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Found 19 results
510(k) Data Aggregation
(428 days)
Instrumentation Industries, Inc.
The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient arway pressure during ventilation with a manual resuscitation device or bag/mask unit. These devices are intended to be used by or on the order of a physician.
The Instrumentation Industries, Inc. NS 120P-TRS airway pressure monitor measures positive pressures from 0-120cm H2O during manual ventilation. The device contains a diaphragm capsule which inflates when positive pressure is introduced and collapses when the pressure decreases. Through several internal, interconnected, movements caused by the inflating/deflating diaphragm, the pointer on the face of the gauge moves to indicate accurate pressure.
The acceptance criteria and the study that proves the device meets those criteria for the NS 120P-TRS Airway Pressure Gauge are detailed below based on the provided FDA submission document.
This device is an airway pressure monitor, not an AI/ML diagnostic device, so many of the requested fields (such as multi-reader multi-case studies, expert consensus for ground truth, training set details) are not applicable to this type of medical device submission. The study focuses on direct performance measurements (accuracy and responsiveness) against engineering specifications and a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Objective | Acceptance Criteria | Reported Device Performance (NS 120P-TRS Subject Device) | Pass/Fail |
|---|---|---|---|
| Accuracy | ≤ ± 1.9 cm H₂O (1.6% of full scale) | Average Accuracy Difference at 60 cm H₂O: 0.6 cm H₂O | Pass |
| Average Accuracy Difference at 120 cm H₂O: 0.9 cm H₂O | Pass | ||
| Responsiveness of Needle Movement | Must respond instantly to pressurization changes. | Responds instantly to pressure | Pass |
Comparison to Predicate Device (NS 120-TRS):
While not directly an acceptance criterion for the subject device, the study also compared its performance to the predicate device.
| Test Objective | Predicate Device Acceptance Criteria / Specification | Reported Predicate Device Performance (NS 120-TRS) | Pass/Fail |
|---|---|---|---|
| Accuracy | ≤ ± 3.8 cm H₂O (1.6% of full scale) | Average Accuracy Difference at 60 cm H₂O: 0.8 cm H₂O | Pass |
| Average Accuracy Difference at 120 cm H₂O: 1.8 cm H₂O | Pass | ||
| Responsiveness of Needle Movement | Must respond instantly to pressure and vacuum changes. | Responds instantly to pressure and vacuum. (Vacuum readings noted as not relevant for comparison with subject device) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Subject Device (NS 120P-TRS) Test Sample Size: 50 units
- Predicate Device (NS 120-TRS) Test Sample Size: 10 units
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for mechanical device testing, it is implicitly a prospective performance validation study conducted by the manufacturer, Instrumentation Industries, Inc., likely at their facilities in Bethel Park, Pennsylvania, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a performance validation study for a mechanical medical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for accuracy would be derived from a high-precision reference pressure measurement system.
4. Adjudication Method for the Test Set
- Not Applicable. As a mechanical device testing, there's no "adjudication" in the sense of human interpretation or consensus. The performance metrics (accuracy and responsiveness) are objectively measured against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This device is a physical instrument for measuring airway pressure. It does not involve human readers interpreting images or data to make a diagnosis, nor does it use AI assistance for that purpose. Therefore, an MRMC study is not relevant.
6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)
- Not Applicable. This is a standalone device, but it does not employ an algorithm or AI. Its performance is measured directly as a physical instrument.
7. Type of Ground Truth Used
- Reference Measurement/Engineering Specification. For accuracy, the ground truth would be established by a precisely calibrated reference pressure source. For responsiveness, it's a qualitative observation of "instant" response against a set pressure change. This is standard for validating the performance of pressure gauges.
8. Sample Size for the Training Set
- Not Applicable. This device is a mechanical pressure gauge and does not involve AI/ML components requiring a "training set" for model development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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(151 days)
INSTRUMENTATION INDUSTRIES, INC.
The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing.
The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 26-C Inline Aerosol Adapter is a single-patient reuse device intended to provide an access port in a ventilator circuit to facilitate the administration of Combivent® (ipratropium bromide and albuterol) Respimat® medication to mechanically ventilated patients.
The provided text describes a 510(k) premarket notification for a medical device, the RTC 26-C Inline Aerosol Adapter. The information needed to answer the prompt, particularly regarding acceptance criteria and a study proving the device meets those criteria, is limited and does not align with the typical structure of an AI/ML medical device submission.
