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Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray. This chemical self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device is packaged in either a pharmaceutical glass bottle or steel aerosol can with several variations of nozzles. The patient contact is less than ten seconds and the skin is cooled through rapid evaporation of the non-medicated volatile propellant.

The provided text describes a 510(k) premarket notification for "Gebauer's Ethyl Chloride Topical Anesthetic Spray", asserting its substantial equivalence to a predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing new acceptance criteria or proving efficacy through clinical studies as would be done for a novel device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on demonstrating equivalence through comparison of technical characteristics and existing test data for the predicate device, along with specific testing related to labeling changes.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present in a 510(k) submission of this nature:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative "acceptance criteria" in the typical sense of a clinical trial (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing the new device has the same technological characteristics and similar indications for use as the predicate device, and that specific tests for labeling changes were met.

Therefore, a table of acceptance criteria and reported device performance directly addressing efficacy is not presented. The performance is summarized by demonstrating no impact on the device's function or safety due to minor changes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient numbers or a large dataset. The "tests" mentioned (Biocompatibility, USP ) are laboratory-based and generally involve material samples or microbiological cultures, not human or large-scale clinical test sets.
• Data Provenance: Not specified, as these are laboratory tests rather than clinical data from a specific country or collected retrospectively/prospectively from patients.

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 information is not applicable to the type of device and tests described. The tests performed (Biocompatibility, USP ) are standardized laboratory tests, not subjective interpretations requiring multiple human experts to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed in clinical studies where multiple readers interpret results, which is not the case for the laboratory tests performed here.

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 system, thus MRMC studies, AI assistance, or human reader improvement are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the tests mentioned:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and the absence of specific adverse biological reactions (cytotoxicity, sensitization, irritation) in validated test models.
• USP Antimicrobial Effectiveness Testing: Ground truth is defined by the pharmacopeial standard (USP ) which sets specific log reduction targets for microorganisms after inoculation over time.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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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.

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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Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant 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 Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (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 Skin Refrigerant (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 provided text is a 510(k) summary for a medical device called Gebauer's Skin Refrigerant. It focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use. It does not contain any acceptance criteria or details of a study that proves the device meets specific performance metrics.

Therefore, I cannot populate the table or answer the questions as requested, because the necessary information is not present in the provided document. The submission states that the new device is "identical in formulation, delivery system and packaging to the predicate device" and that the "expansion of the indications for use is based on FDA's Blue Book #G95-1 and ISO-10993," which are regulatory guidelines and standards, not specific performance studies.

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Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (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 submitted in this application is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist is an appropriate mode of application when users follow the labeled directions for use, cooling skin through rapid evaporation of the non-medicated volatile propellants.

The provided text describes Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document, primarily a 510(k) summary, focuses on establishing substantial equivalence based on:

• Identical formulation and delivery system to Gebauer's Instant ICE (K021726).
• Identical indications for use to Gebauer's Ethyl Chloride (K991514), with additional clarification for pre-injection anesthesia examples.

The only "performance" mentioned is a reference to: "The temperature equivalency data previously submitted in 510(k) K021726, shows that Gebauer's Instant Ice 110 Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time." However, details of this study are not provided in the current document, and it pertains to a predicate device's equivalency, not specific acceptance criteria for the new device itself.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text.

Summary of missing information:

• Acceptance Criteria for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
• Reported Device Performance for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
• Details of the temperature equivalency study (K021726): Not provided in this document, only a high-level summary of its outcome. This study was for a predicate device.

To address your request, information specifically outlining performance acceptance criteria and a study design/results for the Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) would be needed.

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Gebauer's Instant Ice TM (Mist Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.
Gebauer's Instant Ice TM (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.

Gebauer's Instant Ice ™ (Mist Spray and Stream Spray) is an over-the-counter device to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a stream or mist spray. This mixture self-propels itself from the delivery system without the need for a propellant, because of the mixtures high vapor pressure. This form of delivery is an appropriate mode of application when the consumer follows the labeled directions for use, cooling skin through rapid evaporation of non-medicated volatile propellants.

