GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Device Facts
| Record ID | K201179 |
|---|---|
| Device Name | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable |
| Applicant | Covidien, LLC |
| Product Code | DQA · Cardiovascular |
| Decision Date | Jul 20, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The GE ApexPro CH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities. · Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF). · Note: Hospital-type facilities include step-down units and long-term care facilities. The GE ApexPro FH SpO2 - Nellcor Cable is indicated for prescription use only for spot-check or 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 during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities. · Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF). · Note: Hospital-type facilities include step-down units and long-term care facilities.
Device Story
Interface cables providing external oximetry-in-a-cable solution for GE ApexPro Telemetry Systems; utilizes Nellcor pulse oximetry sensors with Oximax technology. Inputs: optical signals from sensors; transforms via embedded oximetry engine using spectrophotometry and plethysmography to calculate SpO2 and pulse rate. Outputs: SpO2, pulse rate, measurement confidence, and sensor status transmitted to host telemetry system via UART protocol. Used in hospitals/hospital-type facilities by clinicians. Provides continuous monitoring, enabling patient mobility. Output displayed on host monitor at central station; assists clinicians in patient assessment and vital sign tracking.
Clinical Evidence
Bench testing only. No clinical data required. Verification included pulse oximetry performance per ISO 80601-2-61:2017, low perfusion accuracy, system/software/hardware verification, and biocompatibility (cytotoxicity, sensitization, irritation).
Technological Characteristics
Interface cable with embedded PCBA oximetry engine. Materials: Thermoplastic polyurethanes, polycarbonate, polyurethane. Sensing: Spectrophotometry/plethysmography. Connectivity: Wired UART to GE ApexPro Telemetry System. Power: Host-supplied. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 10993-1.
Indications for Use
Indicated for prescription use in neonate, pediatric, and adult patients for spot-check or continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate. Suitable for well or poorly perfused patients under motion or no-motion conditions in hospitals and hospital-type facilities.
Regulatory Classification
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.
Predicate Devices
- Nellcor Pulse Oximetry Monitor Interface Cable (K172482)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Covidien Ilc Ligia Mastronardi Regulatory Affairs Manager 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K201179
Trade/Device Name: GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: April 30, 2020 Received: May 1, 2020
Dear Ligia Mastronardi:
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
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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,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K201179
## Device Name GE ApexPro CH SpO2 - Nellcor cable
GE ApexPro FH SpO2 - Nellcor cable
#### Indications for Use (Describe)
GE ApexPro CH SpO2 - Nellcor cable
The GE ApexPro CH SpO2 – Nellcor cable is indicated for prescription use only for spot-check or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
· Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU),and medical/surgical general care floor (GCF).
· Note: Hospital-type facilities include step-down units and longterm care facilities.
GE ApexPro FH SpO2 - Nellcor cable
The GE ApexPro FH SpO2 – Nellcor cable is indicated for prescription use only for spot-check or continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
· Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF).
· Note: Hospital-type facilities include step-down units and longterm care facilities.
| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## Medtronic
# 510(k) Summary
The 510(k) summary for the GE ApexPro CH SpO2 – Nellcor Cable "&" GE ApexPro FH SpO2 – Nellcor Cable outlined below is written in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92.
## K201179
## SUBMITTER INFORMATION:
| Submitted By: | Covidien, IIc<br>6135 Gunbarrel Avenue<br>Boulder, CO 80301 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | July 1, 2020 |
| Contact Person: | Lígia Mastronardi<br>Regulatory Affairs Manager<br>Phone: (303) 912-7752<br>Fax: N/A<br>ligia.mastronardi@medtronic.com |
| SUBJECT DEVICE NAME | |
| Proprietary Name: | GE ApexPro™ CH SpO2 – Nellcor Cable<br>GE ApexPro™™ FH SpO2 – Nellcor Cable |
| Common Name: | SpO2 Cable |
| Classification Name: | Oximeter |
| Device Classification Regulation: | 21 CFR 870.2700 - Class II |
| Regulation Medical Specialty: | Cardiovascular |
| Device Product Code: | DQA |
| 510k Review Panel: | Anesthesiology |
<sup>1</sup> Collectively called GE ApexPro CH/FH SpO2 - Nellcor Cables throughout this submission.
