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Found 16 results
510(k) Data Aggregation
(119 days)
|
| Regulatory Class | 21 CFR 868.5330 | 21 CFR 868.5430
The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily discusses comparisons of technical characteristics and compliance with recognized standards.
Crucially, this document does NOT contain explicit acceptance criteria tables or a detailed study report that proves the device meets specific performance metrics in a clinical or simulated environment with ground truth from experts, as would be expected for an AI/ML powered device.
The document states:
- "The characteristics of the Midas Flowmeter and optional eAVS do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed."
- "The verification and validation testing of the Midas Flowmeter and optional eAVS was found to be acceptable and supports the claims of substantial equivalence."
This indicates that the device's performance was evaluated through bench testing and compliance with recognized consensus standards, rather than a clinical study involving human readers or expert-established ground truth for a test set.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or the type of ground truth used, because such a study (as described in the prompt) was not performed or detailed in this 510(k) submission.
The document focuses on:
- Comparison of Technical Characteristics: Showing the Midas Flowmeter and eAVS are similar in function, intended use, and technology to predicate devices (FlowStar Touch Digital Mixer Flowmeter and Nitronox Scavenger Plus).
- Compliance with Standards: Listing various IEC, ISO, AAMI, and ASTM standards that the device was tested against to demonstrate safety and performance (e.g., IEC 60601-1 for basic safety, ISO 11195 for gas mixers).
- Non-clinical Performance Data (Bench Testing): A bulleted list of "performance bench testing" categories like "Gas Flow Rate Adjustment," "Touchscreen Display," "Accuracies and Faults," and "Life Testing." However, it does not provide the specific acceptance criteria for these tests nor the detailed results in a quantitative manner as requested. It simply states that "The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics..."
In summary, none of the specific elements required to answer your prompt (e.g., table of acceptance criteria with reported performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are present in this 510(k) document because the device is a hardware system (a gas mixer) and was cleared based on non-clinical bench testing and adherence to recognized standards, not clinical performance studies with AI/ML components involving human expert review or data-driven ground truth.
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(110 days)
Pennsylvania 19440
Re: K223452
Trade/Device Name: Nitronox Scavenger Plus Regulation Number: 21 CFR 868.5430
Scavenging apparatus
Classification Name: Gas scavenging apparatus
Regulatory Class: Class II, 21 CFR 868.5430
| Same |
| Regulation
Number | $$868.5430
| $$868.5430
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device called the "Nitronox® Scavenger Plus." This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than proving its absolute safety and efficacy through extensive clinical trials.
The document discusses non-clinical performance data and states that clinical investigation was not required because safety and efficacy were supported by non-clinical testing. Therefore, the information typically associated with a study proving a device meets acceptance criteria for an AI/ML medical device (such as those involving test sets, training sets, expert adjudication, MRMC studies, and detailed ground truth establishment) is not present in this document.
The acceptance criteria described in the document relate to engineering and operational performance of a physical gas-scavenging apparatus, not an AI/ML algorithm.
Here's a breakdown of the relevant information provided, adapted to the questions where possible, and noting where information is absent due to the nature of the device and submission:
Acceptance Criteria and Reported Device Performance
The document describes performance criteria primarily related to pressure limits for gas scavenging.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Under normal operating conditions (75 L/min flow through the inlet), the pressure shall not exceed 3.0 cm H2O. (This is a standard from ISO 80601-2-13, Section 201.103.1.1.1) | Under normal operating conditions (75 L/min flow through the inlet), the pressure did not exceed 3.0 cm H2O. | The device met this ISO standard. |
| Functional, operational, and performance characteristics (general) | The Scavenger Plus met all of the acceptance criteria for functional, operational, and performance characteristics. | Demonstrated through performance bench testing. |
Study Details (as inferable from the document, with many points being N/A for this type of device/submission)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This device is a physical gas scavenging apparatus, not an AI/ML algorithm that processes data. Testing was likely done on physical units of the device under controlled conditions. The number of samples/units tested is not specified but would be part of standard engineering verification.
