(121 days)
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.
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. 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.
The provided text describes a 510(k) summary for the SensaCare SAA-102 Arm Type Digital Blood Pressure Monitor. However, the document does NOT contain a detailed study with acceptance criteria and device performance results in the format requested.
The document states:
- "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." (Section 7)
- It refers to the device being "substantially equivalent" to a predicate device (A&D UA-779PC, FDA 510K, K993888).
This suggests that the SensaCare SAA-102 did not undergo an independent clinical study to establish its performance against specific acceptance criteria, but rather demonstrated substantial equivalence to a previously approved device. Therefore, I cannot fill out the requested table and answer the study-specific questions based on the provided text.
The information I can extract directly related to device characteristics (not performance data from a specific study) is:
1. Table of Acceptance Criteria and Reported Device Performance
- No specific acceptance criteria or reported device performance from a dedicated study are provided in this document. The submission relies on substantial equivalence to a predicate device.
- The document mentions the measuring ranges for the device:
- Systolic pressure: 30 to 280 mmHg
- Diastolic pressure: 20 to 255 mmHg
- Heart rate: 20 to 255 times/minutes
2. Sample size used for the test set and the data provenance
- Not applicable / not provided in the document. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / not provided in the document.
4. Adjudication method for the test set
- Not applicable / not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / not provided in the document. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / not provided in the document. The document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / not provided in the document.
8. The sample size for the training set
- Not applicable / not provided in the document.
9. How the ground truth for the training set was established
- Not applicable / not provided in the document.
In summary, the provided 510(k) summary does not contain the details of a performance study with acceptance criteria for the SensaCare SAA-102. It instead establishes substantial equivalence to a predicate device (A&D UA-779PC, K993888). To get the detailed performance data, one would need to refer to the substantial equivalence documentation for the predicate device, or a full submission document if it contained specific performance testing.
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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
Page 2-2
Page 1 of
KO7008615
§ 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).