Here's a breakdown of the acceptance criteria and study information based on the provided document for Gebauer's Instant Ice ™:

1. Table of Acceptance Criteria and Reported Device Performance

• Basic product design and technology
• Indications for use
• Target population
• Risk factors |
  | Temperature Equivalency (Gebauer's Instant Ice™ Stream vs. Gebauer's Ethyl Chloride® Medium) | Gebauer's Instant Ice™ Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time. |
  | Temperature Range (Gebauer's Instant Ice™ Mist/Stream vs. Mueller® Coolant Cold Spray & Cramer® Cold Spray) | The temperature range of Gebauer's Instant Ice™ Mist Spray and Gebauer's Instant Ice™ Stream Spray are contained within the range of two currently marketed over-the-counter products (Mueller® Coolant Cold Spray and Cramer® Cold Spray).
  Detail: The 95% confidence intervals for average temperatures of Gebauer's Instant Ice™ Stream and Mist Spray products, Mueller® Coolant Cold Spray, and Cramer® Cold Spray were calculated, and the temperature interval between the Mueller® and Cramer® products was determined. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" in terms of number of data points or subjects used for the temperature equivalency testing. It refers to "temperature equivalency data" and "95% confidence intervals for average temperatures."

• Sample Size: Not explicitly stated as a number of measurements or subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It appears to be data collected specifically for the 510(k) submission, likely prospective measurements conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The testing involves physical measurements (temperature), not subjective interpretations by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Ground truth was established through direct physical measurement (temperature), not through expert review needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This device is a cold spray, and its effectiveness is determined by its cooling properties, not by human reader interpretation of images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done in a sense that the device's performance (temperature equivalency) was assessed directly without human input influencing the measurement. The cooling action and temperature output were measured inherent to the device itself.

7. Type of Ground Truth Used

The ground truth used was physical measurement / direct observation of temperature. The claim is that the device produces a certain temperature profile, and this was directly measured and compared against predicate devices.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a physical product (a cold spray), not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.

Salivart Oral Moisturizer, an OTC device, is an aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized with a nitrogen propellant. It comes in two different can sizes. The smaller size is both sold and used as a promotional sample.

The provided text is a 510(k) summary for the Salivart® Oral Moisturizer, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on a comparison of technological characteristics to a predicate device, rather than new clinical studies or performance data against specific acceptance criteria. Therefore, the document does not describe acceptance criteria, a study proving the device meets them, or many of the specific details requested in your prompt.

However, I can extract information related to the comparison of technological characteristics as presented:

1. A table of acceptance criteria and the reported device performance:

This document does not present acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity for a diagnostic device). Instead, it relies on the concept of substantial equivalence to a predicate device. The "acceptance criteria" here are effectively that the device's technological characteristics are similar enough to the predicate to not raise new questions of safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Not applicable. This is a 510(k) submission based on comparison to a predicate, not a study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth was established by experts for a test set in this submission.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication was performed.

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 an oral moisturizer, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth, in the context of diagnostic or AI studies, is not relevant to this 510(k) submission. The "truth" here is the prior marketing of the predicate device and its established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is a 510(k) submission, not a machine learning or algorithm development project.

9. How the ground truth for the training set was established:

Not applicable.

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Gebauer's Ethyl Chloride (Fine and Medium Nozzles): Gebauer's Ethyl Chloride is a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Ethyl Chloride (Fine or Medium Nozzle) is a prescription device consisting of a single organic chemical (Ethyl Chloride) and a precise delivery system. The chemical is selfaerosolized to deliver a pinpoint stream spray.

The provided text describes a 510(k) premarket notification for Gebauer's Ethyl Chloride, a vapocoolant device. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, rather than to establish new performance criteria through a study.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria and reported device performance in a table.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on demonstrating technological equivalence to existing legally marketed predicate devices.

Here's an analysis of what the document does state concerning the comparison:

Comparison of Technological Characteristics (from {1}):

• Mechanism of Action: Both the new devices (Gebauer's Ethyl Chloride Fine/Medium Nozzle) and predicate devices aerosolize Ethyl Chloride. The cooling action is caused by the evaporation of Ethyl Chloride from the patient's skin.
• Active Ingredient Quality: Both new and predicate devices contain Ethyl Chloride that meets the test specifications delineated in the USP Ethyl Chloride raw material monograph.
• Differences: The only difference noted is the "USP designation for the finished aerosolized product."
• Raw Material: The source and grade of the raw material are identical for the predicate and new devices.

Conclusion of Substantial Equivalence (from {2} and {3}):

• The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This determination allows the device to be marketed.

In essence, for this type of submission, the "proof" the device meets acceptance criteria is the demonstration that its technological characteristics and intended use are sufficiently similar to a predicate device that has already been cleared for market. There is no new clinical or performance study conducted by the manufacturer and detailed in this document to establish novel performance metrics or acceptance criteria.

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