(123 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 17cm-48cm (approx, 6 11/16"- 18 29/32").
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, the measurements results can also be classified. If any irregular heartbeat is detected, it can be shown to the user.
The provided FDA 510(k) summary for the "Fully Automatic Electronic Blood Pressure Monitor" pertains to a Class II medical device, specifically a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are outlined, primarily focusing on the device's accuracy in measuring blood pressure and pulse rate.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood pressure monitors are typically defined by international standards like ISO 81060-2. While the exact numerical criteria for "Criteria 1" and "Criteria 2" are not explicitly stated in this document (e.g., mean difference and standard deviation), the document states that the device "met criteria 1 and criteria 2 of ISO 81060-2."
| Performance Criterion | Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Criteria 1 (Mean difference and standard deviation): For each participant, the difference between the device measurement and the reference standard for systolic and diastolic blood pressure should fall within specific limits. Criteria 2 (Individual Differences): A certain percentage of individual differences must fall within specific limits. | The device met "criteria 1 and criteria 2 of ISO 81060-2." (Specific numerical values for mean difference, standard deviation, and individual difference percentages are not provided in this document but are implicitly met by adherence to the standard.) |
| Pulse Rate Accuracy | Less than 60 bpm: ±3 bpm More than or equal to 60 bpm: ±5% | Less than 60 bpm: ±3 bpm More than or equal to 60 bpm: ±5% (This matches the acceptance criteria, implying performance meets this standard.) |
| Pressure Accuracy | Within ±3 mmHg | Within ±3 mmHg (This matches the acceptance criteria, implying performance meets this standard.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 231 patients (107 males and 124 females) were invited for the study.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective, as patients were "invited for the study" and a "standard auscultation method was used as the reference blood pressure monitor measuring," indicating a controlled clinical trial setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth was established using the "standard auscultation method." This method typically involves trained medical professionals (e.g., doctors, nurses) using a stethoscope and sphygmomanometer. The qualifications of the individuals performing the auscultation are not detailed in this document.
4. Adjudication Method for the Test Set
- The document states that the "standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen." This suggests that the reference measurements were obtained sequentially. There is no mention of a multi-reader/adjudication method for resolving discrepancies in ground truth establishment, as the auscultation method itself is the direct reference measurement.
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
- Not Applicable. This document describes the validation of an automated blood pressure monitor, not an AI-assisted diagnostic tool where human readers interact with AI. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant to this device's validation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes. The study evaluates the "Fully Automatic Electronic Blood Pressure Monitor" directly against a "standard auscultation method." This is an assessment of the device's standalone performance, as it operates automatically to provide blood pressure readings without a human actively interpreting or modifying its output during the measurement process.
7. The Type of Ground Truth Used
- Expert Consensus/Reference Standard: The ground truth was established using the "standard auscultation method." This is considered the clinical gold standard reference for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
- Not applicable / Not specified. This document describes a validation study for a medical device's performance, not the development or training of an AI algorithm. Blood pressure monitors with oscillometric principles are based on established engineering principles and typically do not involve a "training set" in the context of machine learning model development. The document refers to "non-clinical tests" and a "clinical test," which relate to verification and validation of the device's design and performance against standards.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As noted above, this section is not relevant to the type of device and validation described.
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April 22, 2024
Andon Health Co Ltd Yi Liu President No. 3 Jin Ping Street, Ya An Road Nankai District Tianjin, Tianjin 300190 China
Re: K234041
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA): Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 1, 2024 Received: April 1, 2024
Dear Yi Liu:
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 (the 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 available 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.
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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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
Stephen C. Browning -S
LCDR Stephen Browning 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K234041
Device Name Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT): Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
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 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 17cm-48cm (approx, 6 11/16"- 18 29/32").
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
(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: | January 29, 2024 |
2.0 Device Information
| Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
|---|---|
| Common Name: | Non-Invasive Blood Pressure Measurement System |
| 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. |
|---|---|
| Device: | Fully Automatic Electronic Blood Pressure Monitor |
| 510(k) Number: | K210770 |
| Classification: | II |
| Product Code: | DXN |
5.0 Intended 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 noninvasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff
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circumference is limited to 17cm-48cm (approx. 6 11/16"- 18 29/32").
