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510(k) Data Aggregation
(189 days)
RESPIRONICS NEW JERSEY, INC.
The OptiChamber Diamond Valved Holding Chamber device is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers. The intended environments for use include the home, hospitals and clinics.
For Single Patient Use .
Recommended Patient Population:
OptiChamber Diamond: Age 5 and up
OptiChamber Diamond with Small LiteTouch mask: 0 to 18 months
OptiChamber Diamond with Medium LiteTouch mask: 1 to 5 years
OptiChamber Diamond with Large LiteTouch mask: 5 years +
The OptiChamber Diamond Valved Holding Chamber (VHC) is a Class II device. It is intended to be used in combination with most pressurized Metered Dose Inhalers (pMDIs) to assist in respiratory drug delivery.
The OptiChamber Diamond Valved Holding Chamber is a device utilizing the same operating principles as the AeroChamber Plus Z-Stat Valved Holding Chamber (K052332). Both the AeroChamber Plus Z-Stat and the OptiChamber Diamond are available with and without mask.
The valved holding chamber (VHC) is designed to assist patients who cannot correctly coordinate actuation of the pressurized metered dose inhaler (pMDIs) with inhalation. The VHC works by 'holding' the aerosol cloud emitted from the pMDI inside the chamber so that the larger aerosol particles are removed from the aerosol cloud by impaction into the chamber walls and sedimentation under the influence of gravity.
The OptiChamber Diamond Valved Holding Chamber is made of antistatic plastic materials alleviating any need to wash prior to first use. OptiChamber Diamond is comprised of: the mouthpiece, the chamber, the adapter (end cap) with inhalation flow alert, the exhaust valve, the inhalation valve, the valve retaining ring, and the cap.
The provided text describes testing conducted for the OptiChamber Diamond Valved Holding Chamber, a device intended to assist in respiratory drug delivery with pressurized Metered Dose Inhalers (pMDIs).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to the predicate device AeroChamber Plus Z-Stat Valved Holding Chamber (K052332) based on in vitro testing. The acceptance criteria are implicitly that the OptiChamber Diamond's performance (MMAD, GSD, FPD, FPF) should be comparable to or within acceptable limits relative to a pMDI alone and presumably similar to the predicate device, although direct comparative values for the predicate are not specified in this summary.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Fine Particle Dose (FPD) | Determined for categories: >4.7um, ≤4.7um, and ≤1.0um. Specific values for the OptiChamber Diamond with pMDI were measured and used to demonstrate performance. |
| Fine Particle Fraction (FPF) | Fraction of dose entering impactor ≤ 4.7um. Specific values were measured and used to demonstrate performance. |
| Mass Medium Aerodynamic Diameter (MMAD) | Geometric mean aerodynamic diameter. Specific values were measured and used to demonstrate performance. |
| Geometric Standard Deviation (GSD) | Measure of dispersion in lognormal distribution. Specific values were measured and used to demonstrate performance. |
| Comparison to pMDI Alone | Performance with OptiChamber Diamond VHC was compared to a pMDI alone. |
| Drug Formulations | Evaluated with albuterol, fluticasone propionate, and ipratropium bromide. |
| Simulated Breathing Patterns | Tested at 15 LPM (pediatric) and 30 LPM (adult). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The pMDI was actuated 10 times into each device (OptiChamber Diamond VHC and pMDI alone) for each test. With three drug formulations and two flow rates, this implies a total of 60 actuations for the OptiChamber Diamond (10 actuations * 3 formulations * 2 flow rates) and another 60 for the pMDI alone.
- Data Provenance: The study was an in vitro test, meaning it was conducted in a lab setting, not on human or animal subjects. Details on the country of origin are not explicitly stated, but the submitter is "Respironics New Jersey, Inc." in Parsippany, New Jersey, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of in vitro performance testing. The "ground truth" is established through standardized laboratory measurements and analytical techniques (HPLC assays, NGI analysis).
4. Adjudication Method for the Test Set
Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert adjudication of patient outcomes or imaging.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This was an in vitro performance study of a physical device, not an AI or diagnostic imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone in vitro performance study was done. The device's performance was evaluated independently without human interaction influencing the drug delivery mechanics during the measurement.
