(80 days)
No
The document describes a cable that connects a pulse oximetry sensor to a telemetry system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the cable's function in transmitting data and its compliance with relevant standards.
No.
Explanation: The device is indicated for monitoring functional oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes
Explanation: The device is used for "monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are physiological parameters used to assess a patient's health status, thereby aiding in diagnosis or treatment decisions.
No
The device description explicitly states the device is composed of two cables, which are hardware components. The performance studies also include hardware verification testing.
Based on the provided information, the GE ApexPro CH/FH SpO2 - Nellcor cable is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This involves measuring physiological parameters directly from the patient's body, not analyzing samples taken from the body (in vitro).
- Device Description: The device is described as a cable that provides an "external oximetry-in-a-cable solution" and is used as part of a telemetry system for "continuous non-invasive monitoring." This reinforces its role in direct patient monitoring.
- Anatomical Site: The anatomical site is listed as "NA – Device not in direct contact with the patient," which is consistent with a cable connecting a sensor to a monitoring system, not a device that analyzes a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the GE ApexPro CH/FH SpO2 - Nellcor cable is a component of a system used for non-invasive physiological monitoring, which falls outside the definition of an In Vitro Diagnostic device.
N/A
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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The subject device consists of two cables: the GE ApexPro CH SpO2 – Nellcor Cable and the GE ApexPro FH SpO2 – Nellcor Cable. These cables provide 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 to facilitate continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, which are measured by Nellcor pulse oximetry sensors. The GE ApexPro Telemetry System, in conjunction with these cables, provides clinicians with patient data while allowing for patient mobility. The cables themselves contain an embedded pulse oximetry engine within their PCBA and communicate with the GE ApexPro FH and CH telemetry system via UART protocol over a wired connection. The embedded software calculates SpO2 and pulse rate for both motion and non-motion conditions using the Nellcor pulse oximetry algorithm. It also uses a GE ASPIP software protocol to communicate various features such as SpO2, pulse rate, Signal Strength Indicator (SSI), and sensor status to the telemetry system. The software runs on a single processor without an operating system or off-the-shelf software. The cables are designed to not store protected health information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found (The device is not in direct contact with the patient; it's an interface cable for sensors that would be placed on the patient.)
Indicated Patient Age Range
neonate, pediatric, and adult patients
Intended User / Care Setting
Hospitals and hospital-type facilities.
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).
Hospital-type facilities include step-down units and long-term care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing was conducted in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff".
Key tests included:
- Motion Pulse Rate Accuracy Verification Test Report, GE ApexPro CH/FH SpO2-Nellcor cable: Confirmed pulse rate accuracy under simulated motion conditions using a pulse simulator device. Evaluated pulse rate accuracy in the range of 25 -250 beats per minute at a fixed O2 saturation of 95% and a Modulation% of 3% during quiescent periods. Pulse rate and SpO2 performance are measured using the calculated RMSD (root mean square of the difference) of the simulated pulse rate input and the DUT displayed pulse rate.
- System Performance Verification Test Report, GE ApexPro CH/FH SpO2-Nellcor cable: Confirmed that the GE ApexPro CH/FH SpO2 – Nellcor cable meets SpO2 and Pulse Rate range and accuracy requirements by reporting pulse rate values between 20 and 250 (bpm) inclusive and SpO2 values between 1 and 100 %.
- Basic Performance Verification Test Report, GE ApexPro CH/FH SpO2 - Nellcor cable: Confirmed that the GE ApexPro CH/FH SpO2 – Nellcor cable meets SpO2 and pulse rate accuracy requirements by reporting SpO2 and pulse rate values.
- Benchtop Low Perfusion Accuracy Verification Test Report, GE ApexPro CH/FH SpO2 - Nellcor cable: Confirmed that the GE ApexPro CH/FH SpO2 – Nellcor cable meets sensor accuracy requirements for low perfusion by calculating the RMSD (Root Mean Square Difference) values and verifying that the reported SpO2 values meet the accuracy requirements for the different sensors.
