The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.

Device Description

Discovery 1 is a portable non-invasive Hemodynamic Blood Pressure Monitor powered by an internal rechargeable lithium polymer battery. It contains a pulse wave probe incorporating two LEDs, which can collect the pulse wave to the device.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study details:

1. A table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Predicate Device K093981) Coverage for Subject Device	Reported Device Performance (Discovery 1)
Blood Pressure
Systolic Range	90 mmHg ~ 240 mmHg	50 mmHg ~ 200 mmHg
Diastolic Range	30 mmHg ~ 130 mmHg	40 mmHg ~ 160 mmHg
Accuracy	<10% (for predicate)	±5 mmHg (for subject device)
Pulse Rate
Measurement Range	30 bpm ~ 200 bpm	40 bpm ~ 240 bpm
Accuracy	Mean Square Error 0.5digits (for predicate)	±2% or ±2 bpm, whichever is greater

Note: The document explicitly states that the subject device's blood pressure accuracy of ±5 mmHg and pulse rate accuracy of ±2% or ±2 bpm (whichever is greater) meet the requirements of the ISO 81060-2: 2013 standard, and the full claimed range has been verified. The differences in specific ranges and accuracy benchmarks between the predicate and subject device were addressed and deemed not to raise safety or effectiveness issues.

2. Sample size used for the test set and the data provenance

The document states that clinical accuracy was assessed according to ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Sample Size for Test Set: The ISO 81060-2: 2013 standard typically requires a minimum of 85 subjects for clinical validation studies for non-invasive sphygmomanometers. While the exact number of subjects is not explicitly stated in this document, adherence to the standard implies this or a similar sample size was used for the clinical accuracy testing.
Data Provenance: Not explicitly stated in the provided text. It's common for such studies to be conducted in a controlled clinical environment, but the country of origin is not mentioned. The study is prospective as it's a clinical validation study performed to evaluate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ISO 81060-2: 2013 standard, which the device adhered to for clinical accuracy, details requirements for observers during manual reference measurements. Typically, this would involve at least two trained observers measuring blood pressure using a standard auscultatory method. Their qualifications would be as trained clinical professionals experienced in taking manual blood pressure measurements. Specific details on the number or qualifications of these experts are not provided in this document, but their involvement is implied by compliance with the standard.

4. Adjudication method for the test set

For clinical validation studies following ISO 81060-2: 2013, if the initial two observers have discrepancies in their measurements, a third independent observer often adjudicates or a defined protocol for resolving discrepancies is followed. The document does not explicitly state the adjudication method, but adherence to ISO 81060-2 implies a standard protocol for reconciling differences in observer measurements.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in this document, nor is there any discussion of human readers improving with AI assistance. The device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the clinical accuracy study described, adhering to ISO 81060-2, is a standalone performance assessment of the device's algorithm. The device itself (Discovery 1) is an automated system for measuring blood pressure; its performance is compared directly to a reference standard (manual measurement), without involvement of human-in-the-loop for measurement interpretation. The device's output is the final measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical accuracy study was established by reference measurements performed by trained observers using a validated method (typically auscultation), as prescribed by the ISO 81060-2 standard. This falls under the category of expert consensus/reference standard measurement.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set. This is typical for 510(k) summaries, which focus on the validation of the final product. The device operates on a principle of hemodynamics and pulse wave analysis, likely developed using a dataset, but details of that developmental dataset are not included here.

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for any training set was established. As mentioned above, the 510(k) summary focuses on the validation of the final device against a recognized clinical standard.

Summary

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August 7, 2019

Vita-Course Technologies Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A. NanShan Medical Devices Industrial Park, Nanshan District, Shenzhen, 518067 Cn

Re: K190893

Trade/Device Name: Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 9, 2019 Received: May 9, 2019

Dear Kevin Wang:

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.

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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 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 (QS) 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 medical devices and radiation-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 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

510(k) Number (if known) K190893

Device Name

Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor

Indications for Use (Describe)

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/04/01

1. Submission sponsor

Name: Vita-Course Technologies Co., Ltd.

Address: 3F, Block B, Dajiahao Plaza, No.362, Yu'an 2nd Road, Bao'an District, Shenzhen, Guangdong, China

Contact person: Kezheng Ma

Title: Management Representative

E-mail: makezheng@vita-course.com

Tel: +86-755-23188226

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen,

Guangdong, P.R. China 518067

Contact person: Kevin Wang

E-mail: kevin(@chonconn.com

Tel: +86-755-33941160

Trade/Device Name	Non-invasive Hemodynamic Blood Pressure Monitor
Model	Discovery 1
Common Name	Non-invasive Blood Pressure Monitor
Regulatory Class	Class II
Classification	21CFR §870.1130 / System, measurement, blood-pressure, non-invasive / DXN
Submission type	Traditional 510(K)

Subject Device Information 3.

4. Predicate Device

By submission of the Traditional 510(k), Vita-Course Technologies Co., Ltd. is requesting clearance for Discovery 1 Non-invasive Hemodynamic Blood Pressure Monitor. It is comparable to the following legally marketed system:

Cnoga Medical ACAL, TensorTip ""- Non-invasive Hemodynamic Blood Pressure Monitor 1. under K093981.

ട്. Intended use & Indication for use

The Discovery 1 Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary

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finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.

