(80 days)
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.
The subject device of this premarket 510(k) notification is composed of two (2) cables as follows: GE ApexPro CH SpO2 Nellcor Cable and GE ApexPro FH SpO2 Nellcor Cable. 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 provided text describes the GE ApexPro CH/FH SpO2 - Nellcor Cable, an interface cable designed to work with the GE ApexPro Telemetry System and Nellcor pulse oximetry sensors. The submission primarily focuses on establishing substantial equivalence to a predicate device (The Nellcor Pulse Oximetry Monitor Interface Cable, K172428) through non-clinical evidence and comprehensive verification testing against established standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for performance are primarily based on the accuracy specifications of the existing Nellcor Pulse Oximetry Monitor Interface Cable, which the subject device aims to match or exceed. The listed performance values are for the predicate device, and the subject device is stated to meet these requirements.
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 measurement range (%) | 1% to 100% | 1% to 100% |
| SpO2 Accuracy (Without motion - Adults) | 70-100% ±2 digits | 70-100% ±2 digits |
| SpO2 Accuracy (Without motion - Neonates) | 70-100% ±2 digits | 70-100% ±2 digits |
| SpO2 Accuracy (With motion - Adults & Neonates) | 70-100% ±3 digits | 70-100% ±3 digits |
| SpO2 Accuracy (Low Perfusion) | 70-100% ±2 digits | 70-100% ±2 digits |
| SpO2 Accuracy (LoSat) | 60% to 80% ±3 digits | 60% to 80% ±3 digits |
| Pulse Rate Measurement Range (BPM) | 20 to 250 BPM | 20 to 250 BPM |
| Pulse Rate Accuracy (Without Motion - Adult & Neonate) | 20 to 250 BPM ±3 digits | 20 to 250 BPM ±3 digits |
| Pulse Rate Accuracy (With Motion) | 20 to 250 BPM ±5 digits | 20 to 250 BPM ±5 digits |
| Pulse Rate Accuracy (Low Perfusion) | 20 to 250 bpm ±3 digits | 20 to 250 bpm ±3 digits |
2. Sample Size Used for the Test Set and the Data Provenance
The text does not specify sample sizes for human subjects in testing. The studies presented are "bench performance testing," "system verification," "software verification," "hardware verification," "compatibility verification," and "compliance testing to standards." This implies the tests were conducted in a controlled laboratory environment without live patient data.
The data provenance is from bench testing and in-house verification and validation studies conducted by Covidien/Medtronic. No country of origin for directly human-derived test data is mentioned as the testing cited is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for the performance testing cited (SpO2 and Pulse Rate accuracy) was established through simulated inputs (e.g., using a pulse simulator device) and adherence to recognized standards (e.g., ISO 80601-2-61:2017). Human expert consensus was not used as a ground truth for these specific performance metrics.
4. Adjudication Method for the Test Set
Not applicable. The testing described focuses on objective measurement against established simulated inputs and standards rather than subjective assessments requiring adjudication by multiple experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an interface cable for a pulse oximeter, not an AI-powered diagnostic imaging tool or a system that requires human "readers" to interpret output for diagnostic purposes. The submission does not mention any AI components in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies are essentially standalone, demonstrating the device's ability to accurately measure SpO2 and pulse rate under various simulated conditions (no motion, motion, low perfusion) by comparing its output against known simulated inputs. The various "Verification Test Reports" listed in Table 4 (e.g., "Motion Pulse Rate Accuracy Verification Test Report," "System Performance Verification Test Report," "Benchtop Low Perfusion Accuracy Verification Test Report") describe this type of standalone performance evaluation. The device contains an embedded software that "uses the Nellcor pulse oximetry algorithm to calculate SpO2 ... and PR."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for performance testing (SpO2 and Pulse Rate accuracy) appears to be simulated inputs from calibrated devices (e.g., pulse simulator devices) and established measurement criteria defined by international standards (e.g., ISO 80601-2-61:2017). This is a form of objective, often laboratory-controlled, ground truth.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/machine learning model in the sense of requiring a "training set" of data to learn or classify. It utilizes a pre-existing "Nellcor pulse oximetry algorithm" which is embedded in its software. The submission does not refer to any training of this algorithm as part of the new device's development or testing for substantial equivalence. The studies mentioned are focused on verification and validation of the device's performance with this existing algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" for an AI or machine learning model developed for this specific device in the provided text. The device incorporates an existing Nellcor algorithm, and the documentation pertains to validating the cable's interface and performance with this algorithm.
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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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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, IIc6135 Gunbarrel AvenueBoulder, CO 80301 |
|---|---|
| Date: | July 1, 2020 |
| Contact Person: | Lígia MastronardiRegulatory Affairs ManagerPhone: (303) 912-7752Fax: N/Aligia.mastronardi@medtronic.com |
| SUBJECT DEVICE NAME | |
| Proprietary Name: | GE ApexPro™ CH SpO2 – Nellcor CableGE 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.
