(250 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes standard physiological measurements and calculations without mentioning any AI/ML algorithms.
No
The device is described as providing non-invasive measurements and information to the physician for assessment and decision-making, rather than directly treating or alleviating a condition.
Yes
The device aids in the physician's assessment of cardiovascular systems and peripheral arterial disease by providing measurements and calculations (e.g., HRV, ABI, ABPI), even though it explicitly states it "does not provide any direct diagnosis." The information it provides is intended to assist in the physician's decision-making process for diagnostic purposes.
No
The device description explicitly states that the system comprises "USB plug and play device hardware and Software installed on a computer." This indicates the presence of dedicated hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- VitalScan ANS Function: The VitalScan ANS device measures physiological parameters directly from the patient's body (pulse waveforms, heart rate, blood pressure, oxygen saturation) using non-invasive methods (PPG, ECG, NIBP, SpO2). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as providing information for physician assessment of the Cardiovascular Systems and assessing the risk of developing peripheral arterial disease. This is based on direct physiological measurements, not analysis of in vitro samples.
Therefore, the VitalScan ANS falls under the category of a medical device that performs physiological measurements, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.
VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).
The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
Product codes
JOM, DPS, DXN
Device Description
VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).
The system comprises: USB plug and play device hardware and Software installed on a computer.
VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;
VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).
The results are saved in a backup and can also be printed.
The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoelectric plethysmography (PPG)
Anatomical Site
Not Found
Indicated Patient Age Range
transitional adolescents and adults
Intended User / Care Setting
medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
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)
The VitalScan ANS device was subjected to the following non-clinical performance testing: Bench testing was carried out on the following characteristics:
- Electrocardiograph (ECG)
- Heart rate variability (R-R interval)
- Heart rate
- SpO2 and Plethysmogram
- Blood-Pressure Measurement accuracy
- Communication, data transmission and storage integrity
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Software verification and validation testing
- Biocompatibility verification
In addition to the above, usability testing was also conducted.
No Clinical testing was necessary to determine substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2020
Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr Dayton, Ohio 45430
Re: K191266
Trade/Device Name: VitalScan ANS Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, Pneumatic, or Photoelectric Plethysmographs Regulatory Class: Class II Product Code: JOM, DPS, DXN Dated: December 11, 2019 Received: December 16, 2019
Dear Daniel Lehtonen:
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
1
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,
Jennifer Shih Assistant Director (Acting) 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) K191266
Device Name
VitalScan ANS
Indications for Use (Describe)
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.
VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).
The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
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) information is submitted in accordance with the Requirements of Safe Medical Device systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number:
a1 APPLICANT INFORMATION:
| Date Prepared: | 03 May 2019 |
|---|---|
| Name: | Medeia, Inc. |
| Address: | 7 W. Figueroa Street |
| Suite 300 | |
| Santa Barbara, CA, 93101 |
| Contact Person: | Slav Danev |
|---|---|
| Phone Number: | +1 800 433 4609 |
| Fax Number: | +1 800 433 4609 |
| Email: | danev@medeia.com |
a2 NAME OF DEVICE:
| Trade Name: | VitalScan ANS |
|---|---|
| Common Name: | Plethysmograph, photoelectric, pneumatic or hydraulic |
| Classification Name: | Plethysmograph, photoelectric, pneumatic or hydraulic |
| 21 CFR 870.2780 (JOM) | |
| Electrocardiograph | |
| 21 CFR 870.2340 (DPS) | |
| Noninvasive blood pressure measurement system | |
| 21 CFR 870.1130 (DXN) |
аЗ PREDICATE DEVICES:
| Primary Predicate Device: | K083735; ANSHA-QHRV1 |
|---|---|
| Secondary Predicate Device: | K101983; Critical Care Assessment |
| Secondary Predicate Device: | K172655; ABPI MD |
| Reference Device: | K012647; Tonoport V |
The FDA database for recalls was searched on 20 March 2019 during the preparation of the 510(k) submission and no recalls for the devices noted above were found.
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INDICATIONS FOR USE: a4
VitalScan ANS is intended for non-invasive measurements of pulse waveforms by photoelectric plethysmography (PPG), heart rate electrocardiograph (ECG), Heart Variability measurements (HRV) and blood pressure (NIBP) in response to paced respiration and controlled testing procedures for physician assessment of the Cardiovascular Systems.
VitalScan ANS also measures/calculates a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assessing development of peripheral arterial disease (PAD).
The device is intended for use on transitional adolescents and adults, including those with unilateral lower limb amputation, in medical clinics, healthcare practices and out-patient departments of hospitals.
