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510(k) Data Aggregation
(177 days)
MICRO DIRECT, INC.
The Micro H2 is a hand held hydrogen monitor used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting.
Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.
Target Population: Adult, Child and Infant.
The Micro H2 Breath Monitoring device is a battery operated hand held hydrogen breath monitor. Clinicians using this device have a patient expel their breath into an inlet port through a disposable mouthpiece adapter. The hydrogen concentration is then displayed in parts per million (ppm). The software utility, product name Hydra, will be supplied to purchasers of the breath hydrogen monitoring device. At the clinician's discretion, they can install Hydra on a Windows based PC. Thereafter, the handheld Micro H2 device can be connected to the PC via a serial communications cable to acquire and log successive breath hydrogen measurements during a diagnostic procedure.
Here's an analysis of the provided text regarding the Micro H2 Breath Monitoring Device with Hydra Software Utility, focusing on acceptance criteria and study details:
Summary of Device and Indication:
The Micro H2 Breath Monitoring Device with Hydra Software Utility is a handheld hydrogen monitor used in the screening and diagnosis of lactose malabsorption. This condition is identified by increased hydrogen levels in the breath after lactose ingestion, following a period of fasting. The Hydra software utility allows for data acquisition, logging, plotting, and report generation on a Windows-based PC.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K033688) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance acceptance criteria through a dedicated clinical study for the Hydra software utility. The acceptance criteria for the core hydrogen monitoring function (Micro H2 device) are based on the performance of its predicate devices. The Hydra software itself primarily offers enhancements in data management, visualization, and reporting, rather than directly impacting the core measurement accuracy.
Therefore, the table below outlines the performance characteristics of the Micro H2 device, which the proposed device (with Hydra) claims to be the "Same as Micro H₂" for, and implicitly, these are the de facto acceptance criteria for the measurement aspect, as they are consistent with a legally marketed predicate. For the Hydra software's new functionalities, the acceptance is based on functional equivalence and verification.
| Acceptance Criteria (from Predicate Micro H2) | Reported Device Performance (Proposed Micro H2 with Hydra) |
|---|---|
| Performance: | |
| Operating Principle: Electrochemical | Same as Micro H₂ (Electrochemical) |
| Type: Micro fuel cell | Same as Micro H₂ (Micro fuel cell) |
| Range: 0 - 500 ppm | Same as Micro H₂ (0 - 500 ppm) |
| Resolution: 1 ppm | Same as Micro H₂ (1 ppm) |
| Accuracy: +/- 10% or 2 ppm whichever is the greater | Same as Micro H₂ (+/- 10% or 2 ppm whichever is the greater) |
| Display: 3 1/2 digit LCD | Same as Micro H₂ (3 1/2 digit LCD) |
| Operating Pressure: Atmospheric +/- 10% | Same as Micro H₂ (Atmospheric +/- 10%) |
| Pressure coefficient: 0.02% signal per mBar | Same as Micro H₂ (0.02% signal per mBar) |
| New/Enhanced Functionality (Introduced by Hydra software): | |
| Recording Date of Test, Clinician Name, Institution ID, Patient ID, DOB, Reported Symptoms: Manual Transcription | Pop-Up Menus Presented to User. Relevant Data Entered into Field Through Mouse Driven Program Interface |
| Plotting Breath Hydrogen Concentration as a Function of Time for Diagnostic Evaluation: Manual Plotting | Breath Hydrogen Concentration Automatically Plotted as a Function of Time and Graphically Displayed. |
| Breath Hydrogen Measurement Interval: Manual Timing with Wall Clock or Stop Watch | Automatic in Real-Time Mode. Hydra Program Tracks Time and Prompts for Next Measurement. |
| Electronic Archival/Retrieving of Test Data: Only if Test Data is Manually Managed with Word Processing/Spreadsheet Application | Fully Automatic within Hydra User Interface |
| Test Protocol: Manually Determined, Managed and Administered | Hydra Software Provided with Several Suggested Diagnostic Presets for Lactose Malabsorption. Clinicians on a Per Patient Basis can Manually Modify Suggested Preset Test Protocol Variables. Included within Protocol Variables are Threshold Parameters that if Used, Resultant Diagnostic Data is Automatically Compared. |
| Report Generation and Communication: Manual Transcription | Automatic within Hydra User Interface. Depending Upon Diagnostic Presets, Measured Breath Hydrogen Data is Compared to Thresholds and Can be Flagged as a Suggested Diagnostic Should this Feature of the Hydra Interface be Invoked. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not detail a specific clinical test set or sample size to prove the device meets acceptance criteria in a traditional sense (e.g., patient-based clinical trial data). This document is a pivotal submission for demonstrating substantial equivalence to previously approved devices (K963376 and HBT Sleuth™).
