(159 days)
QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm.
This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)
QardioArm, model A100 measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The device includes a plastic enclosure and an integrated wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.
This document describes the QardioArm, model A100, a non-invasive blood pressure monitoring system. It references regulatory standards, predicate devices, and performance claims but does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already cleared devices rather than providing a standalone clinical study report.
Thus, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance with specific metrics like sensitivity, specificity, accuracy for a given disease or condition. The document primarily reports pressure and pulse accuracy as engineering specifications.
- Sample size used for a test set, data provenance, number of experts for ground truth, adjudication method, or details of a multi-reader multi-case study.
- Details of a standalone performance study as would be conducted if the device were completely novel.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any clinical testing beyond the general statement of applying clinical test standards.
- Sample size for the training set or how ground truth was established for a training set (as this device is not an AI/ML device in the context of the question).
However, based on the provided text, here is an extraction of relevant information, focusing on the available performance specifications and the clinical testing mentioned:
1. A table of acceptance criteria and the reported device performance
The document mentions meeting specific accuracy criteria for blood pressure and pulse measurements. While not explicitly stated as "acceptance criteria" for a study, these are performance specifications that the device is stated to achieve and would likely be part of the product's design and validation requirements.
| Performance Metric | Acceptance Criteria (as reported specification) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | ±3mmHg or ±2% of readout value | ±3mmHg or ±2% of readout value |
| Pulse Accuracy | ±5% of reading value | ±5% of reading value |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states under "3. PERFORMANCE & CLINICAL TEST" that the device was tested against "ANSI/AAMI ISO 81060-2:2009" and "EN 1060-4:2004". These are international standards for non-invasive sphygmomanometers. ISO 81060-2:2009 specifies requirements for the clinical investigation of non-invasive blood pressure measuring equipment. These standards typically define the population (e.g., age, sex, blood pressure ranges) and the number of subjects required for clinical validation (e.g., at least 85 subjects with specific distributions). However, the specific sample size, data provenance, or whether the study was retrospective or prospective are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the summary. For blood pressure monitors, "ground truth" (or reference measurements) would typically be established using a auscultatory method by trained observers following a specific protocol, often with double or triple readings. However, details of observers' qualifications or number are not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the summary. For clinical validation of blood pressure devices against a reference method, specific protocols for averaging or adjudicating reference readings are standard (e.g., two observers taking simultaneous readings, with a third if there is a significant discrepancy). However, the summary does not detail the methods used.
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
This is not applicable to the QardioArm device as described. The QardioArm is a blood pressure monitor, not an AI-assisted diagnostic imaging or health analytics device that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The document does not suggest any AI components for interpretation or assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable in the context of "algorithm only" as typically applied to AI/ML devices. The device's performance is inherently "standalone" in the sense that it measures blood pressure and pulse rate automatically using an oscillometric method without human intervention in the measurement process itself, though it requires an external device for display and user interaction. The "Performance & Clinical Test" section implies validation of this automated measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood pressure monitor, the "ground truth" would almost certainly be simultaneous or sequential auscultatory blood pressure measurements taken by trained observers using a calibrated sphygmomanometer, following a standard protocol (e.g., as defined by ISO 81060-2). The document implicitly references this by stating conformity to ISO 81060-2.
8. The sample size for the training set
This information is not provided. The concept of a separate "training set" for an algorithm is typically associated with AI/Machine Learning models. The QardioArm uses a fundamental oscillometric method, which is a well-established algorithm, not typically "trained" in the modern AI sense. Its development would involve engineering design and calibration, followed by validation.
9. How the ground truth for the training set was established
As there is no mention of a training set in the AI/ML context, this information is not applicable to the provided summary.
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Summary of Safety and Effectiveness
(According to 21 CFR 807.92)
510(k) Summary for ___________________________________________________________________________________________________________________________________________________________
Submitter's information
| Name | : Qardio, Inc. |
|---|---|
| Address | : 340 S Lemon Ave #1104F, Walnut, CA 91789, USA |
| Phone number | : +1-(415) 670.9668 |
| Fax number | : +1-(415) 520.9601 |
Manufacturer's name
| Name | : YA HORNG ELECTRONIC CO., LTD. |
|---|---|
| Address | : No.35, Shalun, Anding Dist., Tainan City 745, Taiwan (R.O.C.) |
| FDA Registration | : # 3001147827 |
| 510k Contact person | : Dr. Jen, Ke-MinTel: +886-3-5208829 Fax:+886-3-5209783Email: ceirs.jen@msa.hinet.net |
Date of preparation: December 29, 2013
Device name
| Trade name : | QardioArm |
|---|---|
| Device name : | QardioArm, model A100 |
| Common name : | Blood Pressure Monitor |
Classification
| Classification name | : Non-Invasive Blood Pressure Monitoring System |
|---|---|
| Regulation number | : 21CFR Section 870.1130 |
| Class | : II (Two) performance standards |
| Specialty | : Cardiovascular |
| Product code | : DXN |
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| Predicate devices |
|---|
| • KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672) |
| • Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth |
| • Transmission BP-700W (K121025) |
Device Information
Device description : QardioArm, model A100 measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The device includes a plastic enclosure and an integrated wraparound cuff, and it requires an external device (e.g. a smartphone) to display results and perform user interaction.
Indication for use
:
QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm.
