(114 days)
KD-7920 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.
KD-7920 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements 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.
The provided text describes the submission of a 510(k) premarket notification for the "7920 Fully Automatic Electronic Blood Pressure Monitor." This document focuses on demonstrating that the new device is substantially equivalent to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-invasive blood pressure measurement system. The primary acceptance criteria for such a device are accuracy for systolic and diastolic blood pressure, and pulse rate. The document references compliance with ISO 81060-2 for clinical accuracy, which sets specific criteria for these measurements.
| Acceptance Criteria (Implied by ISO 81060-2) | Reported Device Performance (K162915, 7920) |
|---|---|
| Blood Pressure Accuracy | Verified by meeting Criteria 1 and 2 of ISO 81060-2 |
| Mean difference between device and reference for SBP (Criteria 1) | Met ISO 81060-2 criteria |
| Standard deviation of difference between device and reference for SBP (Criteria 1) | Met ISO 81060-2 criteria |
| Mean difference between device and reference for DBP (Criteria 1) | Met ISO 81060-2 criteria |
| Standard deviation of difference between device and reference for DBP (Criteria 1) | Met ISO 81060-2 criteria |
| Individual difference distribution for SBP (Criteria 2) | Met ISO 81060-2 criteria |
| Individual difference distribution for DBP (Criteria 2) | Met ISO 81060-2 criteria |
| Pulse Rate Accuracy | ±5% (Same as predicate) |
| Pulse Rate Range | 40 – 180 times/min (Same as predicate) |
| Systolic Range | 60 – 260 mmHg (Same as predicate) |
| Diastolic Range | 40 – 199 mmHg (Same as predicate) |
| Non-clinical safety (Electrical Safety, EMC) | Compliant with IEC 60601-1 and IEC 60601-1-2 |
| Performance characteristics | Compliant with IEC 80601-2-30 |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2."
- Sample Size for Test Set: The specific sample size for the clinical test set is not explicitly stated in the provided text. However, ISO 81060-2 typically requires a minimum number of subjects (e.g., 85 subjects with specific demographic distribution, often involving both sexes and different age/BP ranges) and a certain number of measurements per subject for statistical validity.
- Data Provenance: The document does not specify the country of origin for the clinical test data. It is also not explicitly stated whether the study was retrospective or prospective, but clinical investigations for device approval are typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document references ISO 81060-2 for clinical accuracy. In such studies, ground truth for blood pressure is typically established by at least two independent, trained observers (experts) using a standardized auscultatory method (e.g., mercury sphygmomanometer calibrated against a reference) and adhering strictly to established protocols.
- Number of Experts: ISO 81060-2 typically requires two trained observers.
- Qualifications of Experts: The standard requires observers to be appropriately trained and certified in the auscultatory technique, demonstrating proficiency and inter-observer reliability before participating in the study. While specific qualifications like "radiologist with 10 years of experience" are not relevant for blood pressure measurement, the emphasis is on rigorous training and demonstrated competency in the reference measurement method.
4. Adjudication Method for the Test Set
For clinical blood pressure validation studies according to ISO 81060-2, the adjudication method generally involves:
- Simultaneous measurements: The device and the two expert observers take measurements simultaneously or in very rapid succession.
- Blinding: The observers are typically blinded to each other's readings and often to the device's readings. The device is also "blinded" if possible (e.g., automated capture without immediate display to the subject).
- Comparison of observer readings: The two observers' readings are compared. If they differ by more than a pre-defined threshold (e.g., 4 mmHg for SBP/DBP), a third observer or a re-measurement/adjudication process might be triggered, or the data point might be discarded. This helps ensure the reliability of the reference standard.
The specific adjudication method (e.g., 2+1, 3+1) is not detailed in the provided text, but it would have followed the requirements of ISO 81060-2 which mandates stringent protocols for reference measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is a fully automatic electronic blood pressure monitor, which does not involve human readers interpreting diagnostic images or data in the same way an AI-assisted diagnostic tool would. The performance is assessed in standalone mode against a reference standard.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was done. The clinical test described as "Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2" is a standalone evaluation. This involved comparing the device's measurements directly against the auscultatory reference standard performed by trained observers, without any human-in-the-loop assistance for the device itself.
7. Type of Ground Truth Used
- The ground truth used for the clinical accuracy study was expert consensus auscultatory measurements. This method involves trained medical professionals (the two observers described in point 3) listening to Korotkoff sounds and recording the systolic and diastolic pressures, serving as the gold standard for non-invasive blood pressure measurement in validation studies.
8. Sample Size for the Training Set
- The document does not provide any information regarding a separate "training set" sample size. This type of medical device (an oscillometric blood pressure monitor) relies on an established algorithm (stated as "Amplitude (Same as K092510)") rather than requiring a continuously updated, large-scale machine learning training set in the way a modern AI diagnostic algorithm might. The algorithm would have been developed and refined using historical data, but the specific size of that foundational dataset is not mentioned or typically required for this type of submission.
