(30 days)
No
The device description explicitly states that the blood pressure measurement is "nonautomatically" determined by the user finding the Korotkoff sounds. While it automatically calculates pulse rate based on oscillometry, this is a standard signal processing technique, not indicative of AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is intended for non-automatic measurement of blood pressure and pulse rate, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
The device is intended for non-automatically measuring blood pressure and pulse rate, which are physiological parameters. While these measurements can be used by a user (professional or home user) to determine blood pressure, the device itself doesn't provide a diagnosis. It provides data for the user to interpret.
No
The device description explicitly lists multiple hardware components: arm cuff, pressure sensing module, hand pump (bulb) with airflow valve, stethoscope with earphone plug, and charging cable. While it utilizes a smartphone app, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Accutension Smartphone Auscultatory Blood Pressure Kit measures blood pressure and pulse rate by external means (cuff pressure and auscultation of Korotkoff sounds). It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for nonautomatic measurement of blood pressure and pulse rate, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DXQ, DQD
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
professionals or home users
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Non-clinical Test (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.
- In Vitro Cytotoxicity Test: Standard requirement ISO 10993-5:2009 Cytotoxicity Should no toxicity. Test Result: The test article did not show potential toxicity to L-929 cells. Conclusion: Qualified.
- Guinea Pig Maximization Test: Standard requirement ISO 10993-10:2010 There should be no skin sensitization. Test Result: No significant evidence of causing skin sensitization in the guinea pig. Conclusion: Qualified.
- Skin Irritation Test: Standard requirement ISO 10993-10:2010 There should be no skin irritation. Test Result: The response of skin on testing side does not exceed that on the control side. Thus, it is identified as grade 0. Conclusion: Qualified.
Non-clinical Test (Performance Testing):
Bench tests were performed 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
- Additional bench tests: Testing to demonstrate pulse rate accuracy, Testing to demonstrate wireless co-existence, Testing to demonstrate stethoscope performance.
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.
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
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);
1
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
2
Indications for Use
510(k) Number (if known)
Device Name Accutension Smartphone Auscultatory Blood Pressure Kit
Indications for Use (Describe)
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.
| 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., Ltd
No. 509 Caobao Road, Room 101-2 Bld 9, Xuhui
District, Shanghai, China |
|-------------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person: | Junfeng Zhao
Phone: 0086-18621892190
Fax: 0086-21-56782078#805
Email: zhaoap@hotmail.com |
| Date Prepared: | Mar 26, 2017 |
| Device Name: | Accutension Smartphone Auscultatory Blood
Pressure 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
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
4
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.
| Technology
Characteristics | Current
Device | Predicate
Device | Comments |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cuff design | Fabric cuff | Fabric cuff | Same |
| | with bladder | with bladder | |
| Cuff inflation
mechanism | Manual
inflation with
hand pump | Manual
inflation with
hand pump | Same |
| Cuff pressure
gauge | Electrical
pressure
sensor | Mechanical
pressure
sensor | These two types of pressure sensor
has the same grade of accuracy
defined in ISO 81060-1. |
| Pressure
display | Displayed on
a
smartphone | Displayed on
a mechanical
dial | The pressure displayed on the
smartphone is digitalized (directly
show the cuff pressure number).
The predicate device uses a needle
to point to the cuff pressure
number in the dial. These two are
similar because a user can get the
cuff pressure number in either way. |
| Korotkoff
sounds picking | Stethoscope
head | Stethoscope
head | The mechanical mechanism of the
stethoscope head is similar |
| Korotkoff
sounds
processing | Recorded
with a
microphone
sensing the
picked
Korotkoff
sounds from
the
stethoscope
head and
then
playback to
the human
ear. | The sounds
directly go to
the human
ear. | The difference is that the current
device records the sounds first and
then playback the sounds to the
human ears for blood pressure
determination while the predicate
device transfer the sounds directly
to the human ears for blood
pressure determination. |
| Blood
pressure
determination | By listening
to the
Korotkoff
sounds with
human ear | By listening
to the
Korotkoff
sounds with
human ear | The same |
| Sounds and
cuff pressure
visualization | Sounds and
cuff pressure
are visualized | No such
feature | This provides an extra feature to
help capture the first and last
Korotkoff sounds for blood pressure
determination. |
| Blood
pressure
storage | The blood
pressure
readings can
be stored in | No such
feature | This provides an extra feature to
track blood pressure history. |
| | the
smartphone | | |
| Pulse rate
calculation | Oscillometry | Oscillometry | The same |
5
6
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.
| Biocompatibility
Test | Standard
requirement | Test Result | Conclusion |
|---------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------|
| In Vitro
Cytotoxicity Test | ISO 10993-5:2009
Cytotoxicity
Should no toxicity. | The test article did
not show potential
toxicity to L-929
cells. | Qualified |
| Guinea Pig
Maximization Test | ISO 10993-10:2010
There should be
no skin
sensitization | No significant
evidence of
causing skin
sensitization in the
guinea pig. | Qualified |
| Skin Irritation Test | ISO | The response of | Qualified |
7
| 10993-10:2010
There should be
no skin irritation. | skin on testing side
does not exceed
that on the control
side. Thus, it is
identified as grade
0. | |
| --------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ | -- |
|---|
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