The physician has the responsibility of interpreting the significance of the resulting data.
a5 DESCRIPTION OF THE DEVICE:
VitalScan ANS system collects multi-parameter patient data including: Electrocardiography (ECG), Plethysmogram (PPG), Pulse Volume Recording (PVR), Blood Pressure, Heart Rate, and Peripheral capillary Oxygen saturation (SpO2).
The system comprises: USB plug and play device hardware and Software installed on a computer.
VitalScan ANS is intended to measure a patient's variations in the heart rate (R-R beat-to-beat intervals from ECG) and perform Heart Rate Variability (HRV) analysis to assess Autonomic Nervous System (ANS) Function;
VitalScan ANS also measure a patient's Brachial and Ankle Blood Pressure, Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography for assess the risk of developing peripheral arterial disease (PAD).
The results are saved in a backup and can also be printed.
The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
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a6 TECHNOLOGICAL CHARACTERISTIC COMPARISON:
VitalScan ANS product share similar device characteristics, intended use, performance, specifications, sensors and is the same in design, function, and application to the predicate devices.
The comparison table, beginning on page 5, demonstrates that the VitalScan ANS device is substantially equivalent to the predicate devices. The nonclinical data support the safety of the device and the hardware and software verification and validation demonstrate that the VitalScan ANS device should perform as intended in the specified use conditions.
Based on comparisons of device technological characteristics, features, materials, intended use and performance the VitalScan ANS has been shown to be substantially equivalent to the commercially available predicate devices.
NON-CLINICAL TESTING: b1
The VitalScan ANS device was subjected to the following non-clinical performance testing:
Bench testing was carried out on the following characteristics:
- Electrocardiograph (ECG)
- Heart rate variability (R-R interval)
- Heart rate
- SpO2 and Plethysmogram ●
- Blood-Pressure Measurement accuracy
- Communication, data transmission and storage integrity
- Electromagnetic compatibility (EMC)
- Electrical safety testing
- Software verification and validation testing
- Biocompatibility verification
In addition to the above, usability testing was also conducted.
Referenced Standards and Performance Testing:
The VitalScan ANS device was tested and meets the applicable requirements of following performance Standards and is in accordance with FDA Class II Special Controls Guidance Document:
- IEC 60601-1 Medical Electrical Equipment - Part 1: Basic safety and essential performance Ed 3.1 2005+A1:2012
- . IEC 60601-1-2 Medical Electrical Equipment - Basic safety and essential performance-EMC-Edition 3: 2007-03
- IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability; Edition 3.1 2013-10
- AAMI / ANSI 60601-2-27 Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 2011
- . ISO 80601-2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment 2011
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- . AAMI / ANSI / IEC 80601-2-30 Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers 2009 + A1:2013
- . AAMI / ANSI EC57 - Testing and reporting performance results of cardiac rhythm and stsegment measurement algorithms 2012 [Select clauses to support device performance]
Software Verification and Validation Testing
Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.
b2 CLINICAL TESTING:
No Clinical testing was necessary to determine substantial equivalence.
b3 CONCLUSIONS DRAWN FROM TESTING:
Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the VitalScan ANS device was subjected to the same type of testing. The results support the conclusion that the VitalScan ANS device is substantially equivalent to the Predicate devices.
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Comparison Table
In section a 3 Predicate Devices section of this Summent, The Critical Care Assessment (CCA) device (K101983) is included as a predicate. The Critical Care Assessment device is a re-labeled ANSHA-QHRV1 device with the only difference being the name of the following comparison table includes only the ANSHA-QHRV1 device for direct comparison as all rows for the CCA device would be identical.
| Feature | VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence
Comments |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | ANSHA-QHRV1 | ABPI MD | Tonoport V | |
| 510(k) Number | Subject Device | K083735 | K172655 | K012647 | -- |
| Device name | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | -- |
| Manufacturer | Medeia Ltd. | Medeia Ltd. | MESI | PAR Medizintechnik
GmbH | -- |
| Regulation
Numbers | 21 CFR 870.2780
21 CFR 870.2340
21 CFR 870.1130 | 21 CFR 870.2780
21 CFR 870.2340 | 21 CFR 870.2780 | 21 CFR 870.1130 | CFR numbers of the
subject device include
those of the predicate and
reference devices |
| Product Codes | JOM, DPS, DXN | JOM, DPS | JOM | DXN | Product Codes of the
subject device include
those of the predicate and
reference devices |
| | VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence
Comments |
| Feature | | ANSHA-QHRV1 | ABPI MD | Tonoport V | |
| Indications for Use | VitalScan ANS is intended for non-
invasive measurements of pulse
waveforms by photoelectric
plethysmography (PPG), heart rate
electrocardiograph (ECG), Heart
Variability measurements (HRV)
and blood pressure (NIBP) in
response to paced respiration and
controlled testing procedures for
physician assessment of the
Cardiovascular Systems.