This document details the substantial equivalence of a new device (RTC 26-C Inline Aerosol Adapter) to a predicate device (RTC 22-D Metered Dose Inhaler Adapter) based on performance testing and material compatibility, rather than a study proving an AI/ML device meets specific performance metrics against a defined ground truth.
Therefore, many of the requested items (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of traditional medical device submission.
However, I can extract the relevant information from the provided document as it pertains to the device's performance characteristics and how they compare to a predicate device.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Evaluation)
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a predicate device, the RTC 22-D Metered Dose Inhaler Adapter, particularly in terms of safety and effectiveness related to its intended use and functional characteristics. The study presented is a series of performance tests comparing the new device (RTC 26-C) to the predicate device (RTC 22-D).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Aspect | Implicit Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance (RTC 26-C vs. RTC 22-D) |
|---|---|---|
| Ease of Setup & Usage | Similar user experience and functionality to predicate device. | "The set-up and usage of the RTC 26-C was no more difficult than that of the predicate in its typical circuit set-up." Also, the Respimat inhaler was "easily and securely placed." |
| Ventilator Cycling Durability and Integrity | Maintain secure placement, no dislodged caps, proper medication dispersion under prolonged ventilator use and environmental changes. | "Each adapter tested remained secure within the test-set; No caps became dislodged. Every medication dose dispersed properly." |
| Airflow Resistance | Acceptable (ideally lower or comparable) resistance to airflow. | "The RTC 26-C Adapter had less resistance than that of the predicate device for every trial run at both 60 and 80 lpm peak flow settings." |
| Cap Security/Leakage | Cap provides secure fit and minimal leakage under high pressure and changing conditions. | "the cap of the RTC 26-C adapter fits more securely, and leaks less than the cap of the predicate device" |
| Temperature Extremes Functionality | Device maintains functionality across extreme temperature fluctuations. | "Both new and predicate adapters cycled through extreme low and high temperatures performed equally well." |
| Shipping Durability | Withstand shipping rigors and maintain fit with ventilator components. | "Test results indicate that the RTC 26-C withstands the rigors of shipping and handling, will continue to fit 22mm mating components..." |
| Adapter Cap Tether Strength | Tether maintains integrity under strain. | "No negative consequences were seen after stretching tethers to twice their normal length." |
| PEEP Loss Management | Any potential PEEP loss (if cap is open) is manageable/preventable by the ventilator. | Test determined PEEP loss "is small enough to be entirely prevented by the ventilator." |
| Drop Durability | Materials and design are durable. | "The materials and design of the RTC 26-C are durable and raise no new safety and effectiveness issues." |
| Respimat® Inhaler Attachment Durability | Medication inlet port withstands repeated attachment cycles without damage, and medication dosage dispersion remains successful. | "After 500 attachment cycles, there was no damage to the medication inlet port of any of the 10 samples tested. Medication dosage dispersion testing was also successful for every trial." |
| Port Connection Durability | Adapter ports retain secure fit after repeated connection cycles. | "the adapters retained their secure fit to mating connectors after 25 cycles, fitting as snugly as they did after the first one." |
| Aerosol Performance (Total Delivered Dose) | Delivered dose of medication remains within acceptable range and is comparable to predicate, ideally with better delivery efficiency. | RTC 26-C generally shows better performance or comparable performance for the intended medication (Combivent Respimat®) than the predicate with its MDI counterparts. |
- Albuterol (RTC 26-C vs. RTC 22-D): Total Delivered Dose (58.1-67.2 µg vs. 50.9-62.3 µg), % Reduction from SMI/MDI alone (27.8% vs. 45.5%).