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## PREDICATE DEVICE
| Manufacturer: | Covidien, IIc |
|-----------------|----------------------------------------------------|
| Device Name: | The Nellcor Pulse Oximetry Monitor Interface Cable |
| 510(k) number: | K172482 |
| Clearance Date: | 12/15/2017 |
## Subject Device Description
The subject device of this premarket 510(k) notification is composed of two (2) cables as follows:
- GE ApexPro CH SpO2 Nellcor Cable i
- GE ApexPro FH SpO2 Nellcor Cable -
Collectively, the two cables are referred to as GE ApexPro CH/FH SpO2 - Nellcor Cable throughout this submission.
The GE ApexPro CH/FH SpO2 – Nellcor Cable (subject device) is a that provides an external oximetry-in-a-cable solution when used with the GE ApexPro™ Telemetry System and a Nellcor™ pulse oximetry sensor with Oximax™ technology. The subject device is used as part of the GE ApexPro Telemetry System that provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate which is measured by Nellcor pulse oximetry sensors. The GE ApexPro Telemetry System provides clinicians with patient data while allowing for patient mobility. The GE ApexPro Telemetry System was cleared by the FDA on June 20, 2008 under 510(k) number K080251.
The GE ApexPro FH/CH SpO2 - Nellcor cable is a modification of the Nellcor Pulse Oximetry Monitor Interface Cable (K172482) which is used as an interface when used with the GE ApexPro Telemetry System.
The device description from the subject device labeling is provided in Table 1.
| | GE ApexPro™* CH SpO2 – Nellcor Cable | GE ApexPro™* FH SpO2 – Nellcor Cable |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | When used with a GE ApexPro™ telemetry system, the GE ApexPro™ CH SpO2 – Nellcor cable (SpO2 oximetry cable) provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, as measured by Nellcor™ pulse | When used with a GE ApexPro™ FH telemetry system, the GE ApexPro™ FH SpO2 – Nellcor cable (SpO2 oximetry cable) provides continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, as measured by Nellcor™ pulse |
## Table 1 - Subject Device Description
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| | oximetry sensors. The SpO2 oximetry<br>cable relies on unique oximetry<br>technology and design to provide<br>hospitals, clinicians, and caregivers<br>with accurate, timely data.<br>The SpO2 oximetry cable must be<br>used with a GE ApexPro™ telemetry<br>system. The SpO2 oximetry cable<br>provides the following vital signs for<br>display:<br>• Arterial blood oxygen saturation<br>(SpO2)<br>• Pulse rate (PR)<br>• Measurement confidence indicator | oximetry sensors. The SpO2 oximetry<br>cable relies on unique oximetry<br>technology and design to provide<br>hospitals, clinicians, and caregivers<br>with accurate, timely data.<br>The SpO2 oximetry cable must be<br>used with a GE ApexPro™ FH<br>telemetry system. The SpO2 oximetry<br>cable provides the following<br>vital signs for display:<br>• Arterial blood oxygen saturation<br>(SpO2)<br>• Pulse rate (PR)<br>• Measurement confidence indicator |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Host Details | The GE ApexPro Telemetry System was cleared by the FDA on June 20,<br>2008 under 510(k) number K080251. | |
| Compatible<br>Sensors | Nellcor™ pulse oximetry sensors with Oximax™ technology and compatible<br>for use with the GE ApexPro™ CH SpO2 – Nellcor cable with respective<br>510(k) numbers are outlined below: | |
| | - Forehead SpO2 sensor: MAXFAST (K012891)<br>- Non-adhesive SpO2 sensors: SC-A, SC-NEO, SC-PR (K030930)<br>- Adhesive SpO2 sensors: MAXA/MAXAL, MAXN, MAXI, MAXP (K012891)<br>- SpO2 sensors: A, N, I, P (K012891)<br>- Reusable SpO2 clip sensors:DS100A, D-YSPD, D-YS, D-YSE (K012891)<br>- Reusable SpO2 clip sensors: FLEXMAX, FLEXMAS-P (K162014)<br>- Two-piece reusable SpO2 sensors: OXI-A/N, OXI-P/I (K012891)<br>- Nellcor™ adult SpO2 nasal sensor: MAX-R (K012891) | |
## Intended Use/Indications for Use
## GE ApexPro CH SpO2 - Nellcor Cable
The GE ApexPro CH SpO2 – Nellcor Cable is indicated for prescription use only for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonate, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
· Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF).
