(15 days)
Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 15 and above, in a home care environment.
Both models of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. All measurements are performed using the oscillometric method. The display unit and the measurement cuff are interconnected by tubing. Both models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitty to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and pushbutton controls. Model HD-2000F includes a memory function.
The provided 510(k) summary for the Jawon Medical Co., Ltd. Models HD-1000S and HD-2000F Noninvasive Blood Pressure Measurement System outlines the acceptance criteria and the study conducted to prove the device meets these criteria.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measurement Accuracy: Compliance with the accuracy criteria established in ANSI/AAMI Standard SP10-1992 for noninvasive blood pressure monitoring. | The measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992 and found to comply fully with the accuracy criteria established in the standard. |
| Safety Testing (Electrical Characteristics): Evaluation of electrical characteristics of the system and components. | Conducted by Underwriters Laboratories with satisfactory results. |
| Safety Testing (Environmental Integrity): Evaluation of environmental integrity under various operating and storage conditions. | Conducted by Underwriters Laboratories with satisfactory results. |
| Safety Testing (Resistance to Vibration and Shock): Evaluation of resistance to vibration and shock. | Conducted by Underwriters Laboratories with satisfactory results. |
| Electromagnetic Compatibility (EMC): Compliance with international standards for electromagnetic compatibility. | Conducted by ONETECH Testing & Evaluation Laboratories and found to comply with international standards. |
| Software Verification and Validation: Performance of software verification and validation. | Performed. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- The document states "clinical studies" were conducted. However, it does not specify the exact sample size (number of patients or measurements) used for the clinical test set.
- Regarding data provenance, the document does not explicitly state the country of origin or whether the studies were retrospective or prospective. However, clinical studies conducted for regulatory approval are almost always prospective.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical studies. For blood pressure monitors, ground truth often involves comparison to a reference standard method (e.g., auscultation by trained observers) rather than expert consensus on images.
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Adjudication Method for the Test Set:
- The document does not specify any adjudication method used for the test set. For blood pressure devices compliant with ANSI/AAMI SP10, the standard defines the methodology for comparison and statistical analysis against a reference method.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret images. For a non-invasive blood pressure measurement system, the "reader" is the device itself, and the comparison is against an established reference measurement method.
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Standalone Performance:
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for the primary measurement accuracy. The clinical studies evaluated the device's ability to measure blood pressure against a reference method. The device's operation is automatic and relies solely on its internal algorithm to determine blood pressure readings.
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Type of Ground Truth Used:
- The implied ground truth for the blood pressure measurement accuracy is comparison to a reference standard, likely auscultation. The ANSI/AAMI SP10-1992 standard typically dictates that the device's readings are compared against simultaneous measurements taken by trained observers using a validated reference method (e.g., mercurial sphygmomanometer with a stethoscope) to establish accuracy.
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Sample Size for the Training Set:
- The document does not provide information on the sample size used for any training set. This is a regulatory filing for a medical device; while algorithm training is a prerequisite, the filing focuses on the validation of the final device.
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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.
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510(k) SUMMARY
K 983855
MODELS HD-1000S AND HD-2000F NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
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- COMPANY INFORMATION. Name: Jawon Medical Co., Ltd. Address: 2F Seoil B/D, #1451-74, Seocho-Dong, Seocho-Ku, Seoul 137-070, Korea (011) 82-2-587-4056 Contact: Mr. J. N. Kim, Manager Phone:
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- DEVICE IDENTIFICATION. Trade Name: Models HD-1000S and HD-2000F Fuzzy Type Digital Blood Pressure Monitor Common Name and Classification Name: Noninvasive Blood Pressure Measurement System, 74 DXN
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- PREDICATE DEVICE. A&D Model TM-2650 Automatic Blood Pressure Meter, K895429, SE decision 11/28/89.
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- DEVICE DESCRIPTION. General: Both models of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. All measurements are performed using the oscillometric method. The display unit and the measurement cuff are interconnected by tubing. Both models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitty to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and pushbutton controls. Model HD-2000F includes a memory function.
Operation: The subject device employs a pressurement 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 mmHz/sec to optimize measurement accuracy.
Power: Both models are powered by four AA-size batteries and contain an indicator to alert the operator when battery charge is weak.
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- INTENDED USES. Models HD-1000S and HD-2000F are intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients. Because they are recommended for use in a home care environment, both models are intended to be used by patients capable of understanding written and/or oral directions.
- COMPARISON WITH PREDICATE DEVICE. The two models of the Jawon device have been compared with the A&D Automatic Blood Pressure Meter, Model TM-2650, The intended use of the two systems is the same. The principle of operation (oscillometric measurement) and many operating features are identical. The only substantive difference between the subject and predicate devices is that the predicate device incorporates a thermal printer and the subject device does not. It is concluded that there are no technologic differences between the subject and predicate devices that raise new questions concerning either safety or effectiveness.
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- PERFORMANCE DATA. The measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-1992 and found to comply fully with the accuracy criteria established in the standard. Safety testing including electrical characteristics of the system and components, environmental integrity under various operating and storage conditions, and resistance to vibration and shock was conducted by Underwriters Laboratories with satisfactory results. Similarly, electromagnetic compatibility studies have been conducted by ONETECH Testing & Evaluation Laboratories and found to comply with international standards. Software verification and validation have been performed. It is concluded that the subject device complies with all relevant safety and performance standards.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by a series of curved lines.
NOV 17 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAWON Medical Co., LTD. c/o Carole Stamp Third Party Official TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891
Re : K983855 Noninvasive Blood Pressure Measurement System Models HD-1000S and HD-2000F Requlatory Class: II (Two) Product Code: 74 DXN October 29, 1998 Dated: Received: October 30, 1998
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions,
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Page 2 - Ms. Carole Stamp
or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
DA Spyk
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological. Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Noninvasive Blood Pressure Measurement System Models HD-1000S and HD-2000F
ﻪ
Indications For Use:
Noninvasive measurement of systolic and diastolic blood pressure and heart rate in adult patients, i.e., age 15 and above, in a home care environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette L Kemper a
(Division Sign-Off) Division of Ordiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use رسما
・・・・・・・・・・・・
§ 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).