(36 days)
Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14"(23cm to 36cm).
Models FT-500 and FT-700 of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. Models FT-500 and FT-700 employ oscillometric method. All models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and push button controls.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study for Jawon Medical FT-500(R,L) and FT-700(R,L) Noninvasive Blood Pressure Measurement System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that the measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002 and was "found to comply fully with the accuracy criteria established in the standard."
However, the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ANSI/AAMI SP10-2002 are not explicitly detailed in the provided text. The text only states that the device complies with the standard.
To illustrate, typical ANSI/AAMI SP10 criteria for accuracy usually involve:
- Mean difference: The absolute mean difference between the device reading and the reference standard should typically be less than or equal to 5 mmHg.
- Standard deviation: The standard deviation of the difference between the device reading and the reference standard should typically be less than or equal to 8 mmHg.
Since the document doesn't provide the exact numerical performance metrics of the device against these criteria, the table below reflects what is stated in the document.
| Acceptance Criteria (Based on ANSI/AAMI SP10-2002) | Reported Device Performance |
|---|---|
| Full compliance with accuracy criteria | Complies fully |
Note: Without the explicit numerical criteria from ANSI/AAMI SP10-2002 and the specific performance data from the study, a more detailed table is not possible based on the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of subjects/measurements) used in the clinical studies. It only mentions "clinical studies."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the studies were "conducted in accordance with ANSI/AAMI Standard SP10-2002."
3. Number of Experts and Their Qualifications for Ground Truth
- The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood pressure measurement, ground truth typically involves a trained observer (often a physician or specially trained technician) using a mercury sphygmomanometer with a stethoscope in a double-blinded fashion according to a standardized protocol.
4. Adjudication Method for the Test Set
- The document does not provide any information on the adjudication method used for the test set. In clinical blood pressure validation studies, ground truth is often established by multiple trained observers, and if there are discrepancies, a third observer might adjudicate. However, this is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study information is provided. The device is a non-invasive blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not applicable in this context.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The "measurement performance of the Jawon systems has been evaluated in clinical studies" directly assesses the algorithm's accuracy in measuring blood pressure against a reference standard. This is inherently a standalone performance evaluation of the device's core function.
7. Type of Ground Truth Used
- Based on the statement "evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002," the ground truth used would be simultaneous, direct auscultatory blood pressure measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer) in a clinical setting. ANSI/AAMI SP10 is a standard for verifying the accuracy of automated sphygmomanometers, which involves comparing the device's readings against validated manual measurements.
8. Sample Size for the Training Set
- The document does not provide information on the sample size for the training set. For established medical devices like blood pressure monitors, the "training" of the internal algorithm is often a part of the initial design and development process, which may not involve a separate "training set" in the same way machine learning models do. If the device uses machine learning, this information is not disclosed.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for any training set was established. As with the training set sample size, this information is not disclosed in the provided text.
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Model FT-500(R,L), Model FT-700(R,L) NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
1. COMPANY INFORMATION.
Name : Jawon Medical Co., Ltd. Address : 1208-12, Sinsang-Li, Jinryang-Eup, Kyungsan-City, Kyungsang-Bukdo, Korea Phone : 82-53-856-0933 Contact : Mr. J.H.CHO , Senior Engineer, R&D Center
2. DEVICE IDENTIFICATION.
Trade Name : Models FT-500 and FT-700 Automatic Blood Pressure Monitor Classification Name : Noninvasive Blood Pressure Measurement System, 74 DXN
3. PREDICATE DEVICE.
A&D Model TM-2650 Automatic Blood Pressure Meter K895429. SE decision 11/28/89
4. DEVICE DESCRIPTION.
General: Models FT-500 and FT-700 of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. Models FT-500 and FT-700 employ oscillometric method. All models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and push button controls.
Operation: The subject device employs a pressure measurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy.
Power: Models FT-500 and FT-700 are AC line powered.
5. INTENDED USES.
Models FT-500 and FT-700 of the Jawon system are intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or ofder and arm circumference range between 9" to 14" (23cm to 36cm).
6. COMPARISON WITH PREDICATE DEVICE.
Models FT-500 and FT-700 of the Jawon device have compared with model of the predicate device, the A&D Automatic Blood Pressure Meter. The intended use of two system is the same. The principle of operation and many operating features are identical. Both the subject device and the predicate device include models in which the control and display console and the cuffs are
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constructed as a single unit. All models of the predicate device and Models FT-500 and FT-700 of the subject and predicate devices incorporate a thermal printer.
7. PERFORMANCE DATA
The measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002 and found to comply filly with the accuracy criteria established in the standard. Non-clinical tests of ANSI/AAMI SP10-2002 were conducted with satisfactory results. Safety testing according to EN60601-1 was conducted by Safety Compliance Ltd and the device fulfills the requirements. Similarly, electromagnetic compatibility studies have been conducted by EMC Compliance Ltd. and found to comply with international standards EN60601-1-2. Software verification and validation have been performed certified. It is concluded that the subject device complies with all relevant safety and performance standards.
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Image /page/2/Picture/1 description: The image shows a stylized drawing of an eagle. The eagle is facing to the right, and its wings are spread. The eagle's head is turned to the left, and its beak is open. The eagle is drawn in black and white, and the background is white. The eagle is a symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
تاريخ ۾ ها ۾ انلاد
Jawon Medical Co., Ltd. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 2501 Street NW Buffalo, MN 55313
Re: K062462
Trade Name: Models FT-500 and FT-700 Automatic 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: September 14, 2006 Received: September 15, 2006
Dear Mr. Job:
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. Mark Job
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.
Sincerely yours,
B. Hammer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kc 62442
Indications for Use
510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
Device Name: Noninvasive Blood Pressure Measurement System Models FT-500(R,L), FT-700(R,L)
Indications For Use:
Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14"(23cm to 36cm).
Prescription Use_
AND/OR
Over-The-Counter Use X
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Brummer
§ 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).