(136 days)
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.
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) 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 a 510(k) premarket notification for Andon Health Co., Ltd.'s Fully Automatic Electronic Blood Pressure Monitor. The document indicates that the device's accuracy was verified by meeting criteria 1 and 2 of ISO 81060-2. However, the text does not explicitly provide a table of acceptance criteria and reported device performance for the subject device itself. Instead, it refers to prior clinical test reports for predicate devices (KD-5961, BP3, and BP5) as references.
Therefore, not all requested information can be extracted directly for the subject device from the provided text. I will answer based on the information available and will highlight where specific details are not provided for the subject device but are referenced through predicate devices.
1. A table of acceptance criteria and the reported device performance
The provided text states that the accuracy of the blood pressure monitors in the clinical test reports was verified by meeting Criteria 1 and Criteria 2 of ISO 81060-2. However, it does not provide a specific table with numerical acceptance criteria and the reported performance for the subject device models (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552). It refers to the clinical test reports of predicate devices.
Based on general knowledge of ISO 81060-2, the criteria typically involve:
ISO 81060-2 Criteria (General Reference, not explicitly stated in document for subject device):
| Acceptance Criteria (ISO 81060-2:2009) | Reported Device Performance (Reference to predicate studies) |
|---|---|
| Criterion 1: Mean difference and standard deviation | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| The mean difference between the device measurements and reference measurements should be within ±5 mmHg. | |
| The standard deviation of the differences should be ≤ 8 mmHg. | |
| Criterion 2 (for device approval for general population): Distribution of individual differences | Not explicitly stated for the subject device. The document states that the clinical test reports of the predicate devices met these criteria. |
| For SYS/DIA, 65% of the differences should be within ±5 mmHg. | |
| 85% of the differences should be within ±10 mmHg. | |
| 95% of the differences should be within ±15 mmHg. |
2. Sample size used for the test set and the data provenance
For the subject devices (KD-5810, KD-5810B, KD-5811, KD-5920TL, and KD-552), the text does not explicitly state the sample size used for the test set or the data provenance directly for these devices.
It states:
- "The proposed devices KD-5810, KD-5810B, KD-5811 and KD-5920TL has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961can be used as a reference when considering the clinical effect of KD-5810, KD-5810B, KD-5811 and KD-5920TL."
- "The proposed devices KD-552 has the same algorithm and design principle with cleared device BP3 (K102939) and BP5 (K120672), so the clinical test report of BP3 (K102939) and BP5 (K120672) can be used as a reference when considering the clinical effect of KD-552."
To determine the sample sizes and data provenance, one would need to access the clinical test reports for K083246 (KD-5961), K102939 (BP3), and K120672 (BP5). The provided document does not contain this information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical studies mentioned (those for KD-5961, BP3, and BP5). For blood pressure measurement validation studies, ground truth is typically established by trained observers (e.g., physicians or nurses) using a sphygmomanometer following a standardized protocol (such as auscultation with a mercury sphygmomanometer or an equivalent reference device).
4. Adjudication method for the test set
The text does not specify an adjudication method for the test set. In blood pressure validation studies, ground truth is usually established by highly trained technicians or physicians taking multiple reference readings, and often, paired readings are averaged or discrepancies between two observers are reconciled, but these specific methods are not described in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device described is a Noninvasive Blood Pressure Measurement System. This type of device is not typically evaluated using MRMC studies as it is a standalone measurement device, not an interpretive imaging or diagnostic system where human readers interpret results. Therefore, this section is not applicable. The document does not describe any MRMC studies or human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical validation referenced through the predicate devices (KD-5961, BP3, BP5) would assess the standalone performance of the algorithm in measuring blood pressure against a reference standard. The text states: "Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." This implies a standalone performance assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood pressure monitors validated against ISO 81060-2, the "ground truth" (or reference measurement) is typically established by simultaneous or sequential measurements taken by trained observers using a calibrated reference sphygmomanometer (e.g., mercury or an equivalent validated device) using the auscultatory method. This is a direct expert measurement, not pathology or outcomes data.
