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The use of the Microcap capnograph monitor is indicated whenever a professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

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This FDA letter from 1998 for the Microcap device (K981114) does not contain any information regarding acceptance criteria or a study proving the device meets such criteria.

The letter is a 510(k) clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This process focuses on comparing the new device's indications for use and technological characteristics to an existing device, rather than requiring the submission of new clinical or performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document primarily confirms regulatory clearance, not detailed performance study results.

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THE MICROSTREAM FILTERLINE OR/EMS DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO2 IN AN INTUBATED PATIENT'S BREATHING.

The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a male Luer lock at one end of the device for connecting to the airway adapter in the ventilator or anesthesia machine airway and a female Luer lock on the other end for connecting to the capnograph. The two connectors are joined by a plastic tube and an in line hydrophobic filter. One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation. The most common way (for intubated patients) to connect the sampling tube to a point where it can get a sample of the patients breathing is to connect one end of the sample tube to a point on the ventilator or anesthesia machine airway circuit. The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The Microstream Filterline OR/EM has integrated an in line hydrophobic filter between the patient and the Capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The provided text is related to a 510(k) premarket notification for a medical device called "Microstream Filterline OR/EMS". This document describes the device, its intended use, and its substantial equivalence to a previously approved device. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for performance metrics of a device or algorithm.

The document is a regulatory submission for premarket clearance, which is focused on demonstrating substantial equivalence to a predicate device, not necessarily on detailing performance studies with specific statistical outcomes against acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the provided text does not contain it. The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as outlined in the prompt (e.g., in terms of sensitivity, specificity, or improvement with AI assistance) is not present in this regulatory document, which focuses on device description and regulatory clearance.

The document's purpose is to get the device approved for market based on its similarity to an already approved device, rather than to present detailed performance study results that would typically include acceptance criteria tables, sample sizes, ground truth establishment, or AI-related metrics.

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THE MICROSTREAM FILTERLINE NC DEVICE IS USED WHENEVER THE PHYSICIAN NEEDS TO MEASURE THE CO₂ IN A PATIENT'S BREATHING IN A NON INTUBATED PATIENT.

The common product name for this device is a gas sampling nasal cannula . The gas sampling nasal cannula is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a nasal cannula at one end of the device for connecting to the patient's nose and a female Luer lock on the Other end for connecting to the capnograph. The design and construction of the nasal cannula is almost identical to the nasal oxygen cannula 21 CFR 868.5340. The main difference is that instead of flowing oxygen through the cannula to the patient we use a vacuum to draw a sample of the breathing from the patient.

The two connectors are joined by a plastic tube and an in line hydrophobic filter.

One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's Breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.

The anesthesiologist sometimes places a hydrophobic filter between the sample line and the capnograph to keep moisture from entering the capnograph. The microstream nasal cannula filterline has integrated an in line hydrophobic filter between the patient and the capnograph to reduce the amount of patient generated moisture that can enter the capnograph.

The provided text describes a 510(k) submission for a medical device called the "Microstream Nasal Cannula Filterline." This submission focuses on establishing substantial equivalence to a previously approved device rather than presenting a de novo study with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth cannot be extracted from this document, as it is not a clinical study report.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document does not provide a table of acceptance criteria or performance metrics. This submission is for a 510(k) and relies on demonstrating "substantial equivalence" to a predicate device (K964239), not on proving specific performance against predefined criteria in a new clinical study. The FDA's letter states, "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no mention of a test set with a specific sample size. The submission is based on the claim that the device is "identical to the same device described as an accessory to the NPB-75/microcap capnograph/pulse oximeter in approved submittal K964239." This implies that the performance data for the predicate device is being leveraged, rather than new performance data for this specific accessory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment is described, as there is no new test set or clinical study presented in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method is described.

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 a gas sampling line accessory for a capnograph, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware accessory, not an algorithm. Standalone performance as described is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. No ground truth is described because no new clinical study is presented for this 510(k). The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

• Not Applicable. This device is a physical accessory, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

9. How the ground truth for the training set was established

• Not Applicable. As above, there is no training set for this type of device.

Summary of available information:

The document is a 510(k) premarket notification for a Class II medical device (Microstream Nasal Cannula Filterline). Its purpose is to demonstrate substantial equivalence to an already approved predicate device (mentioned in K964239). The device is a "gas sampling nasal cannula" designed to conduct a sample of the patient's breathing from the nose to a capnograph for CO2 measurement, featuring an integrated hydrophobic filter. The FDA found the device substantially equivalent.

No clinical study data, performance metrics, or specific acceptance criteria are provided in this submission, as the regulatory pathway chosen (510(k)) for this type of device relies on demonstrating equivalence rather than conducting new efficacy or performance trials.

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The Microstream Filterline ICU device is used whenever the physician needs to measure the CO2 in an intubated patient's breathing.

The common product name for our accessory is a gas sampling tube. The gas sampling tube is used with a capnograph (carbon dioxide analyzer 21CFR 868.1400). There is a Male Luer Lock at one end of the device for connecting to the Airway Adapter in the ventilator or Anesthesia Machine Airway and a Female Luer Lock on the other end for connecting to the Capnograph. The two connectors are joined by a plastic tube an in line hydrophobic filter and an in line Nafion (K881264A) moisture membrane tube.

One end of the tube is connected to the source of the patient's breathing (exhalation) and the other end of the tube is connected to a capnograph. The capnograph has a pump that creates a vacuum of approximately 30mbar which draws a sample of the patient's breathing (exhalation) through the sampling tube into the capnograph for analysis of the CO2 content of the patient's exhalation.

The information provided is a 510(k) premarket notification for a medical device called "Microstream Filterline ICU." This document focuses on establishing substantial equivalence to a predicate device and does not contain acceptance criteria, a detailed study description with performance metrics, or information typically found in a clinical validation study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The document states:

• Intended Use: To conduct a sample of the patient's breathing from a ventilator or anesthesia machine airway to the gas measurement device for measuring the percentage of CO2 in the patient's exhalation.
• Device Description: A gas sampling tube with a Male Luer Lock for connecting to an airway adapter and a Female Luer Lock for connecting to a Capnograph. It includes an in-line hydrophobic filter and an in-line Nafion moisture membrane tube.
• Substantial Equivalence: The Microstream ICU Filterline is "identical to the same device described as an accessory to the NPB-75/Microcap Capnograph/Pulse Oximeter in approved submittal K964239."

Conclusion:

This submission is a premarket notification asserting substantial equivalence, leveraging the prior approval of an identical device (K964239). It does not present new performance data from a specific study to meet acceptance criteria. The FDA's review confirms this substantial equivalence based on the provided information, not on a new, independent performance study with defined acceptance criteria and results.

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