(154 days)
Not Found
No
The document describes a standard oscillometric blood pressure monitor and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a blood pressure monitor intended for measurement and spot-checking, not for treatment or therapy. It also explicitly states it is not intended to be used as a diagnostic device.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended to be used as a diagnostic device."
No
The device description explicitly states it uses a detachable inflatable cuff and determines blood pressure based on the oscillometric method, indicating the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- QardioArm 2 function: The QardioArm 2 measures blood pressure and pulse rate by using an inflatable cuff on the upper arm. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for measuring blood pressure and pulse rate of adult individuals. It explicitly states it is not intended to be used as a diagnostic device.
Therefore, based on the provided information, the QardioArm 2 is a non-invasive medical device for measuring vital signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adult individuals
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 enrolled 86 subjects who met the inclusion requirements of 81060-2. The device met all the requirements of the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
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
2
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 & 700
San Francisco, CA 94104, USA
Phone: (415) 670-9613
Fax: (415) 520-9601 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Rosario Iannella
Chief Technology Officer
compliance@qardio.com |
| Submission Correspondent: | Rosario Iannella
Chief Technology Officer
compliance@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 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 cuff | |
| 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. | 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 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 870.1130 | |
| Class II | 21 CFR 870.1130 | |
| Class II | ||
| Product Code | DXN | DXN |
| Rx or OTC | OTC | OTC |
| Measurement method | Oscillometric | Oscillometric |
| Data collected | Systolic and Diastolic Blood | |
| Pressure | ||
| Pulse | Systolic and Diastolic Blood | |
| Pressure | ||
| Pulse | ||
| Measurement range | Systolic measurement range: | |
| 60~250mmHg Diastolic | ||
| measurement range: | ||
| 40~180mmHg | ||
| Pulse measurement range: | ||
| 40~200 beats/minute for | ||
| pulse | Systolic measurement range: | |
| 60~250mmHg Diastolic | ||
| measurement range: | ||
| 40~180mmHg | ||
| Pulse measurement range: | ||
| 40~200 beats per minute | ||
| 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 for | |
| blood pressure. | ||
| +/-5% for pulse. | +/-3mmHg or 2% reading for | |
| blood pressure. | ||
| +/-5% for pulse. | ||
| Pressure deflation | Automatic Inflation/ | |
| Deflation | Automatic Inflation/ Deflation | |
| Wireless communication | Bluetooth 4.0 | Bluetooth 5.0 |
| Display | Display the measurement | |
| result on smart Phones (iOS | ||
| and Android) | Display the measurement result | |
| on smart Phones (iOS and | ||
| Android) | ||
| Cuff circumference | 8.7 in - 14.6 in diameter (22 | |
| cm - 37 cm diameter), not | ||
| detachable | 22~37cm M, detachable | |
| 37~47cm XL, detachable | ||
| Operating temperature & | ||
| humidity | 50 | |
| temperature, 15~90% relative | ||
| maximum humidity, | 41 | |
| temperature, 15~90% relative | ||
| maximum humidity. | ||
| Atmospheric pressure 86 | ||
| kpa~106 kpa, maximum | ||
| altitude: 2000m (6561 ft). | Atmospheric pressure 70 | |
| kpa~106 kpa, maximum | ||
| altitude: 3000m (9,842 ft). | ||
| Comparison item | Predicate device | Proposed device |
| Storage temperature & | ||
| humidity | -13 ~158°F | |
| (-25~70°C) temperature, | ||
| 10~95% relative maximum | ||
| humidity, | -13 ~158°F | |
| (-25~70°C) temperature, | ||
| 10~95% relative maximum | ||
| humidity, | ||
| Atmospheric pressure 86 | ||
| kpa~106 kpa, maximum | ||
| altitude: 2000m (6561 ft). | Atmospheric pressure 70 | |
| kpa~106 kpa, maximum | ||
| altitude: 3000m (9,842 ft). | ||
| Power | 4 Alkaline 1.5V batteries | |
| (AAA) | Rechargeable Lithium-ion | |
| Battery (3.7V/1000mAh) | ||
| Weight | 0.68 lb (310 g) including | |
| batteries | 0.63 lb (290 g) including | |
| batteries | ||
| device with M cuff | ||
| 0.67 lb (305g) including the | ||
| battery with XL cuff | ||
| Device Dimensions | 5.5 x 2.7 x 1.5 in (140 x 68 x | |
| 38 mm) when closed. | 5.5 x 2.7 x 1.5 in (140 x 68 x | |
| 38 mm) when closed with | ||
| standard cuff. | ||
| 5.5 x 2.7 x 1.7 in (140 x 70 x | ||
| 45mm) when closed with XL | ||
| cuff. |
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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
8
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.