· Note: Hospital-type facilities include step-down units and long-term care facilities.
## GE ApexPro FH SpO2 – Nellcor Cable
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The GE ApexPro FH SpO2 - Nellcor Cable is indicated for prescription use only for spot-check or 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 during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
· Note: Hospital use typically includes such areas as the intensive care unit (ICU), Pediatric Intensive Care Unit (PICU), neonatal intensive care unit (NICU), and medical/surgical general care floor (GCF).
· Note: Hospital-type facilities include step-down units and long-term care facilities.
## Technological Characteristics Comparison
The subject device, the GE ApexPro CH/FH SpO2 - Nellcor Cable has the same intended use, similar indications for use, principles of operation, and fundamental technology as the predicate device, the Nellcor Pulse Oximetry Monitor Interface Cable (K172482). The subject device is a derivative of the predicate device with software and hardware modifications.
Results of verification and validation testing support the use of the GE ApexPro CH/FH SpO2 -Nellcor cable with GE ApexPro Telemetry Systems and with the same Nellcor SpO2 sensors commercially available for use with the predicate device.
Based on results of verification and validation studies (including system verification), Covidien has established that the subject device, the GE ApexPro™ CH/FH SpO2 - Nellcor Cable is substantially equivalent to the predicate device.
## Substantial Equivalence - Non-Clinical Evidence
The performance testing section of this submission includes verification reports for pulse oximetry performance were conducted in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff". Bench Performance Testing conducted includes, but is not limited to testing outlined below:
- Testing conducted per ISO 80601-2-61:2017 and IEC 60601-1:2005 + A1:2012 standards
- . Oximetry performance verification testing in low perfusion conditions
Substantial equivalence was determined through results from verification testing and testing conducted per standards as indicated below:
- System Verification
- Software Verification .
- Hardware Verification
- Compatibility Verification ●
- Compliance testing to the following standards:
- IEC 60601-1:2005 + A1:2012 o
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- o IEC 60601-1-2:2014
- o IEC 60601-1-6:2013
- o IEC 62366-1:2015/ COR1:2016
- ISO 80601-2-61:2017 o
- o ISO 15223-1:2016
- o IEC 62304:2006+AMD1:2015
- o ISO 10993-1:2018
The results of this testing demonstrate that the subject device, the GE ApexPro CH/FH SpO2 -Nellcor Cable, can be considered as substantially equivalent to the predicate device. Substantial Equivalence - Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence. Please refer to Table 2 for Substantial Equivalence comparison.
