(28 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and basic data processing (averaging, classification, irregular heartbeat detection). There is no mention of AI or ML algorithms being used for measurement, analysis, or interpretation.
No.
The device is solely for measurement and monitoring of blood pressure and pulse rate, not for treatment or therapy.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess health status and can indicate the presence of certain medical conditions. It also has a function to detect irregular heartbeats, which is a diagnostic indicator.
No
The device description explicitly states it is a "Fully Automatic Wireless Blood Pressure Wrist Monitor" and describes hardware components like an inflatable cuff, pressure sensor technology, and Bluetooth connectivity. While it relies on an iPhone/iPad for display and software, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using oscillometric technology. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate of an adult individual using a non-invasive technique.
Therefore, based on the provided information, the KD-972 is a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 13.5cm-22cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-972 Wireless 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 13.5cm-22cm.
It is designed and manufactured according to IEC 80601-2-30- Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results.
KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor achieves its function by integrate the device with an iPhone, iPod touch or iPad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod touch or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
wrist
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)
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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.
- · IEC 80601-2-30, Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanmeters,2009.
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).
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§ 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.
JUN 1 4 2012
$1/3
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 Ext 8060 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 05/08/2012 |
2.0 Device information
| Trade name: | iHealth BP7-Wireless Blood Pressure Wrist Monitor |
|---|---|
| Device name: | KD-972 Fully Automatic Wireless Blood Pressure Wrist |
| Monitor | |
| Classification name: | Noninvasive blood pressure measurement system |
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: III Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd. Device: KD-7964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906
5.0 Device description
KD-972 Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system
1
intended to measure the diastolic and systolic blood pressures and pulse rate K121470 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 13.5cm-22cm.
833
It is designed and manufactured according to IEC 80601-2-30- Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results.
KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor achieves its function by integrate the device with an iPhone, iPod touch or iPad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod touch or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth.
6.0 Intended use
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 13.5cm-22cm.
The intended use and the indication for use of KD-972, as described in the labeling are the same as its predicate device KD-7964.
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
2- 3
2
| Biocompatibility | Identical |
|---|---|
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
121470 p3/3
8.0 Performance summary
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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.
- · IEC 80601-2-30, Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanmeters,2009.
9.0 Comparison to the predicate device and the conclusion
Our device KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7964 whose 510(k) number is K102906.
KD-972 and KD-7964 are very similar in the intended use, the design principle, the performance and the applicable standards. Only their appearance, the memory time, the average function are different. The measure process is also changed, that is the new device will get the measurement results when the device is inflating, while KD -7964 gets the result during the deflating period. The data transfer method of the new device KD-972 is changed to Bluetooth and the data displayed on iPhone, while KD-7964 transfer the data to PC while receive available command.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2012
Andon Health Co., Ltd. c/o Ms. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin China 300190
Re: K121470
Trade/Device Name: Fully Automatic Wireless Blood Pressure Wrist Monitor, KD-972 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 14, 2012 Received: May 17, 2012
Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Liu Yi
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.
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.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
5
Statement of Indications for Use
510(k) Number :
Device name:
KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor
Indications for use:
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 13.5cm-22cm.
Prescription use Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES AND/OR (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-on)
Division of Cardiovascular Devices
Page I of
510(k) Number K121470