(185 days)
Not Found
No
The summary describes a standard patient monitor utilizing embedded firmware for physiological measurements. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on standard accuracy metrics for physiological parameters.
No.
The device is a patient monitor intended for the continuous or spot-check monitoring of physiological parameters like carbon dioxide concentration, respiration rate, and arterial hemoglobin oxygen saturation. It is used for diagnosis and monitoring, rather than providing therapy or treatment.
No
The device monitors physiological parameters (CO2, RR, SpO2, PR) for continuous or spot-check purposes, which is a monitoring function, not a diagnostic one. It provides measurements rather than a medical diagnosis.
No
The device description explicitly states it "utilizes embedded firmware" and requires "Patient applied parts... provided via FDA cleared OEM accessories". This indicates the device includes hardware components beyond just software.
Based on the provided information, the WiCap™ patient monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- WiCap Function: The WiCap™ patient monitor directly measures physiological parameters in vivo (within the living body) through non-invasive means (monitoring breath and using pulse oximetry sensors). It does not analyze samples taken from the body.
The device description and intended use clearly indicate that it's a patient monitor for real-time physiological measurements, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA, CCK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Pediatric, and Neonate patients.
Intended User / Care Setting
The WiCap™ patient monitor is to be used by trained healthcare providers.
The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.
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
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%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, and 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.
Clinical Study Data:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
CO2 Accuracy:
0 - 40 mmHg ± 2 mmHg
41 - 70 mmHg ± 5% of reading
71 - 100 mmHg ± 8% of reading
101 - 150 mmHg ± 10% of reading
Above 80 breath per minute ± 12% of reading
(NOTE: Gas temperature at 25°C)
Respiration Rate Accuracy:
± 1 breaths per minute (bpm)
SpO2 Accuracy (70%-100%):
Adult & Pediatric:
No Motion: ± 2 digits
Motion: ± 3 digits
Low Perfusion: ± 2 digits
Neonatal:
No Motion: ± 3 digits
Low Perfusion: ± 2 digits
0% - 69%: Unspecified
Pulse Rate Accuracy:
Varies per sensor type. Typical specs
No Motion/Low Perfusion: ± 3 digits
Motion: ± 5 digits
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
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.
1
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
2
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)
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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
4 -
3
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.
$\qquad 5-1$
4
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 |
5
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)
6
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 Pulse | |||
| Rate) | carbon dioxide analyzer | ||
| (EtCO2) and Pulse-Ox (SpO2 | |||
| and Pulse Rate) | Same | ||
| Patient Population | Adult, pediatric and neonate | ||
| patients | Adult, pediatric and neonate | ||
| patients | Same | ||
| Indications | 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 Capnostream20 is intended for | ||
| CO2 and SPO2 indications. The | |||
| Capnostream20 combined | |||
| capnograph/pulse oximeter monitor | |||
| is intended to provide professionally | |||
| trained health care providers the | |||
| continuous, non-invasive | |||
| measurement and monitoring of | |||
| carbon dioxide concentration of the | |||
| expired and inspired breath and | |||