- Ipratropium (RTC 26-C vs. RTC 22-D): Total Delivered Dose (11.4-13.9 µg vs. 10.4-11.9 µg), % Reduction from SMI/MDI alone (34.0% vs. 40.4%). |
| Aerosol Performance (Respirable Particle Mass/Fraction) | Higher respirable fraction is desirable. | - Albuterol (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (24.7-28.5 µg vs. 16.6-20.9 µg), Respirable Fraction (42.4% vs. 33.0%). - Ipratropium (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (5.0-5.9 µg vs. 1.6-3.1 µg), Respirable Fraction (43.7% vs. 21.4%). |
| Biocompatibility | Materials are suitable for prolonged contact in a medical device and do not raise new safety issues. | Materials (thermoplastic elastomer and polystyrene butadiene) are "previously used in the manufacture of medical devices, specifically the predicate device (K991355)." Categorized as "External Communicating Device" with "Prolonged (>24 hours to 30 days)" contact duration. |
2. Sample Size and Data Provenance:
- Placement and Usage Trials: Not specified, but involved "two typical types of ventilator circuits."
- Ventilator Cycling Test: Not specified, but involved "RTC 26-C Adapters and the predicate device."
- Adapter Resistance Test & Cap Pressure/Leak Test: "Every trial run" implies multiple runs, but specific number of samples
or trials not quantified. - Respimat® Inhaler Attachment Trials: 10 samples tested, 500 attachment cycles each.
- Port Connection Trials: "RTC 26-C samples" tested, 25 cycles each.
- Adult Aerosol Performance Comparison Testing:
- RTC 26-C: One Combivent Respimat SMI, three samples of RTC 26-C, three tests per sample = 9 measurements per medication/output variable.
- RTC 22-D: Two drugs (Ventolin HFA and Atrovent), three samples of RTC 22-D, three tests per device sample = 9 measurements per medication/output variable.
- Data Provenance: The tests are described as "laboratory and simulated usage testing." Given the context of a 510(k) submission, this data is prospective and conducted specifically for the submission. No specific country of origin for data is stated beyond the company's location (Pennsylvania, USA).
3. Number of Experts and Qualifications for Ground Truth:
- This is not applicable. The ground truth for this device's performance is established through direct physical/biomedical engineering measurements and comparisons to a known predicate device's performance, not expert-labeled clinical data.
4. Adjudication Method for the Test Set:
- This is not applicable. There is no "test set" in the sense of a set of cases requiring expert review and adjudication. The data are quantitative measurements from instrumental tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for this device. The device is a mechanical adapter, not an AI/ML diagnostic tool assisting human readers.
6. Standalone Performance:
- The "standalone" performance is assessed by the device's physical and aerosol delivery characteristics (e.g., resistance, delivered dose, particle size distribution) through the various tests described. This is the direct, unassisted performance of the device artifact itself. The human element comes into play only in administering the associated medication.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is primarily quantitative physical measurements (e.g., airflow resistance, delivered dose, particle sizes) obtained from standard engineering and aerosolization test methods, compared against established baseline expectations (e.g., historical performance of the predicate device, general principles of fluid dynamics and aerosol mechanics). No clinical outcomes data or pathology reviews are mentioned for establishing device performance.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set mentioned for this device.
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(45 days)
INSTRUMENTATION INDUSTRIES, INC.
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter.
The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package.
The provided text describes a Special 510(k) submission for the BE 409 Pilot Tube Repair Kit, primarily concerning the addition of a 10cc syringe and an updated instruction sheet. This submission does not contain information about a study proving device performance against acceptance criteria in the way one would typically expect for a new diagnostic or AI-driven device.
Here's an analysis based on the provided text, highlighting what's missing in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for cuff inflation pressure restoration, repair success rates, or durability). The purpose of this 510(k) is an addition to an already approved device, not a new device requiring extensive performance validation from scratch. The implied acceptance criterion is that the device, with the added syringe, continues to effectively restore the integrity of a pilot tube line and maintain cuff inflation pressure.
- Reported Device Performance: The document merely states "Performance: Use of a BE 409 Pilot Tube Repair Kit assists a health professional in safely repairing an endotracheal or tracheostomy tube that no longer maintains cuff inflation pressure due to a leaky pilot line, thus reducing the need to re-intubate the patient." This is a descriptive statement of its function and intended benefit, not a report of quantitative performance data from a study.
2. Sample Size Used for the Test Set and Data Provenance:
- No test set or study is described. Therefore, information on sample size and data provenance is absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since no performance study is described, there's no mention of experts establishing ground truth.
4. Adjudication Method:
- Not applicable. No study or ground truth establishment process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done. This device is a mechanical repair kit, not an AI-driven medical imaging or diagnostic tool where MRMC studies would be relevant.