7. The Type of Ground Truth Used
The "ground truth" for this in vitro study was based on analytical measurements and established standards for aerosol drug delivery. This includes:
- HPLC assays: Quantifying drug deposition in various parts of the Next Generation Impactor (NGI).
- Next Generation Impactor (NGI): A standardized instrument used to measure the aerodynamic particle size distribution of aerosols, which forms the basis for MMAD, GSD, FPD, and FPF calculations.
- CITDAS software: Used for the calculation and analysis of aerosol performance parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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(148 days)
RESPIRONICS NEW JERSEY, INC.
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
The LiteTouch mask is a Class II device. It is a mask for use with Respironics' OptiChamber Valved Holding Chamber (K962822). The LiteTouch mask is a mask that utilizes the same operating principles as the AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972). The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different positions and is not of the same shape. The LiteTouch mask comprises of a Flap Valve and a Cushion plate.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it frames the evaluation as a comparison to a predicate device to demonstrate "substantial equivalence." The performance is reported in terms of Fine Particle Dose and Leak Test results.
| Study Type | Unstated Acceptance Criteria (Implied) | Reported LiteTouch Mask Performance (with OptiChamber) | Predicate Device (AeroChamber Max) Performance (or baseline) |
|---|---|---|---|
| Fine Particle Dose (0.4-4.7 µg) | Maintain comparable Fine Particle Dose to predicate device, ensuring effective drug delivery. | Ventolin: 21.1 µg | |
| Flovent: 18.5 µg | |||
| Atrovent: 3.7 µg | Ventolin: 29.5 µg | ||
| Flovent: 27.1 µg | |||
| Atrovent: 5.4 µg | |||
| Fine Particle Dose Percentage (Drug mass recovered) | Maintain a high percentage of drug mass recovered compared to the chamber without the mask. (No explicit threshold, but values in the 70% range are considered acceptable to support substantial equivalence) | Ventolin: 71.5% | |
| Flovent: 68.3% | |||
| Atrovent: 68.5% | (OptiChamber without LiteTouch is the baseline for this percentage) | ||
| Leak Test Results (with Tilt Angles and Applied Force) | Achieve comparable or superior seal effectiveness (lower leaks) to other facemasks, including the predicate device, under various conditions (tilt angles and applied force). (Implicitly, the lower the leak percentage, the better the seal.) | See Table below for specific angles and forces. (The LiteTouch mask generally shows comparable or lower leak percentages compared to other masks at various conditions, indicating an effective seal.) | See Table below for specific angles and forces of predicate and other masks. |
Detailed Leak Test Results (approximated from the image, as text parsing was difficult)
| Device | 0°/0.4lb | 0°/1lb | 10°/0.4lb | 10°/1lb | 5°/0.4lb | 5°/1lb |
|---|---|---|---|---|---|---|
| LiteTouch | 13.8% | 6.1% | 79.6% | 7.7% | 75.7% | 7.9% |
| AeroChamber Plus | 14.2% | 2.8% | 89.5% | 7.6% | 74.2% | 6.5% |
| OptiChamber | 49.8% | 7.7% | 66.8% | 4.8% | 67.8% | 6.1% |
| AeroChamber Max | 4.4% | 7.3% | 93.3% | 7.7% | 73.6% | 8.4% |
| PocketChamber | 0.8% | 9.9% | 97.0% | 9.8% | 97.0% | 7.1% |
Note: The leak test results in the provided text are difficult to parse accurately due to formatting issues and seemingly non-English characters. The table above is an interpretation based on the discernible numbers and column headers. The document's conclusion states that the LiteTouch mask demonstrates substantial equivalence in terms of seal, dead space volume, and resistance to inhalation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for either the Fine Particle Dose or the Leak Test. The tables present aggregated results (e.g., average values) rather than individual sample measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing would be considered retrospective as it was conducted to support the 510(k) submission for an already developed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical device accessory (mask) for drug delivery. The "ground truth" is established through engineering and performance testing (Fine Particle Dose, Leak Tests) against measurable physical parameters and comparison with predicate devices, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an objective performance study rather than an evaluation requiring human adjudication (like in a diagnostic image study).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being evaluated. The LiteTouch mask is a physical accessory for drug delivery, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted (Fine Particle Dose and Leak Tests) represent "standalone" performance in the context of device function. The device's physical properties and interaction with the OptiChamber were tested without direct human interaction as part of the primary measurement, other than technicians operating the testing equipment. The goal was to assess the mask's functional efficacy and integrity.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on measurable physical performance characteristics and comparison to established predicate devices.