This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in)
Test Summary:
-
- ELECTRIC SAFETY, EMC and FCC test reports,
| General safety | IEC 60601-1:2005 | PASS |
|---|---|---|
| EN 1060-1:2002, EN 1060-3:2005 | PASS | |
| EMC conformity | IEC 60601-1-2: 2007 | PASS |
| FCC conformity | ANSI C63.4 | PASS |
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2. WOVEN COTTON SHEETING:
(Same as the predicate devices: YA HORNG Upper Arm Blood Pressure Monitor, Bluetooth Transmission; Type: BP700W, K121025)
Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).
3. PERFORMANCE & CLINICAL TEST
ANSI/AAMI ISO 81060-2:2009
EN 1060-4:2004
Comparison with predicate device and conclusion
| Comparison item | Proposed device | Predicate device | Predicate device |
|---|---|---|---|
| Applicant | Qardio, Inc. | YA HORNG Electronic Co., Ltd. | Andon Health Co., Ltd. |
| Trade name | QardioArm | YA HORNG Upper Arm BloodPressure Monitor, BluetoothTransmission | iHealth BP5 Fully AutomaticArm Cuff Wireless BloodPressure Dock |
| Model name | A100 | BP700W | KD-936 |
| 510K number | New listing | K121025 | K120672 |
| Technologicalcharacteristics | Oscillometric method | Oscillometric method | Oscillometric method |
| Measuring method | Oscillometric method,automatic inflation andmeasurement | Oscillometric method,automatic inflation andmeasurement | Oscillometric method,automatic inflation andmeasurement |
| Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor |
| Rapid air release | By an active electronic controlvalve | By an active electronic controlvalve | By an active electronic controlvalve |
| Pressure accuracy | Pressure: ±3mmHg or ±2% ofreadout value | Pressure: ±3mmHg or ±2% ofreadout value | Pressure: ±3mmHg |
| Pulse accuracy | ±5% of reading value | ±5% of reading value | ±5% of reading value |
| System architecture | Requires an external device toconstitute a complete bloodpressure measurement system | Independent operation | Requires an external device toconstitute a complete bloodpressure measurement system |
| Display and userinteraction | Requires an external device todisplay results and performuser interaction | LCD monitor and personalcomputer | Requires an external device todisplay results and performuser interaction |
| Power source | Disposable 4 x AAA alkalinebatteries | Disposable 4 x AAA alkalinebatteries | Rechargeable batteries (Li-Ion400 mAh) |
| Communication: | Wireless, based on BluetoothV4.0 (Bluetooth Low Energy) | Wireless, based on BluetoothV2.0 | Wireless, based on BluetoothV3.0 + EDR |
| Cuff type and size | Upper arm type, size: 22 to37cm | Upper arm type, size: 23 to33cm | Upper arm type, size: 22 to48cm |
| Operating temp.and humidity | 10 to 40°C, 15 to 90% RH,atmospheric 86Kpa to 106kpa,altitude: 2000m | 10 to 40°C, 15 to 90% RH,atmospheric 86kpa to 106kpa,altitude: 2000m | 5 to 40°C, < 90 %RH |
| Storage temp. andhumidity | -25 to 70°C, 10 to 95% RH,atmospheric 86Kpa to 106kpa,altitude: 2000m | -25 to 70°C, 10 to 95% RH,atmospheric 86Kpa to 106kpa,altitude: 2000m | -20 to 55°C < 90 %RH |
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Summary with predicate device and conclusion
The new device, QardioArm, model A100 is substantially equivalent to the KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672) and the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025).
YA HORNG Electronic Co., Ltd. (FDA owner number 9040892) is the manufacturer of the QardioArm, model A100 and the predicate device YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025). Furthermore, the QardioArm, model A100 and the predicate device YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W share the same design specifications.
The intended use and the indications for use of the QardioArm, model A100 as described in its labeling are the same as the two predicate devices and all three devices are intended to be used in the same manner and environments.
The QardioArm, model A100 and the predicate devices are substantially equivalent in the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC.
Only the user interface and visual appearance, and the cuff size for the new device and the predicate devices are different. The QardioArm, model A100 and the two predicate devices use Bluetooth technology for wireless communications with an external device. However, QardioArm, model A100 uses Bluetooth V4.0 (Bluetooth Low Energy) to operate with wireless communications with an iPhone, iPod or iPad, while the KD-936 Fully Automatic Wireless Blood Pressure Monitor uses Bluetooth V3.0+EDR to operate with wireless communications with an iPhone, iPod or iPad, and the YA HORNG Upper Arm Blood Pressure Monitor, Bluetooth Transmission BP-700W uses Bluetooth V2.0 to operate with wireless communications with a personal computer.
Thus they are substantially equivalent.
Qardio, Inc. believes this information and the referred documentation to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate products and other products currently in distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 18, 2014
Qardio, Inc. c/o Dr. Jen, Ke-Min 340 S Lemon Ave #1104F Walnut, CA 91789 USA
Re: K140067
Trade/Device Names: QardioArm, Model A100 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 3, 2014 Received: May 9, 2014
Dear Dr. Jen:
i
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. Ilsting 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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Page 2 - Dr. Jen. Ke-Min
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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: K140067 Device Name: QardioArm, model A100
. Indications for use:
QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A 100 utilizes an inflatable cuff that is wrapped around the upper arm.
This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in~14.6in).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Over-The-Counter Us e _
(21 CFR 807 Subpart C)
t 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
ConcurrenceofCDRH,OfficeofDeviceEvaluation(ODE)
| Date | 2017.05.18 |
|---|---|
| 07:30:53 -04'00' |
Page ー of ﻋﺴﻮ . )
§ 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).