Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautomatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.

Device Description

The Accutension Smartphone Auscultatory Blood Pressure Kit (Model XYZ-110) is a non-invasive blood pressure measurement system for professionals and home users to nonautomatically measure systolic and diastolic blood pressure and pulse rate. It utilizes advanced pressure sensing module to transfer cuff pressure value to an iOS App via established Bluetooth connection between the module and the iOS device during measurement, meanwhile a stethoscope detects Korotkoff sounds and transfers the sound signal to the smartphone via its earphone jack. Both the cuff pressure and auscultatory sounds are visualized in the app and a user can determine the systolic and diastolic blood pressure by finding the cuff pressures on the first and last Korotkoff sounds. It automatically calculates the pulse rate based on cuff pressure oscillometry. This device consists of 5 parts, arm cuff, pressure sensing module, hand pump (bulb) with airflow valve, stethoscope with earphone plug and charging cable.

AI/ML Overview

This document describes the 510(k) premarket notification for the Accutension Smartphone Auscultatory Blood Pressure Kit (Model XYZ-110). It demonstrates the device's substantial equivalence to predicate devices for blood pressure and pulse rate measurement. The core of the evidence relies on clinical and non-clinical testing, particularly adherence to ISO 81060-2:2013 for blood pressure accuracy.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the device's accuracy was assessed against the criteria specified in ISO 81060-2:2013. While specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure are not explicitly tabulated in the provided text, the conclusion section confirms that the device "satisfies the criteria specified in ISO 81060-2:2013" and is "as safe and effective (accurate) in a clinical environment".

For pulse rate, the document states: "Testing to demonstrate pulse rate accuracy" was performed, and the Conclusion claims the device demonstrates "the same level of safety, effectiveness and performance" as predicate devices. However, explicit numerical acceptance criteria for pulse rate accuracy are not provided.

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

Sample Size for Clinical Test (Blood Pressure Accuracy): "255 pairs of data from 85 valid subjects were achieved following the clinical study protocol defined in ISO 81060-2:2013."
Data Provenance: The text does not explicitly state the country of origin of the data. Since the submitting company is Shanghai Hulu Devices Co., Ltd, it is highly probable the data originated from China. The study is described as a "clinical study," which implies a prospective collection of data.

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

The document mentions that a "manual Mercury Sphygmomanometer was used as a reference device in the clinical testing." For the primary blood pressure determination, the device relies on a human user "listening to the Korotkoff sounds with human ear." However, the text does not specify the number of expert readers, their qualifications (e.g., radiologists, physicians with X years of experience), or if they were involved in establishing the "ground truth" beyond performing the reference measurements with the mercury sphygmomanometer. The ISO 81060-2 standard usually details requirements for reference measurements and observers.

4. Adjudication method for the test set

The document describes a "Same arm simultaneous method" used during the clinical validation, with a manual Mercury Sphygmomanometer as a reference. This usually implies a direct comparison, rather than an adjudication process between multiple readers. No mention of an adjudication method (e.g., 2+1, 3+1) is made for determining the ground truth for the test set.

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. The device is not an AI-assisted diagnostic tool in the typical sense where AI provides an interpretation and human readers improve with its assistance. Instead, it digitizes and visualizes blood pressure and Korotkoff sounds for a human user to interpret. The study focuses on the accuracy of the device itself compared to a reference standard (manual mercury sphygmomanometer).

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

No, the device is explicitly designed for human-in-the-loop performance. The core method for blood pressure determination is "By listening to the Korotkoff sounds with human ear". The device visualizes the sounds and cuff pressure, which "provides an extra feature to help capture the first and last Korotkoff sounds for blood pressure determination." Therefore, no standalone algorithm-only performance was conducted or is applicable given the device's function. The pulse rate is "automatically calculates based on cuff pressure oscillometry," which is a standalone algorithm component for that specific measurement.

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

The ground truth for blood pressure measurement was established using a "manual Mercury Sphygmomanometer" as a reference device in the clinical testing, following the protocol of ISO 81060-2:2013. This implies a direct, real-time comparison to a well-accepted clinical standard performed by human observers.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI models. Given that the device's primary method for blood pressure determination relies on human auscultation supplemented by visualization, and pulse rate is calculated via oscillometry (a known physiological method), there isn't an explicit "training set" for an AI algorithm for these core functions. The term "training set" is usually relevant for AI/ML devices that learn from data, which doesn't appear to be the case for the primary blood pressure determination function here.

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

As there is no explicit mention of a "training set" for a machine learning model for blood pressure determination, this question is not applicable to the provided information.