- Data Provenance: Not applicable in the context of "data" for an AI model. This refers to bench testing performed on the physical device. The location of testing is not specified, but it would be part of the manufacturer's quality system. The testing would be "prospective" in the sense that it was conducted specifically for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a physical device's performance usually relates to engineering specifications and physical measurements, rather than expert interpretation of complex data (like medical images). Compliance with standards like ISO 80601-2-13 is verified directly through measurement.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for studies involving human interpretation or subjective assessments. Performance testing for this device is based on objective measurements against engineering specifications.
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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:
- No. This is not an AI-assisted device. MRMC studies are used to evaluate diagnostic imaging devices or AI algorithms that assist human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It's a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and objective physical measurements: The "ground truth" for this device's performance is whether its physical output (e.g., pressure) meets predefined engineering and regulatory standards (e.g., ISO 80601-2-13).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
In summary, the provided document details a 510(k) submission for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around bench testing demonstrating compliance with established engineering standards and functional specifications, rather than complex data-driven analyses characteristic of AI/ML device evaluations. The FDA determined that the non-clinical testing was sufficient to establish substantial equivalence to a predicate device, thus no clinical trials were deemed necessary.
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(340 days)
Re: K193646
Trade/Device Name: Dynamic Gas Scavenging System 2 (DGSS - 2) Regulation Number: 21 CFR 868.5430
Classification Name: | Apparatus, Gas-Scavenging |
| Classification Regulation: | 868.5430
|
| Classification Regulation: | 868.5430
The Dynamic Gas Scavenging System is intended to be used for the scavenging of waste anesthesia machines during the provision of general anesthesia to adults and children.
The Dynamic Gas Scavenging System 2 (DGSS-2) is a waste anesthetic scavenging interface placed between the individual anesthetic workstation and the waste gas evacuation vacuum system in a surgical care facility. Through a sensor and solenoid combination, it allows waste gas exhaust flow to the waste gas vacuum line only in the presence of waste anesthetic gas, and interrupts all exhaust flow when no waste gas is present. The system effectively prevents both positive and negative pressure on the patient breathing circuit, and it is usable over a wide range of anesthetic gas flows. It is designed for use in conjunction with low-flow (
The provided text does not describe a study involving an AI/software device that meets specific acceptance criteria related to accuracy, sensitivity, or specificity in a medical imaging context. Instead, it details a 510(k) submission for a medical device called the "Dynamic Gas Scavenging System 2 (DGSS-2)", which is used to scavenge waste anesthetic gases.
This device is not an AI/software product, nor does the document describe any performance study involving human readers, ground truth establishment by experts, or the use of training and test sets as would be typical for an AI/ML medical device. The "Non-Clinical Performance Data" section on page 9 refers to engineering and quality assurance measures and performance testing against standards, not clinical performance in terms of diagnostic accuracy or reader improvement.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as outlined in your prompt, because the provided document relates to a physical medical device and its engineering validation, not an AI/software product with the types of performance metrics you specified.
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(395 days)
316 Clearwater, Florida 33759
Re: K160950
Trade/Device Name: MINISCAVTM Regulation Number: 21 CFR 868.5430
|
| Classification Name /
Product Classification | Apparatus, Gas Scavenging
| CBN, 21CFR 868.5430 |
|---|
| Product Classification |
| CFR 868.5430 |
| CBN |
| CFR 868.5430 |
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.
The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:
The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.
| Acceptance Criteria Category | Specific Criterion / Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI/ES60601-1 standard. | Demonstrated compliance with AAMI/ANSI/ES60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Demonstrated compliance with IEC 60601-1-2. |
| Durability - Continuous Running | Maintain specifications for at least 10,000 hours of continuous running. | Continuous running demonstrated the vacuum pump stays within its specifications for at least 10,000 hours. |
| Durability - Real-time Unit Life | Meet performance specifications after 2 years of use. | Real-time testing of the complete unit supports that the device meets its performance specifications after 2 years use. |
| Vacuum and Flow - Constant Vacuum | Provide a constant vacuum of |
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(86 days)
Research Triangle Park, NC 27709
Re: K142138
Trade/Device Name: ISO-Gard Mask Regulation Number: 868.5430
Apparatus, gas-scavenging |
| Product Code: | CBN |
| Regulation Number: | 868.5430
|
| Product Code / CFR | CBN
868.5430
The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
This document describes the Teleflex Medical, Inc. ISO-Gard Mask (K142138), a gas-scavenging apparatus intended to remove waste anesthetic gases and provide supplemental oxygen to patients recovering from general anesthesia.
Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Test Objective | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|---|
| Oxygen Delivery with Vacuum Tubing | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings and oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Oxygen Delivery with Vacuum Tubing Removed | To evaluate the oxygen delivery performance with vacuum tubing removed at variable oxygen flow rates. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Strength of Connection | To validate the Oxygen Flow Concentrator to Mask bond strength. | The Oxygen Flow Concentrator will not detach at 30 lpm flow rate and the initial gauge pressure reading will remain the same as the final pressure reading for each tested mask. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Biocompatibility Testing: Cytotoxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration ( |
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(128 days)
Apparatus, gas-scavenging |
| Product Code: | CBN |
| Regulation Number: | 868.5430
| Same |
| Product Code / CFR | CBN
868.5430
Research Triangle Park, NC 27709
Re: K132729
Trade Name: ISO-Gard® Mask Regulation Number: 21 CFR 868.5430
The ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAGS is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
ISO-Gard® Mask Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Oxygen Delivery | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml without the use of N₂O | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings | The device met this criterion. |
| Scavenging | To evaluate the scavenging performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml with N₂O | N₂O levels must be lower than with a standard medium concentration oxygen mask | The device met this criterion. |
| ETCO₂ | To evaluate the ETCO₂ performance in simulated conditions | The traces/waveforms during testing must be distinct and generated consistently | The device met this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin. However, the tests are described as nonclinical performance testing and simulated conditions, suggesting laboratory-based studies rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The performance tests appear to be based on objective measurements against established technical standards for oxygen delivery, scavenging efficacy, and ETCO2 waveform characteristics, rather than expert judgment.
4. Adjudication Method for the Test Set
Since there is no mention of experts or human interpretation in establishing the ground truth for the test set, there is no adjudication method described (e.g., 2+1, 3+1, none). The tests rely on quantifiable measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. The device is a physical mask for gas scavenging and oxygen delivery, not an imaging or diagnostic AI tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The ISO-Gard® Mask is a medical device for gas delivery and scavenging, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant. The performance tests evaluate the physical functioning of the device.
7. Type of Ground Truth Used
The ground truth for the performance tests appears to be based on objective technical standards and measurements:
- For Oxygen Delivery: Comparison against "a standard medium concentration oxygen mask" and measurements of delivered oxygen percentage.
- For Scavenging: Measurement of N₂O levels compared against "a standard medium concentration oxygen mask."
- For ETCO₂: Evaluation of generated traces/waveforms for distinctness and consistency.
8. Sample Size for the Training Set
The document does not mention a training set. This is expected as the ISO-Gard® Mask is a physical medical device and not an AI or machine learning system that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set for this device.
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(127 days)
|
| Classification: | Product code - CBN
CFR 868.5430
Classification name
Product Code / CFR | Apparatus, gas scavenging
CBN
868.5430
| Apparatus, gas scavenging
CBN
868.5430
|
| Product Code / CFR | CBN
868.5430
TRIANGLE PARK NC 27709
Re: K123176
Trade/Device Name: ISO-GARD® ClearAir™ Mask Regulation Number: 21 CFR 868.5430
The ISO-GARD® ClearAir™ Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-GARD® ClearAir™ Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-GARD® ClearAir™ mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases ("WAGS") exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit ("PACU"). Vacuum/suction for scavenging of WAGS is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers.
The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
The ISO-GARD® ClearAir™ mask is offered in several configurations, the differences being some of the components.
The provided document describes a 510(k) premarket notification for the ISO-GARD® ClearAir™ mask. This device is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) and provides supplemental oxygen. The submission is a comparison to legally marketed predicate devices, not a study presenting novel acceptance criteria.
