(121 days)
No
The description details a standard oscillometric blood pressure monitor using a mechanical valve and automatic shut-off, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not exert any direct therapeutic action on the user.
Yes
A diagnostic device is used to measure and display physiological parameters to aid in medical diagnosis. This device measures and displays systolic and diastolic blood pressure and pulse rate, which are physiological parameters used in diagnosing various health conditions.
No
The device description explicitly mentions hardware components such as an inflated cuff, air pump, mechanical valve, battery, and LCD display, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The SensaCare SAW-102 measures physiological parameters (blood pressure and pulse rate) directly from the body using a cuff and oscillometric method. It does not analyze any biological specimens.
The device description clearly states its function is to measure blood pressure and pulse rate by applying a cuff to the wrist and using the oscillometric method. This is a direct measurement of a physiological function, not an in vitro analysis of a specimen.
N/A
Intended Use / Indications for Use
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
Product codes
DXN
Device Description
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
SAW-102 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAW-102 turns off automatically.
SAW-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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)
Extensive functional and performance testing , and biocompatibility testing were conducted to assess the safety and effectiveness of the SensaCare SAW-102 Wrist Digital Blood Pressure Monitor . All results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
A&D UB-328 FDA 510K K040229
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
510K Summary
1. DATE PREPARED
NOV - 8 2006
December 10, 2005
2. SPONSOR INFORMATION
SensaCare Ltd. Chris Chan Room 1312, Sterling Centre, 11 Cheung Yue Street, Kowloon, HongKong Tel : 852-3571-8332 Fax :852-3571-8363 Email : chris@sensacare.com
3. DEVICE NAME
Proprietary Name : SensaCare SAW-102 Wrist Digital Blood Pressure Monitor
Common/Usual Name : Blood Pressure Monitor
Classification Name : Non-invasive Blood Pressure Measurement System 21CFR 870-1130, class II, 74DXN
4. DEVICE DESCRIPTION AND INTENDED USE
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
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5. PREDICATED DEVICE
It is substantially equivalent to the following device : A&D UB-328 FDA 510K K040229, issued on March 19, 2004
6. TECHNOLOGICAL CHARACTERISTECS
SAW-102 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAW-102 turns off automatically.
SAW-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
7. DEVICE TESTING
Extensive functional and performance testing , and biocompatibility testing were conducted to assess the safety and effectiveness of the SensaCare SAW-102 Wrist Digital Blood Pressure Monitor . All results are satisfactory.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2006
SensaCare Ltd. c/o Mr. Marc M. Mouser Senior Project Engineer, Program Reviewer Underwriters Laboratories Inc. 2600 NW Lake Road Camas, WA 98607
Re: K061935
Trade Name: The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 24, 2006 Received: October 26, 2006
Dear Mr. Mouser:
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.
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Page 2 - Mr. Marc M. Mouser
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,
Brand D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K061935
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The SensaCare SAW-102 Wrist Digital Blood Pressure Monitor is a hand held battery operated wrist type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) systolic pressure : 30 to 280 mmHg (2) diastolic pressure : 20 to 255 mmHg (3) heart rate : 20 to 255 times/minutes.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| (Division Sign-Off) | |
|---|---|
| DDVision of Cardiovascular Devices | |
| 510(k) Number | K061935 |
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