Summary

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March 8, 2018

Shanghai Hulu Devices Co., Ltd. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K180335

Trade/Device Name: Accutension Smartphone Auscultatory Blood Pressure Kit Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ, DQD Dated: February 5, 2018 Received: February 6, 2018

Dear Dave Yungvirt:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M.A. Hillebrenner

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)

K180335

Device Name Accutension Smartphone Auscultatory Blood Pressure Kit

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitted by:	Shanghai Hulu Devices Co., LtdNo. 509 Caobao Road, Room 101-2 Bld 9, XuhuiDistrict, Shanghai, China
Contact Person:	Junfeng ZhaoPhone: 0086-18621892190Fax: 0086-21-56782078#805Email: zhaoap@hotmail.com
Date Prepared:	Mar 26, 2017
Device Name:	Accutension Smartphone Auscultatory BloodPressure Kit
Model	XYZ-110
Common Name:	Blood Pressure Cuff
Classification:	II
Regulation Number	870.1120
Regulation Name:	Blood Pressure Cuff
Product Code:	DXQ, DQD

5.1 Predicate Device

Aneroid Sphygmomanometer BK2002 (Wenzhou Bokang Instrument Co., Ltd, K043286) is used as a predicate device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on blood pressure measurement.

HEM-7320 (OMRON HEALTHCARE, INC., K133383) is used as a predicate device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on pulse rate measurement.

5.2 Reference Device

AliveCor Heart Monitor (AliveCor, Inc., K142743) is used as a reference device compared to Accutension Smartphone Auscultatory Blood Pressure Kit on store and record waveforms.

5.3 Device Description

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pressure and auscultatory sounds are visualized in the app and a user can determine the systolic and diastolic blood pressure by finding the cuff pressures on the first and last Korotkoff sounds. It automatically calculates the pulse rate based on cuff pressure oscillometry.

This device consists of 5 parts, arm cuff, pressure sensing module, hand pump (bulb) with airflow valve, stethoscope with earphone plug and charging cable. None of the 5 parts of the Accutension Smartphone Auscultatory Blood Pressure Kit have received 510(k) clearance on their own as a stand-alone device. Instead, collectively, they are considered to be components of a device that is substantially equivalent to the cited predicate device.

5.4 Indication for Use

Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautoamatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.

The indication for use statement is similar to that of the predicate device K043286 on blood pressure measurement: The device is intended to be used by medical professional or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to patient and manually inflated along with a manual method for detecting Korotkoff sounds. In both statements, the user who operate the device is the same: either professionals or home users, the subject who is measured is the same: adults, the function is the same: measure systolic and diastolic blood pressure, and the method is the same: detecting Korotkoff sounds. The proposed device emphasizes that it is not for children, heart failure patients and critical patients to further clarify the measurement subjects.

The indication for use statement is similar to that of the predicate device K133383 on pulse rate measurement. The pulse rate measurement method is the same. Both use oscillometry to calculate the pulse rate.

5.5 Technology Characteristics

Accutension Smartphone Auscultatory Blood Pressure Kit uses the Korotkoff sounds based blood pressure determination method that is used by the predicate device. Here is a comparison on the technology characteristics between the current device and the predicate device.

TechnologyCharacteristics	CurrentDevice	PredicateDevice	Comments
Cuff design	Fabric cuff	Fabric cuff	Same
	with bladder	with bladder
Cuff inflationmechanism	Manualinflation withhand pump	Manualinflation withhand pump	Same
Cuff pressuregauge	Electricalpressuresensor	Mechanicalpressuresensor	These two types of pressure sensorhas the same grade of accuracydefined in ISO 81060-1.
Pressuredisplay	Displayed onasmartphone	Displayed ona mechanicaldial	The pressure displayed on thesmartphone is digitalized (directlyshow the cuff pressure number).The predicate device uses a needleto point to the cuff pressurenumber in the dial. These two aresimilar because a user can get thecuff pressure number in either way.
Korotkoffsounds picking	Stethoscopehead	Stethoscopehead	The mechanical mechanism of thestethoscope head is similar
Korotkoffsoundsprocessing	Recordedwith amicrophonesensing thepickedKorotkoffsounds fromthestethoscopehead andthenplayback tothe humanear.	The soundsdirectly go tothe humanear.	The difference is that the currentdevice records the sounds first andthen playback the sounds to thehuman ears for blood pressuredetermination while the predicatedevice transfer the sounds directlyto the human ears for bloodpressure determination.
Bloodpressuredetermination	By listeningto theKorotkoffsounds withhuman ear	By listeningto theKorotkoffsounds withhuman ear	The same
Sounds andcuff pressurevisualization	Sounds andcuff pressureare visualized	No suchfeature	This provides an extra feature tohelp capture the first and lastKorotkoff sounds for blood pressuredetermination.
Bloodpressurestorage	The bloodpressurereadings canbe stored in	No suchfeature	This provides an extra feature totrack blood pressure history.
	thesmartphone
Pulse ratecalculation	Oscillometry	Oscillometry	The same

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Overall, the current device uses more up-to-date technologies to implement the same blood pressure measurement method used by the predicate device to improve blood pressure measurement.

