(154 days)
The QardioArm 2 is a fully automatic, wireless blood pressure monitor intended to measure the systolic and diastolic blood pressures and pulse rate of adult individuals. It utilizes an inflatable cuff that is wrapped around the upper arm. The arm circumference is limited to 8.7 - 18.5 inches (22 - 47 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is not intended to be used as a diagnostic device and users are instructed to contact their physician if hypertensive values are indicated.
The QardioArm 2 is an over-the-counter (OTC) non-invasive blood pressure monitor intended for spot-checking in adults. It uses a detachable inflatable cuff that is wrapped around the upper arm to determine blood pressure based on the oscillometric method. Two cuff sizes are available: standard size for an arm circumference of 8.7 to 14.6 inches or large size for an arm circumference of 14.6 to 18.5 inches.
The QardioArm 2 is a non-invasive blood pressure measurement system. The acceptance criteria and the study that proves the device meets them are detailed below.
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not contain a specific table of acceptance criteria or reported device performance in the format of a direct comparison table. However, it states that the device "met all the requirements of the standard" and "passed all tests" for various criteria.
Based on the general information provided, we can infer some key performance criteria and the reported performance:
| Acceptance Criteria Category | Specific Criteria (Inferred from standards) | Reported Device Performance |
|---|---|---|
| Accuracy (Blood Pressure) | As per ISO 81060-2:2018 (Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type), which is a recognized standard for blood pressure monitor accuracy. This standard typically requires a mean difference between the device and reference standard of ≤ ±5 mmHg, and a standard deviation of differences ≤ 8 mmHg. (Implicit) | "The device met all the requirements of the standard [ISO 81060-2:2018]." This implies the accuracy criteria of ISO 81060-2 were met. The technological comparison section explicitly states an accuracy of "+/-3mmHg or 2% reading for blood pressure." |
| Accuracy (Pulse) | As per ISO 81060-2:2018 or similar standards for pulse measurement. (Implicit) | The technological comparison section explicitly states an accuracy of "+/-5% for pulse." |
| Electrical Safety | Compliance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance. | "The device passed all tests, including the US deviations." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. | "The QardioArm 2 passed all tests." |
| Battery Safety | Compliance with IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems. | "found to comply with all relevant sections." |
| Wireless Coexistence | Compliance with AAMI TIR69:2017 and ANSI C63.27:2017. | "All tests passed." |
| Software Verification & Validation | Adherence to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," for a "Moderate" level of concern. | "Software verification and validation testing were conducted, and documentation was provided as recommended... The software for this device was considered as a 'Moderate' level of concern." While not explicitly stating "passed," meeting the guidance for a moderate level of concern implies successful validation. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015, 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. | "The device passed all tests." |
| Automated Non-Invasive Sphygmomanometer Performance | Compliance with IEC 80601-2-30:2018, Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. | "The device passed all tests." |
| Human Factors | Adherence to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices," demonstrating the device is safe and effective for its intended users, uses, and use environments. | "The QardioArm 2 was found to be safe and effective for its intended users, uses, and use environments." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Clinical Data (Test Set): 86 subjects.
- Data Provenance: The study was a "prospective, single arm paired comparison study." The document does not specify the country of origin of the data, but it was conducted to demonstrate performance in accordance with ISO 81060-2:2018 and FDA's requirements for 510(k) submissions, suggesting a standard clinical study environment.
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)
The study description mentions a "same arm sequential method with dual auscultators." This implies that the ground truth for blood pressure measurements was established by two human observers (auscultators) using a reference sphygmomanometer. The document does not specify the number of experts beyond "dual auscultators" or their specific qualifications (e.g., years of experience, medical role). However, for such studies, these individuals are typically trained and validated healthcare professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The method used was a "same arm sequential method with dual auscultators." While not explicitly stated as "2+1" or "3+1" (which are typically used for imaging assessments), the use of dual auscultators suggests a comparison or consensus method between the two observers for establishing reference measurements. Differences between the dual auscultators would typically be adjudicated or the reading discarded according to the ISO standard's protocol, though the specific adjudication method is not described in detail.
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
No, an MRMC comparative effectiveness study was not done. This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic imaging device that involves human interpretation of images. The study focused on the device's accuracy compared to a reference standard, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, a standalone performance assessment was done. The QardioArm 2 measures blood pressure automatically (oscillometric method) and provides a reading. The clinical study directly compared these device-generated readings against reference measurements obtained by human auscultators. The device operates autonomously to produce the blood pressure and pulse rate values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for blood pressure measurements was established using a reference sphygmomanometer via a same arm sequential method with dual auscultators. This constitutes an expert consensus or expert-derived reference standard for physiological measurements, rather than pathology or outcomes data.