VitalScan ANS also
measures/calculates a patient's
Brachial and Ankle Blood Pressure,
Ankle Brachial Pressure Index
(ABPI) and Ankle Brachial Index
(ABI) and provides Pulse Volume
Recording (PVR) / volume
plethysmography for assessing
development of peripheral arterial
disease (PAD).
The device is intended for use on
transitional adolescents and
adults, including those with
unilateral lower limb amputation,
in medical clinics, healthcare
practices and out-patient
departments of hospitals.
The physician has the
responsibility of interpreting the
significance of the resulting data. | ANSHA-QHRV1 is intended for
non-invasive measurements of
pulse waveforms by
photoelectric
plethysmography and heart
rate electrocardiograph.
The system is intended for use
of patients in medical clinics,
healthcare practices and in
out-patient department of
hospitals. | The ABPI MD system is
indicated for use on adult
subjects at risk of having or
developing peripheral arterial
disease (PAD).
The ABPI MD system is
intended for the rapid
measurement of ankle-
brachial pressure index (ABPI),
or ankle-brachial index (ABI)
and pulse volume recording
(PVR) / volume
plethysmography in adults.
It is suitable for wound care
assessment, for assessing
symptomatic PAD, and as a
screening device for PAD. It
may also be used on patients
with venous or arterial ulcers
prior to application of
compression therapy.
The ABPI MD system can be
used on patients with
unilateral lower limb
amputation. The ABPI MD
system is intended to be used
to spot-check patients. The
ABPI MD system provided
information regarding patient
risk. The physician has the
responsibility of making
proper judgements based on
this information. | [Excerpt of IFU] The Tonoport
V is a compact, lightweight,
patient-borne, non-invasive
blood pressure (NIBP) bolter
using the oscillometric
method. The cuff is borne on
the upper arm and an
electrical pump inside the
device generates the pressure
in the cuff. Tonoport V is
intended to be used for
measuring the systolic,
diastolic, mean blood pressure
and the heart rate of human
beings for periods up to 30
hours. The intended patient
populations are adults and
children (but not neonates)
with a circumference of the
upper arm in the range of 17
cm to 42 cm. A measurement
with Tonoport V is combined
with other measurements and
medical examinations at the
patient, so that a diagnosis
about the patient's health
condition depends not alone
from the measurement of the
Tonoport V. | There are no differences in the
intended use of the devices.
The indications for use are
clarified, but not changed.
The measurements made by
the ANSHA-QHRV1 are used
for the same purposes as the
VitalScan ANS device - analysis
of HRV, PWV, and PVR. The
VitalScan ANS uses the same
algorithms as the ANSHA-
QHRV1 for PPG and ECG
acquisition and analysis.
The measurements made by
the ABPI-MD device are used
for assessing symptomatic PAD
or for screening for PAD. The
VitalScan ANS makes
measurements for the same
purposes.
The VitalScan ANS uses the
same algorithm as the
Tonoport V for NIBP
measurements.
The VitalScan ANS and
predicate/reference devices
are used for the adult
population in professional
settings and a medical
professional is responsible for
interpreting the data /
determining its significance
related to the patient's health. |
| | | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence |
| Feature | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments |
| Measurements | HRV – by ECG using
electrodes placed on the
chest or on hands. The
monitoring program has
been developed according to
the standards and
mathematical procedures for
short-term HRV Autonomic
nervous system analysis as
well as for performing and
evaluating blood pressure,
blood flow and autonomic
challenge tests.
Test Administration:
Cardio respiratory Coupling
and Autonomic Balance
(Sympathetic and
Parasympathetic Tone),
Autonomic dysregulation
Stress Analysis. Time: 4.30
minutes
Parasympathetic Breathing
Reflex.
Time: 1 minute
Sympathetic
Vasoconstriction Reflex;
Time: 1.30 minutes
Orthostatic Test,
Cardiovascular Reflex,
Cardiovascular Fitness
Analysis
Time: 5.00 minutes
Systolic, Diastolic and Ankle
Brachial pressures using the
oscillometric method | HRV – by ECG using
electrodes placed on the
chest or on hands. The
monitoring program has
been developed according to
the standards and
mathematical procedures for
short-term HRV Autonomic
nervous system analysis as
well as for performing and
evaluating blood flow and
autonomic challenge tests.
