAPAN
K071384 Re: Trade/Device Name: Digital Blood Pressure Monitor, Model DS-1901 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 11, 2007 Received: September 13, 2007
Dear Mr. Kubo:
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.
3
Page 2 -- Mr. Koji Kubo
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 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 Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blyminmorfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number: K071384
Device Name: Model DS-1901 Digital Blood Pressure Monitor
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 known hypertension in a home care environment as an adjunct to medical management.
The device displays irregular pulse rhythm indication when it is detected during measurement.
× AND / OR Over-The-Counter Use Prescription Use_ ____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Per 21 CFR 801.109 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmmer
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