5.6 Applicable Guidance Document

FDA Guidance for Industry: Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1 (1998).

5.7 Clinical Test

255 pairs of data from 85 valid subjects were achieved following the clinical study protocol defined in ISO 81060-2:2013. Same arm simultaneous method was adopted during the clinical validation for Accutension Smartphone Auscultatory Blood Pressure Kit. A manual Mercury Sphygmomanometer was used as a reference device in the clinical testing. All the subjects who enrolled in this study were well informed of the value and the risk of the study by the researchers and signed the consent forms before they took part in the clinical study. The results showed the accuracy of the device made by Shanghai Hulu Devices Co, Ltd. satisfies the criteria specified in ISO 81060-2:2013.

5.8 Non-clinical Test

5.8.1 Biocompatibility Testing

The biocompatibility evaluation for this device was conducted in accordance with the FDA Bluebook Memorandum G95-1 "Use Of International Standard ISO-10993, 'Biological Evaluation Of Medical Devices Part 1: Evaluation And Testing.'" and the International Standard ISO 10993-1 Fourth Edition 2009-10-15, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)], as recognized by FDA.

BiocompatibilityTest	Standardrequirement	Test Result	Conclusion
In VitroCytotoxicity Test	ISO 10993-5:2009CytotoxicityShould no toxicity.	The test article didnot show potentialtoxicity to L-929cells.	Qualified
Guinea PigMaximization Test	ISO 10993-10:2010There should beno skinsensitization	No significantevidence ofcausing skinsensitization in theguinea pig.	Qualified
Skin Irritation Test	ISO	The response of	Qualified

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10993-10:2010There should beno skin irritation.	skin on testing sidedoes not exceedthat on the controlside. Thus, it isidentified as grade0.
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5.8.2 Performance Testing

We have performed bench tests and found that the Accutension Smartphone Auscultatory Blood Pressure Kit met all requirements specifications and standards requirement. Testing includes the following:

-Testing for compliance to IEC 60601-1:2012
-Testing for compliance to IEC 60601-1-2:2014
-Testing for compliance to IEC 60601-1-11:2015
-Testing for compliance to ISO 81060-1:2007
Testing for compliance to FCC CFR Title 47 Part 15 Subpart C Section 15.247 -
Besides the testing for compliance, we did the additional bench tests:
-Testing to demonstrate pulse rate accuracy
Testing to demonstrate wireless co-existence -
-Testing to demonstrate stethoscope performance

5.8.2.1 Usability Study Summary

30 people participated in human factor validation testing, in which 15 participants are general users while another 15 participants are healthcare professionals, to simulate the use of the device in both home and clinical office environment. All the participants completed all the tasks without use error.The results showed the Accutension Smartphone Auscultatory Blood Pressure (BP) Kit is safe and effective for the intended users, uses and use environments.

5.8.2.2 Synchronization Testing Summary

Synchronization of the stethoscope sounds and cuff pressures was tested. In the test, the same stethoscope sounds and cuff pressures collected by the Accutension Smartphone Auscultatory Blood Pressure Kit were compared with those directly sensed by a data acquisition card. The later one has a zero time difference in theory. The time difference criteria was set as -150ms<ΔT<150ms. The measured ΔTmax is less than 150ms and passed the test.

5.9 Conclusion

The biocompatibility testing results demonstrate the equivalence to the predicate device on biocompatibility requirement. The performance testing results demonstrate the same level of safety, effectiveness and performance though new technology characteristics are introduced. The clinical test results demonstrate the current device is as safe and effective (accurate) in a clinical environment. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, based on

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the information provided in this premarket notification, Shanghai Hulu Devices Co., Ltd concludes that Model XYZ-110 Accutension Smartphone Auscultatory Blood Pressure Kit is substantially equivalent to the predicate and complies to testing defined in ISO 81060-1 standard.

5.10 Others

Shanghai Hulu Devices Co., Ltd will update and include in this summary any other information deemed necessary by FDA.

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).