The Substantial Equivalence Table is provided below:
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# Medtronic
## Table 2: Substantial Equivalence
| Device<br>Characteristics | Predicate Device: | Subject Devices: | Similarities and<br>Differences |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Nellcor Pulse Oximetry Monitor Interface<br>Cable – 510(K) 172482 ("Oxicable") | GE ApexPro CH SpO2 – Nellcor Cable<br>GE ApexPro FH SpO2 – Nellcor Cable | |
| Device Pictures | | Image: GE ApexPro CH SpO2 – Nellcor Cable:<br>Image: GE ApexPro FH SpO2 – Nellcor Cable: | Visually different |
| Indications for Use | The Nellcor™ USB Pulse Oximetry Monitor<br>Interface Cable is indicated for prescription use<br>only for spot check or continuous non-invasive<br>monitoring of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and pulse rate. It is<br>intended for use with neonatal, pediatric, and<br>adult patients during both no motion and motion<br>conditions and for patients who are either well or<br>poorly perfused, in hospitals and hospital-type<br>facilities. | The GE ApexPro™ CH/FH SpO2 – Nellcor cable is<br>indicated for prescription use only for spot-check<br>or continuous non-invasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate. It is intended<br>for use with neonatal, pediatric, and adult<br>patients during both no motion and motion<br>conditions and for patients who are either well or<br>poorly perfused, in hospitals and hospital-type<br>facilities. | Similar |
| Prescription/Over-<br>the-counter Use | Prescription | Prescription | Similar |
| Intended Use<br>Populations | Neonatal, Pediatric, and Adult populations | Neonatal, Pediatric, and Adult populations | Similar |
| Environment of<br>Use | Hospitals, hospital-type facilities.<br>Note: Hospital use typically includes such areas as<br>the intensive care unit (ICU), neonatal intensive<br>care unit (NICU), operating room (OR), post-<br>anesthesia care unit (PACU), emergency<br>department, and medical/surgical general care<br>floor (GCF).<br>Note: Hospital-type facilities include step-down<br>units and longterm care facilities. | Hospitals, hospital-type facilities.<br>Note: Hospital use typically includes such areas as<br>the intensive care unit (ICU), Pediatric Intensive<br>Care Unit (PICU), neonatal intensive care unit<br>(NICU),and medical/surgical general care floor<br>(GCF).<br>Note: Hospital-type facilities include step-down<br>units and longterm care facilities. | Similar |
| Measurement<br>Parameters | Oxygen Saturation, Pulse Rate | Oxygen Saturation, Pulse Rate | Similar |
| Sensor<br>Compatibility | Use only Nellcor-approved sensors. | Use only Nellcor-approved sensors. | Similar |
| Intended<br>Application Site | NA – Device not in direct contact with the<br>patient. | NA – Device not in direct contact with the<br>patient. | Similar |
| | Performance Characteristics and Specifications | | |
| SpO2 Technology | Spectrophotometry and plethysmography | Spectrophotometry and plethysmography | Similar |
| SpO2 Algorithm | Comparison of red/infrared modulation % | Comparison of red/infrared modulation % | Similar |
| SpO2<br>measurement<br>range (%) | 1% to 100% | 1% to 100% | Similar |
| SpO2 Measurement Accuracy Specifications | | | |
| Without motion -<br>Adults | 70-100% ±2 digits | 70-100% ±2 digits | Similar |
| Without motion -<br>Neonates | 70-100% ±2 digits | 70-100% ±2 digits | Similar |
| With motion -<br>Adults & Neonates | 70-100% ±3 digits | 70-100% ±3 digits | Similar |
| Low Perfusion | 70-100% ±2 digits | 70-100% ±2 digits | Similar |
| LoSat | 60% to 80%±3 digits | 60% to 80% ±3 digits | Similar |
| | Pulse Rate Measurement Range (BPM) and Accuracy | | |
| Without Motion<br>(Adult & Neonate) | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits | Similar |
| With Motion | 20 to 250 BPM ±5 digits | 20 to 250 BPM ±5 digits | Similar |
| Low Perfusion | 20 to 250 bpm ±3 digits | 20 to 250 bpm ±3 digits | Similar |
| Safety Specifications | | | |
| Electrical | IEC 60601-1-2:2007<br>IEC 60601-1-2:2014<br>IEC 60601-1:2005/AMD1:2012 | IEC 60601-1-2:2014<br>IEC 60601-1:2005/AMD1:2012 | Subject device<br>meets current<br>standards. |