8. The sample size for the training set
The document does not provide information about a separate "training set" or its sample size. This type of device's core functionality (oscillometric measurement) is based on established principles and algorithms, often developed and refined internally. For a 510(k) submission of a blood pressure monitor, the primary focus is on the performance of the final device as compared to a reference standard in a clinical test set, rather than detailing the training data for an AI algorithm.
9. How the ground truth for the training set was established
As no specific training set data is mentioned for an AI algorithm, the method for establishing ground truth for a training set is not applicable or detailed in this document. The device's operation is based on physical measurement principles rather than a deep learning model requiring a large labeled training dataset in the same way an image analysis AI would.
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June 15, 2022
Qardio Inc Rosario Iannella Chief Technology Officer 345 California Street, Suite 600 & 700 San Francisco, California 94104
Re: K220106
Trade/Device Name: QardioArm 2 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 16, 2022 Received: May 16, 2022
Dear Rosario Iannella:
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.
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
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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 (OS) 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 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,
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
510(k) Number (if known) K220106
Device Name QardioArm 2
Indications for Use (Describe)
The QardioArm 2 is a fully automatic, wireless blood pressure monitor intended to measure the systolic and diastolic blood pressures and pulse rate of adult individuals. It utilizes an inflatable cuff that is wrapped around the upper arm. The arm circumference is limited to 8.7 - 18.5 inches (22 - 47 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is not intended to be used as a diagnostic device and users are instructed to contact their physician if hypertensive values are indicated.
| 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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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the QardioArm 2 is provided below.
1. SUBMITTER
| Applicant: | Qardio, Inc.345 California Street, Suite 600 & 700San Francisco, CA 94104, USAPhone: (415) 670-9613Fax: (415) 520-9601 |
|---|---|
| Contact: | Rosario IannellaChief Technology Officercompliance@qardio.com |
| Submission Correspondent: | Rosario IannellaChief Technology Officercompliance@qardio.com |
| Date Prepared: | May 5, 2022 |
2. DEVICE
Device Trade Name: OardioArm 2 Device Common Name: Noninvasive blood pressure measurement system 21 CFR 870.1130 Classification Name Regulatory Class: Class II Product Code: DXN
3. PREDICATE DEVICE
Predicate Device: K140067, QardioArm A100
DEVICE DESCRIPTION 4.
The QardioArm 2 is an over-the-counter (OTC) non-invasive blood pressure monitor intended for spot-checking in adults. It uses a detachable inflatable cuff that is wrapped around the upper arm to determine blood pressure based on the oscillometric method. Two cuff sizes are available: standard size for an arm circumference of 8.7 to 14.6 inches or large size for an arm circumference of 14.6 to 18.5 inches.
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5. INTENDED USE/INDICATIONS FOR USE
The QardioArm 2 is a fully automatic, non-invasive, wireless blood pressure monitor intended to measure the systolic and diastolic blood pressures and pulse rate of adult individuals. It utilizes an inflatable cuff that is wrapped around the upper arm. The arm circumference is limited to 8.7 -18.5 inches (22 - 47 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is not intended to be used as a diagnostic device and users are instructed to contact their physician if hypertensive values are indicated.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
| Subject Device | Predicate Device [K140067] |
|---|---|
| The QardioArm 2 is a fully automatic, non-invasive, wireless blood pressure monitorintended to measure the systolic and diastolicblood pressures and pulse rate of adultindividuals. It utilizes an inflatable cuff that iswrapped around the upper arm. The cuffcircumference is limited to 8.7-18.5 inches (22-47cm). The device detects the appearance ofirregular heartbeats during measurement and givesa warning signal with readings. It is not intendedto be used as a diagnostic device and users areinstructed to contact their physician ifhypertensive values are indicated. | QardioArm, model A100 is a fully automatic,non-invasive, wireless blood pressure monitor.QardioArm, model A100 is a blood pressuremeasurement system intended to measure thediastolic and systolic blood pressures and pulserate of an adult individual. QardioArm, modelA100 utilizes an inflatable cuff that is wrappedaround the upper arm. This device is not intendedto be a diagnostic device. Contact your physicianif hypertensive values are indicated. The cuffcircumference is limited to 22 cm-37 cm (8.7 in -14.6 in). |
The indications for use of the QardioArm 2 are very similar to the predicate device in that they are both fully automatic, oscillometric devices intended for measuring blood pressure and pulse rate in adult patients. The devices are both available OTC and neither device is intended to be used to provide a diagnosis. The differences in the indications are limited to larger cuff sizes being available for the QardioArm 2, and an explicit reference to the ability of the device to detect the appearance of irregular heartbeats during measurement (this feature was also present in the predicate device). These minor differences do not impact the fundamental intended use of the device, which is to measure blood pressure and pulse rate.
Technological Comparisons
The table below compares the key technological features of the subject devices to the predicate device (QardioArm A100, K140067).
