Search Results
Found 4 results
510(k) Data Aggregation
(105 days)
The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases.
The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor.
Environment of use - hospital, sub-acute, and pre-hospital settings
Patient population - Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics.
Dispo-Med has designed a series of exhaled gas sampling devices. They include:
- Nasal cannula styles that can provide supplemental O2 and sample exhaled gases
- Gas sampling only devices which sample the patient's exhaled gas at the nares or in the circuit
All of the devices have the same indications for use and therefore can be combined into a single submission.
We will present several different configurations which have been tested and compared to several predicates.
Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling design connect to the monitor via a standard luer fitting, whether it is a female or male fitting.
The provided text describes a 510(k) summary for DISPO-MED (MALAYSIA) SDN BHD regarding their Oxygen Delivery / CO2 Sampling Cannula Style and Gas Sampling Only Style devices. The document aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets in the same way one might find for a diagnostic test's sensitivity or specificity. Instead, it frames "acceptance" as demonstrating substantial equivalence to predicate devices through comparative performance testing and shared characteristics. The performance criteria are implicit within the comparative testing performed.
| Acceptance Criteria Category | Reported Device Performance (DISPO-MED) |
|---|---|
| Indications for Use | Oxygen Delivery / CO2 Sampling Cannula Style: "The Dispo-Med nasal cannula styles are intended to deliver supplemental oxygen to patients and provide a means to sample expired gases." (Identical to predicates K010024 and K011050) |
| Gas Sampling Only Style: "The Dispo-Med gas sampling lines are intended to interface with the patient via nasal cannula, nares connector, or standard sampling port connectors to the expired gas monitor." (Identical to predicates K980325 and K980327) | |
| Environment of Use | "Hospitals, sub-acute, and pre-hospital settings." (Identical to predicates) |
| Patient Population | "Patients requiring supplemental oxygen and / or expired gas monitoring, adult to pediatrics." (Identical to predicates) |
| Technology / Construction | Oxygen Delivery / CO2 Sampling Cannula Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates several styles of split/channeled nasal cannula. |
| Gas Sampling Only Style: Design, fabrication, shape, size etc. are equivalent to predicates. Design incorporates simple means to interface with the patient or breathing/ventilator circuit. | |
| CO2 Sampling Performance | Oxygen Delivery / CO2 Sampling Cannula Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%), and oxygen flow rates (1 lpm, 5 lpm). "The results presented show that the proposed Dispo-Med Oxygen delivery / CO2 sampling cannula style devices performed equivalent to the predicates." Acknowledged that higher O2 flow (5 lpm) can cause lower CO2 values (washout), but "performance met the performance specifications" and differences "not considered clinically significant." |
| Gas Sampling Only Style: Comparative CO2 sampling and waveform performance at breathing rates (12 bpm, 20 bpm), tidal volumes (300 ml, 500 ml), CO2 concentrations (1%, 5%). "The results show that the proposed Dispo-Med CO2 sampling only style devices performed equivalent to the predicates." Noted "better performance of the proposed device vs. the predicates." | |
| Mechanical Testing | Resistance to flow, Tensile strength of connections, Luer fitting testing (per ISO 594-2), O2 Flow, Strength of bonds. (Performed and deemed equivalent to predicates for both styles.) |
| Environmental/Age Testing | Performed for both device styles; results not explicitly detailed but stated to support substantial equivalence. |
| Biocompatibility (Materials) | ISO 10993 testing performed for cytotoxicity, sensitization, and intracutaneous irritation for indirect and direct (skin) contact materials. (Performed, ensuring materials are appropriate.) |
| Single Patient Use, Disposable | Yes (Identical to predicates) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested, number of simulated breaths, or duration of tests) for the comparative performance and mechanical testing. It mentions "several different configurations which have been tested".