9. How the Ground Truth for the Training Set Was Established
- Similar to the above, information on how a "training set ground truth" was established is not provided. The device's algorithm is stated to be the same as the predicate device (K092510). This implies that the underlying algorithm was previously validated and established. The design principle is based on "oscillometric and silicon integrates pressure sensor technology," which uses physical principles and signal processing to derive blood pressure values, rather than being a learnable AI model from a labelled training dataset in the contemporary sense. Any initial development of such an algorithm would have involved comparisons to reference measurements, but specific details are not in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 17, 2017
Andon Health Co., Ltd. % Liu Yi President No. 3 Jinping Street, Ya An Road, Nankai District Tianjin, CN 300190 Tianjin
Re: K162915
Trade/Device Name: 7920 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 23, 2016 Received: December 29, 2016
Dear Liu Yi:
This letter corrects our substantially equivalent letter of February 8, 2017.
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mude Jellm
for
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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Indications for Use
510(k) Number (if known) K162915
Device Name
7920 Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
KD-7920 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive blood pressure measurement system intended to measure the diastolic 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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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.
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 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Preparation: | 9/23/2016 |
2.0 Device information
| Trade name: | 7920 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: II Panel: Cardiovascular
4.0 Predicate device information
Primary Predicate:
Manufacturer: Andon Health Co., Ltd. Device: KD-7964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906
Reference Predicate:
Manufacturer: Andon Health Co., Ltd. Device: KD-7901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K092510
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5.0 Intended use
KD-7920 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-7920, as described in its labeling are the same as the predicate device KD-7964(K102906).
6.0 Device description
KD-7920 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements 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.
7.0 Summary comparing technological characteristics with predicate device
| Item | Subject Device (K162915) | Predicate Device (K102906) | Conclusion |
|---|---|---|---|
| Models | KD-7920 | KD-7964 | – |
| Population | Adult | Adult | Same |
| Cuff location | Wrist | Wrist | Same |
| Indicationsfor Use | KD-7920 Fully AutomaticElectronic Blood PressureMonitor is for use bymedical professionals orat home and is anon-invasive bloodpressure measurementsystem intended tomeasure the diastolic andsystolic blood pressuresand pulse rate of an adultindividual by using a | KD-7964 Fully AutomaticElectronic Blood PressureMonitor is for use bymedical professionals orat home and is anon-invasive bloodpressure measurementsystem intended tomeasure the diastolic andsystolic blood pressuresand pulse rate of an adultindividual by using a | Same |
| non-invasive technique inwhich an inflatable cuff iswrapped around the wrist.The cuff circumference islimited to 14cm-25cm. | non-invasive technique inwhich an inflatable cuff iswrapped around the wrist.The cuff circumference islimited to 14cm-25cm. | ||
| RX or OTC | OTC | OTC | Same |
| Physical attributes | |||
| Weight | 69.5g | 133g (w/o batteries) | The appearance ofthe newdevice is changed,so the weightand dimension arealso changed,the electricalsafety test reportandthe EMC testreport confirm thatallthe new device isas safe andeffective as thepredicate device |
| Dimensions (mm) | 80 x 60 x 31 | 90 x 68 x 30 | |
| Memory | 4 x 30 times | 2 x 60 times | The memory timesof the newdevices ischanged, but thesoftware validationdocumentationconfirms that allthe new device isthe same effectiveand safe as thepredicate device |
| Displayed andcalculatedparameters | Systolic, Diastolic, Pulse,Irregular heartbeat | Systolic, Diastolic, Pulse,Irregular heartbeat | Same |
| Display | LCD | LCD | Same |
| Electrical | |||
| Power rating | 3VDC | 3VDC | Same |
| Battery | 2 x 1.5 VDC AAA size | 2 x 1.5 VDC AAA size | Same |
| Performance |
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7920 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
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7920 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
| Pulse rate | 40 – 180 times/min | 40 – 180 times/min | Same |
|---|---|---|---|
| Pulse rate accuracy | ±5% | ±5% | Same |
| BP monitoring method | Oscillometric | Oscillometric | Same |
| Measurement process | Taken during deflation | Taken during deflation | Same |
| Systolic range | 60 – 260 mmHg | 60 – 260 mmHg | Same |
| Diastolic range | 40 – 199 mmHg | 40 – 199 mmHg | Same |
| Overpressure limit | 300 mmHg | 300 mmHg | Same |
| Algorithm | Amplitude (Same as K092510) | Amplitude (same as K092510) | Same |
8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests have been done as follows:
a. Electromagnetic compatibility test according to IEC 60601-1-2;
- b. Electrical safety according test to IEC 60601-1;
c. Safety and performance characteristics of the test according to IEC 80601-2-30
Clinical Tests were done as follows:
Accuracy of the electronic blood pressure monitors was verified by meeting Criteria 1 and 2 of ISO 81060-2
None of the test demonstrates that KD-7920 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.
9.0 Performance summary
KD-7920 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- IEC 60601-1:2005/(R)2012 A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007, Medical Electrical Equipment -- Part 1-2: General
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Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
- · ISO 81060-2: Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type
10.0 Comparison to the predicate device and the conclusion
Our device KD-7920 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the predicate device KD-7964 Fully Automatic Electronic Blood Pressure Monitor.
KD-7920 is very similar with its predicate device in the intended use, the design principle, the data transmission mode, the material, the performance and the applicable standards. Only their appearance, the memory capacity, the average function, the power and the MCU are different.
However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.
KD-7920 uses the same design principle, blood pressure cuff and same algorithm as the KD-7901 blood pressure monitor. KD-7901 is also manufactured by Andon Health Co., Ltd and has been cleared by FDA with 510K number of K092510.
§ 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).