(250 days)
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.
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.
The provided document is a 510(k) summary for the VitalScan ANS device. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table (pages 7-8) that highlights the VitalScan ANS device's specifications against predicate devices. While this table shows performance characteristics, it does not explicitly state "acceptance criteria" in a quantifiable sense for the VitalScan ANS itself. Instead, it demonstrates that the VitalScan ANS either matches or is similar to the established performance of legally marketed predicate devices.
Here's an extracted and summarized table based on the direct comparison for the VitalScan ANS device's performance, using the predicate device values as a proxy for what would be considered acceptable based on substantial equivalence:
| Feature/Parameter | Acceptance Criteria (from Predicate/Reference) | Reported Device Performance (VitalScan ANS) |
|---|---|---|
| ECG | ||
| Method | ECG lead wires attached to disposable electrodes to the skin | ECG lead wires attached to disposable electrodes to the skin |
| Resolution | 16 bit (from ANSHA-QHRV1) | 24 bit |
| Input impedance | > 20 Mohm (from ANSHA-QHRV1) | > 20 Mohm |
| Common mode rejection | -80dB - 100dB (from ANSHA-QHRV1) | -80dB - 100dB |
| Sampling frequency | 800, 400 and 200 Hz (from ANSHA-QHRV1) | 1000, 500, 200 Hz |
| Channels | 3 channels (from ANSHA-QHRV1) | 3 or 12 channels |
| QRS detection | 99.8% (from ANSHA-QHRV1) | 99.8% |
| Permanent Display | Not provided (from ANSHA-QHRV1) | Not provided |
| Applied parts in contact with patient | ECG Electrodes (from ANSHA-QHRV1) | ECG Electrodes |
| HEART RATE | ||
| Method | QRS detection (from ANSHA-QHRV1) | QRS detection |
| Range | 40 - 200 bpm (from ANSHA-QHRV1) | 38 - 250 bpm |
| Accuracy | ± 2 bpm (from ANSHA-QHRV1) | ± 2 bpm |
| BLOOD PRESSURE | ||
| Measurement types | Oscillometric measuring method during deflation of the cuff (from ABPI MD / Tonoport V) | Oscillometric measuring method during deflation of the cuff |
| Measurement ranges (Systolic) | 60 to 260 mmHg (from Tonoport V) | 60 to 260 mmHg |
| Measurement ranges (Diastolic) | 40 to 220 mmHg (from Tonoport V) | 40 to 220 mmHg |
| Measurement ranges (HR) | 35 to 240 min-1 (from Tonoport V) | 35 to 240 min-1 |
| Limit values of measurement errors (ABPI) | ± 0.1 (from ABPI MD) | ± 0.1 |
| Limit values of measurement errors (Systolic) | 4.6 mmHg (Empirical Standard Deviation - from Tonoport V) | 4.6 mmHg (Empirical Standard Deviation) |
| Limit values of measurement errors (Diastolic) | 4.4 mmHg (Empirical Standard Deviation - from Tonoport V) | 4.4 mmHg (Empirical Standard Deviation) |
| Cuffs inflation and deflation | Automatic inflation using an air pump and deflation using an electromagnetic valve. Max 300 mmHg (from Tonoport V) | Automatic inflation using an air pump and deflation using an electromagnetic valve. Max 300 mmHg |
| Pulse Volume / Plethysmography | Pneumo-plethysmography method using the cuffs measuring the blood pressure values: Plethysmography displayed at the inflation and deflation pressure (from ABPI MD) | Pneumo-plethysmography method using the cuffs measuring the blood pressure values: Plethysmography displayed at the inflation and deflation pressure |
| Applied parts in contact with patient | 3 cuffs, tubes and bladders (from ABPI MD) / 1 cuff, tube and bladder (from Tonoport V) | 2 or 4 cuffs, tubes and bladders |
| OXYGEN SATURATION | ||
| Method | Photo plethysmogram on finger. Infrared: 910 nm @ 1.2 mW maximum average, Red: 660 nm @ 0.8 mW maximum average (from ANSHA-QHRV1) | Photo plethysmogram on finger. Infrared: 910 nm @ 1.2 mW maximum average, Red: 660 nm @ 0.8 mW maximum average |
| Range | 70-100% (from ANSHA-QHRV1) | 70-100% |
| Accuracy | ± 2 digits (from 70-100%) (from ANSHA-QHRV1) | ± 2 digits (from 70-100%) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence." (Page 6, section b2). This means there was no test set of patient data used to evaluate the device's clinical performance. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices, not on direct human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since no clinical testing was performed, there were no experts used to establish ground truth for a clinical test set. The substantial equivalence was determined by comparing the device's technical specifications and safety/performance data (from bench testing) to those of already approved predicate devices.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, if we interpret "standalone" as the device operating according to its technical specifications and algorithms during non-clinical (bench) testing. The document states:
- "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." (Page 5, section b1)
- And, "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" followed by a list of relevant IEC and ISO standards (pages 5-6).