The core performance of the Micro H2 device itself is claimed to be "Same as Micro H₂" (referring to the predicate K9633765 Micro H2 device). This implicitly relies on the proven performance of the predicate device. For the new functionalities introduced by the Hydra software, the evidence would typically come from software verification and validation (V&V) activities, such as functionality testing, integration testing, and system testing, rather than a clinical 'test set' with patient data.
Therefore:
- Sample Size for the Test Set: Not specified in this 510(k) summary as a dedicated clinical test set. The performance claims rely on the predicate device's existing validation.
- Data Provenance: Not applicable for a new clinical test set. The performance characteristics of the device component (Micro H2) are derived from a previously cleared device. The software functions would be validated through technical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. As noted above, the submission relies on substantial equivalence to existing devices and likely software V&V for the new software features, not a new clinical study requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given that a dedicated clinical test set with expert ground truth isn't detailed, there's no mention of an adjudication method.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. The device is a diagnostic tool for hydrogen breath testing, and the Hydra software primarily automates data handling and report generation, rather than providing AI-assisted diagnostic interpretation that would typically necessitate an MRMC
study. The "Suggested Diagnostic" feature in Hydra automatically compares data to thresholds but does not involve complex AI interpretation requiring human reader comparison with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The 510(k) summary does not describe a standalone algorithm performance study in the way typically seen for AI/ML devices. The "Hydra Software Utility" enhances the existing Micro H2 device by automating data management, plotting, and report generation based on pre-defined thresholds. It allows for "Resultant Diagnostic Data [to be] Automatically Compared" to "Threshold Parameters," and can "Flagged as a Suggested Diagnostic." This suggests an algorithmic comparison, but the study supporting this automation (likely software V&V) is not detailed here in terms of standalone performance metrics like sensitivity/specificity on a labelled dataset. Its primary role is to streamline the clinician's workflow and provide suggested diagnostics based on pre-set rules, not to provide an independent, unassisted diagnosis.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the device and the 510(k) submission, the ground truth for the performance characteristics (like accuracy, range, resolution of hydrogen measurement) is implicitly tied to the established methods and validation of the predicate Micro H2 device. For the software's functionalities, the "ground truth" would be the successful execution of the specified functions (e.g., correct plotting of data, accurate entry of patient ID, proper comparison against predefined thresholds) as tested during software verification and validation, rather than clinical ground truth like pathology or expert consensus on patient cases.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a training set. This is consistent with the device not being an adaptive AI/ML model that would typically require a training set. The Hydra software is a rule-based utility for data management and simplified analysis.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for an AI/ML model, the establishment of ground truth for a training set is not applicable to this submission.
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(238 days)
MICRO DIRECT, INC.
The Microlab spirometer is intended, for prescription use rno Mioreleb ope the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The Microlab spirometry systems consists of the Microlab spirometer, digital volume transducer, transducer housing, AC power adapter, power supply cord, disposable cardboard mouthpieces, carrying case, quick start guide and operators manual. Optional accessories include calibration syringe, nose clips, serial cable and a serial to parallel converter for use of an external compatible printer.
Here's an analysis of the provided text regarding the Microlab Spirometer, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by) | Reported Device Performance |
|---|---|
| Accuracy and precision standards set by the American Thoracic Society (ATS) | "Performance testing was conducted to demonstrate compliance with the accuracy and precision standards set by the American Thoracic Society." |
| Electrical safety requirements per IEC60601-1-2 | "The device was tested to demonstrate conformance with IEC60601-1-2 requirements for electrical safety." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing related to ATS standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The testing appears to be against established technical standards (ATS and IEC), rather than requiring expert-adjudicated ground truth derived from patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the testing was against pre-defined technical standards rather than requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided document. The submission focuses on demonstrating technical compliance and substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the testing described appears to be a standalone performance evaluation of the device against a set of predetermined technical standards (ATS for accuracy/precision and IEC for electrical safety). There is no indication of human-in-the-loop performance testing being conducted or required for this type of device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is the technical accuracy and precision standards set by the American Thoracic Society (ATS) and the electrical safety requirements of IEC60601-1-2. These are objective, pre-defined standards rather than patient-specific or expert-derived ground truth.
