(63 days)
Not Found
No
The device description details a standard oscillometric blood pressure monitor using a microprocessor, pump, valve, and display. There is no mention of AI, ML, or any related technologies in the text. The performance studies rely on identical software and hardware to predicate devices, further indicating a lack of novel AI/ML components.
No.
The device measures blood pressure and heart rate, which are diagnostic functions, not therapeutic ones. It does not actively treat or alleviate a medical condition.
No
The device is described as a blood pressure monitor for noninvasive measurement of blood pressure and heart rate. It measures physiological parameters but doesn't interpret these measurements to diagnose a condition or disease.
No
The device description explicitly states it includes hardware components such as an air pump, electronic valve, microprocessor, and LCD display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device performs noninvasive measurement of blood pressure and heart rate on the arm. This is a measurement taken directly from the body, not on a sample taken from the body.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
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).
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Adults with age 16 or order
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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.
2
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
4
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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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n
51046, 1041. K09 2432
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