These non-clinical tests demonstrate the device's performance in a standalone capacity against established technical and safety standards.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by the specifications and measurement accuracies defined in the referenced standards (e.g., IEC 60601-1, AAMI / ANSI 80601-2-30 for blood pressure accuracy). The device's measurements were compared against calibrated instruments or reference signals as part of these bench tests. The substantial equivalence argument also uses the established performance of the legally marketed predicate devices as a form of "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. This device is not described as utilizing machine learning or artificial intelligence that would require a "training set" of data. Its functionalities are based on established physiological measurement principles and algorithms.
9. How the ground truth for the training set was established
Not applicable, as there is no training set described for this device.
{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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.
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 StreetSuite 300Santa 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 hydraulic21 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.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, blue sans-serif font.
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.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Medeia. The logo has a large letter "M" in green and blue, followed by the rest of the word "edeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.
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
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the "M" in green and blue and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, blue sans-serif font.
- . 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.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in black font, with the first letter "M" in green and blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller blue font.
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 EquivalenceComments |
|---|---|---|---|---|---|
| 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 MedizintechnikGmbH | -- |
| RegulationNumbers | 21 CFR 870.278021 CFR 870.234021 CFR 870.1130 | 21 CFR 870.278021 CFR 870.2340 | 21 CFR 870.2780 | 21 CFR 870.1130 | CFR numbers of thesubject device includethose of the predicate andreference devices |
| Product Codes | JOM, DPS, DXN | JOM, DPS | JOM | DXN | Product Codes of thesubject device includethose of the predicate andreference devices |
| VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial EquivalenceComments | |
| Feature | ANSHA-QHRV1 | ABPI MD | Tonoport V | ||
| Indications for Use | VitalScan ANS is intended for non-invasive measurements of pulsewaveforms by photoelectricplethysmography (PPG), heart rateelectrocardiograph (ECG), HeartVariability measurements (HRV)and blood pressure (NIBP) inresponse to paced respiration andcontrolled testing procedures forphysician assessment of theCardiovascular Systems.VitalScan ANS alsomeasures/calculates a patient'sBrachial and Ankle Blood Pressure,Ankle Brachial Pressure Index(ABPI) and Ankle Brachial Index(ABI) and provides Pulse VolumeRecording (PVR) / volumeplethysmography for assessingdevelopment of peripheral arterialdisease (PAD).The device is intended for use ontransitional adolescents andadults, including those withunilateral lower limb amputation,in medical clinics, healthcarepractices and out-patientdepartments of hospitals.The physician has theresponsibility of interpreting thesignificance of the resulting data. | ANSHA-QHRV1 is intended fornon-invasive measurements ofpulse waveforms byphotoelectricplethysmography and heartrate electrocardiograph.The system is intended for useof patients in medical clinics,healthcare practices and inout-patient department ofhospitals. | The ABPI MD system isindicated for use on adultsubjects at risk of having ordeveloping peripheral arterialdisease (PAD).The ABPI MD system isintended for the rapidmeasurement of ankle-brachial pressure index (ABPI),or ankle-brachial index (ABI)and pulse volume recording(PVR) / volumeplethysmography in adults.It is suitable for wound careassessment, for assessingsymptomatic PAD, and as ascreening device for PAD. Itmay also be used on patientswith venous or arterial ulcersprior to application ofcompression therapy.The ABPI MD system can beused on patients withunilateral lower limbamputation. The ABPI MDsystem is intended to be usedto spot-check patients. TheABPI MD system providedinformation regarding patientrisk. The physician has theresponsibility of makingproper judgements based onthis information. | [Excerpt of IFU] The TonoportV is a compact, lightweight,patient-borne, non-invasiveblood pressure (NIBP) bolterusing the oscillometricmethod. The cuff is borne onthe upper arm and anelectrical pump inside thedevice generates the