8. The Sample Size for the Training Set
This information is not applicable/provided. Spirometers are hardware devices that measure physiological parameters. They do not typically involve training sets in the machine learning sense. The "training" would be inherent in the device's design and calibration against established physical standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated above. The device's "training" and calibration would be against physical standards and known physiological principles, not through a training dataset of medical images or patient outcomes.
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(184 days)
MICRO DIRECT, INC.
The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
This document describes a 510(k) premarket notification for the MicroPeak Peak Flow Meter. The following information is extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroPeak Peak Flow Meter are implicitly defined by its performance comparison to the Vitalograph Asmaplan+, a predicate device. The document states "The only difference is a small difference in the measurement range," implying that the MicroPeak device's performance attributes (accuracy, intra-device precision, inter-device precision) are considered acceptable if they match or are comparable to the predicate device's.
| Attribute | Acceptance Criteria (Predicate Device: Vitalograph Asmaplan+) | Reported Device Performance (MicroPeak) |
|---|---|---|
| Range | 50 - 800 L/M | 60 - 900 L/Min |
| Accuracy | +/- 10% | +/- 10% |
| Intra device Precision | +/- 5% | +/- 5% |
| Inter device Precision | +/- 5% | +/- 5% |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The comparison is based on the technical specifications of the device rather than a clinical study with a detailed test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention a ground truth established by experts for a test set. The validation appears to be based on engineering specifications and comparison to a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no described test set involving human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a measurement tool, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
The document implicitly describes the standalone performance of the device by listing its performance attributes (range, accuracy, precision). However, it does not detail a specific standalone study design or results beyond these specifications. The device itself is a mechanical measurement tool, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be based on engineering specifications and direct measurement capabilities of the device itself, compared against the known specifications of the predicate device. There is no mention of pathology, expert consensus (in the context of clinical interpretation), or outcomes data for performance validation in this submission.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a mechanical peak flow meter, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set mentioned.
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(79 days)
MICRO DIRECT, INC.
To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing
A disposable bacterial/viral filter used in pulmonary function testing
The provided text describes the SpiroSafe Filter, a disposable bacterial/viral filter for pulmonary function testing. The study demonstrates the device's substantial equivalence to a predicate device (PDSI KoKo Filter - K914272) based on performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Intended device Performance (SpiroSafe Filter) | Predicate Device Performance (PDSI KoKo Filter) |
|---|---|---|
| Bacterial Efficiency | >99% | 99.99% |
| Viral Efficiency | >99% | 99.98% |
| Resistance to Airflow | >1.5 cmH2O/L/Sec. @ 12/L/Sec. | 0.9 cmH2O/L/Sec. @ 12/L/Sec. |
| Use as bacterial/viral filter | Yes | Yes |
| Use during pulmonary function test | Yes | Yes |
| Single patient use | Yes | Yes |
| Housing material - Impact Polystyrene | Yes | Yes |
| Filter Media | Electrostat | Filtrete |
Note: While the text doesn't explicitly state "acceptance criteria", the comparison table to the predicate device implies that the performance characteristics of the predicate serve as the benchmark for substantial equivalence. The SpiroSafe Filter meets or exceeds the critical performance aspects (bacterial/viral efficiency) of the predicate. The resistance to airflow value for the predicate is 0.9, and the intended device is ">1.5", which seems to indicate the SpiroSafe filter exceeds the predicate in this metric; however, for resistance, lower is generally better. This could be a typo in the document or interpreted differently. Assuming the acceptance criteria aligns with being "comparable or better" than the predicate, the device broadly meets this.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing shown. It is simply presenting performance data.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be a direct presentation of product specifications rather than a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's performance is measured against technical specifications, not subject to expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-in-the-loop assessment or expert review for adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a physical filter, and the evaluation is based on its physical and filtering properties, not on diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" performance assessment was done. The performance metrics (bacterial efficiency, viral efficiency, resistance to airflow) are inherent to the device itself and do not involve human interaction beyond conducting the tests. The results presented are solely based on the device's intrinsic characteristics.
