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510(k) Data Aggregation
(106 days)
Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102
Pain Freeze™ Mist Spray and Medium Stray 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. Pain Freeze™ 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). Pain Freeze™ Medium Stream Spray is also intended for the management of myofascial pain, restricted motion and muscle tension.
Nuance Medical's Pain Freeze™ (subject device) is a prescription device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 2102) and Medium Stream Spray (Model No. 2101). 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 Pain Freeze™ 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 provided text describes a 510(k) premarket notification for a medical device called "Pain Freeze™," a vapocoolant. The document focuses on demonstrating that the subject device is substantially equivalent to a legally marketed predicate device, "Gebauer's Pain Ease."
Here's a breakdown of the acceptance criteria and the study (or, rather, the testing performed to demonstrate substantial equivalence) according to the provided text:
Key Takeaway: This submission is for a vapocoolant (skin refrigerant) and the entire premise of the "study" is to prove substantial equivalence to a predicate device, not to prove clinical efficacy of a novel AI-powered diagnostic/treatment device. Therefore, many of the typical acceptance criteria and study design elements you might expect for an AI/ML device (e.g., AUC, sensitivity/specificity, expert consensus for ground truth, MRMC studies) are not applicable here. The "proof" is based on the devices being nearly identical in composition and performance parameters.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a vapocoolant asserting substantial equivalence), the "acceptance criteria" are based on matching the predicate device's characteristics and performance, rather than achieving specific clinical efficacy metrics.
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (Pain Freeze™) |
|---|---|
| Chemical Composition: Identical to predicate (95% 245fa, 5% 134a) | Confirmed: "Both systems use identical aerosols profiles: 245fa (1,1,3,3-Pentafluoropropane) at 95% of the total and 134a (1,1,1,2-Tetrafluoroethane) at 5% of the total mixture. The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate." |
| Structural & Parts Composition: Substantially equivalent canisters, valves, caps | Confirmed: "Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were substantially equivalent between the predicate and the subject device." |
| Directions for Use (DFU): Substantially equivalent indications, precautions, warnings | Confirmed: "All key elements of the Directions for Use (DFU) for the predicate device and the subject device are all substantially equivalent including indication for use, intended use, precaution statements, warning statements, and contraindication statements, and treatment regiment. No substantial differences exist between the predicate and subject device's Directions for Use." |
| Temperature & Output Performance: Comparable to predicate in bench testing | Confirmed: "Comparative performance testing was conducted to determine the temperature and output of the predicate and subject devices." (Implied to be comparable; the summary states overall safety and effectiveness profile is similar/identical). |
| Stability & Shelf Life: Maintain identity, strength, quality, purity over dating period | Confirmed: "A stability protocol was developed to ensure that the identity, strength, quality, and purity of the product is maintained throughout its labeled dating period. Testing assessments were conducted under controlled conditions at room temperature and under accelerated conditions. All requirements were confirmed to meet established acceptance criteria." (Specific numerical criteria not provided, but confirmed to be met.) |
| Overall Safety and Effectiveness Profile: Similar/identical to predicate | Concluded: "Based on the testing performance conducted the subject device, Pain Freeze™, was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease." |
| Labeling: Substantially equivalent to predicate | Concluded: "Also, the labeling is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the conventional sense of a clinical or image-based study. The "tests" performed are primarily bench testing and material/composition analyses comparing the subject device directly to the predicate device.
- Sample Size: Not explicitly stated numerically for each test. For chemical composition, it refers to "the subject device's aerosol" being checked, implying multiple samples would be tested to confirm consistency. For structural composition, "measurements were taken and visual inspections were made," again, not indicating a specific n. For temperature and output bench testing, it states "comparative performance testing was conducted," implying multiple measurements for both devices.
- Data Provenance: The data originates from bench testing and material analysis of the manufactured subject device and the predicate device. This is not patient-derived data; it's product performance data. There's no mention of country of origin of data in this context. It's a retrospective comparison to the established predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable. For this type of device (a vapocoolant asserting substantial equivalence), there is no "ground truth" established by human experts in a clinical interpretation sense. The ground truth for chemical composition is determined by analytical instruments. The ground truth for physical characteristics is determined by engineering measurements and visual inspection. The "truth" of comparability is established by the direct measurements against the known characteristics of the predicate device.
4. Adjudication Method for the Test Set
This section is not applicable. Since there are no human interpretations or classifications that require adjudication for a diagnostic or AI algorithm, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how human performance is altered by an AI assistant. The Pain Freeze™ device is a topical vapocoolant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
This section is not applicable. There is no algorithm or AI component to the Pain Freeze™ device. It is a physical medical device (a spray vapocoolant).
7. Type of Ground Truth Used
The "ground truth" in this context refers to the established physical and chemical characteristics and performance profiles of the legally marketed predicate device, Gebauer's Pain Ease.
- Chemical Composition: Verified by analytical testing of the chemical mixture.
- Physical/Structural Design: Verified by engineering measurements and visual inspection.
- Performance (Temperature & Output): Verified by direct bench testing measurements.
- Stability: Verified by controlled environmental testing over time.
- Labeling and Indications: Verified by direct comparison of text and statements.
8. Sample Size for the Training Set
This section is not applicable. There is no AI or machine learning algorithm in the Pain Freeze™ device, and therefore no training set. The device is a "reverse-engineering of its predicate," meaning its design and composition are based directly on the predicate, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for an AI/ML algorithm.
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