6.0 Device Description
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, the measurements results can also be classified. 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(KD-5811VA, KD-5811BT,KD-5810VA, KD-5810BT,KD-5920VA, KD-5920BT,KD-5923TS) | Predicate Device(KD-5811 K210770) | ComparisonResult |
|---|---|---|---|
| Name andmode | Fully Automatic ElectronicBlood Pressure Monitor | Fully Automatic ElectronicBlood Pressure Monitor | Same |
| Model | KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT,KD-5923TS | KD-5811 | -- |
| Intended use | Fully Automatic ElectronicBlood Pressure Monitor is foruse by medical professionals orat home and is a non-invasiveblood pressure measurementsystem intended to measure thediastolic and systolic bloodpressures and pulse rate of anadult individual by using a non-invasive technique in which aninflatable cuff is wrappedaround the upper arm. The cuffcircumference is limited to17cm-48cm (approx. 6 11/16"- 18 29/32" ). | Fully Automatic ElectronicBlood Pressure Monitor is foruse by medical professionalsor at home and is a non-invasive blood pressuremeasurement system intendedto measure the diastolic andsystolic blood pressures andpulse rate of an adultindividual by using a non-invasive technique in which aninflatable cuff is wrappedaround the upper arm. The cuffcircumference is limited to22cm-48cm. | Different 1(Note 1) |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff Location | Upper arm | Upper arm | Same |
| Physical Attributes | |||
| Weight(excludebatteries andcuff) | KD-5811VA, KD-5811BT:Approx. 239g (8 7/16 oz.)KD-5810VA, KD-5810BT:Approx. 191g (6 3/4oz.) | About 239g | Different 2(Note 2) |
| Item | Subject Device | Predicate Device(KD-5811 K210770) | ComparisonResult |
| (KD-5811VA, KD-5811BT,KD-5810VA, KD-5810BT,KD-5920VA, KD-5920BT,KD-5923TS) | |||
| KD-5920VA, KD-5920BT:Approx. 235g (8 9/32oz.) | |||
| KD-5923TS:Approx. 166g (5 27/32 oz.) | |||
| Dimensions | KD-5811VA, KD-5811BT:Approx.139.4mm×93.8mm×43.4mm (5 1/2" × 3 11/16″ × 1 23/32")KD-5810VA, KD-5810BT:Approx.139.4mm×93.8mm×41.8mm (5 1/2" × 3 11/16" x 1 21/32")KD-5920VA, KD-5920BT:Approx.150mm×95mm×41mm (5 29/32" × 3 3/4″ × 1 5/8")KD-5923TS:Approx.107mm×80mm×52mm (4 7/32" × 3 5/32" × 2 1/16") | 139.4mm×93.8mm×43.4mm | Different 3(Note 3) |
| Memory | KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT:2x120 timesKD-5923TS: 4×30 times | 2×120 times2×60 times2×30 times | Different 4(Note 4) |
| DisplayedCalculatedParameters | SYSDIAPulseIHB | SYSDIAPulseIHB | Same |
| WirelessFunction | KD-5811BT, KD-5810BT, KD-5920BT:Bluetooth wireless transmissionfunctionKD-5811VA, KD-5810VA,KD-5920VA, KD-5923TS:None | None | Different 5(Note 5) |
| Voice Function | KD-5811VA, KD-5810VA,KD-5920VA:Voice guidance test procedurefunctionKD-5811BT, KD-5810BT, KD-5920BT, KD-5923TS:None | None | Different 6(Note 6) |
| BodyMovementReminder | KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT and KD-5923TS: | None | Different 7(Note 7) |
| Item | Subject Device | Predicate Device | Comparison Result |
| (KD-5811VA, KD-5811BT,KD-5810VA, KD-5810BT,KD-5920VA, KD-5920BT,KD-5923TS)Body movement reminderfunction | (KD-5811 K210770) | ||
| Cuff WrapReminder | KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT and KD-5923TS:Cuff wrap reminder function | None | Different 8(Note 8) |
| Electrical Power | |||
| Battery | KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT:4 ×1.5V SIZE AAKD-5920VA, KD-5920BT,KD-5923TS:4 ×1.5V SIZE AAA | 4 ×1.5V SIZE AA | Different 9(Note 9) |
| Environmental Operation | |||
| Temperature | 5°C | 10~40°C | Different 10(Note 10) |
| Humidity | ≤85%RH | ≤85% | Same |
| Environmental Storage | |||
| Temperature | -20°C | -20~50°C | Different 11(Note 11) |
| Humidity | ≤90%RH | ≤85% | Different 12(Note 12) |
| Performance NIBP | |||
| Pulse RateRange | 40-180 beats/minute | 40 -180times/min | Same |
| Pulse RateAccuracy | Less than 60: ±3bpmMore than 60 (incl.): ±5% | Less than 60: ±3bpmMore than 60 (incl.): ±5% | Same |
| Technique/Method | Oscillometric | Oscillometric | Same |
| PressureAccuracy | Within±3mmHg | Within ±3mmHg | Same |
| Cuff PressureRange | 0-300mmHg | 0-300mmHg | Same |
| Over pressureLimit | 300mmHg | 300mmHg | Same |
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Note 1: The cuff range has changed, but the clinical report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 2: Some of the device weight has changed, but the electrical safety report and the EMC report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 3: Some of the device dimensions have changed, but the electrical safety report and the EMC report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 4: Some of the device memory times have changed, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 5: Bluetooth wireless transmission function has been added to some models, but the software validation
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K234041
we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 6: Voice function has been added to some models, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 7: The body movement reminder function has been added to all subject models, but the software
validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 8: The cuff wrap reminder function has been added to all subject models, but the software validation we submitted confirmed that the subjected are as safe and effective as the predicate.
Note 9: The battery volume of some new models has changed, but the electrical safety report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 10: The temperature range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 11: The temperature range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
Note 12: The humidity range of all the new models are changed, but the performance report we submitted confirmed that the subjected devices are as safe and effective as the predicate.
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.
8.0 Discussion of Non-Clinical Testing
Non-clinical tests 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+AMD1: 2012+AMD2:2020 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2:2014+A1:2020Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-11:2015 +A1:2020 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: Edition 2.0 2018-03 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
None of the test demonstrates that the new Blood Pressure Monitors bring new questions of safety and effectiveness.
9.0 Clinical Test
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Clinical test has been performed in accordance with ISO 81060-2. For the cuff size with 15-24 cm, 20-34 cm, 30-44 cm, 15-24 cm, 22-42 cm, and 42-48 cm, 231 patients ( 107 males and 124 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
10.0 Conclusion
The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA, KD-5811BT, KD-5810VA, KD-5810BT, KD-5920VA, KD-5920BT and KD-5923TS) is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5811 (K210770).
§ 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).