(390 days)
PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT
The Mercury Expiratory Resistance Exerciser, when placed in-line with an aerosol treatment, permits resistance breathing during aerosol treatment in a manner consistent with the Circulaire "Aerosol Drug Delivery System by Westmed.
The provided document is a 510(k) summary for the Mercury Expiratory Resistance Exerciser (RESISTEX) and does not contain detailed information about acceptance criteria or specific study results that would allow for a comprehensive breakdown as requested.
However, based on general understanding of 510(k) submissions, the “Table of Comparison” serves as the core of the submission, demonstrating substantial equivalence to a predicate device. This table effectively is the study, and the criteria for acceptance are met if the device is found to be "substantially equivalent."
Here's an attempt to structure the available information according to your request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the Mercury Expiratory Resistance Exerciser (RESISTEX) is that it is substantially equivalent to the predicate device, the Westmed Circulaire™ Aerosol Drug Delivery System, in terms of intended use, materials, mode of operation, and key functional components. The device performance is demonstrated by directly comparing its features and specifications to those of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k) submission, the "acceptance criteria" are the characteristics of the predicate device, and the "reported device performance" is the equivalent characteristics of the Mercury Expiratory Resistance Exerciser.
| Acceptance Criteria (Predicate: Westmed Circulaire™) | Reported Device Performance (Mercury Expiratory Resistance Exerciser) |
|---|---|
| INTENDED USE: PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT | PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT |
| MATERIALS: POLYPROPYLENE | STYRENE & LDPE |
| MODE OF OPERATION: ROTATING RESISTANCE ORIFICE WITH IN-LINE NEBULIZER | ROTATING RESISTANCE ORIFICE WITH IN-LINE NEBULIZER |
| ONE WAY VALVE: BETWEEN NEBULIZER AND EXHALATION RESISTOR | BETWEEN NEBULIZER AND EXHALATION RESISTOR |
| PROVIDES POSITIVE EXPIRATORY PRESSURE BENEFIT DURING TREATMENT: HAS VARIABLE RESISTANCE ADJUSTMENT | HAS VARIABLE RESISTANCE ADJUSTMENT |
| PATIENT CONNECTION: LDPE MOUTHPIECE | LDPE MOUTHPIECE |
| PACKAGING: SINGLE PACKED 25/BOX | SINGLE PACKED 20/BOX |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this comparison table. This is a descriptive comparison of device specifications, not a clinical trial or performance test on a sample of devices.
- Data Provenance: The data is presented by the manufacturer, Mercury Medical, as part of their 510(k) submission. It's a retrospective comparison based on existing device specifications rather than prospective data collection. The country of origin of the data is implicitly the USA, where both companies operate and the submission was made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. For 510(k) submissions of this nature, the "ground truth" (i.e., the specifications of the predicate device) is typically established by the manufacturer through their own design and testing documentation, along with publicly available information for the predicate device. It doesn't usually involve external experts establishing ground truth for the comparison itself.
- Qualifications of Experts: Not specified. The comparison table is likely compiled by the manufacturing and regulatory teams at Mercury Medical.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a direct feature-by-feature comparison rather than an interpretation study requiring adjudication. The FDA's review process itself serves as a form of "adjudication" on whether the presented comparison supports substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a therapeutic spirometer/exerciser, and the 510(k) process for such devices typically relies on demonstrating substantial equivalence through design and functional comparisons, and sometimes bench testing, rather than complex clinical effectiveness studies involving multiple readers. The document does not mention any human-in-the-loop performance evaluation for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical device (spirometer/exerciser), not an AI algorithm or software-only device. Its performance is inherent in its physical design and operation, which is compared to the predicate device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this comparison is the published and established specifications and intended use of the predicate device, the Westmed Circulaire™ Aerosol Drug Delivery System. It is essentially an "expert consensus" or "regulatory acceptance" of the predicate device's characteristics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no concept of a "training set" for this type of device submission. The device design and specifications are developed internally by Mercury Medical, and compared against the fixed characteristics of the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for this type of 510(k) submission.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).