- Sensor Failure Verification Test Report, GE ApexPro CH/FH SpO2-Nellcor cable: Confirmed that the GE ApexPro CH/FH SpO2 – Nellcor Cable meets Sensor Interface requirements by simulating sensor faults (i.e., sensor unrecognized or sensor off) and by verifying that errors (such as boot errors) are reported as per Software Requirements Specification, GE ApexPro FH/CH SpO2-Nellcor cables within the time specified in the requirements.
- Ambient Light Step Response Verification Test Report, GE ApexPro CH/FH SpO2-Nellcor cable: Confirmed that the GE ApexPro CH/FH SpO2 – Nellcor Cable meets requirements by changing the levels and verifying the time taken for the system to respond. Confirmed that the system recovers after removal of excessive ambient light from the sensor.
- Device and Sensor States Verification Test Report, GE ApexPro CH/FH SpO2-Nellcor cable: Confirmed that GE ApexPro CH/FH SpO2 – Nellcor Cable meets the following: Reports Sensor connected/sensor disconnected status to host; Communicates with GE telemetry system when no sensor connected; Start communicating after power on/reset; Reports Device ID; Reports device status bytes; Sends Low battery status; Sends invalid SPO2 and PR when sensor disconnected; Reports Invalid SPO2 and invalid PR; Reports Low perfusion and Marginal perfusion; Communicates with host when input voltage within required interface range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Measurement Accuracy Specifications:
- Without motion - Adults: 70-100% ±2 digits
- Without motion - Neonates: 70-100% ±2 digits
- With motion - Adults & Neonates: 70-100% ±3 digits
- Low Perfusion: 70-100% ±2 digits
- LoSat: 60% to 80%±3 digits
Pulse Rate Measurement Range (BPM) and Accuracy:
- Without Motion (Adult & Neonate): 20 to 250 BPM ±3 digits
- With Motion: 20 to 250 BPM ±5 digits
- Low Perfusion: 20 to 250 bpm ±3 digits
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 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/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
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,
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
2
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) |
|---|
| ☑ 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
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
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | July 1, 2020 |
| Contact Person: | Lígia Mastronardi
Regulatory Affairs Manager
Phone: (303) 912-7752
Fax: N/A
ligia.mastronardi@medtronic.com |
| SUBJECT DEVICE NAME | |
| Proprietary Name: | GE ApexPro™ CH SpO2 – Nellcor Cable
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 |
1 Collectively called GE ApexPro CH/FH SpO2 - Nellcor Cables throughout this submission.
4
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
5
| | oximetry sensors. The SpO2 oximetry
cable relies on unique oximetry
technology and design to provide
hospitals, clinicians, and caregivers
with accurate, timely data.
The SpO2 oximetry cable must be
used with a GE ApexPro™ telemetry
system. The SpO2 oximetry cable
provides the following vital signs for
display:
• Arterial blood oxygen saturation
(SpO2)
• Pulse rate (PR)
• Measurement confidence indicator | oximetry sensors. The SpO2 oximetry
cable relies on unique oximetry
technology and design to provide
hospitals, clinicians, and caregivers
with accurate, timely data.
