(185 days)
The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.
The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry. The WiCap Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WiCap monitor. WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.
The WiCap Patient Monitor is designed for continuous or spot-check monitoring of EtCO2, FiCO2, respiration rate (RR), SpO2, and pulse rate (PR).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (WiCap Monitor) | Reported Device Performance (WiCap Monitor) |
|---|---|---|
| Capnography | ||
| CO2, EtCO2, FiCO2 Range | 0 to 150 mmHg, 0 to 19.7% | 0 to 150 mmHg, 0 to 19.7% |
| CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg | 0 - 40 mmHg ± 2 mmHg |
| 41 - 70 mmHg ± 5% of reading | 41 - 70 mmHg ± 5% of reading | |
| 71 - 100 mmHg ± 8% of reading | 71 - 100 mmHg ± 8% of reading | |
| 101 - 150 mmHg ± 10% of reading | 101 - 150 mmHg ± 10% of reading | |
| Above 80 breath per minute ± 12% of reading. Note: Gas temperature at 25°C. | Above 80 breath per minute ± 12% of reading. Note: Gas temperature at 25°C. | |
| Respiration Rate Range | 2 to 150 breaths per minute (bpm) | 2 to 150 breaths per minute (bpm) |
| Respiration Rate Accuracy | ± 1 breaths per minute (bpm) | ± 1 breaths per minute (bpm) |
| Flow Rate | 50 ml/min ±10 ml/min | 50 ml/min ±10 ml/min |
| Pulse Oximetry | ||
| SpO2 Measurement Range | 0-100% | 0-100% |
| SpO2 Accuracy (No Motion, Adult & Pediatric) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Adult & Pediatric No Motion 70%-100%) |
| SpO2 Accuracy (Motion, Adult & Pediatric) | ± 3 digits (70%-100%) | Varies per sensor type (Typical specs: ± 3 digits for Adult & Pediatric Motion 70%-100%) |
| SpO2 Accuracy (Low Perfusion, Adult & Pediatric) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Adult & Pediatric Low Perfusion 70%-100%) |
| SpO2 Accuracy (No Motion, Neonatal) | ± 3 digits (70%-100%) | Varies per sensor type (Typical specs: ± 3 digits for Neonatal No Motion 70%-100%) |
| SpO2 Accuracy (Low Perfusion, Neonatal) | ± 2 digits (70%-100%) | Varies per sensor type (Typical specs: ± 2 digits for Neonatal Low Perfusion 70%-100%) |
| Pulse Rate Range | 30 to 250 beats per minute (bpm) | 30 to 250 beats per minute (bpm) |
| Pulse Rate Accuracy (No Motion/Low Perfusion) | ± 3 digits | Varies per sensor type (Typical specs: ± 3 digits for No Motion/Low Perfusion) |
| Pulse Rate Accuracy (Motion) | ± 5 digits | Varies per sensor type (Typical specs: ± 5 digits for Motion) |
2. Sample size used for the test set and the data provenance:
- Capnography: The document does not explicitly state the sample size for the capnography accuracy testing or its provenance. However, the accuracy specifications (e.g., "Above 80 breath per minute ± 12%") imply testing across a range of physiological conditions.
- Pulse Oximetry:
- Sample Size: The number of subjects is not explicitly stated, but it mentions "healthy, non-smoking, light-to-dark-skinned subjects."
- Data Provenance: The SpO2 accuracy testing was conducted "during induced hypoxia studies... in an independent research laboratory." The location of this laboratory (country of origin) is not specified. The study was prospective in the sense that hypoxia was induced for the purpose of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Capnography: Not mentioned.
- Pulse Oximetry: For SpO2 accuracy testing, the "ground truth" (reference standard) was arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter. This method does not involve human experts establishing ground truth in the traditional sense, but rather a validated clinical measurement device.