6. Standalone Performance Study:
- No standalone performance study is explicitly described. The 510(k) focuses on the mechanical function of the repair kit and the addition of a syringe. The underlying performance of the repair mechanism was presumably established during the original K973755 approval in December 1997. The current submission relies on the established function of the device.
7. Type of Ground Truth Used:
- Not applicable. No performance study to establish ground truth is mentioned in this document. The "ground truth" for this device's function would likely be its ability to physically seal a pilot tube and allow cuff inflation, which would have been validated through mechanical testing or benchtop studies during the original device approval.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is a mechanical device.
Summary of Device and 510(k) Focus:
The BE 409 Pilot Tube Repair Kit is a non-AI medical device used to repair pilot tubes of endotracheal or tracheostomy tubes. The K113644 510(k) submission is a "Special 510(k)" primarily for two modifications:
- Adding a 10cc syringe to the kit.
- Updating the User Instruction sheet.
Given the nature of these changes, the FDA's review would focus on ensuring these modifications do not negatively impact the safety or effectiveness of the already cleared device. The submission explicitly states, "No changes are being made to the device, thus no Predicate Device is listed in this summary," further indicating that the core functionality of the repair kit itself is not being re-evaluated for performance. The "performance" section describes the intended function and benefit rather than presenting new study data on its effectiveness.
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(29 days)
INSTRUMENTATION INDUSTRIES, INC.
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.
The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.
The provided text is a 510(k) Summary for JEM Endotracheal Tube Changers. It describes the device, its intended use, and the purpose of the 510(k) submission, which is to add ethylene oxide as an alternate sterilization method and to expand the user instructions.
However, the provided document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a Special 510(k) submission, which means it addresses minor changes to a previously cleared device. In such a submission, the focus is typically on demonstrating that the changes do not alter the substantial equivalence of the device, rather than conducting new performance studies against acceptance criteria for the core functionality. The original PMS submission (Premarket Approval of the JEM 400 in 1981) would have contained such data, but it is not included in this document.
Therefore, I cannot provide the requested information from the given text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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(20 days)
INSTRUMENTATION INDUSTRIES, INC.
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers.
The provided text describes a submission for a medical device (RTC 24-VP Metered Dose Inhaler Adapter) to the FDA, focusing on its substantial equivalence to a predicate device. However, it does not describe an AI/ML-driven device or study. Therefore, most of the requested fields regarding AI/ML device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable.
Below is the information that can be extracted or deduced from the provided text, primarily addressing the performance and comparison to a predicate device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant impact on the rate of flow through the device. | "The decreased inlet port size on the RTC 24-VP has no significant impact on the rate of flow through the device..." |
| No significant impact on circuit back pressure. | "...or on the circuit back pressure." |
| Demonstrate substantial equivalence to the predicate device (RTC 24-V MDI adapter) in terms of function, materials, and safety. | The device found "substantially equivalent" to the RTC 24-V MDI adapter (K091111). Similarities include function, materials (latex-free Polystyrene Butadiene body, Thermoplastic Rubber cap), functional dimensions (Outlet – 15mm I.D. / 22 mm O.D.), and markings (molded-in arrow for flow direction). Performance testing showed "very little difference...in peak circuit back pressure." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "When a range of flow rates is used to ventilate air through both the new RTC 24-VP MDI adapter and the original RTC 24-V MDI adapter...", but no specific number of trials, devices, or flow rates is mentioned.
- Data Provenance: The testing was described as "laboratory testing." No country of origin for data or retrospective/prospective nature is specified, but it implies internal R&D testing by the manufacturer (Instrumentation Industries, Inc., located in Bethel Park, PA).
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. This device is a mechanical MDI adapter, and the evaluation is based on engineering performance metrics (flow rate, back pressure), not expert interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML or diagnostic device requiring expert adjudication.
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 is not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or reference standard) in this context would be the measured physical properties: peak circuit back pressure and flow rate, as determined by laboratory instruments under controlled conditions. This is an objective measurement rather than a subjective interpretation.
8. The sample size for the training set
- Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for a mechanical device.
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(229 days)
INSTRUMENTATION INDUSTRIES, INC.
The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-V MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
The Instrumentation Industries, Inc. RTC 24-V metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 24-V metered dose inhaler adapter kit is comprised of the Instrumentation Industries, Inc. components normally used by respiratory therapists to integrate our existing actuators into a ventilator circuit. The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm ID tubing and one 15mm ID/22mm OD adapter.
