(164 days)
No
The description focuses on standard oscillometric and pressure sensor technology, with no mention of AI, ML, or related concepts. The performance studies are based on standard medical device testing and clinical equivalence to predicate devices, not on AI/ML model training or validation.
No.
The device is described as a "blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate," which indicates a diagnostic or monitoring function rather than a therapeutic one.
Yes
Explanation: The device measures diastolic and systolic blood pressures and pulse rate, and can detect irregular heartbeats, which are all indicators used to assess a medical condition.
No
The device description explicitly states it is a "Fully Automatic Electronic Blood Pressure Monitor" and describes physical components like an inflatable cuff, pressure sensor technology, and an LCD display, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm."
- Non-Invasive: The key here is "non-invasive." The device measures physiological parameters directly from the body without taking any samples.
Therefore, since the device measures blood pressure and pulse rate directly from the body using a cuff and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult
Intended User / Care Setting
medical professionals or at home
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 Tests have been done as follows:
- a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;
- b. Electrical safety test according test to IEC 60601-1 :
- c. Safety and performance characteristics of the test according to SP10
None of the test demonstrates that KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J bring new questions of safety and effectiveness.
Clinical Test Concerning the Compliance of ANSI/AAMI SP10
From the technical point of view, the subject device KD-557J, KD-5963NGJ, KD-5963NUJ and KD-5971J are identical to its predicate device KD-557 and KD-5963NU. The difference between the subject devices and their predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-598(K083395) is applicable to our subject devices. KD-5031NJ use the same cuff, the same design principle and the same algorithm with KD-5961(K093387), so the clinical test report of KD-5961 is applicable to KD-5031NJ.
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.
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
. . .
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 06/20/2011 |
2.0 Device information
Fully Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Cardiovascular Panel: .
4.0 Predicate device information
| Manufacturer: Andon Health Co., Ltd. | |
|---|---|
| 1 | Device: KD-557 Fully Automatic Electronic Blood Pressure |
| Monitor | |
| 510(k) number: K100014 | |
| Manufacturer: Andon Health Co., Ltd. | |
| 2 | Device: KD-5963NU Fully Automatic Electronic Blood Pressure |
| Monitor | |
| 510(k) number: K101010 |
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5.0 Device description
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.
6.0 Intended use
"ﺩﻳﺮ ﺑﺘﺎﺭﻳﺨﺎ
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J, as described in the labeling are the same as their predicate devices KD-557 and KD-5963NU.
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7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests have been done as follows:
- a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;
- b. Electrical safety test according test to IEC 60601-1 :
- c. Safety and performance characteristics of the test according to SP10
None of the test demonstrates that KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J bring new questions of safety and effectiveness.
Clinical Test Concerning the Compliance of ANSI/AAMI SP10
From the technical point of view, the subject device KD-557J, KD-5963NGJ, KD-5963NUJ and KD-5971J are identical to its predicate device KD-557 and KD-5963NU. The difference between the subject devices and their predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-598(K083395) is applicable to our subject devices. KD-5031NJ use the same cuff, the same design principle and the same algorithm with KD-5961(K093387), so the clinical test report of KD-5961 is applicable to KD-5031NJ.
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9.0 Performance summary
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2. 1995.
- · EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. .
- AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
10.0 Comparison to the predicate device and the conclusion
Our device KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-557(K100014) and KD-5963NU(K101010).
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J are very similar with their predicate devices in the intended use, the design principle, the material, the performance and the applicable standards. The main difference is that the hypertension classification of KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J are changed. KD-557J. KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J will use the JNC hypertension classification while their predicate device KD-557 and KD-5963NU use the WHO hypertension classification.
However, the test and evaluation in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
Andon Health Co., Ltd. c/o Ms. Elizabeth M. Bierman Morgan, Lewis & Bockius LLP 1111 Pennsylvania Avenue, NW Washington, DC 20004
Re: K111826
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor with models: KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J
Regulatory Number: 21 CFR 870.1130
Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: November 10, 2011 Received: November 10, 2011
Dear Ms. Bierman:
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 – Ms. Elizabeth M. Bierman
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,
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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Statement of Indications for Use
| 510(k) Number: | K111826 |
|---|---|
| ---------------- | --------- |
Device name:
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ Fully Automatic Electronic and KD-5971J Blood Pressure Monitor
Indications for use:
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Prescription use Part 21 CFR 801 Subpart D)
... j
AND/OR Over-The-Counter Use YES (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number
4- |