Table 1: Technological Comparison
| Comparison item | Predicate device | Proposed device |
|---|---|---|
| 510(k) Number | K140067 | To be assigned |
| Comparison item | Predicate device | Proposed device |
| Applicant | Oardio, Inc. | Qardio, Inc |
| Device Name | QardioArm A100 | QardioArm 2 |
| Classification Regulation | 21 CFR 870.1130Class II | 21 CFR 870.1130Class II |
| Product Code | DXN | DXN |
| Rx or OTC | OTC | OTC |
| Measurement method | Oscillometric | Oscillometric |
| Data collected | Systolic and Diastolic BloodPressurePulse | Systolic and Diastolic BloodPressurePulse |
| Measurement range | Systolic measurement range:60 | Systolic measurement range:60 |
| Measurement Resolution | 1 mmHg for blood pressure.1 beat/min for pulse. | 1 mmHg for blood pressure.1 beat/min for pulse. |
| Accuracy | +/-3mmHg or 2% reading forblood pressure.+/-5% for pulse. | +/-3mmHg or 2% reading forblood pressure.+/-5% for pulse. |
| Pressure deflation | Automatic Inflation/Deflation | Automatic Inflation/ Deflation |
| Wireless communication | Bluetooth 4.0 | Bluetooth 5.0 |
| Display | Display the measurementresult on smart Phones (iOSand Android) | Display the measurement resulton smart Phones (iOS andAndroid) |
| Cuff circumference | 8.7 in - 14.6 in diameter (22cm - 37 cm diameter), notdetachable | 22 |
| Operating temperature &humidity | 50 | 41 |
| Atmospheric pressure 86kpa~106 kpa, maximumaltitude: 2000m (6561 ft). | Atmospheric pressure 70kpa~106 kpa, maximumaltitude: 3000m (9,842 ft). | |
| Comparison item | Predicate device | Proposed device |
| Storage temperature &humidity | -13 | -13 |
| Atmospheric pressure 86kpa~106 kpa, maximumaltitude: 2000m (6561 ft). | Atmospheric pressure 70kpa~106 kpa, maximumaltitude: 3000m (9,842 ft). | |
| Power | 4 Alkaline 1.5V batteries(AAA) | Rechargeable Lithium-ionBattery (3.7V/1000mAh) |
| Weight | 0.68 lb (310 g) includingbatteries | 0.63 lb (290 g) includingbatteriesdevice with M cuff0.67 lb (305g) including thebattery with XL cuff |
| Device Dimensions | 5.5 x 2.7 x 1.5 in (140 x 68 x38 mm) when closed. | 5.5 x 2.7 x 1.5 in (140 x 68 x38 mm) when closed withstandard cuff. |
| 5.5 x 2.7 x 1.7 in (140 x 70 x45mm) when closed with XLcuff. |
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7. PERFORMANCE DATA
Biocompatibility Testing
The subject device in its final finished form is identical to QardioArm A100, cleared in K140067, in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).Therefore, no additional biocompatibility information is required to establish substantial equivalence.
Electrical safety and electromagnetic compatibility (EMC)
The QardioArm 2 was tested in accordance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, with the exception of Clause 11.7 regarding biocompatibility. The device passed all tests, including the US deviations.
The QardioArm 2 was tested in accordance with the FDA-recognized standard IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. The QardioArm 2 passed all tests.
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The QardioArm 2 was tested in accordance with the FDA-recognized standard, IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and found to comply with all relevant sections.
The QardioArm 2 underwent wireless coexistence testing in accordance with AAMI TIR69:2017 and ANSI C63.27:2017. All tests passed.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
Bench Testing
The following bench testing was performed to demonstrate substantial equivalence: :
- . Home Healthcare Environment Testing. The OardioArm 2 was tested in accordance with IEC 60601-1-11:2015, 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. The device passed all tests.
- . Automated Non-Invasive Sphygmomanometer Testing. The QardioArm 2 was testing in accordance with IEC 80601-2-30:2018, Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. The device passed all tests.
- Summative Human factors testing was performed in accordance with the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". The QardioArm 2 was found to be safe and effective for its intended users, uses, and use environments
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
A prospective, single arm paired comparison study designed in accordance with ISO 81060-2:2018 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type was conducted to demonstrate the performance of the QardioArm 2 on adult subjects. In the study the QardioArm 2 blood pressure monitor was compared to the Reference sphygmomanometer via a same arm sequential method with dual auscultators. The primary study endpoints and statistical analysis plan were established in accordance with ISO 81060-2 and FDA's requirements for 510(k) submissions for oscillometric blood pressure devices. The study
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enrolled 86 subjects who met the inclusion requirements of 81060-2. The device met all the requirements of the standard.
CONCLUSION 8.
The QardioArm 2 has the same intended use as the predicate device, namely, to measure blood pressure and pulse rate in adult users. Performance testing demonstrates that the QardioArm 2 meets the specifications for its intended use, complies with relevant standards, and performs equivalently to the predicate device. Therefore, the QardioArm 2 can be found substantially equivalent to the predicate device.
§ 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).