- Fine Particle Dose: Measured efficacy of drug delivery, quantified in micrograms (µg) and percentages. This is an objective, quantitative measure.
- Leak Test Results: Measured seal effectiveness under controlled conditions (tilt angles, applied force), quantified as a percentage of leak. This is also an objective, quantitative measure.
- The overall "ground truth" for submission is demonstrating substantial equivalence to an already marketed predicate device based on these engineering and performance tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device accessory, not an AI or machine learning algorithm that requires a "training set." The design and manufacturing processes are validated, but there isn't a data-driven training phase in the context of artificial intelligence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(15 days)
RESPIRONICS NEW JERSEY, INC.
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.
OptiChamber Advantage Anti-Static (OCAS) is a Class II device. It is a valved holding chamber for use with metered dose inhalers (MDIs). The OCAS is a valved holding chamber utilizing the same operating principles as the OptiChamber (K962822) and the AeroChamber Z-Stat (K052322). The difference between the OCAS and the OptiChamber is that, like the AeroChamber Z-Stat, the OCAS is made of an anti-static plastic material. OptiChamber Advantage Anti-Static Valved Holding Chamber has a chamber and mouthpiece made of anti-static material. Non-anti-static valved holding chambers must be washed prior to use. The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device.
The provided text describes a 510(k) submission for a medical device and therefore does not contain information about acceptance criteria and a study proving a device meets those criteria in the typical sense of AI/algorithm performance. Instead, it details a comparison of a new physical device (OptiChamber Advantage Anti-Static Valved Holding Chamber - OCAS) to predicate devices to establish substantial equivalence.
Here's an interpretation based on the provided text, focusing on the device characteristics compared for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
For a physical medical device seeking 510(k) clearance, "acceptance criteria" are typically defined by the FDA's guidance documents and the characteristics of the predicate device. The "reported device performance" refers to how the new device compares to the predicate device against these characteristics.
| Acceptance Criteria (based on predicate device performance) | Reported Device Performance (OptiChamber Advantage Anti-Static) |
|---|---|
| Aerosol Characteristics: | |
| - Particle size distribution (Mass Median Aerodynamic Diameter - MMAD) allowing respirable particles to lungs and retaining larger non-respirable particles. | "Testing documentation shows that the aerosol characteristics of the OCAS and the AeroChamber Z-Stat are substantially equivalent." |
| - Delivers a therapeutically beneficial amount of drug to the lungs. | (Implied by substantial equivalence in aerosol characteristics and operating principle) |
| - Minimal drug deposition in the oropharynx. | (Implied by substantial equivalence in aerosol characteristics and operating principle) |
| Operating Principles: | "The three devices are also substantially equivalent in terms of their operating principle and indications for use." |
| Intended Use: | "The subject (OCAS) and predicate devices (OptiChamber, K962822 and AeroChamber Z-Stat, K052322) are indicated for the same intended use." |
| Anti-static property: | "The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device." "The performance of the OCAS before and after washing are also substantially equivalent." |
| Material Composition: | Chamber and mouthpiece made of anti-static material (similar to AeroChamber Z-Stat predicate). |
| Portability and Lightweight: | "Both devices are portable and lightweight." (Referring to OCAS and AeroChamber Z-Stat) |
| Safety and Effectiveness: | "We have demonstrated that the OptiChamber Advantage Anti-Static Valved Holding Chamber is as safe and effective as a predicate device..." |
2. Sample size used for the test set and the data provenance
The text mentions "testing documentation" for aerosol characteristics but does not specify the sample sizes (e.g., number of devices tested, number of inhalations performed).
Data provenance is not explicitly stated. The testing was performed in the context of a 510(k) submission by Respironics New Jersey, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a technical performance comparison of physical devices, not an AI/algorithm study involving expert review for ground truth.
