(15 days)
No
The description focuses on standard oscillometric technology and basic calculations (average of last three measurements), with no mention of AI or ML terms or concepts.
No.
This device is for measuring blood pressure and pulse rate (diagnostic), not for treating a condition.
Yes
This device measures blood pressure and pulse rate, providing physiological information that is used to diagnose conditions like hypertension or other cardiovascular issues. The detection of irregular heartbeat also points to its diagnostic function.
No
The device description explicitly mentions an "inflatable cuff," "silicon integrates pressure sensor technology," and an "LCD" for displaying results. These are all hardware components, indicating the device is not software-only.
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 KD-556J Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the upper arm. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-5561 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and 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. The cuff circumference is limited to 22cm-48cm.
Product codes
DXN
Device Description
KD-556J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and 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. The cuff circumference is limited to 22cm-48cm.
It is 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-556J 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-556J is identical to its predicate device KD-556. The difference between the subject device and its predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-556(K091500) is applicable to our subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
16 1103
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
FEB 1 8 2011
| 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: | 01/27/2011 |
2.0 Device information
| Trade name: | Fully Automatic Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive blood pressure measurement system |
| Classification name: | Noninvasive blood pressure measurement system |
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd.
- KD-556 Fully Automatic Electronic Blood Pressure Device: Monitor
510(k) number: K091500
1
5.0 Device description
KD-556J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and 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. The cuff circumference is limited to 22cm-48cm.
16110330
It is 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
KD-556J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and 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. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of KD-556J, as described in the labeling are the same as their predicated device KD-556.
| 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 |
7.0 Summary_comparing_technological_characteristics_with_predicate device
2
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-556J 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-556J is identical to its predicate device KD-556. The difference between the subject device and its predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-556(K091500) is applicable to our subject device.
3
9.0 Performance summary
KD-556J 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-556J Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K091500.
KD-556J is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards. Only the appearance, the time format and the hypertension classification of KD-556J is changed. KD-556J will use the JNC hypertension classification while its predicate device KD-556 uses the WHO hypertension classification.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 8 201
Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3, JinPing Street, Ya An Road, Nankai District Tianjin, P.R. China, 300190
Re: K110330
Trade/Device Name: KD-556J Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement systems Regulatory Class: Class II (two) Product Code: DXN Dated: January 31, 2011 Received: February 3, 2011
Dear Mr. Yi:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave 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 for ass stated in the encreat 1976, the enactment date of the Medical Device Amendments, or to econmores 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). Tou may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefer your of the Act include requirements for annual registration, listing of general voltren provincities, 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 · If your device is classified (500 above) 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 found in the Code of Features concerning your device in the Federal Register.
5
Page 2 – Ms. Liu Yi
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 (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.
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.html 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 vours.
W.M.S.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
| 510(k) Number : | K110330 |
|---|---|
| ----------------- | --------- |
Device name: KD-556J Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5561 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and 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. The cuff circumference is limited to 22cm-48cm.
Prescription use Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR 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)
W. Wtast.
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(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number