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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 oximetrycable relies on unique oximetrytechnology and design to providehospitals, clinicians, and caregiverswith accurate, timely data.The SpO2 oximetry cable must beused with a GE ApexPro™ telemetrysystem. The SpO2 oximetry cableprovides the following vital signs fordisplay:• Arterial blood oxygen saturation(SpO2)• Pulse rate (PR)• Measurement confidence indicator | oximetry sensors. The SpO2 oximetrycable relies on unique oximetrytechnology and design to providehospitals, clinicians, and caregiverswith accurate, timely data.The SpO2 oximetry cable must beused with a GE ApexPro™ FHtelemetry system. The SpO2 oximetrycable provides the followingvital 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. | |
| CompatibleSensors | Nellcor™ pulse oximetry sensors with Oximax™ technology and compatiblefor use with the GE ApexPro™ CH SpO2 – Nellcor cable with respective510(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
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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
| DeviceCharacteristics | Predicate Device: | Subject Devices: | Similarities andDifferences |
|---|---|---|---|
| The Nellcor Pulse Oximetry Monitor InterfaceCable – 510(K) 172482 ("Oxicable") | GE ApexPro CH SpO2 – Nellcor CableGE 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 MonitorInterface Cable is indicated for prescription useonly for spot check or continuous non-invasivemonitoring of functional oxygen saturation ofarterial hemoglobin (SpO2) and pulse rate. It isintended for use with neonatal, pediatric, andadult patients during both no motion and motionconditions and for patients who are either well orpoorly perfused, in hospitals and hospital-typefacilities. | The GE ApexPro™ CH/FH SpO2 – Nellcor cable isindicated for prescription use only for spot-checkor continuous non-invasive monitoring offunctional oxygen saturation of arterialhemoglobin (SpO2) and pulse rate. It is intendedfor use with neonatal, pediatric, and adultpatients during both no motion and motionconditions and for patients who are either well orpoorly perfused, in hospitals and hospital-typefacilities. | Similar |
| Prescription/Over-the-counter Use | Prescription | Prescription | Similar |
| Intended UsePopulations | Neonatal, Pediatric, and Adult populations | Neonatal, Pediatric, and Adult populations | Similar |
| Environment ofUse | Hospitals, hospital-type facilities.Note: Hospital use typically includes such areas asthe intensive care unit (ICU), neonatal intensivecare unit (NICU), operating room (OR), post-anesthesia care unit (PACU), emergencydepartment, and medical/surgical general carefloor (GCF).Note: Hospital-type facilities include step-downunits and longterm care facilities. | Hospitals, hospital-type facilities.Note: Hospital use typically includes such areas asthe intensive care unit (ICU), Pediatric IntensiveCare Unit (PICU), neonatal intensive care unit(NICU),and medical/surgical general care floor(GCF).Note: Hospital-type facilities include step-downunits and longterm care facilities. | Similar |
| MeasurementParameters | Oxygen Saturation, Pulse Rate | Oxygen Saturation, Pulse Rate | Similar |
| SensorCompatibility | Use only Nellcor-approved sensors. | Use only Nellcor-approved sensors. | Similar |
| IntendedApplication Site | NA – Device not in direct contact with thepatient. | NA – Device not in direct contact with thepatient. | 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 |
| SpO2measurementrange (%) | 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 60601-1-2:2007IEC 60601-1-2:2014IEC 60601-1:2005/AMD1:2012 | IEC 60601-1-2:2014IEC 60601-1:2005/AMD1:2012 | Subject devicemeets currentstandards. |
| Environmental | Operating Temperature: 5ºC to 40ºC (41ºF to104ºF)Operating Atmospheric Pressure: 1075 hPa to616 hPaOperating Relative Humidity: 15% to 95% non-condensingTransport and Storage Temperature: -40ºC to70ºC (-40ºF to 158ºF)Transport and Storage Operating AtmosphericPressure: 1075 hPa to 500 hPaTransport and Storage Operating RelativeHumidity: 15% to 95% non-condensing | Operating Temperature: 5ºC to 40ºC (41ºF to104ºF)Operating Atmospheric Pressure: 1075 hPa to616 hPaOperating Relative Humidity: 15% to 95% non-condensingTransport and Storage Temperature: -40ºC to70ºC (-40ºF to 158ºF)Transport and Storage Operating AtmosphericPressure: 1200 hPa to 475 hPaTransport and Storage Operating RelativeHumidity: 10% to 95% non-condensing | No operatingdifferences.Transport andstorage differencesdue to overlaps andextensions beyondthose of predicatedevice. |
| Mechanical | IEC 60601-1:2005/AMD1:2012 | IEC 60601-1:2005/AMD1:2012 | Similar |
| Features | |||
| Portability | Portable | Portable (Body-worn) | Different: Subjectdevice can be wornby the patient orattached to apatient's clothing. |
