(93 days)
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions)
The Syringe Holder accessory is intended to be attached to the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.
The Syringe Holder accessory (K201248) on the Nozzle of the Primary predicate Vapocoolshot Mist (K193349), allows the attachment of a user supplied syringe diameter 1cc (4.5mm) to 3 cc (10.8mm) for the practitioner to focus on the transient blanching effect for the best rapid, targeted, comfortable and efficient use of the gas Blend misting action onto the skin surface accordance with the best judgment of the physician under aseptic conditions. The Primary predicate Vapocoolshot Mist (K193349) is a vapocoolant (skin refrigerant) canister with standard gas Blend 245fa (1,1,3,3 Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane) that is designed to spray onto the skin surface for a comfort injection procedure. The vapocoolant cools the skin through rapid evaporation of the non-medicated propellants.
The subject device, Syringe Holder accessory (K201248) helps direct the site with the following efficient use of the gas Blend with the syringe: configures refrigerant gas to a mist, targets the transient blanche site, one handed use, keeps the syringe in the same path, and controls the amount of the vapocoolant mixture that is dispensed for the practitioner. Thus, the accessory device avoids over spraying and having to switch from a canister spray effect to a syringe injection technique that may have dissipated the transient numbing effect for comfort results.
This FDA 510(k) summary describes a premarket notification for a Syringe Holder accessory (VM03000). The document aims to demonstrate that this accessory, when used with the Vapocoolshot Mist (primary predicate), is substantially equivalent to an existing predicate device called "Ouchless".
It is crucial to understand that this document does not describe an AI medical device or a study involving an algorithm's performance. The device in question is a physical accessory for a medical tool, not a software or AI product. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable to this submission.
Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations for an AI-centric request:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative manner for performance metrics (like sensitivity, specificity, accuracy). Instead, substantial equivalence is established by comparing technological characteristics and intended use. The "performance" described is about meeting the functional criteria set by the predicate device and being safe and effective.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be substantially equivalent to the predicate device. | The Syringe Holder accessory, when used with the Vapocoolshot Mist, facilitates the injection procedure following Vapocoolshot Mist application, targeting and minimizing cooling area for lessening pain associated with injections, minor surgical procedures, and minor sports injuries. This is deemed similar to the Predicate 1 (Ouchless) which "helps direct for topical application of refrigerant (cold like ice) to the skin with the attachment of a user supplied syringe." |
| Technological Characteristics | Must have similar technological characteristics to the predicate device, or differences must not raise new questions of safety or effectiveness. | The Syringe Holder accessory shares the basic principle of attaching (1cc (4.5mm) to 3cc (10.8mm) diameter) user-supplied syringes to a vapocoolant canister. It helps direct the refrigerant gas to a mist, targets the transient blanche site, allows one-handed use, keeps the syringe in the same path, and controls the amount of vapocoolant dispensed, thereby avoiding overspraying and maintaining the numbing effect. The comparison chart indicates similarities in: |
- Type (Rx)
- Attaches a syringe (Yes)
- Same Technology (Yes)
- Syringe controlled by Practitioner (Yes)
- Drug controlled by Practitioner (Yes)
Differences noted: - Subject device attaches to a syringe by "one device," while predicate 1 attaches based on "3 colors." This difference is not deemed to raise new questions of safety or efficacy.
- Design as a unit: Subject device is the accessory itself; Primary Predicate is the pressurized dispensing container. Predicate 1 includes the container, valve, and syringe attachment. The Syringe Holder accessory (subject device) combined with the Primary Predicate (Vapocoolshot Mist) forms a unit with similar technological characteristics to Predicate 1 (Ouchless). |
| Biocompatibility | Materials must be biocompatible. | The subject accessory device has no contact with the gas Blend or the patient, and its materials are reported as biocompatible. |
| Chemical Composition| Material composition must be consistent and verified. | The subject device's material is checked and verified upon receipt from the supplier to ensure the same chemical profile. |
| Structural Integrity| Must be equivalent to the predicate device(s). | Engineering verification measurements were taken, and visual inspections were made to determine the Syringe Holder accessory (K201248) when used with the Primary predicate were equivalent to the Predicate 1 (Ouchless). |
| Directions for Use (DFU) | Must be substantially equivalent. | All key elements of the DFU between Predicate 1 and the subject device accessory attached to Primary predicate as a unit are similar. No significant differences exist. |
| Safety and Effectiveness | Must be safe and effective for its intended use, not raising new questions compared to predicates. | Based on the performance evaluations conducted (usability study, biocompatibility, chemical composition, structural integrity, DFU comparison, bench testing), the Syringe Holder Accessory (K201248) when used with the Primary Predicate Vapocoolshot Mist (K193349) were found to be safe and effective to the Predicate 1 (Ouchless). It does not raise additional questions of safety, efficacy, and effectiveness different from the Predicate (Ouchless). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions a "Usability study was performed" and "Comparative performance testing was conducted." However, no specific sample sizes (e.g., number of participants, number of devices tested, number of observations) are provided for any of the performance evaluations.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the "bench testing" and "usability study" mentioned, it would typically be prospective, internally conducted testing, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a physical medical device accessory that is undergoing a substantial equivalence review. There is no "ground truth" establishment in the context of an AI algorithm's performance review. The evaluations are against engineering specifications, biocompatibility, and functional equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic results or interpretations.
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 is not an AI device or a diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted in #3, there is no "ground truth" in the AI/diagnosis sense. The "ground truth" for this device's performance would be engineering specifications, material standards, and the functional characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" in the machine learning sense.
N/A