6. Device Description

7. Principle of Operation

The product is designed to calculate the blood pressure in terms of conduction time of pulse and wave parameters of pulse. This method is proposed based on interdependent characteristics between conduction time of the pulse wave along the arterial as well as characteristic parameters of the pulse wave and arterial pressure. Through the determination of the PPG signal, conduction time of the pulse wave along thee arterial and other correlation variables would be obtained and accordingly the systolic and diastolic pressures of the body are gotten by fitting operation. The pulse rate can be obtained by calculating the pulse wave signal.

Comparison to the Predicate Device 8.

The Discovery 1 non-invasive Hemodynamic Blood Pressure Monitor and TensorTip™ - Non-invasive Hemodynamic Blood Pressure Monitor (K093981), are identical in purpose, function, core technology and method of operation. Only minor differences exist between the Discovery 1 and predicate, which do not affect the safety or effectiveness of the subject device. Table 1 provides a comparison of the subject and predicate devices.

Features	Subject Device	Predicate Device K093981	Remark
	Discovery 1 non-invasiveHemodynamic Blood PressureMonitor	TensorTipTM - Non-invasiveHemodynamic Blood Pressure Monitor
Indicationfor use	The Discovery 1 - Non-invasiveHemodynamic Blood Pressure Monitordevice is a small, lightweight,handheld, device intended formeasuring and display of BloodPressure trending (systolic anddiastolic) and spot-check of Peripheralpulse rate (PPR) and Peripheral pulsewave (PPW). Measurement isperforming on capillary finger tip tissue(other than the thumb). The ring fingeris the recommended site. The results of	The TensorTip - Non-invasive bloodpressure trending device is a small,lightweight, handheld, device intended formeasuring and display of Blood Pressuretrending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) andPeripheral pulse wave (PPW).Measurement is performing on capillaryfingertip tissue (other than the thumb). Thering finger is the recommended site. Theresults of each measurement are stored inthe system memory. The device is intended	Same
Features	Subject DeviceDiscovery 1 non-invasiveHemodynamic Blood PressureMonitorsystem memory. The device is intendedfor use in the home environment. It isintended to be used by any person agedabove 18 years old.	Predicate Device K093981TensorTipTM- Non-invasiveHemodynamic Blood Pressure Monitorfor use in the home environment. It isintended to be used by any person agedabove 18 years old.	Remark
PatientPopulation	>18 years old	>18 years old	Same
Principle ofOperation	Hemodynamics	Hemodynamics	Same
Powersource	DC adaptor: 5Vd.c.,Internal lithium polymer (Li-Pol)battery: 3.7Vd.c., 2200 mAh	DC adaptor: 5Vd.c.Internal Li-Polymer battery: 3.7Vd.c.,740mAh	Different 1)
Bloodpressure	Systolic pressure range: 50 mmHg ~200 mmHgDiastolic pressure range: 40 mmHg ~160 mmHgAccuracy: ±5 mmHg	Systolic pressure range: 90 mmHg ~ 240 mmHgDiastolic pressure range: 30 mmHg ~ 130 mmHgAccuracy: <10%	Different 2)
Pulse rate	Measurement range: 40 bpm ~ 240 bpmAccuracy: ±2% or ±2 bpm, whicheveris greater	Measurement range: 30 bpm ~200 bpmAccuracy: Mean Square Error 0.5digits	Different 3)
Operatingenvironment	Temperature: 5 °C ~ 45 °CHumidity: 10% ~ 95%	Temperature: 6 °C ~ 45 °CHumidity: 10 ~ 80%	Different 4)
IP degree	IP22	IP00	Different 5)
Standards	IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 81060-2	IEC 60601-1IEC 60601-1-2ISO 81060-2	Different 6)

Table 1: Comparison to Predicate Device

each measurement are stored in the

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Justifications for differences between Discovery 1 and the predicate device are shown as below:

Different (1): The capacity of battery is different. However, the battery of subject device is in compliance with IEC 62133: 2012- Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. Thus, this difference will not raise any safety or effectiveness issue.

Different (2): The measurement range and the accuracy of blood pressure is different. The subject device is compliant with FDA recognized consensus standard ISO 81060-2: 2013. This difference will not raise any safety or effectiveness issue.

Different (3): The measurement range and the accuracy of pulse rate is different. The subject device has been verified all the full claimed range. This difference will not raise any safety or effectiveness issue.

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Different (4): The operating environment is minor different. However, the difference will not raise any safety or effectiveness issue.

Different (5): The degree of protection is different and the subject device is better than predicate device. The subject device is compliant with FDA recognized consensus standard IEC 60601-1-11: 2015. This difference will not raise any safety or effectiveness issue.

Different (6): The compliance standards are different. The subject device is compliant with FDA recognized consensus standard IEC 60601-1-11: 2015. This difference will not raise any safety or effectiveness issue.

9. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

NO.	Item	Description
1	Safety	Ensures the device meet the requirements of IEC 60601-1: 2012 andIEC 60601-1-11: 2015
2	EMC	Ensures the temperature probes meet the requirements of IEC60601-1-2: 2014, IEC 60601-1-11: 2015 clause 12 and ISO 80601-2-61: 2017 clause 201.17 and clause 202
3	Clinical accuracy	ISO 81060-2: 2013 Non-invasive sphygmomanometers - Part 2:Clinical validation of automated measurement type

10. Conclusion

It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, performance characteristics, and intended use.

Regulation Number and Section

§ 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).