- Data Provenance: The testing appears to be prospective (conducted specifically for this 510(k) submission) and simulated/laboratory-based. There is no mention of human subject data or data from a specific country of origin for the performance testing results themselves. The company, DISPO-MED (MALAYSIA) SDN BHD, is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The "ground truth" for comparative performance data in this context would likely be derived from a validated capnometer or gas analyzer, rather than expert interpretation of data. The document focuses on the objective measurement and waveform equivalency.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided. Since the testing is focused on objective measurements of gas sampling and mechanical properties, there wouldn't typically be a need for an adjudication method in the way one would for clinical image interpretation.
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 submission is for a physical medical device (nasal cannula/gas sampling line), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI algorithm. The device performance (standalone) was evaluated in laboratory settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the CO2 sampling performance was the measured CO2 concentration and waveform generated by the simulated breathing conditions. This would be established by a reference gas analyzer or capnometer, which serves as the "gold standard" for measuring CO2.
- For mechanical and material testing, the ground truth refers to established standards and specifications (e.g., ISO 594-2 for Luer fittings, standard material properties, and mechanical limits).
8. The sample size for the training set:
- This information is not applicable. As this is a physical medical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set.
Ask a specific question about this device
(83 days)
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1302 / 1202 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp System consists of the IDkit:Hp™ and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
The modified BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:
- IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325)
- A 75mq 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid)
- Drinking straw
- Package Insert (Instructions for Use)
The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 1202 ratio before and after ingestion of 13C-urea is referred to as the Delta over Baseline (DOB).
The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for substantial equivalence in the clinical validation centered on the agreement between the modified BreathID® Hp System and its predicate device (unmodified BreathID® System) for H. pylori diagnosis.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positive Percent Agreement: ≥ 95% | 100% [95% Cl (81.6, 100)] |
| Negative Percent Agreement: ≥ 95% | 97% [95% Cl (89.0, 99.1)] |
| Comparative Validation (Analytical): | |
| Pearson's Correlation Coefficient (r) | r = 0.9944 (95% Cl: [0.9904, 0.9966]) |
| p-value | p |
Ask a specific question about this device
(250 days)
The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.
The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).
The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (typically quantitative thresholds for accuracy, precision, etc.) | "The performance data included in this submission indicate that the Medley™ EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study (Algorithm Only)
The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as no training set is described.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.
Ask a specific question about this device
(19 days)
The intended use of the MAC-Line Oz/CO2 Nasal Cannula sample line is to conduct a sample of the adult/pediatric subject's breathing from the subject, via a nasal cannula, to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation.
The MAC-Line O2/CO2 Nasal Cannula sample line device is used whenever the physician needs to measure the CO2 in an adult or pediatric non intubated subject's breathing via a nasal cannula while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.
The common product name for this device is Nasal Cannula Gas sampling line for capnograph with integrated Oxygen Administration means for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The complete device is a combined device consisting of two devices, as described below, integrated to simultaneously perform the function of both devices.
The CO2 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, a Microstream sample tube with a Male or Female Luer lock on the other end for connecting to the capnograph. The CO2 Cannula is identical to the Oridion CO2 Nasal Cannula K980325.
Attached and integrated with the CO2 nasal cannula is another device for simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The O₂ cannula has a tube with a standard O₂ connector bushing on the end for connecting to a normal O2 supply. The O2 device is classified as class I according to 21CFR868.5340.
The provided document is a 510(k) summary for a medical device (MAC-Line O2/CO2 Nasal Cannula sample line) and outlines its intended use, device description, predicate devices, and biocompatibility testing. It does not contain information regarding an AI model, acceptance criteria for an AI model, or a study proving an AI device meets acceptance criteria.
Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:
- A table of acceptance criteria and the reported device performance (for an AI model)
- Sample size used for the test set and the data provenance (for an AI model)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for an AI model)
- Adjudication method (for an AI model test set)
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (for an AI model)
- The sample size for the training set (for an AI model)
- How the ground truth for the training set was established (for an AI model)
The document focuses on the regulatory clearance of a physical medical device (a nasal cannula with integrated oxygen and CO2 sampling) based on substantial equivalence to predicate devices and biocompatibility testing. There is no mention of an AI component or any studies related to AI model performance.
Ask a specific question about this device
Page 1 of 1