4. Adjudication method for the test set:
- Not applicable as the ground truth for the clinical study was established by objective measurements (laboratory co-oximeter for SpO2). For capnography, no specific adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done, as this device (WiCap Patient Monitor) does not involve human readers interpreting data in the way an imaging AI product would. It directly measures and reports physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented is for the standalone performance of the WiCap Patient Monitor itself. It measures and displays real-time physiological data without requiring human interpretation that would be significantly enhanced or altered by AI assistance in the context of this device type. The clinical accuracy report for the pulse oximeter module and sensor demonstrated its standalone performance.
7. The type of ground truth used:
- Capnography: Not explicitly stated, but typically involves calibrated gas mixtures and/or comparison against a highly accurate reference capnograph.
- Pulse Oximetry: Arterial hemoglobin oxygen (SaO2) values determined from blood samples with a laboratory co-oximeter. This is considered a clinical reference standard.
8. The sample size for the training set:
- The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development for the WiCap Patient Monitor. The device relies on established physiological measurement principles (NDIR infrared spectroscopy for capnography, spectrophotometry for pulse oximetry) rather than a deep learning model that would require a large training dataset. The OEM modules and their underlying algorithms would have been developed and validated by their respective manufacturers, but those specifics are not detailed here for the WiCap device itself.
9. How the ground truth for the training set was established:
- Not applicable, as no dedicated training set for a machine learning model is mentioned for the WiCap Patient Monitor. The "training" for such devices is typically in the form of engineering design, calibration, and validation against physical and physiological models and clinical reference standards by the OEM module manufacturers.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Athena GTX Sean Mahoney V.P. Regulatory Affairs 5900 NW 86th Street, Suite 300 Johnston, IA 50131
Re: K160582
Trade/Device Name: WiCap™ Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, CCK Dated: August 4, 2016 Received: August 5, 2016
Dear Sean Mahoney:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known)
Device Name
WiCap™ Patient Monitor
Indications for Use (Describe)
The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.
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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FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
I. SUBMITTER 807.92(a)(1)]:
Athena GTX 5900 NW 86th Street, Suite 300 Johnston, lowa 50131
Phone: 515.288.3360 Fax: 515.288.3394
Company Contact: Sean Mahoney (VP of Regulatory Affairs) 515.288.3360 x103 smahoney@athenagtx.com
Date Prepared: August 31, 2016
II. DEVICE [807.92(a)(2)]:
| Trade Name: | WiCapTM |
|---|---|
| Common Name: | Patient Monitor |
| Classification Name: | Oximeter (21 CFR 870.2700) |
| Device Class: | Class II |
|---|---|
| Product Code: | CCK, DQA |
| Basis for Submission: | New Device |
III. PREDICATE DEVICE [807.92(a)(3)]:
Legally Marketed Oridion Medical 1987 Limited, Capnostream 20 (K060065) (Predicate) Device:
IV. DEVICE DESCRIPTION [807.92(a)(4)]:
Device Identification
The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry.
Device Characteristics
The WiCap Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WiCap monitor.
Environment of Use
WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.
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Principle of Operation
WiCap uses non-dispersive infrared (NDIR) infrared spectroscopy to perform the capnography function (measuring carbon dioxide in exhaled breath (etCO2)). It is a side stream monitoring technique that utilizes a sample of the inhaled/exhaled patient's breath aspirated via a sample line (nasal cannula) to the CO2 OEM Module. The sample is drawn into the measurement module via DC driven pump.
Pulse oximetry measures the functional oxygen saturation of arterial hemoglobin. The patient's tissue is interrogated optically and the difference in the absorption of red and infrared light (spectrophotometry) by oxyhemoqlobin and deoxyhemoglobin is analyzed. This measurement is also done non-invasively via light emitting diodes (LEDs) in the sensors applied to the patient.
Materials
The WiCap Patient Monitor enclosure is primarily plastic and does not contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact.
