(159 days)
Not Found
No
The description details a standard oscillometric method for blood pressure measurement using a microcomputer for signal processing. There is no mention of AI, ML, or related concepts in the intended use, device description, or the "Mentions AI, DNN, or ML" section. The performance studies focus on electrical safety, EMC, and standard blood pressure measurement accuracy, not AI/ML performance metrics.
No.
The device is strictly a measurement device for blood pressure and pulse rate and explicitly states "This device is not intended to be a diagnostic device." It does not provide any therapy or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to be a diagnostic device."
No
The device description explicitly states that the device includes a plastic enclosure and an integrated wraparound cuff, which are hardware components.
Based on the provided text, the QardioArm, model A100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This device is not intended to be a diagnostic device."
- Nature of Measurement: The device measures blood pressure and pulse rate, which are physiological parameters measured in vivo (on the living body), not in vitro (outside the body, typically on biological samples like blood or urine).
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such examinations.
Therefore, the QardioArm, model A100 is a non-invasive blood pressure monitor, not an IVD.
N/A
Intended Use / Indications 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).
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
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 individual
Intended User / Care Setting
Not Found
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)
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
- ELECTRIC SAFETY, EMC and FCC test reports,
-
- PERFORMANCE & CLINICAL TEST
ANSI/AAMI ISO 81060-2:2009
EN 1060-4:2004
- PERFORMANCE & CLINICAL TEST
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure accuracy: ±3mmHg or ±2% of readout value
Pulse accuracy: ±5% of reading value
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.
KD-936 Fully Automatic Wireless Blood Pressure Monitor (K120672), Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W (K121025)
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).
0
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-Min |
| Tel: +886-3-5208829 Fax:+886-3-5209783 | |
| Email: 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 |
1
| 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 |
2
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 Blood | |
| Pressure Monitor, Bluetooth | |||
| Transmission | iHealth BP5 Fully Automatic | ||
| Arm Cuff Wireless Blood | |||
| Pressure Dock | |||
| Model name | A100 | BP700W | KD-936 |
| 510K number | New listing | K121025 | K120672 |
| Technological | |||
| characteristics | Oscillometric method | Oscillometric method | Oscillometric method |
| Measuring method | Oscillometric method, | ||
| automatic inflation and | |||
| measurement | Oscillometric method, | ||
| automatic inflation and | |||
| measurement | Oscillometric method, | ||
| automatic inflation and | |||
| measurement | |||
| Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | Semiconductor gauge sensor |
| Rapid air release | By an active electronic control | ||
| valve | By an active electronic control | ||
| valve | By an active electronic control | ||
| valve | |||
| Pressure accuracy | Pressure: ±3mmHg or ±2% of | ||
| readout value | Pressure: ±3mmHg or ±2% of | ||
| readout value | Pressure: ±3mmHg | ||
| Pulse accuracy | ±5% of reading value | ±5% of reading value | ±5% of reading value |
| System architecture | Requires an external device to | ||
| constitute a complete blood | |||
| pressure measurement system | Independent operation | Requires an external device to | |
| constitute a complete blood | |||
| pressure measurement system | |||
| Display and user | |||
| interaction | Requires an external device to | ||
| display results and perform | |||
| user interaction | LCD monitor and personal | ||
| computer | Requires an external device to | ||
| display results and perform | |||
| user interaction | |||
| Power source | Disposable 4 x AAA alkaline | ||
| batteries | Disposable 4 x AAA alkaline | ||
| batteries | Rechargeable batteries (Li-Ion | ||
| 400 mAh) | |||
| Communication: | Wireless, based on Bluetooth | ||
| V4.0 (Bluetooth Low Energy) | Wireless, based on Bluetooth | ||
| V2.0 | Wireless, based on Bluetooth | ||
| V3.0 + EDR | |||
| Cuff type and size | Upper arm type, size: 22 to | ||
| 37cm | Upper arm type, size: 23 to | ||
| 33cm | Upper arm type, size: 22 to | ||
| 48cm | |||
| 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, |