(28 days)
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.
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. 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.
This is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory compliance and substantial equivalence to a predicate device. It doesn't detail a clinical study with an acceptance criteria table in the way one might expect for a diagnostic AI device.
However, based on the provided text, I can infer and extract information relevant to the device's acceptable performance criteria and how it's assessed against international standards for blood pressure monitors.
1. Table of Acceptance Criteria and Reported Device Performance
The device is designed and manufactured according to IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. This standard defines the accuracy requirements for blood pressure devices. While the exact numerical criteria from IEC 80601-2-30 aren't explicitly listed in the document, adherence to this standard implies meeting its specified accuracy thresholds.
Since no specific performance metrics like sensitivity, specificity, or AUC are provided in the document for a "device performance" section, the reported performance is simply its conformity to the mentioned standards.
| Acceptance Criteria (Implied by Standard Adherence) | Reported Device Performance |
|---|---|
| Conformance to IEC 80601-2-30 (Basic safety and essential performance of automated non-invasive sphygmomanometers) | "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards: ... 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." |
| Conformance to IEC 60601-1 (General requirements for safety) | "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." |
| Conformance to EN 60601-1-2 (Electromagnetic Compatibility) | "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards: ... EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007." |
| Substantial Equivalence to Predicate Device (KD-7964) | "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." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for a clinical test set related to the blood pressure measurement accuracy. It mentions "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that some testing was done to support the claim of substantial equivalence despite changes from the predicate device (e.g., measurement during inflation vs. deflation, Bluetooth connectivity). However, the details of such a test (sample size, methodology, data provenance) are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not mention the use of experts or the establishment of ground truth in the context of a clinical test set for accuracy. Blood pressure device validation typically involves comparison to a reference standard, often taken by trained clinicians, but these details are absent from the summary.
4. Adjudication Method for the Test Set
Since no specific clinical study with a test set involving human interpretation is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned in this document. This type of study is typically associated with diagnostic imaging AI devices where human readers interpret cases with and without AI assistance. This document describes a blood pressure monitor, which is a measurement device, not a diagnostic imaging AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This document describes a standalone device in the sense that it measures blood pressure automatically. The "standalone" performance, in this context, would be its adherence to the accuracy requirements of the specified standards (IEC 80601-2-30). The statement "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards" serves as the proof that the device, in its intended operational mode (without continuous human intervention during the measurement process itself, though human interaction is needed to initiate and view results via an iPhone/iPad), meets these performance criteria. No explicit study titled "standalone performance study" is detailed, but conformance to the standard implies this.
7. Type of Ground Truth Used
The ground truth for a blood pressure monitor's accuracy is typically established by comparing its readings to a validated reference method, such as invasive arterial pressure measurement or auscultatory measurement by trained observers using a mercury sphygmomanometer. However, the document does not explicitly state the type of ground truth used for any specific performance testing. Conformity to IEC 80601-2-30 implies that the appropriate ground truth measurement methods were used during the validation testing required by that standard.
8. Sample Size for the Training Set
This device is a traditional medical device (a blood pressure monitor) and not an AI/ML-based device that would typically involve a "training set" for model development. Therefore, a training set and its sample size are not applicable or mentioned in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set.
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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
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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 WristMonitor |
| 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
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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 |
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| Biocompatibility | Identical |
|---|---|
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
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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
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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
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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
§ 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).