Key Performance Specification
Key performance specifications are listed in the table in section VI below under capnography and pulse oximeter. Specific accuracy specifications for sensors that are compatible with the XPod pulse oximeter OEM module, are listed in the table below.
| Accuracy (± X digits) | |||
|---|---|---|---|
| Sensor Model | No Motion | Motion | Low Perfusion |
| Adult/Pediatric | |||
| 8000AA-1, -2, -3 | ± 2 | ± 3 | ± 2 |
| 8000AP-1, -3 | ± 2 | ± 3 | ± 2 |
| 8000SS-1, -3 | |||
| 8000SM-1, -3 | ± 2 | ± 3 | ± 2 |
| 8000SL-1, -3 | |||
| 8000J-1, -3 | ± 2 | --- | ± 2 |
| 8001J | ± 2 | --- | ± 2 |
| 8008J | ± 2 | --- | ± 2 |
| 8000Q2 | ± 3 | --- | ± 2 |
| 8000R | ± 2 | --- | ± 2 |
| 6000CA, CP, CI | ± 2 | ± 3 | ± 2 |
| 7000A, P, I | ± 2 | ± 3 | ± 2 |
| 6500MA, SA | ± 2 | ± 2 | ± 3 |
| Neonate | |||
| 6000CN | ± 3 | --- | ± 2 |
| 7000N | ± 3 | --- | ± 2 |
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V. INDICATIONS FOR USE [807.92(a)(5)]:
The WiCap patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap patient monitor is to be used by trained healthcare providers.
The Indications for Use statement for the WiCap device is not identical to the predicate device: however, the differences do not alter the key intended use of the device nor affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices measure the same physiological parameters, are to be used on the same patient populations and in the same environments and are for use by trained healthcare providers.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The WiCap Patient Monitor for monitoring end tidal CO2 and Pulse Oximetry employs the same technology principles as the predicate device. For CO2 measurements non-dispersive infrared (NDIR) infrared spectroscopy is used and for pulse oximetry functional oxygen saturation of arterial hemoglobin by analyzing the difference in the absorption of red and infrared light (spectrophotometry) by oxyhemoglobin and deoxyhemoglobin is used.
At a high level, the subject and predicate devices are based on the following same technological elements:
- . Uses OEM modules for Pulse Oximetry and Capnography (CO2 gas monitor)
- Same measurement techniques are used for both oximetry and capnography .
- Both have alarms
- Both comply to the same industry and FDA recognized standards ●
- Both use rechargeable lithium based batteries .
The following technological differences exist between the subject and predicate devices:
- Different OEM modules are used for Pulse Oximetry and Capnography (CO2 gas ● monitor)
- . WiCap imparts a lower optical power to the patient
- WiCap is smaller and lighter
- WiCap has a lower battery/system voltage
- . WiCap has been tested to more severe EMC requirements (Class B vs. Class A)
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The following is provided as a summary of how the technological characteristics of the device compare to the predicate device:
| Product Element | WiCap | Capnostream20 | Comments |
|---|---|---|---|
| Manufacturer | Athena GTX | Oridion Capnography Inc. | - - - |
| Model Number(s) | WiCap | Capnostream20 | - - - |
| 510(k) Number | Pending - new device | K060065 | - - - |
| Physiological Parameters | carbon dioxide analyzer (EtCO2)and Pulse-Ox (SpO2 and PulseRate) | carbon dioxide analyzer(EtCO2) and Pulse-Ox (SpO2and Pulse Rate) | Same |
| Patient Population | Adult, pediatric and neonatepatients | Adult, pediatric and neonatepatients | Same |