4. Adjudication method for the test set
Not applicable. This is a technical performance comparison of physical devices, not an AI/algorithm study 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
No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This relates to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the performance characteristics of the predicate devices, specifically the AeroChamber Z-Stat, which is considered legally marketed and effective. The new device's performance (e.g., particle size distribution) is compared to this established benchmark.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical device comparison, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
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(34 days)
RESPIRONICS NEW JERSEY, INC.
MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.
This AC (adaptor with DC converter) or battery-pack powered nebulizer is housed in a plastic case. Dimensions are 4.96"(II) x 2.80° (V) x 1.46"(I) x 1.46"(I) and weighs 4 ounces. It consists of a piezoelectric element driven by a microprocessor with dedicated software. The batteries are rechargeable via an AC power supply (100-240 VAC, 50-60 Hz). The external battery pack is made up of 2 lithium polymer cells.
The following is the method of acrosol generation:
Step 1: Ultrasonic energy is created and focused by a concave piezoelectric element, located within the generator, to a point at the base of the medication chamber that is located at the top of the generator.
Step 2: The focused ultrasonic energy forms a liquid fountain that is driven up through the guide tube inside the nebulizer head. Upon exiting the tube, the energized liquid fountain generates cavitation of acrosol particles and the liquid medication is converted into an aerosol.
Step 3: The forces associated with the fountain generate an air draft whereby air is drawn into the nebulizer head via the air vents. The aerosolized medicine is carried by this air draft, through the nebulizer's chimney and out through the nebulizer's mouthpiece opening.
Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.
Here's the analysis of the provided text regarding the MyNeb Nebulizer, Model RDD100:
Acceptance Criteria and Device Performance Study
Based on the provided 510(k) summary, the MyNeb Nebulizer's acceptance criteria and performance are established through demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. No clinical studies are mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Convert liquid medication into aerosol for inhalation by the patient. | The MyNeb nebulizer is designed and functions to convert liquid medication into aerosol for inhalation. It achieves this through a piezoelectric element creating ultrasonic energy, forming a liquid fountain, generating aerosol particles via cavitation, and an air draft for delivery. This functionality is considered "basically the same" as predicate devices. |
| Electrical Safety | Compliance with relevant electrical safety standards for medical devices. | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed but compliance is asserted. |
| Mechanical/Environmental | Durability, stability, and operational integrity under specified environmental conditions (e.g., temperature, humidity, shock, vibration). | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed. |
| Electromagnetic Compatibility (EMC) | No undue electromagnetic interference with other devices, and proper functioning in the presence of expected EMI. | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." It "meet[s] Environmental Safety and EMC requirements." Specific test results are not detailed. |
| Performance Characteristics | Similar compressor operating pressure and flow ranges to predicate devices; efficient aerosol generation. | The MyNeb's aerosol generation method (piezoelectric element) is explicitly compared to the MABISMist II, noting its use of a piezoelectric element for energy generation. The document states, "Performance characteristics are basically the same" as the predicate devices, implying comparable aerosol output and delivery efficiency. It's noted that all three units (MyNeb and predicates) are lightweight. Although specific pressure and flow ranges are mentioned for predicates, direct values for MyNeb are not provided, only a general "similar" comparison. |
| Design | Portability (lightweight), power options (AC/battery). | Dimensions: 4.96"(II) x 2.80"(V) x 1.46"(I); weighs 4 ounces. Powered by AC (adaptor with DC converter) or battery-pack (2 lithium polymer cells, rechargeable). Unit is described as "lightweight" and comparable to predicates. The housing is plastic. |
| Material Safety | Biocompatibility of materials in contact with medication/patient (not explicitly stated, but implied for medical devices). | Not explicitly discussed in the provided text. Usually addressed under general manufacturing practices and material specifications, which are not detailed in this summary. However, the mention of adhering to "FDA's DCRND 'Reviewer Guidance for Home Use Respiratory Devices'" would imply compliance with material safety for home use devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A) for human subjects. The testing was non-clinical, focusing on the device itself.