7. The Type of Ground Truth Used
The ground truth used is based on measured physical and performance characteristics (e.g., bacterial efficiency percentage, viral efficiency percentage, resistance to airflow in cmH2O/L/Sec.). This is analogous to laboratory testing/engineering specifications.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of a "training set" in the context of this device. The evaluation is focused on the manufactured product's specifications rather than a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" or a machine learning context.
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(182 days)
MICRO DIRECT, INC.
To measure lung functions - FEV 1 , FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers
A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF.
The provided document is a 510(k) summary for the MicroDL DiaryCard Spirometer. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states "Performance Testing: None applicable" in the comparison table and includes no dedicated section on performance criteria or a study demonstrating the device meets those criteria.
Therefore, based on the provided text, it's not possible to extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present. The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance study results.
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(150 days)
MICRO DIRECT, INC.
The Micro Hs is a hand held hydrogen monitor, used in the screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines. This increased level of hydrogen is expired and can be measured after ingestion of lactose following a period of fasting.
The Micro Hs is a hand held hydrogen monitor.
The provided text is a 510(k) premarket notification letter from the FDA to Micro Direct, Inc. regarding their device, MicroH2. This letter is a regulatory document and does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a detailed submission.
Therefore, I cannot extract the requested information as it is not present in the provided document.
The document primarily focuses on:
- Confirming substantial equivalence of MicroH2 to a predicate device.
- Indicating the device's classification (Class I).
- Outlining relevant general controls and regulations.
- Stating the intended use of the device: "screening and diagnosis of lactose malabsorption, a condition that produces increased hydrogen levels in the blood when unabsorbed lactose reacts with bacteria in the intestines."
To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for the MicroH2 device, which would contain the performance data and details about the studies conducted.
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(88 days)
MICRO DIRECT, INC.
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
A hand-held portable electronic spirometer measuring FEV1 and FVC
The provided text is a non-confidential summary of safety and effectiveness for the Micro Spirometer, comparing it to a predicate device, the Spirometrics Model 2600 Micro Spirometer (K901057).
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are implicitly defined by the attributes of the predicate device, which the new device claims to match exactly. The reported device performance is that it matches all acceptance criteria because it is stated: "There is no difference between the intended device and the listed predicate device." and "Exact same unit as supplied to and marketed by Spirometrics and approved under K901057".
| Acceptance Criteria (from Predicate Device - Spirometrics Model 2600) | Reported Device Performance (Micro Spirometer) |
|---|---|
| Intended as a spirometer | Yes |
| Intended to measure lung function FEV1 and FVC | Yes |
| Indicated for measuring patient's lung function | Yes |
| Indicated for use by a clinician in environments such as home or hospital | Yes |
| Manufactured by Micro Medical | Yes |
| Transducer - flow sensing turbine | Yes |
| No output (assumed as in 'no external output' as opposed to 'no data output') | Yes |
| Flow range lps BTPS 0-12 | Yes |
| Volume range liters 0-9.99 | Yes |
| Measures - FVC - FEV1 | Yes |
| Accuracy + / - 3 | Yes |
| Display LCD | Yes |
| Transducer cleaned after use | Yes |
| Utilizes paper mouthpiece | Yes |
| Same materials as K901057 | Yes |
| Performance Testing - None applicable | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Performance Testing - None applicable" and later "There is no difference between the intended device and the listed predicate device." This indicates that no new performance testing (and thus no test set or associated data provenance) was conducted for this specific submission to demonstrate the device meets acceptance criteria. The claim of equivalence to the predicate device, which was already approved (K901057), is the basis for approval.
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, as no new performance testing with a test set was conducted for this submission. The device's safety and effectiveness are based on its equivalence to an already approved predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new performance testing with a test set was conducted for this submission.
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 diagnostic spirometer, not an AI-powered image analysis tool or a device requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical diagnostic device, not an algorithm, and its performance is assessed against established spirometry standards, not in an AI standalone context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the predicate device's original approval, but for spirometers, ground truth is typically established against calibrated flow/volume simulators and established clinical guidelines for spirometry. For this specific submission, the "ground truth" for the new device's acceptability is its equivalence to the predicate device (Spirometrics Model 2600 Micro Spirometer).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(638 days)
MICRO DIRECT, INC.
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