pressurein the cuff. Tonoport V isintended to be used formeasuring the systolic,diastolic, mean blood pressureand the heart rate of humanbeings for periods up to 30hours. The intended patientpopulations are adults andchildren (but not neonates)with a circumference of theupper arm in the range of 17cm to 42 cm. A measurementwith Tonoport V is combinedwith other measurements andmedical examinations at thepatient, so that a diagnosisabout the patient's healthcondition depends not alonefrom the measurement of theTonoport V. | There are no differences in theintended use of the devices.The indications for use areclarified, but not changed.The measurements made bythe ANSHA-QHRV1 are usedfor the same purposes as theVitalScan ANS device - analysisof HRV, PWV, and PVR. TheVitalScan ANS uses the samealgorithms as the ANSHA-QHRV1 for PPG and ECGacquisition and analysis.The measurements made bythe ABPI-MD device are usedfor assessing symptomatic PADor for screening for PAD. TheVitalScan ANS makesmeasurements for the samepurposes.The VitalScan ANS uses thesame algorithm as theTonoport V for NIBPmeasurements.The VitalScan ANS andpredicate/reference devicesare used for the adultpopulation in professionalsettings and a medicalprofessional is responsible forinterpreting the data /determining its significancerelated 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 usingelectrodes placed on thechest or on hands. Themonitoring program hasbeen developed according tothe standards andmathematical procedures forshort-term HRV Autonomicnervous system analysis aswell as for performing andevaluating blood pressure,blood flow and autonomicchallenge tests.Test Administration:Cardio respiratory Couplingand Autonomic Balance(Sympathetic andParasympathetic Tone),Autonomic dysregulationStress Analysis. Time: 4.30minutesParasympathetic BreathingReflex.Time: 1 minuteSympatheticVasoconstriction Reflex;Time: 1.30 minutesOrthostatic Test,Cardiovascular Reflex,Cardiovascular FitnessAnalysisTime: 5.00 minutesSystolic, Diastolic and AnkleBrachial pressures using theoscillometric method | HRV – by ECG usingelectrodes placed on thechest or on hands. Themonitoring program hasbeen developed according tothe standards andmathematical procedures forshort-term HRV Autonomicnervous system analysis aswell as for performing andevaluating blood flow andautonomic challenge tests.Test Administration:Cardio respiratory Couplingand Autonomic Balance(Sympathetic andParasympathetic Tone),Stress Analysis. Time: 4.30minutesParasympathetic BreathingReflex.Time: 1 minuteSympatheticVasoconstriction ReflexTime: 1.30 minutesOrthostatic Test,Cardiovascular Reflex,Fitness AnalysisTime: 5.00 minutes | Ankle brachial pressure indexusing the oscillometricmethodSystolic blood pressure usingthe oscillometric methodDiastolic blood pressureusing the oscillometricmethodHeart rate using theoscillometric method | Measuring the systolic,diastolic and mean bloodpressure and the heart rateusing the oscillometricmethod | For HRV / PWV / PVR theVitalScan ANS device isidentical to the ANSHA-QHRV1. The measurementsand test protocol are thesame between the twodevices.For ABPI / ABI / PADassessment the VitalScanANS is the same as theABPI-MD device. Bothdevices use the oscillometricmethod to makedeterminations. |
| VitalScan ANS | Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence | |
| Feature | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments | |
| Alarms | No alarms as part of thedevice | No alarms as part of thedevice | No alarms are part of thedevice | Unknown | Same - no alarms areprovided for the predicatedevices. |
| GeneralSpecifications | |||||
| 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 / massdoesn't impact devicefunction or raise differentquestions of safety oreffectiveness. |
| 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 lithiumpolymer battery | Powered by two AA sizebatteries | VitalScan ANS uses the USBfor powering the device andan external power supply forpowering the NIBP function |
| Target population | Adult | Adult | Adult | Adults and children, but notneonates | Same |
| Where used | Clinical environment | Clinical environment | Clinical environment | In hospital | Same |
| PC Datatransmission | USB | USB | USB | USB or RS-232 | Same |
| Temperature andhumidity range | Working environment:10 to 40°C, 30 to 75%Relative air humidity, IPX1protection.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, IPX0protection.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, IPX0protection.Transport and storage:0 to 60°C, up to 85% Relativeair humidity. | Working environment:10 to 40°C, 30 to 75%Relative air humidity, IPX0protection.Transport and storage:-20 to 70°C, up to 90%Relative air humidity. | Similar - Change from IPX0to IPX1 does not affectmeasurements. Change wasnecessitated by testing tothe device to ISO 80601-2-61which mandates IPX1 fordevices not used fortransport |
