(63 days)
Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or order and arm circumference range between 9" to 14" (23cm to 36cm).
The EASY X 800 (R/L) and EASY 900 (R/L) are blood pressure monitors to non-invalied. The devices of The EAST X 600 (102) and EXS P 500 (102) The devices employ oscillometric method. The devices are airsuing microprocessor-controlled and include an air pump, an electronic valve to regulate deflation and controlled of microprocessor-controlled and included and in and in and in the many of LCD(EASY X 900) display of systolic and diastolic pressure readings and heart rate, and push buttons. Systom and dastone proboard roading of the designed to detect, filter, filter, process, and store The devices employ a probation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EASY X 800 (R/L) and EASY X 900 (R/L) are AC adapter-powered.
The Jawon Medical Automatic Blood Pressure Monitor, Models EASY X 800 (R/L) & EASY X 900 (R/L), is intended for 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).
The device's acceptance criteria and performance are based on compliance with the ANSI/AAMI SP10 standard. The submission indicates that the modified devices (EASY X 800 (R/L) and EASY X 900 (R/L)) were deemed substantially equivalent to the predicate devices (FT-500 (R/L) and FT-700 (R/L)) due to similarities in intended use, technology, and software/pressure detection hardware. No new clinical trials were conducted for the modified devices.
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10 Compliance | The modified devices EASY X 800 (R/L) and EASY 900 (R/L) are stated to meet the requirements of ANSI/AAMI SP10, IEC 60601-1-2, and EN 60601-1. |
Note: The document only specifies compliance with standards as the acceptance criteria, and the reported performance is the device meeting these standards. Specific numerical performance metrics (e.g., mean difference and standard deviation between device and reference measurements) as typically found in AAMI validation studies are not explicitly detailed in this summary, but are implicitly met if the device complies with the standard.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The modified devices... are not clinically tested because the devices use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This implies that no new test set was used for the modified devices for clinical performance evaluation. The substantial equivalence relies on the established performance of the predicate devices. The document does not provide details of the predicate device's test set or data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no new clinical testing was performed for the modified devices, this information is not applicable to the current submission for the EASY X 800 (R/L) & EASY X 900 (R/L) devices. The ground truth for the predicate devices would have been established through clinical validation studies, likely involving trained healthcare professionals, but these details are not provided in this summary.
4. Adjudication Method for the Test Set
Since no new clinical testing was conducted for the modified devices, the adjudication method for a new test set is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No (N/A). This type of study investigates the improvement of human readers with AI assistance. The device in question is an automatic blood pressure monitor, which does not involve human readers interpreting images or data for diagnosis, therefore, an MRMC study is not relevant.
6. Standalone Performance Study
Yes, implied. The statement "The modified devices... meet the requirements of ANSI/AAMI SP10, IEC 60601-1-2, and EN 60601-1" suggests that the standalone performance of the device (or its predicate) was evaluated against these recognized standards for automated sphygmomanometers. ANSI/AAMI SP10 outlines requirements for accuracy of automated blood pressure devices compared to a reference standard. However, detailed results of such a standalone study for the modified devices are not provided, as they relied on the predicate's performance.
7. Type of Ground Truth Used
For blood pressure monitors, the "ground truth" for clinical validation (as required by standards like ANSI/AAMI SP10) is typically established using simultaneous auscultatory measurements by trained observers (experts) using a mercury sphygmomanometer or another validated reference method. This is the standard method for establishing the accuracy of automated blood pressure devices.
8. Sample Size for the Training Set
The document explicitly states that the modified devices use "identical software codes and pressure detection related hardware as the predicate devices." This means there was no separate training set for algorithm development for these modified devices, as the algorithm was already developed and validated with the predicate devices. The details of the training set (if any, as traditional machine learning "training" might not apply in the same way to this type of device at that time) for the predicate devices' algorithm are not provided.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there was no separate "training set" for these modified devices. For the predicate devices, if an algorithm involved learning, its ground truth would have been established through clinical measurements against a reference standard, as described in point 7. However, the exact methods or criteria for establishing ground truth for any potential algorithm training for the predicate devices are not detailed in this summary.