| Indications | The WiCap patient monitor is intendedfor the continuous or spot-checkmonitoring of carbon dioxideconcentration of the expired (EtCO2)and inspired (FiCO2) breath andrespiration rate (RR), and functionaloxygen saturation of arterialhemoglobin (SpO2) and pulse rate (PR)measurements. Intended patientpopulations include: Adult, Pediatric,and Neonate patients. The device is foruse in hospitals, healthcare facilities andclinics, nursing home facilities, and otherhealthcare environments. The WiCappatient monitor is to be used by trainedhealthcare providers. | The Capnostream20 is intended forCO2 and SPO2 indications. TheCapnostream20 combinedcapnograph/pulse oximeter monitoris intended to provide professionallytrained health care providers thecontinuous, non-invasivemeasurement and monitoring ofcarbon dioxide concentration of theexpired and inspired breath andrespiration rate, and for thecontinuous non-invasive monitoringof functional oxygen saturation ofarterial hemoglobin (SpO2 and pulserate). It is intended for use withneonatal, pediatric and adult patientsin hospitals, hospital type facilities,intra hospital moves and homeenvironments. | SubstantiallyEquivalent |
| Environment of Use | Hospitals, healthcare facilitiesand clinics, nursing homefacilities, and other healthcareenvironments | Hospitals, hospital typefacilities, intra hospital movesand home environments. | Similar -Capnostream20 includeshome use. |
| Product Element | WiCap | Capnostream20 | Comments |
| Compliance | IEC 60601-1:2012 Basic safetyand essential performance | IEC/EN60601-1UL 60601-1CSA C22.2 No 601.1-M90 | |
| IEC 60601-1-2:2007-03 and2014-02 EMC | IEC/EN60601-1-2 Class ARadiated and ConductedEmission | ||
| IEC 60601-1-8:2012-11 Alarms | IEC 60601-1-8 (Audible andVisual Alarms) | Same | |
| ISO 80601-2-55:2011-12-15Respiratory gas monitors | ISO 80601-2-55(Capnography) | ||
| ISO 80601-2-61:2011-04-01Pulse oximeters | ISO 80601-2-61 (PulseOximetry) | ||
| IEC 60601-2-49:2011Multifunction patientmonitoring equipment | IEC 60601-2-49 Multifunctionpatient monitoringequipment | ||
| Capnography | |||
| CO2, EtCO2, FiCO2 Range | 0 to 150 mmHg, 0 to 19.7% | 0-150 mmHg | Same |
| CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg41 - 70 mmHg ± 5% of reading71 - 100 mmHg ± 8% of reading101 - 150 mmHg ± 10% ofreadingAbove 80 breath per minute ±12% of reading* NOTE: Gas temperature at25°C | 0-38 mmHg: ± 2 mmHg39-150 mmHg: ± (5% ofreading + 0.08 x (expectedreading in mmHg -39mmHg)Accuracy applies for breathrates of up to 80 bpm. Forbreath rates above 80 bpm,accuracy is 4 mmHg or ±12 %of reading whichever isgreater, for etCO2 valuesexceeding 18 mmHg. | SubstantiallyEquivalent |
| Respiration Rate Range | 2 to 150 breaths per minute(bpm) | 0-150 bpm | SubstantiallyEquivalent |
| Respiration Rate Accuracy | ± 1 breaths per minute (bpm) | 0-70 bpm: ±1 bpm71-120 bpm: ±2 bpm121-150 bpm: ±3 bpm | SubstantiallyEquivalent |
| CO2 Alarms | No breath, etCO2 high, etCO2low, FiCO2 high, FiCO2 low, RRhigh, RR low | No breath, etCO2 high, etCO2low, RR high, RR low, IPI low | Same |
| Flow Rate | 50 ml/min ±10 ml/min | 50 (42.5 ≤ flow ≤ 65) ml/min,flow measured by volume | SubstantiallyEquivalent |
| Product Element | WiCap | Capnostream20 | Comments |
| Pulse-Oximeter | |||
| SpO2 Measurement Range | 0-100% | 0-100% | Same |
| SpO2 Accuracy | Varies per sensor type.Typical specs | ||
| 70%-100%Adult & PediatricNo Motion | ± 2 digits | ± 2 digits | SubstantiallyEquivalent |
| MotionLow Perfusion | ± 3 digits± 2 digits | ||
| NeonatalNo Motion | ± 3 digits | ± 3 digits | Equivalent |
| Motion | --- | ||
| Low Perfusion | ± 2 digits | ||
| 0% - 69% | Unspecified | Unspecified | |
| Pulse Rate Range | 30 to 250 beats per minute(bpm) | 20-250 bpm | SubstantiallyEquivalent |
| Pulse Rate Accuracy | Varies per sensor type.Typical specs | ± 3bpm | SubstantiallyEquivalent |
| No Motion/Low Perfusion | ± 3 digits | ||
