(73 days)
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No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No
The device is a blood pressure monitor, which measures blood pressure and pulse rate, but does not provide therapy or treatment.
Yes
The device is described as a "Blood Pressure Monitor" which measures "diastolic and systolic blood pressures and pulse rate." These are physiological parameters used to assess a patient's health status, which falls under the definition of a diagnostic device. Additionally, it mentions if "any irregular heartbeat is detected, it can be shown on the LCD," further indicating its role in identifying a potential health condition.
No
The device description explicitly mentions hardware components like an inflatable cuff, LCD, electronic interface module, and memory capability, indicating it 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-5903, KD-5909 Fully Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by using a cuff wrapped around the upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, this device 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-5903, KD-5909 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 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-5903, KD-5909 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The operational principle of KD-5903 and KD-5909 are 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, If any irreqular heartbeat is detected, it can be shown on the LCD. The memory capability of KD-5903 is 3×40 times, the memory capability of KD-5909 is 2×60 times.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
ROYOI
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
JUN - 4 2009
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: | 03/16/2009 |
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-591 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K080319 5.0 Device description
KD-5903, KD-5909 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 upper arm. The cuff circumference is limited to 22cm-48cm.
KD-5903 and KD-5909 are all designed and manufactured according to
1
ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.
The operational principle of KD-5903 and KD-5909 are 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, If any irreqular heartbeat is detected, it can be shown on the LCD. The memory capability of KD-5903 is 3×40 times, the memory capability of KD-5909 is 2×60 times.
6.0 Intended use
KD-5903, KD-5909 Fully Automatic Electronic Blood Pressure Nionitor 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 upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of KD-5903 and KD-5909, as described in their labelings are the same as the predict device KD-591,
7.0 Summary comparing technological characteristics with predicate device
Technological Characteristics | Comparison result |
---|---|
Design principle | Identical |
Appearance | Similar |
Patients contact Materials | Identical |
Performance | Identical |
Biocompatibility | Identical |
Mechanical safety | Identical |
Energy source | Identical |
Standards met | Identical |
Electrical safety | Identical |
EMC | Identical |
Function | Similar |
The difference of technological characteristic between KD-5903 and its predicted device KD-591 is the appearance) the performance and the memory mode, the difference of technological characteristic between KD-5909 and its predicted device KD-591 is also the appearance, the performance and the memory mode.
2
8.0 Performance summary
KD-5903, KD-5909 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 BEGO1-1-2. Medical Electrical Equipment Port 1-2. General Requirements for Safety - Collateral standard: Evectromagnetic Compability - 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-5903 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-591 whose 510(k) number is K080319, KD-5909 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-591 whose 510(k) number is K080319.
KD-5903 and KD-591 are very similar in the intended use, the design principle, the material, the performance, the energy source, the applicable standards. Only their appearances and the memory mode are different. KD-5903 has 3 X 40 times memories, that is, 3 group memories, with 40 times memory each group. The operational range for humidity (