(128 days)
KD-7901, KD-7905, KD-7911
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components.
No
The device is described as a "non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate." This indicates a diagnostic or monitoring function, not a therapeutic one which would involve treating or curing a medical condition.
Yes
This device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly mentions hardware components like an inflatable cuff, LCD, electronic interface module, and silicon integrate pressure sensor technology. It is a physical blood pressure monitor, 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-7901, KD-7905, and KD-7911 Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by wrapping a cuff around the wrist. It does not analyze samples taken from the body.
Therefore, it falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is 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 wrist. The cuff circumference is limited to 14cm-25cm.
Product codes
DXN
Device Description
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is 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 wrist. The cuff circumference is limited to 14cm-25cm.
It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers.
The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-7901, KD-7905 and KD-7911 are 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult individual
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
KD-7901, KD-7905 and KD-7911 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.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)}.
- 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.
The test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
Key Metrics
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
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
510(k) Summary
DEC 2 3 2009
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 31, Changjiang 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: 08/07/2009
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: = Panel: Cardiovascular
4.0 Predict device information
Manufacturer: Andon Health Co., Ltd. Device: KD-795 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K070826
5.0 Device description
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is 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 wrist. The cuff circumference is limited to 14cm-25cm.
It is designed and manufactured according to ANSI/AAMI SP10--manual,
1
electronic or automated sphygmomanometers.
The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-7901, KD-7905 and KD-7911 are 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
6.0 Intended use
1
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is 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 wrist. The cuff circumference is limited to 14cm-25cm.
The intended use and the indication for use of KD-7901, KD-7905 and KD-7911, as described in its labeling are the same as the predict device KD-795.
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
3/4
8.0 Performance summary
ર્દ
KD-7901, KD-7905 and KD-7911 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.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)}.
- 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.
9.0 Comparison to the predict device and the conclusion
Our device KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-795 whose 510(k) number is K070826.
KD-7901 and KD-795 are very similar in the design principle, the material, the energy source and the applicable standards. Their cuff circumference are different, their appearance are different. As regard to functions, KD-7901 has 2 ×60 times memory, no voice and LCD backlight. The operational humidity and the pulse rate are also different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-795. .
KD-7905 and KD-795 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The operational humidity and the pulse rate are also different.
KD-7911 and KD-795 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The operational humidity and the pulse rate are also different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-795. KD-7911 and KD-795 also has different MCU.
3
ਾ ਕ
4/4
:
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
4
Image /page/4/Picture/1 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 a stylized eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
Mr. Liu Yi President Andon Health Co., Ltd. No. 31 Changjiang Road, Nankai District Tianjin, 300190 CHINA
Re: K092510
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: December 1, 2009
Dear Mr. Liu:
·
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, Insting 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.
5
Page 2 – Mr. 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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.P.
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 : | K092510 |
---|---|
Device name: | KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor |
Indications for use:
KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor is 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 wrist. The cuff circumference is limited to 14cm- 25cm.
Prescription use Part 21 CFR 801 Subpart D) 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)
WMP
rdiovascular Dev
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