(18 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities.
No.
The device is a blood pressure monitor intended for measurement, not for treatment.
Yes
The device is intended to measure diastolic and systolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and can indicate the presence of certain conditions. This measurement aids in the diagnosis and monitoring of medical conditions.
No
The device description explicitly mentions hardware components such as an inflatable cuff, pressure sensor technology, LCD, electronic interface module, and memory capability. It also references standards related to electrical equipment and sphygmomanometers, which are hardware devices.
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 the KD-5963 and KD-7963 are "non-invasive blood pressure measurement systems." They measure blood pressure and pulse rate by using an inflatable cuff wrapped around the arm or wrist. This is a physical measurement taken externally from the body.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the individual.
Therefore, since the device operates by taking a physical measurement externally and does not involve the analysis of in vitro samples, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KD-5963 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-7963 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-5963 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-7963 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 sphygmanometers.
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-5963 and KD-7963 are both 60 times. If any irreqular heartbeat is detected, it can be shown on the LCD, KD-5963 has the voice function, KD-7963 has the function of touch button and LCD backlight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
KD-5963 and KD-7963 Fully Automatic Electronic Blood Pressure Monitor conform 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 (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
(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
DEC - 4 2009
Name: Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, Address: P.R. China 86-22-6052 6161 Phone number: 86-22-6052 6162 Fax number: Contact: Liu Yi Date of Application: 11/13/2009
2.0 Device information
Trade name: Fully Automatic Electronic Blood Pressure Monitor Common name: Noninvasive blood pressure measurement system Noninvasive blood pressure measurement system Classification name:
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Requlation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predict device information
Andon Health Co., Ltd. Manufacturer: KD-5962 Fully Automatic Electronic Blood Pressure Monitor Device: KD-7962 Fully Automatic Electronic Blood Pressure Monitor K090771, K091997 510(k) number:
5.0 Device description
KD-5963 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.
5-1
10F4
1
KD-7963 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 sphygmanometers.
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-5963 and KD-7963 are both 60 times. If any irreqular heartbeat is detected, it can be shown on the LCD, KD-5963 has the voice function, KD-7963 has the function of touch button and LCD backlight.
6.0 Intended use
KD-5963 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-7963 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-5963 and KD-7963, as described in its labeling are the same as the predict device KD-5962 and KD-7962.
7.0 Summary comparing technological characteristics with predicate device
PAGE 2 OF 4
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:
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:
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| 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 |
PAGE 3 OF 4
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3
8.0 Performance summary
KD-5963 and KD-7963 Fully Automatic Electronic Blood Pressure Monitor conform 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-5963 and KD-7963 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5962 and KD-7962 whose 510(k) number is K090771 and K091997.
KD-7963 and KD-7962 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, they have different memory times, KD-7963 doesn't have the function of voice and averaging the last 3 times memory, the cuff circumference of KD-7963 is different from KD-7962.
KD-5963 and KD-5962 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, KD-5963 also has a new cuff.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
PAGE 4 OF 4
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Image /page/4/Picture/0 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 a stylized image of a human figure with outstretched arms, resembling a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC - 4 2009
Andon Health Co., Ltd. c/o Mr. Liu Yi No. 31 Changjiang Road, Nankai District, Tianjin CHINA
Re: K093528
Trade/Device Name: KD-5963 Fully Automatic Electronic Blood Pressure Monitor; and, KD-7963 Fully Automatic Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: November 13, 2009 Received: November 16, 2009
Dear Mr. Yi:
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.
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 (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/ReportalProblem/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,
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 :
•
Device name:
KD-5963 and KD-7963 Fully Automatic Electronic Blood Pressure Monitor
Indications for use:
KD-5963 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-7963 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 AND/OR Over-The-Counter Use YES Part 21 CFR 801 Subpart D) (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 of Cardiovascular Devices
10(k) Number K07
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