(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.
§ 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).