(233 days)
Coventry ™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Coventry ™ controls pain associated with injections (venipuncture, IV starts, cosmetic procedures (such as lancing boils, incisions, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Coventy ™ Medium Stream Spray is also intended for use the management of myofascial pain, restricted motion and muscle tension.
Coventry™ Topical Anesthetic Spray HAZMAT FREE (subject device) is a non prescription device designed to deliver a standard mixture (1,1,1,3,3-245fa Pentafluoropane) and 134a (1.1.1.2-Tetrafluoroethane). which is being offered in two delivery configurations, Mist Spray Model No. 700-453 and Medium Stream Spray Model Number 700-454 This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the Coventry "" mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Medium Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.
The document provided is a 510(k) Premarket Notification from the FDA for a medical device called "Coventry Topical Anesthetic Mist/Stream Spray HAZMAT FREE". This notification is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the document primarily focuses on comparing the subject device to its predicate, rather than providing a detailed study of the subject device against specific acceptance criteria for a novel device.
However, based on the provided text, I can extract information related to the demonstration of substantial equivalence, which serves as the "study" in this context.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics. Instead, "performance" is demonstrated through the similarity to the predicate device. The acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device, demonstrated by having similar technological characteristics, indications for use, and a similar safety and effectiveness profile.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as demonstrated through comparison to predicate) |
|---|---|
| Indications for Use: Similar to the predicate device. | Coventry™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for identical uses: topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips), and minor open wounds; controls pain associated with injections, minor surgical procedures, temporary relief of minor sports injuries. Medium Stream Spray also for myofascial pain, restricted motion, and muscle tension. (Identical to predicate) |
| Technological Characteristics: No technological differences (materials, design, energy source, other features). | Product Design: Pressurized dispensing container, including vapocoolant, canister, valve, actuator, and cap. (Identical to predicate) |
| Vapocoolant Composition: 1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and 1,1,1,2-Tetrafluoroethane (HFC-134a) 5%. (Identical to predicate) | |
| Energy Delivered: Thermal Energy via Refrigerant Spray. (Identical to predicate) | |
| Vapocoolant Discharge Method: Depress Actuator Button to release vapocoolant. (Identical to predicate) | |
| Environmental Compatibility: Non-Flammable. (Identical to predicate) | |
| Mechanical Safety: Mechanism has positive shut-off release. (Identical to predicate) | |
| Structural and Parts Composition: Engineering verification measurements and visual inspections confirmed canisters, valves, and caps were substantially equivalent. | |
| Chemical Composition: Identical chemical composition by type and percent of components as the predicate. | Both systems use identical aerosol profiles: 245fa (1,1,1,3,3-Pentafluoropropane) at 95% and 134a (1,1,1,2-Tetrafluoroethane) at 5%. The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate. (Identical to predicate) |
| Biocompatibility: Device biocompatibility is supported. | Evidence supporting the biocompatibility of the device was included in the submission. |
| Directions for Use (DFU): Key elements (indications, precautions, warnings, contraindications, treatment regimen) are substantially equivalent to the predicate device. | All key elements of the DFU for the predicate and subject device are substantially equivalent. No substantial differences exist. (Substantially equivalent to predicate) |
| Stability and Shelf Life: Product identity, strength, quality, and purity maintained throughout labeled dating period, meeting established acceptance criteria under controlled conditions. | A stability protocol was developed. Testing assessments under controlled conditions (room temperature and accelerated) confirmed all requirements met established acceptance criteria. |
| Safety and Effectiveness Profile: Similar, if not identical, to the predicate device. | Based on conducted testing performance, the Coventry™ device was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease. (Similar/Identical to predicate) |
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 does not specify a "test set" in the traditional sense of a clinical trial with human subjects. The evidence for substantial equivalence primarily relies on comparative technical testing and verification of manufacturing parameters against the predicate device. Therefore, explicit sample sizes for a patient test set are not provided because a clinical study of that nature was not required for this 510(k) submission.
- Data Provenance: The tests mentioned (Chemical Composition Confirmation, Structural and Parts Composition, Stability Protocol and Shelf Life Testing) were performed by the manufacturer, ITW Contamination Control Electronics. The location is Marietta, GA 30152, USA. The nature of these tests suggests they are prospective for the subject device.
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 510(k) submission. The ground truth for this submission is the established safety and effectiveness of the predicate device, and the technical performance and composition of the subject device aligning with that. There's no mention of expert review of a "test set" in the context of clinical outcomes to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical "test set" requiring adjudication of outcomes is not described in the document for this 510(k) clearance.
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 topical anesthetic spray, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (anesthetic spray), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, Gebauer's Pain Ease. The subject device is deemed substantially equivalent because its technical characteristics, formulation, indications for use, and manufacturing controls are identical or sufficiently similar such that it performs in the same way and raises no new safety or effectiveness concerns.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning. The "training" in manufacturing would involve process validation, which is implicitly covered by quality systems and the stability protocol.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning for this device.
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