The document explicitly states: "There is no pass / fail criteria for the ISO-GARD® ClearAir™ mask. The testing performed is for disclosure only." This indicates that the study was not designed to meet specific, pre-defined acceptance criteria with pass/fail thresholds. Instead, the testing aimed to characterize the device's performance and demonstrate substantial equivalence to predicate devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, as such criteria were not defined as "pass/fail" for this submission type. However, I can summarize the performance data disclosed and the nature of the study.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, no explicit "pass/fail" acceptance criteria were set for this device in the context of this 510(k) submission for the performance testing. The reported performance data is primarily for disclosure and comparison.
| Performance Characteristic | Reported Device Performance (ISO-GARD® ClearAir™ Mask) | Comparison/Context |
|---|---|---|
| Delivered Oxygen % (4 lpm O2 flow, 30-50 mm Hg Vacuum) | 21-23% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (6 lpm O2 flow, 30-50 mm Hg Vacuum) | 31-32% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (8 lpm O2 flow, 30-50 mm Hg Vacuum) | 38% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| Delivered Oxygen % (10 lpm O2 flow, 30-50 mm Hg Vacuum) | 43-44% | Equal to or greater than a standard medium concentration oxygen mask while scavenging. |
| No₂O detection in chamber | No measurable N₂O detected | Supports effective scavenging at the patient. |
| Delivered Oxygen % (with no N₂O, compared to standard mask with no N₂O) | Higher than a standard oxygen mask at all flow rates and vacuum settings. | Performance superior to a standard oxygen mask in these conditions. |
| End-tidal CO₂ tracing and waveform | More consistent than the predicate Bi-Flo nasal sampling cannula. | Indicates improved or equivalent ETCO2 monitoring capabilities. |
| Biocompatibility | Meets the requirements of ISO 10993 (cytotoxicity, sensitization, irritation). | Demonstrates material safety. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a numerical sample size for the "test set" in terms of how many devices were tested or how many test conditions were numerically replicated. It describes performance testing in a "simulation bench set-up."
- Data Provenance: The studies are described as "Non-clinical Performance Testing" and "simulation bench set-up." This indicates a prospective, controlled laboratory setting. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA by Teleflex Medical, Inc., located in Research Triangle Park, NC, USA.
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)
This type of information is not applicable to this submission. The "ground truth" for this device's performance (e.g., oxygen percentage, scavenging effectiveness) would be established through a validated physical measurement system in the benchtop simulation, not through expert consensus or clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. As the testing involved objective physical measurements on a benchtop, there was no need for expert adjudication of results.
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
This information is not applicable. This is a medical device, not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device. "Standalone (algorithm only)" is a concept for AI or software devices, not relevant here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims in this submission is based on objective physical measurements from a validated simulation bench set-up. For example, oxygen percentage was measured, and the absence of N₂O was detected. Biocompatibility was assessed against ISO 10993 standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are typically associated with machine learning or AI algorithm development.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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(531 days)
| 21 CFR 868.5330 |
| Apparatus, Gas-Scavenging | CBN | II | 21 CFR 868.5430
The SEDARA™ Gas Mixer System is indicated for mixing and delivering Nitrous Oxide (N₂O) and Oxygen (0₂), in a ratio of 1:1, at a fixed concentration of 50% / 50% (V/V), to spontaneously breathing patients of at least 15 kg body weight and four years of age, who have been examined by the attending physician prior to SEDARA™ System use and are under the continuous supervision of a healthcare professional in a clinical facility, such as a hospital, a free-standing ambulatory surgical center, or an outpatient clinic.
USP N₂O and 0₂gases are blended to the 50%/50% concentration (V/V) and delivered upon demand to spontaneously breathing patients through a demand valve internal to the SEDARA™ Gas Mixer. Patient inspiration draws the gas mixture via a breathing circuit with a hand-held strapless face mask. The Oxygen is supplied by the user either from a standard gas cylinder or from an 0₂ wall outlet. The Nitrous Oxide is supplied from a small cylinder equipped with a tamper-resistant valve. The SEDARA™ Gas Mixer can be operated only with the use of a Security Key. The Security Key allows access and activation of the Gas Mixer, secures the N₂O Cylinder in use, and provides safekeeping of incremental N₂O Cylinders in the accompanying Transport Cart storage drawers, to guard against abuse and theft of the gas. The SEDARA™ Gas Mixer is provided with multiple levels of safety to ensure proper dosing. Visual and audible alarms signal the absence of adequate gas flow, the emptying of a gas cylinder, or technical failure of the mixer. The gas exhaled by the patient into the face mask is channeled through the exhalation limb of the breathing circuit to the SEDARA™ Scavenger and removed via the hospital's waste gas disposal system.