| respiration rate, and for the | |||
| continuous non-invasive monitoring | |||
| of functional oxygen saturation of | |||
| arterial hemoglobin (SpO2 and pulse | |||
| rate). It is intended for use with | |||
| neonatal, pediatric and adult patients | |||
| in hospitals, hospital type facilities, | |||
| intra hospital moves and home | |||
| environments. | Substantially | ||
| Equivalent | |||
| Environment of Use | Hospitals, healthcare facilities | ||
| and clinics, nursing home | |||
| facilities, and other healthcare | |||
| environments | Hospitals, hospital type | ||
| facilities, intra hospital moves | |||
| and home environments. | Similar - | ||
| Capnostream | |||
| 20 includes | |||
| home use. | |||
| Product Element | WiCap | Capnostream20 | Comments |
| Compliance | IEC 60601-1:2012 Basic safety | ||
| and essential performance | IEC/EN60601-1 | ||
| UL 60601-1 | |||
| CSA C22.2 No 601.1-M90 | |||
| IEC 60601-1-2:2007-03 and | |||
| 2014-02 EMC | IEC/EN60601-1-2 Class A | ||
| Radiated and Conducted | |||
| Emission | |||
| IEC 60601-1-8:2012-11 Alarms | IEC 60601-1-8 (Audible and | ||
| Visual Alarms) | Same | ||
| ISO 80601-2-55:2011-12-15 | |||
| Respiratory gas monitors | ISO 80601-2-55 | ||
| (Capnography) | |||
| ISO 80601-2-61:2011-04-01 | |||
| Pulse oximeters | ISO 80601-2-61 (Pulse | ||
| Oximetry) | |||
| IEC 60601-2-49:2011 | |||
| Multifunction patient | |||
| monitoring equipment | IEC 60601-2-49 Multifunction | ||
| patient monitoring | |||
| equipment | |||
| Capnography | |||
| CO2, EtCO2, FiCO2 Range | 0 to 150 mmHg, 0 to 19.7% | 0-150 mmHg | Same |
| CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg | ||
| 41 - 70 mmHg ± 5% of reading | |||
| 71 - 100 mmHg ± 8% of reading | |||
| 101 - 150 mmHg ± 10% of | |||
| reading | |||
| Above 80 breath per minute ± | |||
| 12% of reading |
- NOTE: Gas temperature at
25°C | 0-38 mmHg: ± 2 mmHg
39-150 mmHg: ± (5% of
reading + 0.08 x (expected
reading in mmHg -39mmHg)
Accuracy applies for breath
rates of up to 80 bpm. For
breath rates above 80 bpm,
accuracy is 4 mmHg or ±12 %
of reading whichever is
greater, for etCO2 values
exceeding 18 mmHg. | Substantially
Equivalent |
| Respiration Rate Range | 2 to 150 breaths per minute
(bpm) | 0-150 bpm | Substantially
Equivalent |
| Respiration Rate Accuracy | ± 1 breaths per minute (bpm) | 0-70 bpm: ±1 bpm
71-120 bpm: ±2 bpm
121-150 bpm: ±3 bpm | Substantially
Equivalent |
| CO2 Alarms | No breath, etCO2 high, etCO2
low, FiCO2 high, FiCO2 low, RR
high, RR low | No breath, etCO2 high, etCO2
low, 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 | Substantially
Equivalent |
| 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 & Pediatric
No Motion | ± 2 digits | ± 2 digits | Substantially
Equivalent |
| Motion
Low Perfusion | ± 3 digits
± 2 digits | | |
| Neonatal
No 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 | Substantially
Equivalent |
| Pulse Rate Accuracy | Varies per sensor type.
Typical specs | ± 3bpm | Substantially
Equivalent |
| No Motion/Low Perfusion | ± 3 digits | | |
| Motion | ± 5 digits | | |
| Alarms | SpO2 high, SpO2 low, Pulse Rate
high, Pulse Rate low | Adjustable Alarm Limits
SpO2 high, SpO2 low, Pulse
Rate high, Pulse Rate low | Same |
| Measurement Technology | | | |
| CO2 Gas Detection OEM
Module | Yes | Yes | Same |
| CO2 Measurement
Technique | Non-dispersive infrared (NDIR)
Infrared spectroscopy | Non-dispersive infrared
(NDIR) Infrared spectroscopy | Same |
| Pulse-Ox OEM Module | Yes | Yes | Same |
| Sp02 Measurement
Technique | Functional oxygen saturation of
arterial hemoglobin | Functional oxygen saturation
of arterial hemoglobin | Same |
| Pulse-Ox Sensors
Red Wavelength
IR Wavelength | LED
660 nanometers
910 nanometers | LED
660 nanometers
900 nanometers | Substantially
Equivalent
wavelengths. |
7
8
9
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.
5 - 7
10
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.