The provided text describes a 510(k) summary for a medical device called the "RTC 24-V MDI Adapter and RTC 24-V MDI Adapter Kit." This summary details the device's characteristics, intended use, and a comparison to a predicate device (RTC 22-D). It also includes information about aerosol performance testing.
Here's an analysis of the acceptance criteria and the study based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as strict pass/fail thresholds with numerical values in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RTC 22-D) in terms of aerosol performance. The reported device performance is a comparison of the new device (RTC 24-V) to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (RTC 24-V vs. RTC 22-D) |
|---|---|
| Aerosol Performance Equivalence to Predicate Device | |
| Particle Size (MMAD) | Actual differences were not statistically significant. |
| Geometric Standard Deviation (GSD) | Actual differences were not statistically significant. |
| Medication Captured on USP Throat | Actual differences were not statistically significant. |
| Superiority in Specific Aerosol Performance Metrics (Optional but shown) | |
| Total Dose Delivered | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Respirable Fraction | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Total Respirable Dose Delivered | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
| Medication Retained in Device | Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D. |
Study Proving Acceptance Criteria:
The study described is a laboratory performance test comparing the new RTC 24-V MDI adapter to its predicate device, the RTC 22-D.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or number of tests. The text mentions testing with "the following MDI medications: Ventolin® HFA, Atrovent® HFA, QVAR®." It implies a set of tests were performed for each medication type, comparing the RTC 24-V and RTC 22-D.
- Data Provenance: The study was conducted "in the laboratory." There is no information about the country of origin or whether it was retrospective or prospective. Given it's a lab performance test of physical devices, it's inherently prospective in nature for the performance data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this study. The study focuses on objective, measurable physical parameters (aerosol performance) of the device, not a subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies. The "ground truth" here is the measured physical performance.
4. Adjudication Method for the Test Set
This is not applicable as there is no subjective assessment being made that would require adjudication.
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 is not applicable. This is a device performance study, not an AI or diagnostic imaging study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical device performance study, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is objective physical measurements of aerosol performance parameters. These measurements are assumed to be accurate representations of the device's output under controlled laboratory conditions.
8. The Sample Size for the Training Set
This is not applicable. This is a device performance study, not a machine learning study that would typically involve a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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(81 days)
INSTRUMENTATION INDUSTRIES, INC.
The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. These devices are intended to be used by or on the order of a physician.
During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall. These devices are intended to be used by or on the order of a physician.
The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm. H20, dependent upon the specific model used.
The provided text is a 510(k) summary for the NS Series Airway Pressure Monitors, which are physical devices. This document does NOT contain information about an AI/ML powered medical device, therefore, the requested information in the prompt is not applicable.
Here's why and what information is available:
- Device Type: The document describes "NS Series Airway Pressure Monitors" and "NS Series Cuff Pressure Monitors," which are explicitly stated to be "analog-faced manometers used to measure low pressures within a patient breathing circuit." This indicates a mechanical or electronic pressure gauge, not an AI/ML software device.
- No AI/ML Specifics: The text does not mention any algorithms, software, training data, test sets, ground truth, expert adjudication, or any other element typically associated with AI/ML device studies.
- Focus of the Document: The document focuses on demonstrating substantial equivalence to predicate devices (BE 148 and Anesthesia Associates, Inc. Model # 00-199) based on similarities in function, performance, and intended use, as well as differences in capacity/pressure ranges. This is a standard 510(k) pathway for traditional medical devices.
Therefore, I cannot provide the requested information, as it pertains to AI/ML device studies that are not described in this document.
The document does provide:
- Device Description: The NS Airway Pressure Gauges are intended to measure airway pressures of up to 30, 60 or 120 cm H2O.
- Intended Use: To monitor patient airway pressure during ventilation within a breathing circuit, or to periodically monitor endotracheal or tracheostomy tube balloon pressure.
- Predicate Devices: Instrumentation Industries, Inc. - BE 148 - Preamendment device; Anesthesia Associates, Inc. Model # 00-199 - Preamendment device; and Smith Portex Cuff Pressure Indicator (for the cuff pressure monitors).
