(114 days)
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, mucous membranes and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Gebauer's Pain Ease (Mist and Medium Spray) Topical Anesthetic Skin Refrigerant is a prescription device designed to deliver HFC 245fa high purity (1,1,1,3,3-Pentafluoropropane) and HFC 134a pharmaceutical grade (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system. which is designed to account for its low vapor pressure. The device delivery system is specifically designed to deliver a medium and mist spray of the Gebauer's Pain Ease (Mist Spray and Stream Spray) mixture. The medium and mist spray is an appropriate mode of application when users follow directions for use, cooling the skin through rapid evaporation of the non-medicated volatile propellants. The new device, Gebauer's Pain Ease, is identical in all aspects to the predicate device, Gebauer's Pain Ease (Mist Spray and Medium Spray) 510(k) K032671, except that the product can be applied to the skin for pre-injection anesthesia by cotton swab or gauze on intact skin. (If the skin is breached use this application method only with STERILE, disposable cotton balls, cotton swabs or gauze. The cotton balls, cotton swabs or gauze are not supplied with the device.)
The provided document is a 510(k) premarket notification for a medical device called "Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)." The purpose of the submission is to expand the approved application methods for the device. The document claims substantial equivalence to a previously cleared predicate device (K032671).
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for performance metrics. Instead, it aims to demonstrate substantial equivalence to a predicate device. The performance is assessed by comparing key characteristics of the subject device (Gebauer's Pain Ease with expanded application methods) to the predicate device (Gebauer's Pain Ease, K032671).
The core "performance" reported is related to temperature and output, specifically that the subject device's profile is "similar" to the predicate.
| Acceptance Criterion (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Formulation: Identical to predicate device | Identical to predicate device (HFC 245fa high purity, HFC 134a pharmaceutical grade) |
| Delivery System: Identical to predicate device | Identical to predicate device (Pressurized dispensing container, aerosol can, valve, actuator, standard aerosol nozzle technology) |
| Packaging: Identical to predicate device | Identical to predicate device |
| Intended Use: Same as predicate device except for expanded application method | Same as predicate device (topical application to skin, mucous membranes, minor open wounds; controls pain for minor surgical procedures, injections, minor sports injuries; Medium Spray for myofascial pain) |
| Product Fill Volume: Same as predicate device | 3.5 oz. (103.5 mL) - Same as predicate |
| Vapocoolant Composition: Same as predicate device | 1,1,1,3,3 Pentafluoropropane (HFC 245fa high purity) and 1,1,1,2 Tetrafluoroethane (HFC 134a pharmaceutical grade) - Same as predicate |
| Energy Delivered: Same as predicate device | Thermal energy via Refrigerant Spray - Same as predicate |
| Vapocoolant Discharge Method: Same as predicate device | Depress the actuator to release the vapocoolant - Same as predicate |
| Environmental Compatibility: Non-Flammable | Non-Flammable - Same as predicate |
| Mechanical Safety: Positive shut-off release | Positive shut-off release - Same as predicate |
| Manufacturing Environment: Controlled Environment | Controlled Environment - Same as predicate |
| Microbial Limits Testing: In accordance with USP and | In accordance with USP and - Same as predicate |
| Biocompatibility Testing: In accordance with ISO 10993 for dermal irritation, sensitization, cytotoxicity, oral mucosal irritation, acute dermal toxicity | In accordance with ISO 10993 for dermal irritation, sensitization, cytotoxicity, oral mucosal irritation, acute dermal toxicity - Same as predicate |
| Boiling Point: 44.6°F (7.0°C) | 44.6°F (7.0°C) - Same as predicate |
| Storage Temperature: Do not store above 50°C (120°F) | Do not store above 50°C (120°F) - Same as predicate |
| Shelf Life: 3 years | 3 years - Same as predicate |
| Temperature & Output Profile: Similar when applied via expanded method (cotton ball/swab/gauze) compared to direct spray of predicate | "safety and effectiveness profile that is similar to the predicate device" based on "temperature data generated" and output of the device |
2. Sample size used for the test set and the data provenance
The document states: "Comparative testing was conducted to demonstrate equivalence between direct topical application via spraying and topical application using cotton ball, cotton swab or gauze." It refers to this as "Side-by-Side Temperature & Output Bench Testing."
- Sample Size: The document does not specify the sample size for this bench testing. It simply states "tests were selected and performed."
- Data Provenance: The data is from bench testing, meaning it was conducted in a controlled laboratory environment to compare the physical characteristics of the devices. No information is provided regarding the country of origin, nor whether it was retrospective or prospective in the clinical sense, as it was a bench study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a bench test comparison of physical parameters (temperature and output), not a clinical study involving human assessment or expert judgment to establish a "ground truth" for a medical condition.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. There was no "ground truth" adjudicated by experts for a clinical outcome.
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
There was no MRMC comparative effectiveness study done. This is a 510(k) submission for a topical anesthetic, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (vapocoolant spray), not an algorithm or AI system.
7. The type of ground truth used
As this was a bench test comparing physical characteristics, the "ground truth" was essentially instrumental measurements of temperature and output. There was no expert consensus, pathology, or outcomes data used to establish a ground truth for a disease or condition.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
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