Test Administration:
Cardio respiratory Coupling
and Autonomic Balance
(Sympathetic and
Parasympathetic Tone),
Stress Analysis. Time: 4.30
minutes
Parasympathetic Breathing
Reflex.
Time: 1 minute
Sympathetic
Vasoconstriction Reflex
Time: 1.30 minutes
Orthostatic Test,
Cardiovascular Reflex,
Fitness Analysis
Time: 5.00 minutes | Ankle brachial pressure index
using the oscillometric
method
Systolic blood pressure using
the oscillometric method
Diastolic blood pressure
using the oscillometric
method
Heart rate using the
oscillometric method | Measuring the systolic,
diastolic and mean blood
pressure and the heart rate
using the oscillometric
method | For HRV / PWV / PVR the
VitalScan ANS device is
identical to the ANSHA-
QHRV1. The measurements
and test protocol are the
same between the two
devices.
For ABPI / ABI / PAD
assessment the VitalScan
ANS is the same as the
ABPI-MD device. Both
devices use the oscillometric
method to make
determinations. |
| | VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence |
| Feature | | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments |
| Alarms | No alarms as part of the
device | No alarms as part of the
device | No alarms are part of the
device | Unknown | Same - no alarms are
provided for the predicate
devices. |
| General
Specifications | | | | | |
| Dimensions | 24 x 8.4 x 20 cm | 110 x 70 x 11 mm | 25 x 7.3 x 20 cm | 80 x 27 x 100 mm | Similar – dimensions / mass
doesn't impact device
function or raise different
questions of safety or
effectiveness. |
| Weight | 1000 grams | 100 grams | 600 grams | 199 grams | |
| Display | PC | PC | 4.3″ color LCD screen | 30.0 mm x 10.5 mm | Same as ANSHA-QHRV1 |
| Energy source | 5VDC/1.6 A +
USB from laptop | USB from laptop | Rechargeable lithium
polymer battery | Powered by two AA size
batteries | VitalScan ANS uses the USB
for powering the device and
an external power supply for
powering the NIBP function |
| Target population | Adult | Adult | Adult | Adults and children, but not
neonates | Same |
| Where used | Clinical environment | Clinical environment | Clinical environment | In hospital | Same |
| PC Data
transmission | USB | USB | USB | USB or RS-232 | Same |
| Temperature and
humidity range | Working environment:
10 to 40°C, 30 to 75%
Relative air humidity, IPX1
protection.
Transport and storage:
-20 to 70°C, up to 90%
Relative air humidity. | Working environment:
10 to 40°C, 30 to 75%
Relative air humidity, IPX0
protection.
Transport and storage:
-20 to 70°C, up to 90%
Relative air humidity. | Working environment:
10 to 40°C, 30 to 85%
Relative air humidity, IPX0
protection.
Transport and storage:
0 to 60°C, up to 85% Relative
air humidity. | Working environment:
10 to 40°C, 30 to 75%
Relative air humidity, IPX0
protection.
Transport and storage:
-20 to 70°C, up to 90%
Relative air humidity. | Similar - Change from IPX0
to IPX1 does not affect
measurements. Change was
necessitated by testing to
the device to ISO 80601-2-61
which mandates IPX1 for
devices not used for
transport |
| Standards | 60601-1
60601-1-2
60601-1-6
60601-2-27
80601-2-30
80601-2-61 | 60601-1
60601-2-27 (limited clauses) | 60601-1
60601-1-2
60601-1-6
80601-2-30 | 80601-2-30 | Similar - the VitalScan ANS
was tested to the full suite of
standards based on the
functions included. This
testing does not raise
different questions of safety
or effectiveness |
| | | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence |
| Feature | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments |
| PHYSIOLOGICAL
PARAMETERS | | | | | |
| ECG | | | | | |
| Method | ECG lead wires attached to
disposable electrodes to the
skin | ECG lead wires attached to
disposable electrodes to the
skin | | | Same as ANSHA-QHRV1 |
| Resolution | 24 bit | 16 bit | | | Similar. Increased resolution
improves noise reduction.
There is no impact on device
function. No different
questions of safety or
effectiveness are raised. |
| Input impedance | > 20 Mohm | > 20 Mohm | | | Same as ANSHA-QHRV1 |
| Common mode
rejection | -80dB - 100dB | -80dB - 100dB | | | Same as ANSHA-QHRV1 |
| Sampling frequency | 1000, 500, 200 Hz | 800, 400 and 200 Hz | | | Similar. For HRV analysis the
default sampling frequency is
set at 200 Hz via software in
both devices. The sampling
frequency options do not
impact device function. No
different questions of safety
or effectiveness are raised. |
| Channels | 3 or 12 channels | 3 channels | | | Similar to ANSHA-QHRV1.