- Technological Characteristics: Similarities and differences in function, performance, usage, and pressure range compared to predicate devices.
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(86 days)
INSTRUMENTATION INDUSTRIES, INC.
The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.
The NS Series NIF Meters are intended to measure inspiratory airway pressures of up to 30, 60 or 120 cm H2O , dependent upon the specific model used.
This document is a 510(k) summary for the NS Series NIF (Negative Inspiratory Force) Meters, which are inspiratory airway pressure meters. It does not contain information about a study that proves the device meets specific acceptance criteria in the way described in the prompt.
The document focuses on demonstrating substantial equivalence to predicate devices (Instrumentation Industries, Inc. - BE 149 and Smiths Medical - NIF Kit) based on similar technological characteristics and intended use. The "acceptance criteria" discussed are implicit in the comparison of the new device's function, anticipated usage, and operation to the predicate devices.
Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not present in this 510(k) summary. I can only provide the information that is explicitly or implicitly present.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported device performance metrics in the sense of a clinical or performance study. Instead, the acceptance criteria are implied by the "Technological Characteristics" section, which highlights similarities and differences with predicate devices.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported NS Series NIF Meters Performance (from "Device Description" / "Technological Characteristics") |
|---|---|
| Functionality: To measure inspiratory pressure. (Similar to predicate devices) | Functionality: "NS Series NIF Meters are intended to measure inspiratory airway pressures..." and "The function of the NS Series NIF Meters... are the same. All are analog-faced manometers used to measure inspiratory pressure." |
| Anticipated Usage: Similar to predicate devices, including a memory indicator pointer (MIP) for maximum pressure. | Anticipated Usage: "The anticipated usage of all of the devices is the same. All versions of the NS NIF meters... include a memory indicator pointer (MIP) that records the maximum pressure reached during inspiration. The pointer can be re-set and the exercise repeated." |
| Operation: Analog manometer with a diaphragm that activates pressure and MIP via a spring when exposed to inhaled breath. (Technologically the same) | Operation: "The operation of the NIF meters is technologically the same: All have a diaphragm which, when exposed to a patient's inhaled breath, activates the pressure and MIP via a spring." |
| Measurement Range: Compatible with clinical needs for NIF measurement. | Measurement Range: The NS Series offers three pressure ranges: 0-30, 0-60, 0-120 cm H2O. (This is a difference from predicates which typically have 0-60 cm H2O, but is presented as an enhancement rather than a failure to meet criteria). The specific models are for "up to 30, 60 or 120 cm H2O." |
| Attachment Points: Provide suitable means for patient connection. | Attachment Points: The III NIF meters have three: ¼” NPT bottom fitting, ¼” NPT rear fitting, and a small-bore tubing fitting. (This is a difference from Smiths Medical NIF meter which has one type, but is presented as an enhancement). |
| Sold as: Device sold alone. (Different from Smiths Medical NIF kit) | Sold as: The NS Series NIF meters are sold alone; adapters and tubing are not included. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary does not describe a test set, sample size, or data provenance from a specific study to evaluate the device's performance against detailed acceptance criteria.
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 information is not provided in the document. No test set or ground truth establishment process by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method for a test set 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
This information is not applicable / not provided. This device is a manual inspiratory airway pressure meter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable / not provided. This device is a manual, analog medical instrument. It does not involve algorithms or AI, so "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. No specific ground truth methodology is described, as the submission focuses on substantial equivalence to existing predicate devices based on design and intended use, rather than a clinical performance study with an established ground truth.
8. The sample size for the training set
This information is not provided in the document. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided in the document. No ground truth for a training set is mentioned.
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(283 days)
INSTRUMENTATION INDUSTRIES, INC.
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.
The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a Metered Dose Inhaler Adapter (K991355). It does not contain information about acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information. This document is a regulatory clearance letter, not a study report or technical specification.
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(88 days)
INSTRUMENTATION INDUSTRIES, INC.
The SG 066 and SG 067 Oxygen Enrichment Kits are designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
Oxygen Enrichment Kit
I apologize, but this document is a 510(k) clearance letter from the FDA for an "Oxygen Enrichment Kit" and does not contain the information requested in your prompt.
Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Information on sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- Details about the type or establishment of ground truth for a test or training set.
- Sample size for a training set.
This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical and clinical study data you are asking for.
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