| Environmental | Operating Temperature: 5ºC to 40ºC (41ºF to<br>104ºF)<br>Operating Atmospheric Pressure: 1075 hPa to<br>616 hPa<br>Operating Relative Humidity: 15% to 95% non-<br>condensing<br>Transport and Storage Temperature: -40ºC to<br>70ºC (-40ºF to 158ºF)<br>Transport and Storage Operating Atmospheric<br>Pressure: 1075 hPa to 500 hPa<br>Transport and Storage Operating Relative<br>Humidity: 15% to 95% non-condensing | Operating Temperature: 5ºC to 40ºC (41ºF to<br>104ºF)<br>Operating Atmospheric Pressure: 1075 hPa to<br>616 hPa<br>Operating Relative Humidity: 15% to 95% non-<br>condensing<br>Transport and Storage Temperature: -40ºC to<br>70ºC (-40ºF to 158ºF)<br>Transport and Storage Operating Atmospheric<br>Pressure: 1200 hPa to 475 hPa<br>Transport and Storage Operating Relative<br>Humidity: 10% to 95% non-condensing | No operating<br>differences.<br>Transport and<br>storage differences<br>due to overlaps and<br>extensions beyond<br>those of predicate<br>device. |
| Mechanical | IEC 60601-1:2005/AMD1:2012 | IEC 60601-1:2005/AMD1:2012 | Similar |
| | | Features | |
| Portability | Portable | Portable (Body-worn) | Different: Subject<br>device can be worn<br>by the patient or<br>attached to a<br>patient's clothing. |
| Alarms | N/A-The host monitor is responsible for<br>detecting, triggering, prioritizing, and notifying<br>the operator of the alarm conditions. | N/A-The GE ApexPro telemetry system is<br>responsible for detecting, triggering, prioritizing,<br>and notifying the operator of the alarm<br>conditions. | Similar |
| Indicators | N/A-No Indicator | N/A-No Indicator | Similar |
| | | | |
| Modes | Working Mode: Continuous Mode<br>Response Mode: Normal Response Mode, Fast Response Mode.<br>Power Mode: Legacy Power Mode, Normal Power Mode, Low Power Only Mode | Working Mode: Continuous Mode<br>Response Mode: Normal Response Mode<br>Power Mode: Normal Power Mode | Different: Subject device only sends message to host.<br>Predicate device sends to and receives messages from host. See impact below. |
| Display | N/A – readings are displayed by the Host Monitor at the central station | N/A – results are displayed by the Host Monitor at the central station | Similar |
| Power Source | Energy source is provided by host which is powered by main via USB connection. | Energy source is provided by host's battery operated transceiver or transmitter. | Different: Change of energy source |
| Physical Features | Includes second bump (ISO) as the line module consists of patient isolation, power regulation, current limitation and USB communication interface. | No second bump required. Power regulation, current limitation, and serial communication interface are provided by Boost Board embedded in the cables. | Different: ISO bump versus boost board. See impact below. |
| | USB Type A connector | GE ApexPro CH/FH connector, with power converter overmolded | Different: Different connector due to different hosts. |
| | Length: 305 cm long | FH Length: 37 cm long<br>CH Length: 32.5 cm long | Different: Different length due to different hosts. |
| | | Function | |
| Device<br>Functionality | Host: Qualified host display monitor. | Host: GE ApexPro CH/FH Telemetry Systems (K080251) | Similar |
| | Provides patient isolation protection | No additional isolation forming MOPP needed in U-NSAT | Different: MOPP variance is due to different energy sources. |
| | Bidirectionally communicates (sends and receives information) with externally interfaced host monitor | Unidirectionally communicates with externally interfaced host monitor. Cable will only send information to GE ApexPro CH/FH Telemetry Systems | Different: Unidirectional communication versus bidirectional. |
| | UtilizesUSB 2.0 full speed VCP (Virtual<br>Communications Port) driver to communicate<br>with externally interfaced host monitor. | Utilizes UART (Universal Asynchronous<br>Transmitter Receiver) protocol to communicate<br>with externally interfaced host monitor. | Different: Different<br>communication<br>protocol due to<br>different hosts. |
| Software<br>Communication<br>Protocols | Communication protocol: Covidien Standard<br>Protocol | Communication protocol: ASPIP (GE Protocol) | Different: Different<br>communication<br>protocol due to<br>different hosts. |
| Signal Strength<br>Indicator | None | Asterisk system | Subject device host<br>monitor will display<br>***/**/* will be<br>displayed to indicate<br>the SSI). |
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### Software and Cybersecurity
Software Description:
The subject device GE ApexPro CH/FH SpO2 - Nellcor Cable is an interface cable with the pulse Oximetry engine embedded in its PCBA. The cable connects to the GE ApexPro FH and CH telemetry system and communicates via UART protocol via a wired connection.
