(49 days)
The Clever TD-3018A Blood Pressure Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
The CLEVER TD-3018A™ Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and wrist cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the CLEVER TD-3018A™ Blood Pressure Monitor:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Conformance to SP10 Standard | The device met the criteria in the SP10 standard for both non-clinical and clinical tests. | The SP10 standard is the relevant consensus standard for automated sphygmomanometers. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the clinical test set.
The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. For blood pressure monitors, ground truth is typically established by comparing the device's readings against a "reference" blood pressure measurement, often taken by trained observers using a mercury sphygmomanometer, not by "experts" in the typical AI sense.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. For blood pressure monitors, adjudication methods usually refer to how multiple reference measurements are handled, e.g., averaging across multiple observers or repeat measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described. This type of study is more relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. The CLEVER TD-3018A™ is a medical device for direct physiological measurement, not an AI-powered diagnostic tool requiring human interpretation comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone blood pressure monitor that measures blood pressure using the oscillometric method. The clinical performance study described would inherently be a standalone performance evaluation of the device without human-in-the-loop assistance in the sense of a machine learning algorithm providing interpretations to clinicians. The "human-in-the-loop" for a blood pressure monitor would be the user initiating the measurement and reading the display, not an interpretive process.
7. Type of Ground Truth Used
The ground truth used for validating the device's performance against the SP10 standard would be reference blood pressure measurements. While not explicitly stated, the SP10 standard typically requires simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., mercury sphygmomanometer) against which the automated device's readings are compared.
8. Sample Size for the Training Set
The concept of a "training set" as it applies to machine learning algorithms is not applicable here. The TD-3018A™ Blood Pressure Monitor uses fundamental principles of oscillometric measurement, not a trained machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of medical device in the AI sense. The device's underlying algorithm is based on established oscillometric principles and calibration, not on learning from a dataset.
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KD51703
510(k) Summary
Submitter's Information
| Submitter's Name: | TaiDoc Technology Corporation |
|---|---|
| Contact person: | Shu-Mei Wu, Ph.D. |
| Address: | 4F, No. 88, Sec. 1, Kwang-Fu Rd.,San-Chung, Taipei County, Taiwan |
| Phone: | +886-2-66358080 |
| Fax: | +886-2-66355959 |
| E-mail: | shumei@taidoc.com.tw |
| Date Prepared: | June 21, 2005 |
1. Device
Trade Name: CLEVER TD-3018A™ Blood Pressure Monitor. Common Name: Noninvasive Blood Pressure Measurement System Classification Name: blood pressure monitor : Class II devices, 21 CFR 870.1130
Product Code: DXN
2. Predicate Device
Trade /Proprietary Name: APM Blood Pressure Monitor, BP108A Common Name: Noninvasive Blood Pressure Measurement System Classification Name: blood pressure monitor
Class II devices, 21 CFR 870.1130
Manufacturer: Asia Pacific Microsystems, Inc. 510 (k) Number: K040159
3. Device Description
The CLEVER TD-3018A™ Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall
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memory button, and wrist cuff. The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
4. Intended Use
The intended use of CLEVER TD-3018A™ Blood Pressure Monitor is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the wrist of the subject.
5. Technology Characteristics Comparison
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
6. Non-clinical Performance
The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.
7. Clinical Performance
As the predicate device, the clinical test results of the TD-3018A showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.
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- Conclusions
:
The CLEVER TD-3018A Blood Pressure Monitor demonstrates satisfactory performance and is suitable for its intended use.
:
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of the HHS symbol, which is a stylized representation of three human profiles, along with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The symbol and text are in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2005
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Tai Doc Technology Corporation c/o Mr. Shu-Mei Wu Project Manager 4F No. 88, Sec1 Kwang-Fu Rd Taipei County, Taiwan
Re: K051703
Trade Name: Clever T-D 3018A Blood Pressure Monitor Regulation Number: 21 CFR 870. 1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 22, 2005 Received: June 24, 2005
Dear Mr.Wu:
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. Shu-Mei Wu
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) 276-0295. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B. Sommer for
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
1761703 510(k) Number:
Device Name: Clever TD-3018A Blood Pressure Monitor
Indications For Use:
The Clever TD-3018A Blood Pressure Monitor provide intended to use non-invasive measure the systolic and diastolic blood pressure and pulse rate or an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)
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(División Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051703
§ 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).