(121 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is stated to be used for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device measures systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly details hardware components like an inflated cuff, air pump, mechanical valve, and LCD display, indicating it is a physical medical device, not software-only.
No, this device 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.
- Device function: The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor measures blood pressure and pulse rate directly from the body (on the arm) using a physical method (oscillometric). It does not analyze samples taken from the body.
Therefore, based on the provided information, the SensaCare SAA-102 is a medical device, but it falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is a hand held battery operated arm type blood pressure monitor which is intended for use by adults (age 18 or older) 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.
SAA-102 uses an inflated cuff which is wrapped around the upper arm. 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 and The pressure of the cuff is completely released automatically at the end w the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAA-102 turns off automatically.
SAA-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper arm
Indicated Patient Age Range
adults (age 18 or older)
Intended User / Care Setting
Over-The-Counter Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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K070086151 7 (1 -
510K Summary
MAY 1 0 2007
1. DATE PREPARED
June 20, 2006
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 SAA-102 Arm Type Digital Blood Pressure Monitor
Common/Usual Name : Blood Pressure Monitor
Classification Name : Non-invasive Blood Pressure Measurement System 21CFR 870.1130, DXN
4. DEVICE DESCRIPTION AND INTENDED USE
The SensaCare SAA-102 Arm Type 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 UA-779PC FDA 510K, K993888, issued on December 20, 1999
6. TECHNOLOGICAL CHARACTERISTECS
SAA-102 uses an inflated cuff which is wrapped around the upper arm. 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 and The pressure of the cuff is completely released automatically at the end w the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, SAA-102 turns off automatically.
SAA-102 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
7. SUMMARY INCLUDING CONCLUSION DRAWN FROM CLINICAL TESTS
When compared to the predicate device, SAA-102 does not incorporate any significant changes in the intended use, method of operation, material or design that could affect safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the wings or feathers. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUV America, Inc. c/o Mr. Stefan Preiss 1175 Old Highway 8 NW, Suite 104 New Brighton, MN 55112
MAY 1 0 2007
Re: K070086
Trade/Device Name: MedilogAR4 and MedilogAR12 Digital Holter Recorders Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: DSH Dated: March 22, 2007 Received: March 26, 2007
Dear Mr. Preiss:
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 (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 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.
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
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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 continue 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) 276-4008. 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/dsma/dsmamain.html
Sincerely yours,
Blymmermonfr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor is a hand held battery operated arm type blood pressure monitor which is intended for use by adults (age 18 or older) 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 Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hummerston
(Division Sign-Off Division of Cardlovascular Devices 510(k) Number
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KO7008615