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Attachment 4
510(k) Summary
[As Required by 21 CFR 807.92]
OCT - 9.2009
Date Prepared:
July 30, 2009
Submitter:
Jawon Medical Co., Ltd. #1208-12, Sinsang-Li, Jinryang-Eup, Kyungsan-city, Kyungsang-Bukdo, 712-830, Republic of Korea Tel: 82-53-856-0993 Establishment Registration Number: 9616164
Contact Person:
MI Consulting Co., Ltd. (Mr. HL Jung) RM 431, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731, Republic of Korea Tel: 82-2-6264-9001 Fax: 82-2-6269-9001
Trade Name:
Common Name: Classification Name: Predicate Device:
Automatic Blood Pressure Monitor Models EASY X 800(R/L) & EASY X 900 (R/L) Blood Pressure Monitor Non-Invasive Blood Pressure Measurement System; 21CFR870.1130 (DXN) Automatic Blood Pressure Monitor, Models FT-500 (R/L) and FT-700 (R/L) (K062462, Sep. 29, 2006)
Device Description:
Device Desamplom.
The EASY X 800 (R/L) and EASY 900 (R/L) are blood pressure monitors to non-invalied. The devices of The EAST X 600 (102) and EXS P 500 (102) The devices employ oscillometric method. The devices are airsuing microprocessor-controlled and include an air pump, an electronic valve to regulate deflation and controlled of microprocessor-controlled and included and in and in and in the many of LCD(EASY X 900) display of systolic and diastolic pressure readings and heart rate, and push buttons.
Systom and dastone proboard roading of the designed to detect, filter, filter, process, and store The devices employ a probation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy.
The EASY X 800 (R/L) and EASY X 900 (R/L) are AC adapter-powered.
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Intended use:
Automatic Blood Pressure Monitor Models EASY X 800 (R/L) and EASY 900 (R/L) are intended for the odult Autonatic Diod 1100012 Miratolic blood pressure and determination of heart rate in adult nonificative measure in circumference range between 9" to 14" (23cm to 36cm).
Technologic characteristics:
The modified devices EASY X 800 (R/L) and EASY 900 (R/L) have the same intended use and technology The nounled devices ENE-700 (R/L) and FT-700 (R/L) The differences in this submission don't raise new questions concerning either safety or effectiveness.
Non-clinical and clinical tests:
Non-omisour and only and EASY 900 (R/L) and EASY 900 (R/L) meet the requirements of ANSI/AAMI SP10, The nodilled deviced in 1990 (R/L) and EASY X 800 (R/L) and EASY X 900 (R/L) are not clinically tested ILC 0000111, and EN 00001.
because the devices use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.
Conclusions:
Based on the non-clinical tests, the modified devices EASY X 800 (R/L) and EASY 900 (R/L) are as safe, Dasca of the not of the predicate devices FT-500 (R/L) and FT-700 (R/L). Accordingly the modified devices are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Jawon Medical Co., Ltd. c/o Mr. H. L. Jung Manager and Official Correspondent MI Consulting Co., Ltd. Room 431, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, Korea 150-731 REPUBLIC OF KOREA
OCT - 9 2009
Re: K092432
Trade/Device Name: Jawon Medical Automatic Blood Pressure Monitor, Models EASY X 800 (R/L) & EASY X 900 (R/L)
Regulatory Number: 21 CFR 870.1130
Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: August 8, 2009 Received: September 14, 2009
Dear Mr. Jung:
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 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. H. L. Jung
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. A. Kilborne
A 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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Attachment 1
Indications for Use Statement
510(k) Number (if known):
Device Name: Jawon Medical Automatic Blood Pressure Monitor . Models EASY X 800 (R/L) & EASY X 900 (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 order and arm circumference range between 9" to 14" (23cm to 36cm).
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. A. Wilhelm
(Division Sign-Off)
Divis: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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51046, 1041. K09 2432
Page 1 of 1
§ 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).