| Standards | 60601-160601-1-260601-1-660601-2-2780601-2-3080601-2-61 | 60601-160601-2-27 (limited clauses) | 60601-160601-1-260601-1-680601-2-30 | 80601-2-30 | Similar - the VitalScan ANSwas tested to the full suite ofstandards based on thefunctions included. Thistesting does not raisedifferent questions of safetyor effectiveness |
| Primary Predicate | Secondary Predicate | Reference Device | Substantial Equivalence | ||
| Feature | VitalScan ANS | ANSHA-QHRV1 | ABPI MD | Tonoport V | Comments |
| PHYSIOLOGICALPARAMETERS | |||||
| ECG | |||||
| Method | ECG lead wires attached todisposable electrodes to theskin | ECG lead wires attached todisposable electrodes to theskin | Same as ANSHA-QHRV1 | ||
| Resolution | 24 bit | 16 bit | Similar. Increased resolutionimproves noise reduction.There is no impact on devicefunction. No differentquestions of safety oreffectiveness are raised. | ||
| Input impedance | > 20 Mohm | > 20 Mohm | Same as ANSHA-QHRV1 | ||
| Common moderejection | -80dB - 100dB | -80dB - 100dB | Same as ANSHA-QHRV1 | ||
| Sampling frequency | 1000, 500, 200 Hz | 800, 400 and 200 Hz | Similar. For HRV analysis thedefault sampling frequency isset at 200 Hz via software inboth devices. The samplingfrequency options do notimpact device function. Nodifferent questions of safetyor effectiveness are raised. | ||
| Channels | 3 or 12 channels | 3 channels | Similar to ANSHA-QHRV1.Added ECG leads does notimpact measurementfunctionality. Both 3 and 12lead cables were evaluatedto 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 incontact with thepatient | ECG Electrodes | ECG Electrodes | Same as ANSHA-QHRV1 | ||
| Feature | VitalScan ANS | Primary PredicateANSHA-QHRV1 | Secondary PredicateABPI MD | Reference DeviceTonoport V | Substantial EquivalenceComments |
| 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 changedoesn't impact devicefunction or raise differentquestions of safety oreffectiveness |
| Accuracy | ± 2 bpm | ± 2 bpm | ± 5% of value | Not Specified | Same as ANSHA-QHRV1 |
| BLOOD PRESURE | |||||
| Measurement types | Oscillometric measuringmethod during deflation ofthe cuff | Oscillometric measuringmethod during deflation ofthe cuff | Oscillometric measuringmethod during deflation ofthe cuff | Same as ABPI-MD | |
| Measurementranges | Systolic: 60 to 260 mmHgDiastolic: 40 to 220 mmHgBP Pulse rate (HR): 35 to 240min-1 | 39 – 242 mmHg Systolic40 – 180 mmHg Diastolic30 to 199 bpm (Pulse) | Systolic: 60 to 260 mmHgDiastolic: 40 to 220 mmHgBP Pulse rate (HR): 35 to 240min-1 | Same as Tonoport V | |
| Limit values ofmeasurementerrors | ABPI: ± 0.1Empirical Standard DeviationSystolic 4.6 mmHgDiastolic 4.4 mmHg | ± 0.1 ABPI± 3 mmHg (BP)± 5% of value (Pulse) | Empirical Standard DeviationSystolic 4.6 mmHgDiastolic 4.4 mmHg | Same as Tonoport V | |
| Cuffs inflation anddeflation | Automatic inflation using anair pump and deflation usingan electromagnetic valve.Max 300 mmHg | Automatic inflation using anair pump and deflation usingand electromagnetic valve | Automatic inflation using anair pump and deflation usingan electromagnetic valve.Max 300 mmHg | Same as Tonoport V | |
| Pulse Volume /Plethysmography | Pneumo-plethysmographymethod using the cuffsmeasuring the bloodpressure values:Plethysmography displayedat the inflation and deflationpressure | Pneumo-plethysmographymethod using the cuffsmeasuring the bloodpressurevalues: Plethysmographydisplayed at the inflationand deflation pressure | N/A | Same as ABPI-MD | |
| Feature | VitalScan ANS | Primary PredicateANSHA-QHRV1 | Secondary PredicateABPI MD | Reference DeviceTonoport 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 averageRed: 660 nm @ 0.8 mW maximum average | Photo plethysmogram on finger.Infrared: 910 nm @ 1.2 mW maximum averageRed: 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%) |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for Medeia. The logo has the word "Medeia" in bold black font, with the "M" in green and blue. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller blue font.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Medeia. The logo has the word "Medeia" in a sans-serif font, with the first letter "M" in green and blue, and the rest of the letters in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in a smaller, sans-serif font.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image contains the logo for Medeia. The logo has a stylized "M" in green and blue, followed by the word "Medeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image contains the logo for Medeia. The logo has a stylized "M" in green and blue, followed by the word "Medeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for Medeia. The logo has a stylized "M" in green and blue, followed by the word "Medeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image contains the logo for Medeia. The logo has a stylized "M" in green and blue, followed by the word "Medeia" in black. Below the word "Medeia" is the phrase "Designed for Clinicians" in blue.
§ 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).