The SpO2 oximetry cable must be
used with a GE ApexPro™ FH
telemetry system. The SpO2 oximetry
cable provides the following
vital signs for display:
• Arterial blood oxygen saturation
(SpO2)
• Pulse rate (PR)
• Measurement confidence indicator |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Host Details | The GE ApexPro Telemetry System was cleared by the FDA on June 20,
2008 under 510(k) number K080251. | |
| Compatible
Sensors | Nellcor™ pulse oximetry sensors with Oximax™ technology and compatible
for use with the GE ApexPro™ CH SpO2 – Nellcor cable with respective
510(k) numbers are outlined below: | |
| | - Forehead SpO2 sensor: MAXFAST (K012891)
- Non-adhesive SpO2 sensors: SC-A, SC-NEO, SC-PR (K030930)
- Adhesive SpO2 sensors: MAXA/MAXAL, MAXN, MAXI, MAXP (K012891)
- SpO2 sensors: A, N, I, P (K012891)
- Reusable SpO2 clip sensors:DS100A, D-YSPD, D-YS, D-YSE (K012891)
- Reusable SpO2 clip sensors: FLEXMAX, FLEXMAS-P (K162014)
- Two-piece reusable SpO2 sensors: OXI-A/N, OXI-P/I (K012891)
- 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
6
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
7
- 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:
8
Medtronic
Table 2: Substantial Equivalence
| Device
Characteristics | Predicate Device: | Subject Devices: | Similarities and
Differences |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Nellcor Pulse Oximetry Monitor Interface
Cable – 510(K) 172482 ("Oxicable") | GE ApexPro CH SpO2 – Nellcor Cable
GE ApexPro FH SpO2 – Nellcor Cable | |
| Device Pictures | | Image: GE ApexPro CH SpO2 – Nellcor Cable:
Image: GE ApexPro FH SpO2 – Nellcor Cable: | Visually different |
| Indications for Use | The Nellcor™ USB Pulse Oximetry Monitor
Interface 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. | The GE ApexPro™ CH/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. | Similar |
| Prescription/Over-
the-counter Use | Prescription | Prescription | Similar |
| Intended Use
Populations | Neonatal, Pediatric, and Adult populations | Neonatal, Pediatric, and Adult populations | Similar |
| Environment of
Use | Hospitals, hospital-type facilities.
Note: Hospital use typically includes such areas as
the intensive care unit (ICU), neonatal intensive
care unit (NICU), operating room (OR), post-
anesthesia care unit (PACU), emergency
department, and medical/surgical general care
floor (GCF).
Note: Hospital-type facilities include step-down
units and longterm care facilities. | Hospitals, 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. | Similar |
| Measurement
Parameters | Oxygen Saturation, Pulse Rate | Oxygen Saturation, Pulse Rate | Similar |
| Sensor
Compatibility | Use only Nellcor-approved sensors. | Use only Nellcor-approved sensors. | Similar |
| Intended
Application Site | NA – Device not in direct contact with the
patient. | NA – Device not in direct contact with the
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
measurement
range (%) | 1% to 100% | 1% to 100% | Similar |
| SpO2 Measurement Accuracy Specifications | | | |
| Without motion -
Adults | 70-100% ±2 digits | 70-100% ±2 digits | Similar |
| Without motion -
Neonates | 70-100% ±2 digits | 70-100% ±2 digits | Similar |
| With motion -
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
(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
IEC 60601-1-2:2014
IEC 60601-1:2005/AMD1:2012 | IEC 60601-1-2:2014
IEC 60601-1:2005/AMD1:2012 | Subject device
meets current
standards. |
| Environmental | Operating Temperature: 5ºC to 40ºC (41ºF to
104ºF)
Operating Atmospheric Pressure: 1075 hPa to
616 hPa
Operating Relative Humidity: 15% to 95% non-
condensing
Transport and Storage Temperature: -40ºC to
70ºC (-40ºF to 158ºF)
Transport and Storage Operating Atmospheric
Pressure: 1075 hPa to 500 hPa
Transport and Storage Operating Relative
Humidity: 15% to 95% non-condensing | Operating Temperature: 5ºC to 40ºC (41ºF to
104ºF)
Operating Atmospheric Pressure: 1075 hPa to
616 hPa
Operating Relative Humidity: 15% to 95% non-
condensing
Transport and Storage Temperature: -40ºC to
70ºC (-40ºF to 158ºF)
Transport and Storage Operating Atmospheric
Pressure: 1200 hPa to 475 hPa
Transport and Storage Operating Relative
Humidity: 10% to 95% non-condensing | No operating
differences.