| Motion | ± 5 digits | ||
| Alarms | SpO2 high, SpO2 low, Pulse Ratehigh, Pulse Rate low | Adjustable Alarm LimitsSpO2 high, SpO2 low, PulseRate high, Pulse Rate low | Same |
| Measurement Technology | |||
| CO2 Gas Detection OEMModule | Yes | Yes | Same |
| CO2 MeasurementTechnique | Non-dispersive infrared (NDIR)Infrared spectroscopy | Non-dispersive infrared(NDIR) Infrared spectroscopy | Same |
| Pulse-Ox OEM Module | Yes | Yes | Same |
| Sp02 MeasurementTechnique | Functional oxygen saturation ofarterial hemoglobin | Functional oxygen saturationof arterial hemoglobin | Same |
| Pulse-Ox SensorsRed WavelengthIR Wavelength | LED660 nanometers910 nanometers | LED660 nanometers900 nanometers | SubstantiallyEquivalentwavelengths. |
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VII. PERFORMANCE DATA [807.92(b)(1)]:
Biocompatibility
The WiCap patient monitor does not come in contact with the patient and was not tested for biocompatibility.
OEM cleared accessories are specified for use that contact the patient. The 510(k) clearance information was provided as part of this submission.
OEM in-cable oximeter has been tested for Biocompatibility since it may come in contact with the patient.
These products comply with ISO 10993 for intact skin contact for greater than 30 days and were tested for compliance to requirements for
- Cytotoxicity ●
- . Sensitization
- . Irritation
Industry Standards for Electrical Safety, EMC and Essential Performance
Testing of the WiCap Patient Monitor has been completed to verify compliance with FDA guidance, recognized national and international standards for electrical safety and performance for medical devices, and particular requirements applicable to this device including:
- Pulse Oximeters Premarket Notification Submissions [510(k)s] Guidance for Industry . and Food and Drug Administration Staff. Document issued on: March 4, 2013.
- IEC 60601-1:2012 Basic safety and essential performance ●
- IEC 60601-1-2:2007-03 and 2014-02 EMC ●
- IEC 60601-1-8:2012-11 Alarms ●
- IEC 60601-2-49:2011 Multifunction patient monitoring equipment
- ISO 80601-2-55:2011-12-15 Respiratory gas monitors ●
- ISO 80601-2-61:2011-04-01 Pulse oximeters
- IEC 60601-1-6: 2010 + IEC 62366:2007 Usability ●
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.
Animal Study Data
None.
Clinical Study Data [807.92(b)(2)]:
OEM module and sensor clinical accuracy reports and manufacturer compliance statements were provided for the pulse oximeter parameter of the WiCap patient monitor that demonstrated compliance with the FDA Pulse Oximeter Guidance and ISO 80601-2-61 requirements. No further clinical testing was performed. Successful integration of the OEM module and sensor(s) was tested via a functional tester (pulse oximeter simulator) spanning the monitor's claimed range of pulse rate and saturation values.
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SpO2 accuracy testing was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects during motion and no-motion conditions in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors were compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO2 range of 70 - 100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-02-61:2011, Standard Specification for Pulse Oximeters for Accuracy.
VIII. CONCLUSION [807.92(b)(3)]:
The results for all safety, compliance, and non-clinical performance testing demonstrates that the Athena GTX WiCap Patient Monitor is as safe and as effective as the above listed predicate device, has the same performance characteristics and is substantially equivalent to the above listed predicate device.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).