| Alarms | N/A-The host monitor is responsible fordetecting, triggering, prioritizing, and notifyingthe operator of the alarm conditions. | N/A-The GE ApexPro telemetry system isresponsible for detecting, triggering, prioritizing,and notifying the operator of the alarmconditions. | Similar |
| Indicators | N/A-No Indicator | N/A-No Indicator | Similar |
| Modes | Working Mode: Continuous ModeResponse Mode: Normal Response Mode, Fast Response Mode.Power Mode: Legacy Power Mode, Normal Power Mode, Low Power Only Mode | Working Mode: Continuous ModeResponse Mode: Normal Response ModePower 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 longCH Length: 32.5 cm long | Different: Different length due to different hosts. | |
| Function | |||
| DeviceFunctionality | 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 (VirtualCommunications Port) driver to communicatewith externally interfaced host monitor. | Utilizes UART (Universal AsynchronousTransmitter Receiver) protocol to communicatewith externally interfaced host monitor. | Different: Differentcommunicationprotocol due todifferent hosts. | |
| SoftwareCommunicationProtocols | Communication protocol: Covidien StandardProtocol | Communication protocol: ASPIP (GE Protocol) | Different: Differentcommunicationprotocol due todifferent hosts. |
| Signal StrengthIndicator | None | Asterisk system | Subject device hostmonitor will display// will bedisplayed to indicatethe 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 FHSpO2Nellcor cable | GE ApexPro CHSpO2 Nellcorcable | ||
|---|---|---|---|---|
| Subcomponent | Host connector over-mold | Material | (Thermoplastic polyurethanes, GRAYMUNSELL 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
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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 RateAccuracy VerificationTest Report, GEApexPro CH/FH SpO2-Nellcor cable | This report confirms the pulse rate accuracy of GEApexPro CH/FH SpO2 – Nellcor cable under simulatedmotion conditions using a pulse simulator device per thefollowing:Pulse rate accuracy is evaluated under motionconditions in the range of 25 -250 beats per minute ata fixed O2 saturation of 95% and a Modulation% of3% during quiescent periods, or as close as the pulsesimulator was able to produce. Pulse rate and SpO2 performance is measured usingthe calculated RMSD (root mean square of thedifference) of the simulated pulse rate input and theDUT displayed pulse rate. |
| RE00238211 | System PerformanceVerification TestReport, GE ApexProCH/FH SpO2-Nellcorcable | This report confirms that the GE ApexPro CH/FH SpO2 –Nellcor cable meets SpO2 and Pulse Rate range andaccuracy requirements by the following:Reporting pulse rate values between 20 and 250(bpm) inclusive Reporting SpO2 values between 1 and 100 % |
| RE00238215 | Basic PerformanceVerification TestReport,GE ApexPro CH/FHSpO2 - Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 –Nellcor cable meets SpO2 and pulse rate accuracyrequirements by reporting SpO2 and pulse rate values. |
| RE00238216 | Benchtop LowPerfusion AccuracyVerification TestReport,GE ApexPro CH/FHSpO2 - Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 –Nellcor cable meets sensor accuracy requirements for lowperfusion by calculating the RMSD (Root Mean SquareDifference) values and verifying that the reported SpO2values meet the accuracy requirements for the differentsensors. |
| RE00238217 | Sensor FailureVerification TestReport,GE ApexPro CH/FHSpO2-Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 –Nellcor Cable meets Sensor Interface requirements bysimulating sensor faults (i.e., sensor unrecognized orsensor off) and by verifying that errors (such as booterrors) are reported as per Software RequirementsSpecification, GE ApexPro FH/CH SpO2-Nellcor cableswithin the time specified in the requirements. |
| RE00238213 | Ambient Light StepResponse VerificationTest Report,GE ApexPro CH/FHSpO2-Nellcor cable | This report confirms that the GE ApexPro CH/FH SpO2 –Nellcor Cable meets requirements by changing the levelsand verifying the time taken for the system to respond.This report also confirms that the system recovers afterremoval of excessive ambient light from the sensor. |
| RE00238210 | Device and SensorStates Verification TestReport,GE ApexPro CH/FHSpO2-Nellcor cable | This report confirms that GE ApexPro CH/FH SpO2 –Nellcor Cable meets the following:• Reports Sensor connected/sensor disconnectedstatus to host• Communicates with GE telemetry system whenno 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 sensordisconnectedReports Invalid SPO2 and invalid PR• Reports Low perfusion and Marginal perfusion• Communicates with host when input voltagewithin required interface range. |
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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
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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.
§ 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).