(266 days)
The Nellcor™ OxySoftN single patient use sensor is indicated for use with neonatal, infant, pediatric and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospit, mobile emergency medical applications including both ground and air transport and home environments. Transport environments include intra-hospital transport and air emergency transport: road ambulances and fixed-wing aircraft and helicopters. The Nellcor™ OxySoft SpO2 Sensor works in conjunction with monitoring systems that use OxiMax™ and Nellcor compatible pulse oximetry systems to facilitate spot checking or continuous monitoring of a patient's arterial hemoglobin (SpO2) and pulse rate via topical application of the sensor over a pulsating arteriolar vascular bed, such as a finger, foot or hand. This device is for prescription use only.
The Nellcor™ OxySoft™ Neonatal/Adult SpO2 Sensor, OxySoftNHC monitors the amount of oxygen in the patient's blood (oxygen saturation) or SpO2 and pulse rate after applying the sensor on the finger, foot, or hand. The sensor utilizes a pair of light emitting diodes (LEDs) employing light at two wavelengths, and the time varying absorbance of the tissue due to the pulsatile blood signal is obtained, amplified from a photodiode to determine functional arterial oxygen saturation. A clinician will prescribe the sensor for use as spot check or continuous use in hospitals, hospital-type facilities, intra-hospital transport, mobile emergency medical applications including both ground and air transport and home environments. The OxySoftNHC sensor can be used with all Nellcor™ compatible systems. The sensor consists of a sensor assembly and cable assembly and is provided sterile (EtO) and is meant for single use.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
Device Name: Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor, OxySoftN/OxySoftNHC
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pulse rate accuracy | +/- 3 BPM RMS (non-motion) |
| +/- 5 BPM RMS (motion, 70-100% SpO2 range, using N-600x) | |
| SpO2 Accuracy (Adult and Neonate) | 70% to 100% (+/- 2% RMS) (non-motion) |
| 70% to 100% (+/- 3% RMS) (motion) | |
| SpO2 Accuracy (Low Saturation) | 60% to 80% (+/- 3% RMS) |
| SpO2 Accuracy (Low Perfusion) | 70% to 100% (+/- 2% RMS) |
| Sensor Off Feature Functionality | Displays "Sensor Off" message within 1 minute at least 90% of the time (Measured at 99.6% with 95% lower bound of 98.3%) |
| Gentleness on Fragile Skin | Adhesive removed significantly less cells than predicate and caused minimal increase in TEWL. |
| Adhesion after Repositioning | Remains adhered to the skin after 18th repositioning. |
| Biocompatibility | Meets ISO 10993-1 and FDA Biocompatibility Guidance (Cytotoxicity, Sensitization, Intracutaneous reactivity, Chemical characterization and toxicological risk assessment passed). |
| Electrical Safety | Complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. |
| Mechanical, Use Life, Light Shunting, Storage, Ambient Light, Ingress Protection, Shock & Vibration, Time to Post, Adhesive Liner Card and Initial Peel Force, Nellcor Functional Compatibility, Surface Temperature Rise, Operational Altitude & Temperature & Humidity, Transient Temperature & Humidity, Human Factors | Met for all conditions of use. |
Study Details
The provided text describes several clinical and non-clinical studies to demonstrate the device's performance.
1. "MDT20002VALNIC: Performance evaluation of the OxySoftN neonatal sensor in the NICU compared to SaO2"
- Sample size: 27 patients (neonates)
- Data Provenance: Clinical study, prospective (data collected to evaluate sensor in NICU). No country of origin is explicitly stated, but clinical studies for FDA clearance are typically conducted in the US or in countries adhering to similar ethical and regulatory standards.
- Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis of simultaneously drawn arterial blood samples, which is an objective measurement.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
- Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard.
- Type of ground truth: Objective measurement (SaO2 values obtained from CO-oximeter analysis of arterial blood).
- Training set sample size: Not specified as this is a clinical validation study, not an algorithm training study.
- Training set ground truth: Not applicable.
2. "MDT20037CYBOXY: Validation of the OxySoftN to Determine the Gentleness on Fragile Skin"
- Sample size: Not explicitly stated but implied through "healthy elderly subjects."
- Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
- Experts for ground truth: Not applicable – ground truth involved objective measurements like evaporative water loss (TEWL) and skin protein disruption.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This study compared the subject device to the predicate device regarding skin gentleness.
- Standalone performance: Yes, it directly measured the device's effect on skin.
- Type of ground truth: Objective measurements (TEWL, amount of skin protein disruption).
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
3. "MDT20047OXSNOF: Sensor-Off Validation of the OxySoftN sensor in Healthy Adults"
- Sample size: Not explicitly stated but implied through "a sequence of steps for different sensor off configurations was performed per subject."
- Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
- Experts for ground truth: Not applicable – ground truth was the observation of whether a "Sensor Off" message appeared.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This was a standalone functional validation.
- Standalone performance: Yes, it evaluated a specific safety feature of the device.
- Type of ground truth: Objective observation (presence/absence of "Sensor Off" message within 1 minute).
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
4. "MDT20038CYBADH: Multiple Reposition Peel Adhesion on Human Skin Validation, OxySoftN"
- Sample size: Not explicitly stated but implied through "volar forearm of healthy adults."
- Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
- Experts for ground truth: Not applicable – ground truth was the objective measurement of peel adhesion.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This was a standalone functional validation.
- Standalone performance: Yes, it directly measured the adhesion performance.
- Type of ground truth: Objective measurement (peel adhesion after repositioning).
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
5. "MDT20028OXYLOV: SpO2 Accuracy Validation of the OxySoftN sensor via Reference CO-Oximetry in Healthy, Well-Perfused Subject"
- Sample size: "healthy adult subjects" - specific number not provided.
- Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
- Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis of simultaneously drawn arterial blood samples, and for pulse rate, via 3-lead ECG.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
- Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard.
- Type of ground truth: Objective measurement (SaO2 values from CO-oximeter; 3-lead ECG for pulse rate).
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
6. "MDT20006OXYVMT: SpO2 Accuracy Validation of the OxySoft sensor via Reference CO-Oximetry Motion Study"
- Sample size: "diverse subject population" - specific number not provided.
- Data Provenance: Clinical study, prospective. No country of origin is explicitly stated.
- Experts for ground truth: Not applicable – ground truth for SpO2 was established through CO-oximeter analysis.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: No. This was a standalone performance evaluation.
- Standalone performance: Yes, this study directly evaluated the device's accuracy against a reference standard under motion and non-motion conditions.
- Type of ground truth: Objective measurement (SaO2 values from CO-oximeter).
- Training set sample size: Not applicable.
- Training set ground truth: Not applicable.
General Notes on Training Sets:
For medical devices like oximeters, "training set" and "ground truth for training set" are typically relevant to machine learning algorithms. Pulse oximeters, as described, use a fundamental technology based on spectrophotometry and plethysmography, which are physics-based principles, not typically machine learning algorithms requiring explicit training data in the same way an AI diagnostic tool would. The performance data presented here are for validation and verification of the physical sensor and its underlying technology against established physiological standards and safety requirements.
§ 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).