8. The sample size for the training set
The provided text does not provide any information regarding a "training set" or its sample size. Blood pressure monitors like this typically use established algorithms (oscillometric method) and are validated against clinical standards rather than being "trained" in the machine learning sense with a distinct training set. If the algorithm involved machine learning, this information would be critical, but the description ("operational principle is based on oscillometric and silicon integrates pressure sensor technology") suggests a traditional signal processing approach.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided document. The ground truth for the validation (test) set would be established as described in point 7.
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July 29, 2021
Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China
Re: K210770
Trade/Device Name: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2021 Received: July 1, 2021
Dear Liu 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210770
Device Name
Fully Automatic Electronic Blood Pressure Monitor
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(In accordance with 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,300190, P.R. China |
| Phone Number: | 86-22-87611660 |
| Fax Number: | 86-22-87612379 |
| Contact: | Mr. Liu Yi |
| Date of Preparation: | March 1, 2021 |
2.0 Device Information
| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
|---|---|
| Common Name: | Arm Blood Pressure Monitor |
| Classification Name: | Non-Invasive Blood Pressure Measurement System |
3.0 Classification
| Product Code: | DXN |
|---|---|
| Regulation Number: | 21 CFR 870.1130 |
| Classification: | II |
| Review Panel: | 870 Cardiovascular |
4.0 Predicate Device Information
| Manufacturer: | Andon Health Co., Ltd. | Andon Health Co., Ltd. |
|---|---|---|
| Device: | Fully Automatic ElectronicBlood Pressure Monitor | Wireless Electronic BloodPressure Monitor |
| 510(k) Number: | K183534 | K162668 |
| Classification | II | II |
| Product Code | DXN | DXN |
5.0 Indications for Use
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.
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6.0 Device Description
Fully Automatic Electronic Blood Pressure Monitor (KD-5810, KD5810B, KD-5811, KD-5920TL and KD-552) 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 Comparison of Technological Characteristics with Predicate Device
The following table is the summary of the technological characteristics of the proposed subject device and predicate device.
| Item | Subject Device | PredicateDevice(KD-5031MK183534) | PredicateDevice(KD-926)(K162668) | ComparisonResult |
|---|---|---|---|---|
| Name andmode | Fully Automatic ElectronicBlood Pressure Monitor | Fully AutomaticElectronicBlood PressureMonitor | WirelessElectronicBloodPressureMonitor | -- |
| Model | KD-5810, KD5810B,KD-5811,KD-5920TLKD-552 | KD-5031M | KD-926 | -- |
| Rx or OTC | OTC | OTC | OTC | Same |
| Population | Adult | Adult | Adult | Same |
| CuffLocation | Upper arm | Upper arm | Upper arm | Same |
| Physical Attributes | ||||
| Weight(excludebatteries andcuff) | KD-5810: About 191gKD-5810B: About 180gKD-5811: About 239gKD-5920TL:About 235gKD-552: About 270g | About 300g | About 234g | Changed |
| Dimensions | KD-5810:139.4mm×93.8mm×41.8mmKD-5810B:139.4mm×93.8mm×41.8mm | 165mmx96mmx65mm | 145mm×90mm×51mm | Changed |
| Item | Subject Device | Predicate Device(KD-5031MK183534) | Predicate Device(KD-926)(K162668) | Comparison Result |
| KD-5811:139.4mm×93.8mm×43.4mmKD-5920TL:150mm×95mm×41mmKD-552:158.5mm×92.3mm×76.7mm | ||||
| Memory | KD-5810, KD-5810B,KD-5920TL& KD-552:2×120 times4×60 times2×60 times4×30 timesKD-5811:2×120 times2×60 times2×30 times | 1×120 times1×60 times2×60 times4×30 times | 2×60 times | More memoryfunction onmeter |
| DisplayedCalculatedParameters | SYSDIAPulseIHB | SYSDIAPulseIHB | SYSDIAPulseIHB | Same |
| Displaycomponent | KD-5810, KD-5811,KD-5920TL &KD-552:LCD with backlightKD-5810B: LCD | LCD | 1. LCD2. Display onSmart Phone | Similar |