The Oximetry PCBA in the subject device contains an embedded software that uses the Nellcor pulse oximetry algorithm to calculate SpO2 (oxygen saturation in the body) and PR (pulse rate) for both motion and non-motion conditions.
Embedded software also includes a GE ASPIP software protocol to communicate with GE ApexPro FH and CH telemetry system. Features include SpO2. PR. SSI and sensor status (i.e., sensor off the patient, sensor disconnected) which are reported to the GE ApexPro telemetry system.
The software is executed on a single processor. Additionally, the software does not use an operating system or off the shelf software.
## Cybersecurity Summary:
The GE ApexPro CH/FH SpO2 – Nellcor cable do not include wireless communication capability for communication to a host. Communication to a host is accomplished via a wired connection using the UART protocol. Any changes to the cable (like software updates) are carried out via custom software tools that are only available to Medtronic / trained technicians.
The device is designed so that it does not store any protected health information. Access to the software update protocols, the specialized hardware, the software update application is limited to Medtronic / trained technicians. Cybersecurity controlled access is accomplished through design that prevents any control signals from being sent to the host device and by of the inability to store patient identifiers. These features were evaluated and determined to meet controlled access needed for cybersecurity.
The GE ApexPro CH/FH SpO2 – Nellcor cable communicates to the GE ApexPro telemetry system through a wired connection using the UART protocol. Wireless communication is not a feature of the device. Thus, a cybersecurity incident affecting the device could only directly affect a single patient. The GE ApexPro CH/FH SpO2 – Nellcor cables are considered as Tier 2 "Standard Cybersecurity Risk" as defined in FDA quidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (May, 2005).
Any software-related vulnerabilities of GE ApexPro CH/FH SpO2 - Nellcor cable are identified, scored and mitigated through the vulnerability assessment process.
### Biocompatibility Information
The subject device GE ApexPro CH/FH SpO2 – Nellcor Cable is a non-sterile medical device that may intermittently come into direct skin contact with the patient.
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A list identifying each of tissue-contacting device components and associated materials of construction for each component, including identification of color additives are provided in Table 3 below.
| Component | | | GE ApexPro FH<br>SpO2<br>Nellcor cable | GE ApexPro CH<br>SpO2 Nellcor<br>cable |
|--------------|--------------------------|--|----------------------------------------|---------------------------------------------------|
| Subcomponent | Host connector over-mold | | Material | (Thermoplastic polyurethanes, GRAY<br>MUNSELL N7) |
| | | | Patient contact | Yes |
| | Clear coat | | Material | Tampa Star TPR 910 ink + H1 hardener |
| | | | Patient contact | Yes |
| | Assy, Oxicor-Unlabeled | | Part Number | PT00092575 |
| | Oxicor over-mold | | Material | PELLETHANE (PANTONE 281C) |
| | | | Patient contact | Prolonged exposure |
| | Cable outer jacket | | Material | POLYURETHANE, PANTONE COOL GRAY 90 |
| | | | Patient contact | Yes…