Added ECG leads does not
impact measurement
functionality. Both 3 and 12
lead cables were evaluated
to 60601-2-27 |
| QRS detection | Yes - 99.8% | Yes - 99.8% | | | Same as ANSHA-QHRV1 |
| Permanent Display | Not Provided | Not Provided | | | Same as ANSHA-QHRV1 |
| Applied parts in
contact with the
patient | ECG Electrodes | ECG Electrodes | | | Same as ANSHA-QHRV1 |
| Feature | VitalScan ANS | Primary Predicate
ANSHA-QHRV1 | Secondary Predicate
ABPI MD | Reference Device
Tonoport V | Substantial Equivalence
Comments |
| HEART RATE | | | | | |
| Method | QRS detection | QRS detection | Oscillometric method | Oscillometric method | Same as ANSHA-QHRV1 |
| Range | 38 - 250 bpm | 40 - 200 bpm | 30 - 199 bpm | 35 - 240 bpm | Similar - minor change
doesn't impact device
function or raise different
questions of safety or
effectiveness |
| Accuracy | ± 2 bpm | ± 2 bpm | ± 5% of value | Not Specified | Same as ANSHA-QHRV1 |
| BLOOD PRESURE | | | | | |
| Measurement types | Oscillometric measuring
method during deflation of
the cuff | | Oscillometric measuring
method during deflation of
the cuff | Oscillometric measuring
method during deflation of
the cuff | Same as ABPI-MD |
| Measurement
ranges | Systolic: 60 to 260 mmHg
Diastolic: 40 to 220 mmHg
BP Pulse rate (HR): 35 to 240
min-1 | | 39 – 242 mmHg Systolic
40 – 180 mmHg Diastolic
30 to 199 bpm (Pulse) | Systolic: 60 to 260 mmHg
Diastolic: 40 to 220 mmHg
BP Pulse rate (HR): 35 to 240
min-1 | Same as Tonoport V |
| Limit values of
measurement
errors | ABPI: ± 0.1
Empirical Standard Deviation
Systolic 4.6 mmHg
Diastolic 4.4 mmHg | | ± 0.1 ABPI
± 3 mmHg (BP)
± 5% of value (Pulse) | Empirical Standard Deviation
Systolic 4.6 mmHg
Diastolic 4.4 mmHg | Same as Tonoport V |
| Cuffs inflation and
deflation | Automatic inflation using an
air pump and deflation using
an electromagnetic valve.
Max 300 mmHg | | Automatic inflation using an
air pump and deflation using
and electromagnetic valve | Automatic inflation using an
air pump and deflation using
an electromagnetic valve.
Max 300 mmHg | Same as Tonoport V |
| Pulse Volume /
Plethysmography | Pneumo-plethysmography
method using the cuffs
measuring the blood
pressure values:
Plethysmography displayed
at the inflation and deflation
pressure | | Pneumo-plethysmography
method using the cuffs
measuring the blood
pressure
values: Plethysmography
displayed at the inflation
and deflation pressure | N/A | Same as ABPI-MD |
| Feature | VitalScan ANS | Primary Predicate
ANSHA-QHRV1 | Secondary Predicate
ABPI MD | Reference Device
Tonoport V | Substantial Equivalence Comments |
| Applied parts in contact with the patient | 2 or 4 cuffs, tubes and bladders | | 3 cuffs, tubes and bladders | 1 cuff, tube and bladder | Similar – The VitalScan ANS allows the user to place a cuff on each arm and each leg simultaneously rather than having to move a cuff from one limb to another. |
| OXYGEN SATURATION | | | | | |
| Method | Photo plethysmogram on finger.
Infrared: 910 nm @ 1.2 mW maximum average
Red: 660 nm @ 0.8 mW maximum average | Photo plethysmogram on finger.
Infrared: 910 nm @ 1.2 mW maximum average
Red: 660 nm @ 0.8 mW maximum average | | | Same as ANSHA-QHRV1. Only difference between subject and predicate device is that the VitalScan ANS device was fully tested to 80601-2-61 for safety and performance |
| Range | 70-100% | 70-100% | | | |
| Accuracy | ± 2 digits (from 70-100%) | ± 2 digits (from 70-100%) | | | |
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