(275 days)
- Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
- Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing ●
- Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing 0
Used to conduct a sample of the subject's breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology.
o Microstream™ Luer Adult Oral-Nasal Sampling Line Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.
Similar to their predicates, the Microstream non-intubated sampling line/Filter Line family is intended to conduct CO2 from the patient's breath to a gas measurement device (Capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation (when connected to an O2 source).
The proposed devices are a modification of their predicates' material compounds (not made with DEHP or PHT materials), a change of dryer location to off the patient's face, and the integration of softer face-contacting tubes, mainly to enhance patient comfort, increase flexibility and reduce smell.
The proposed devices are sampling lines which are intended to be used with Capnograph monitors using Microstream technology. These sampling lines incorporate a luer connector with a recognition system:
- Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
- . Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing
- Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing .
In addition, this sampling line which is intended to be used with any Capnograph monitor is proposed:
- Microstream™ Luer Adult Oral-Nasal Sampling Line .
The provided text describes a 510(k) premarket notification for a medical device (Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing and related products). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing new performance metrics.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, provenance of data) are not applicable in this context, as this submission relies on bench testing and biocompatibility assessments to show the new device is as safe and effective as existing ones.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Substantial Equivalence Table" on page 6-7 serves as the primary source for acceptance criteria (implicitly, the values of the predicate devices) and the reported performance of the new devices.
| Feature | Acceptance Criteria (Predicate Device K010024, K011536, or K013845) | Reported Device Performance (Microstream™ Advance Neonatal-Infant, Pediatric, Adult, or Luer Adult) |
|---|---|---|
| Intended Population | Adults and pediatrics (K010024) | Neonatal-Infant |
| Adult, intermediate, or pediatric (K011536) | Pediatric | |
| Adult, intermediate, or pediatric (K013845) | Adult | |
| Single Patient Use | Yes | Yes |
| Patient Interface | Nasal Cannula (K010024) | Same as K010024 (Nasal Cannula) |
| Oral Nasal Cannula (K011536) | Same as K011536 (Oral Nasal Cannula) | |
| Oral Nasal Cannula (K013845) | Same as K013845 (Oral Nasal Cannula) | |
| Biocompatibility | ISO 10993-1 | ISO 10993-1, ISO 18562-1 |
| Dehumidifier/Dryer | - (K010024, K011536, K013845) | + (Neonatal-Infant) |
| +/- (Pediatric, Adult) | ||
| - (Luer Adult) | ||
| Rise time | ≤200 msec @ 50ml/min sample flow rate, sea level, RT minimal background= 50msec (K010024, K011536) | ≤260 msec @ 50ml/min sample flow rate, sea level, RT minimal background= 50msec (Neonatal-Infant) |
| ≤200 msec for 2m; ≤260 msec for 4m @50ml/min sample flow rate, sea level, RT minimal background= 50msec (Pediatric) | ||
| 200 msec @ 50ml/min sample flow rate, sea level, RT minimal background=50msec (Adult) | ||
| ≤200 msec @ 50ml/min sample flow rate, sea level. ≤100msec @ 180ml/min. RT background= 50msec (K013845) | 200 msec @ 50ml/min sample flow rate, sea level. ≤100msec @ 180ml/min RT background = 50msec (Luer Adult) | |
| Pressure Drop - CO2 sampling set | 40mbar @ 50ml/min, sea level (K010024, K011536) | ≤75[mbar] @ 50ml/min, sea level (Neonatal-Infant, Pediatric (max 4m length), Adult) |
| ≤70mbar @ 180ml/min, sea level (K013845) | ≤70[mbar] @ 180ml/min sea level (Luer Adult) | |
| Pressure Drop - O2 line | ≤135mBar @ 8L/min, at sea level (K010024, K011536, K013845) | 225mBar @ 3L/min, at sea level (Neonatal-Infant) |
| ≤110mBar @ 5L/min, at sea level (Pediatric, Adult) | ||
| ≤80mBar @ 5L/min, at sea level (Luer Adult) | ||
| Leak Tightness | Was not provided under the 510k submission (K010024, K013845) | ≤2[mbar/sec] @ 100[mbar] vacuum |
| ≤10mbar/sec (K011536) | ≤2[mbar/sec] @ 100[mbar] vacuum | |
| Tensile Strength | Was not provided under the 510k submission (K010024, K011536, K013845) | CO2 line: Withstand a pull test of 1kg. O2 line: Withstand a pull test of 2kg (Neonatal-Infant) |
| Withstand a pull test of 2kg (Pediatric, Adult, Luer Adult) |
2. Sample size used for the test set and the data provenance
N/A. This submission indicates the use of "bench testing" and "biocompatibility assessment" rather than clinical test data or real-world patient data. The purpose is to demonstrate that the physical and material properties of the new devices are substantially equivalent to existing ones.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth from experts is not relevant for bench testing and biocompatibility assessments of physical properties.
4. Adjudication method for the test set
N/A. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers. This submission relies on objective physical measurements and material testing.
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
N/A. This device is a passive CO2 sampling line, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a hardware device; there is no "algorithm" in the sense of AI or image analysis.
7. The type of ground truth used
The "ground truth" for this type of submission is based on engineering specifications and established standards (e.g., ISO 10993 for biocompatibility, and the performance characteristics of the predicate devices for physical parameters like rise time, pressure drop, leak tightness, and tensile strength).
8. The sample size for the training set
N/A. There is no "training set" in the context of this traditional 510(k) submission, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).