| Averagefunction | KD-5810, KD-5810B,KD-5920TL& KD-552:1.Average value of allresults in the current usermemory zone.2. Average the value of thelatest 3 times3. Average value of all theresults in last 7 days AM4. Average value of all theresults in last 7 days PMKD-5811: | Average thevalue of thelatest 3 times | Averaging ofthe last threetimesmeasurement | More functionsare added |
| Item | Subject Device | PredicateDevice(KD-5031MK183534) | PredicateDevice(KD-926)(K162668) | ComparisonResult |
| 1. Average value of allresults in the current usermemory zone.2. Average the value of thelatest 3 times | ||||
| OtherDisplayedInformation | DateTimeMemoryBattery usageBlood pressure classification | DateTimeMemoryBattery usageBlood pressureclassification | DateTimeMemoryBattery usageBlood pressureclassification(Displayed ondevice) | Similar |
| Electrical Power | ||||
| DC Mains | 6V | 6V | 6V | Same |
| Battery | KD-5810, KD-5810B,KD-5811, & KD-552:4 ×1.5V SIZE AAKD-5920TL:4 ×1.5V SIZE AAA | 4 ×1.5V SIZEAAA | 4 ×1.5V SIZEAAA | Same |
| Environmental Operation | ||||
| Temperature | 10~40℃ | 10~40℃ | 10~40°C | Same |
| Humidity | <85% | <85% | <85% | Same |
| Environmental Storage | ||||
| Temperature | -20~50°C | -20~50℃ | -20~50°C | Same |
| Humidity | <85% | <85% | <85% | Same |
| Performance NIBP | ||||
| Pulse RateRange | 40 -180times/min | 40-180times/min | 40-180times/min | Same |
| Pulse RateAccuracy | Within ±5% | Within ±5% | Within ±5% | Same |
| Technique/Method | Oscillometric | Oscillometric | Oscillometric | Same |
| Measureprocess | KD5810, KD-5810B,KD-5811, &KD-5920TL:Measure during deflating | Measure duringdeflating | Measure duringinflating | KD-5810,KD-5810B,KD-5811 andKD-5920TL are |
| Item | Subject Device | Predicate Device(KD-5031MK183534) | Predicate Device(KD-926)(K162668) | Comparison Result |
| KD-552:Measure during inflating | predicate KD-5031M, andKD-552 aresame withpredicateKD-926 | |||
| PressureAccuracy | Within ±3mmHg | Within±3mmHg | Within±3mmHg | Same |
| CuffPressureRange | 0-300mmHg | 0-300mmHg | 0-300mmHg | Same |
| OverpressureLimit | 300mmHg | 300mmHg | 300mmHg | Same |
| Algorithm | Amplitude | Amplitude | Amplitude | Same |
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There are no significant differences between the two products and they are identical in terms of intended use, materials, design, manufacturing methods.
8.0 Discussion of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- . IEC 60601-1:2005/(R)2012 And 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 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- 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
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None of the tests demonstrate that the new Blood Pressure Monitors raises new questions of safety and effectiveness as compared to the predicate
9.0 Clinical Test
Comparison and evaluation are carried out between the subject device and cleared devices, and it is showed that:
The proposed devices KD-5810, KD-5810B, KD-5811 and KD-5920TL has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961can be used as a reference when considering the clinical effect of KD-5810, KD-5810B, KD-5811 and KD-5920TL.
The proposed devices KD-552 has the same algorithm and design principle with cleared device BP3 (K102939) and BP5 (K120672), so the clinical test report of BP3 (K102939) and BP5 (K120672) can be used as a reference when considering the clinical effect of KD-552.
Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
10. Comparison to the Predicate Device and Conclusion
The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device, Fully Automatic Electronic Blood Pressure Monitor (KD-5810. KD-5810B, KD-5811, KD-5920TL and KD-552), is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5031M (K183534) and KD-926 (K162668).
The subject devices are very similar with its predicate device in the intended use, design principle, materials, performance and applicable standards. Their appearance, the memory capacity, the average function, and MCU is different.
However, the tests in this submission demonstrates that these small differences do not raise any new questions of safety and effectiveness and the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate K183534 and K162668.
§ 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).