- Data Provenance: N/A. The data originates from internal device testing (electrical, mechanical, environmental, EMC) performed by the manufacturer or a contracted lab to conform to FDA guidance. No patient-derived data is involved.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not relevant here as no clinical studies were performed.
- Qualifications of Experts: Not applicable. The "ground truth" for the non-clinical tests was established by adhering to recognized testing standards and FDA guidance documents, which are assessed by engineers and regulatory specialists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no human interpretation or decision-making on test "cases" that would require adjudication. Device performance against technical specifications and regulatory guidance was assessed directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as "Not Applicable" for this 510(k) submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Standalone Performance: While the device operates automatically (non-human-in-the-loop) once initiated, the term "standalone" usually refers to AI/algorithm performance. This device is a nebulizer, a mechanical medical device with embedded software for control, not an AI diagnostic algorithm. Its "standalone performance" refers to its efficacy in aerosol generation as described, which was assessed through non-clinical testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's safety and effectiveness relies on compliance with established engineering and safety standards, as well as FDA guidance documents. Specifically, "Reviewer Guidance for Premarket Notification Submissions (November 1993)" and "Reviewer Guidance for Home Use Respiratory Devices" served as the benchmarks for determining acceptable performance in electrical, mechanical, environmental, and EMC testing. The "truth" is whether the device meets these pre-defined, objective engineering metrics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of medical device.
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(15 days)
RESPIRONICS NEW JERSEY, INC.
This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.
This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.5" (L) x 7.49" (W) x 4.18" (H) and weighs 3.3 lbs. It consists of a motor-driven piston compressor and a switch; it contains no consists of a noter electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a Sidestream (510(k) cleared) nebulizer. The Inspiration Elite, Model HS456 is not be used without the nebulizer.
In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.
The provided text describes a medical device submission (510(k)) for a nebulizer compressor but does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for such a study.
The document is a summary of the 510(k) submission for the "Inspiration Elite Nebulizer Compressor with Nebulizer, Model HS456". It focuses on demonstrating substantial equivalence to a predicate device (InvaCare Envoy Jr., K# 992643) rather than proving performance against specific acceptance criteria through a clinical study.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: The document provides a "Functional Comparison Chart" (Section 8) comparing the subject device to the predicate device based on specifications like dimensions, weight, electrical requirements, average power consumption, and average flow rate. This chart does not present "acceptance criteria" in the sense of predefined thresholds for performance, but rather shows how the subject device's specifications align with those of the predicate.
- Study That Proves the Device Meets Acceptance Criteria: Section 9 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical study was performed to "prove the device meets acceptance criteria." Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence.
- Sample size for the test set and data provenance: No test set is described as no clinical study was performed.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no clinical study with a ground truth was performed.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance/equivalence:
-
A table of acceptance criteria and the reported device performance:
The document includes a "Functional Comparison Chart" which outlines specifications for the subject device and its predicate. While not framed as "acceptance criteria," these are the performance characteristics presented for comparison:FUNCTION INSPIRATION ELITE (Reported Performance) ENVOY JR. (Predicate Performance) Model HS456 1001RC Dimension 4.2" x 7.5" x 7.5" 4.1"x 7.0"x 7.0" Weight 3.3 lbs 3.5 lbs Electrical requirements 115VAC/60Hz 115VAC/60Hz Avg. Power consumption 89 -90 watts* 88 -89 watts* Avg. Flow Rate @ 10-15 psig 7.6 -6.8 Lpm* 7.6 -6.8 Lpm* Power Indication No No Intensity Control No No Intensity Indication No No Turn ON/OFF switch Yes (switch) Yes (switch) *Reference Exhibit #2 (Rietschle Thomas Compressor Comparison Data Table dated 8/10/04) -
Study that proves the device meets the acceptance criteria:
The submission explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." The basis for demonstrating safety and effectiveness and substantial equivalence is non-clinical testing: "electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'."
The remaining points about sample sizes, data provenance, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in the provided text because no clinical or AI performance study, as typically understood in those contexts, was conducted or reported. The device's approval hinges on its substantial equivalence to a legally marketed predicate based on non-clinical performance characteristics and adherence to relevant standards and guidance documents.
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