The provided text describes the EDARA™ Gas Mixer System, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific studies conducted to demonstrate performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a 510(k) summary and FDA clearance letter, which typically focuses on demonstrating equivalence to existing devices rather than detailing novel performance studies with explicit acceptance criteria.
Therefore, I cannot provide the requested table and detailed study information based on the given text.
The text does state the following about the device's performance characteristics in comparison to the predicate device:
- "mixes Nitrous Oxide and Oxygen to a 50%/50% (V/V) mixture with the same accuracy"
- "includes a waste gas scavenger fully equivalent to the predicate scavenger"
This implies that the accuracy of gas mixing and the effectiveness of waste gas scavenging are key performance aspects, and for these, the standard set is "the same accuracy" or "fully equivalent" to the predicate devices. However, the specific quantitative acceptance criteria and the studies proving them are not detailed in this document.
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(80 days)
JUN 2 3 2011
Re: K110930
Trade/Device Name: Active Waste Gas Scavenger Regulation Number: 21 CFR 868.5430
The Waste Gas Scavenger is designed for use with vacuum (suction) waste gas disposal systems with anesthesia machines and heart/lung bypass machines.
Active Waste Gas Scavenger
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called an "Active Waste Gas Scavenger." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report.
Therefore, I cannot provide the requested information based solely on the text provided. This document simply states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
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(284 days)
Orr - President Vapor-Clear Breathing circuit anesthetic gas scavenger Gas Scavenging Apparatus CBN 868.5430
City, Utah 84098
APR 1 3 2010
Re: K092031 Trade/Device Name: Vapor-Clear Regulation Number: 21CFR 868.5430
To remove unwanted anesthetic gases from the patient breathing circuit
This device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
Here's a breakdown of the acceptance criteria and study information for the Vapor-Clear device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Anesthetic adsorption rate | Vapor-Clear scavenges >99.95% of isoflurane at a high flow rate. |
| Scavenging residual vapor from modern anesthesia gas machines to 99% was observed. No degradation of anesthetic gas removal capacity was observed when using aged product (71 months). | |
| Environmental testing | No change in device performance was observed following mechanical and environmental stresses (shock, vibration, high/low temperature, humidity) for anesthetic removal, leakage, and increased back pressure. |
| Internal volume | The internal volume of the device is 92 ml. |
| Internal compliance | The internal compliance is 14 ml/kPa. |
| Burst pressure | The Vapor-Clear burst at a pressure of 70 pounds per square inch. |
| Back-pressure | Added back pressure of 0.5 cm H₂O at 30 L/min was observed. |
| Leak rate | No leak (0.0 ml/min) was detectable. |
Study Details
The provided document describes non-clinical bench testing to demonstrate the substantial equivalence of the Vapor-Clear device to its predicate.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in terms of patient data. The testing involved multiple units of the Vapor-Clear device and utilized two modern anesthesia gas machines (Draeger Apollo and Ohmeda Aestiva) for the residual vapor scavenging test. "A single Vapor-Clear canister" was used for the removal capacity test. "Product containing activated charcoal that has been aged for 71 months" was tested for product life testing.
- Data Provenance: The data is from non-clinical bench testing. The country of origin is not specified but is implied to be related to the manufacturer (Axon Medical Inc., Park City, Utah, USA) and the FDA submission process. This is retrospective in the sense that the studies were completed before the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth for this non-clinical testing was established through direct measurement using analytical instruments (e.g., anesthetic gas analyzer capable of detection 99% removal) was determined by comparing measured input and output concentrations.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical medical device and does not involve AI or machine learning models that require a training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, no training set was used.
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