Transport and
storage differences
due to overlaps and
extensions beyond
those of predicate
device. |
| Mechanical | IEC 60601-1:2005/AMD1:2012 | IEC 60601-1:2005/AMD1:2012 | Similar |
| | | Features | |
| Portability | Portable | Portable (Body-worn) | Different: Subject
device can be worn
by the patient or
attached to a
patient's clothing. |
| Alarms | N/A-The host monitor is responsible for
detecting, triggering, prioritizing, and notifying
the operator of the alarm conditions. | N/A-The GE ApexPro telemetry system is
responsible for detecting, triggering, prioritizing,
and notifying the operator of the alarm
conditions. | Similar |
| Indicators | N/A-No Indicator | N/A-No Indicator | Similar |
| | | | |
| Modes | Working Mode: Continuous Mode
Response Mode: Normal Response Mode, Fast Response Mode.
Power Mode: Legacy Power Mode, Normal Power Mode, Low Power Only Mode | Working Mode: Continuous Mode
Response Mode: Normal Response Mode
Power Mode: Normal Power Mode | Different: Subject device only sends message to host.
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
CH Length: 32.5 cm long | Different: Different length due to different hosts. |
| | | Function | |
| Device
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
Communications Port) driver to communicate
with externally interfaced host monitor. | Utilizes UART (Universal Asynchronous
Transmitter Receiver) protocol to communicate
with externally interfaced host monitor. | Different: Different
communication
protocol due to
different hosts. |
| Software
Communication
Protocols | Communication protocol: Covidien Standard
Protocol | Communication protocol: ASPIP (GE Protocol) | Different: Different
communication
protocol due to
different hosts. |
| Signal Strength
Indicator | None | Asterisk system | Subject device host
monitor will display
// will be
displayed to indicate
the SSI). |
9
10
11
12
13
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.
14
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
SpO2
Nellcor cable | GE ApexPro CH
SpO2 Nellcor
cable |
|--------------|--------------------------|--|----------------------------------------|---------------------------------------------------|
| Subcomponent | Host connector over-mold | | Material | (Thermoplastic polyurethanes, GRAY
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 |
| | Sensor latch | | Material | POLYCARBONATE |
| | | | Patient contact | Yes |
Table 3. Tissue contacting Subject Device Components and Materials
The GE ApexPro CH/FH SpO2 – Nellcor Cable is considered to be a surface device with intact skin contact of prolonged duration (>24 hours to 30 days) per ISO 10993-1 and FDA Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation
15
and testing within a risk management process". Therefore, cytotoxicity, sensitization, and irritation testing were conducted with the subject cables.
A Biocompatibility Assessment was conducted for GE ApexPro CH/FH SpO2 – Nellcor cable to review the material information, applicable data, and results of the biological safety tests required to support the biocompatibility of this device for its intended use. This assessment was performed in accordance to ISO 10993-1-Part 1 and the FDA Guidance Document entitled "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
Based on ISO 10993-1 and the FDA quidance: Use of International Standard ISO 10993-1, the following tests were performed with the subject device:
- -Cytotoxicity,
- Sensitization -
- -Irritation
The results of all testing showed that GE ApexPro CH/FH SpO2 – Nellcor cable poses negligible risk of cytotoxicity, sensitization and irritation for human use.
Pulse Rate and Spo2 Accuracy Bench Testing Conducted
Table 4 provides the bench testing studies that were conducted to verify the subject device performance for to Pulse Rate and SpO2 accuracy:
Table 4. Pulse rate and SpO2 Accuracy Bench Testing
| Report No. | Report Title | Report Conclusions |
|---|---|---|
| RE00238214 | Motion Pulse Rate | |
| Accuracy Verification | ||
| Test Report, GE | ||
| ApexPro CH/FH SpO2- | ||
| Nellcor cable | This report confirms the pulse rate accuracy of GE | |
| ApexPro CH/FH SpO2 – Nellcor cable under simulated | ||
| motion conditions using a pulse simulator device per the | ||
| following: | ||
| Pulse rate accuracy is evaluated under motion | ||
| conditions in the range of 25 -250 beats per minute at | ||
| a fixed O2 saturation of 95% and a Modulation% of | ||
| 3% during quiescent periods, or as close as the pulse | ||
| simulator was able to produce. Pulse rate and SpO2 performance is measured using | ||
| the calculated RMSD (root mean square of the | ||
| difference) of the simulated pulse rate input and the | ||
| DUT displayed pulse rate. | ||
| RE00238211 | System Performance | |
| Verification Test | ||
| Report, GE ApexPro | ||
| CH/FH SpO2-Nellcor | ||
| cable | This report confirms that the GE ApexPro CH/FH SpO2 – | |
| Nellcor cable meets SpO2 and Pulse Rate range and | ||
| accuracy requirements by the following: | ||
| Reporting pulse rate values between 20 and 250 | ||
| (bpm) inclusive Reporting SpO2 values between 1 and 100 % | ||
| RE00238215 | Basic Performance | |
| Verification Test | ||
| Report, | ||
| GE ApexPro CH/FH | ||
| SpO2 - Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 – | |
| Nellcor cable meets SpO2 and pulse rate accuracy | ||
| requirements by reporting SpO2 and pulse rate values. | ||
| RE00238216 | Benchtop Low | |
| Perfusion Accuracy | ||
| Verification Test | ||
| Report, | ||
| GE ApexPro CH/FH | ||
| SpO2 - Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 – | |
| Nellcor cable meets sensor accuracy requirements for low | ||
| perfusion by calculating the RMSD (Root Mean Square | ||
| Difference) values and verifying that the reported SpO2 | ||
| values meet the accuracy requirements for the different | ||
| sensors. | ||
| RE00238217 | Sensor Failure | |
| Verification Test | ||
| Report, | ||
| GE ApexPro CH/FH | ||
| SpO2-Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 – | |
| Nellcor Cable meets Sensor Interface requirements by | ||
| simulating sensor faults (i.e., sensor unrecognized or | ||
| sensor off) and by verifying that errors (such as boot | ||
| errors) are reported as per Software Requirements | ||
| Specification, GE ApexPro FH/CH SpO2-Nellcor cables | ||
| within the time specified in the requirements. | ||
| RE00238213 | Ambient Light Step | |
| Response Verification | ||
| Test Report, | ||
| GE ApexPro CH/FH | ||
| SpO2-Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 – | |
| Nellcor Cable meets requirements by changing the levels | ||
| and verifying the time taken for the system to respond. | ||
| This report also confirms that the system recovers after | ||
| removal of excessive ambient light from the sensor. | ||
| RE00238210 | Device and Sensor | |
| States Verification Test | ||
| Report, | ||
| GE ApexPro CH/FH | ||
| SpO2-Nellcor cable | This report confirms that GE ApexPro CH/FH SpO2 – | |
| Nellcor Cable meets the following: | ||
| • Reports Sensor connected/sensor disconnected | ||
| status to host | ||
| • Communicates with GE telemetry system when | ||
| no sensor connected | ||
| • Start communicating after power on/reset | ||
| • Reports Device ID | ||
| • Reports device status bytes | ||
| • Sends Low battery status | ||
| • Sends invalid SPO2 and PR when sensor | ||
| disconnected | ||
| Reports Invalid SPO2 and invalid PR | ||
| • Reports Low perfusion and Marginal perfusion | ||
| • Communicates with host when input voltage | ||
| within required interface range. |
16
Substantial Equivalence - Conclusions
Substantial equivalence of the subject device to the predicate device was determined by comparison that showed that the devices have same intended use ,similar technological characteristics, indications for use, and principles of operation. The, Software and hardware modifications were made to the subject device, GE ApexPro CH/FH SpO2 - Nellcor Cable in
17
order to maintain the intended performance of the device and to enable interface to the GE ApexPro Telemetry Systems.
No new questions regarding safety and effectiveness have been raised because of these modifications and addition of features. The difference in technological features of the subject device compared to the predicate device does not raise different questions of safety and effectiveness. Based on the evidence presented in this Premarket Notification, the subject device can be considered substantially equivalent to the predicate device.