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.

Device Description

AI/ML Overview

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.

Test Conducted for Labeling Changes	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 for surface device, limited contact	Testing supported biocompatibility for cytotoxicity, sensitization, and irritation. (No specific values reported)
USP <51> Antimicrobial Effectiveness Testing (Preservative Effectiveness)	Demonstrate product acts as its own preservative and does not support microbial growth.	All test method acceptance criteria were met. (No specific values reported)

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 <51>) 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 <51>) 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 <51> Antimicrobial Effectiveness Testing: Ground truth is defined by the pharmacopeial standard (USP <51>) 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.

Summary

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May 7, 2019

Gebauer Company Brittney Cooper Sr. Regulatory Affairs and Quality Specialist 4444 East 153rd Street Cleveland, Ohio 44128

Re: K190161

Trade/Device Name: Gebauer's Ethyl Chloride Topical Anesthetic Spray Regulatory Class: Unclassified Product Code: MLY Dated: January 29, 2019 Received: January 30, 2019

Dear Brittney Cooper:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

VivekJ. Pinto -S

for Carlos Peña, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190161

Device Name

Gebauer's Ethyl Chloride Topical Anesthetic Spray

Indications for Use (Describe)

Gebauer's Ethyl Chloride Topical Anesthetic 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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Gebauer Company. The logo consists of a blue stylized letter "G" above the words "GEBAUER COMPANY", which are also in blue. The letter "G" is designed with a curved shape and a horizontal line extending from the top.

510(k) Summary—K190161

This 510(k) Summary is being submitted in accordance of 21 CFR Part 807.92.

I. SUBMITTER

II.

III.

Secondary:

Owner:	Gebauer Company4444 East 153rd StreetCleveland, OH 44128(216) 581-3030
Contact Person:	Brittney CooperGebauer Company4444 East 153rd StreetCleveland, OH 44128(216) 581-3030
Date Prepared:	May 6, 2019
DEVICE
Trade Name:	Gebauer's Ethyl Chloride TopicalAnesthetic Spray
Common Name:	Cold Spray
Classification Name:	Refrigerant Topical, Vapocoolant
Product Code:	MLY
PREDICATE DEVICE:
Primary:	Gebauer's Ethyl Chloride (Fine Spray andMedium Spray)K991514

e Ecgaily marketed medical device
Gebauer's Pain Ease Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic

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K032671

IV. DESCRIPTION

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 new device, Gebauer's Ethyl Chloride is identical in all aspects to the predicate device, Gebauer's Ethyl Chloride 510(k) K991514, with the exception of revised precautions and warnings and information regarding biocompatibility and USP <51> Antimicrobial Effectiveness Testing.

V. INDICATIONS FOR USE OF DEVICE

The Indications for Use is similar to the predicate devices.

VI. TECHNICAL SUMMARY

The new device has the same technical characteristics as the predicate device including materials, design, and energy source. There are no technological differences between the predicate and the new device. As with the predicate device, the cooling action experienced by the patient is caused by the evaporation of the chemical from the patient's skin. The user applies pressure to the nozzle to dispense the aerosol product onto the skin. The material is contained in a steel aerosol can or pharmaceutical glass bottle, filled under pressure, and dispensed using standard aerosol nozzle technology. The only difference is product fill volume which is 3.9 f1. oz in the new device versus the predicate device which is 3.5 fl. oz. This change does not impact the performance of the device, only the number of uses per can or bottle. See table below for the comparison between the new device and the predicate:

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	Comparison Chart – Technological Characteristics
Trade Name	Gebauer's EthylChloride PredicateDevice	Gebauer's PainEase SkinRefrigerant (MistSpray and MediumSpray) TopicalAnestheticPredicate Device	Gebauer's EthylChloride TopicalAnesthetic SprayNew Device
Product Design	Pressurizeddispensingcontainer whichincludes thevapocoolant, steelaerosol can, orpharmaceuticalglass bottle, valve(if a can) andactuator.	Pressurizeddispensingcontainer whichincludes thevapocoolant,aerosol can, valveand actuator.	Pressurizeddispensing containerwhich includes thevapocoolant, steelaerosol can, orpharmaceutical glassbottle, valve (if acan) and actuator.
Indication for Useand Intended Use	Gebauer's EthylChloride (Fine andMedium Nozzles):Gebauer's EthylChloride is avapocoolant (skinrefrigerant)intended fortopical applicationto control painassociated withminor surgicalprocedures (suchas lancing boils,incisions anddrainage of smallabscesses),injections and thetemporary relief ofminor sportsinjuries. It is alsointended for thetreatment ofrestricted motionassociated withmyofascial paincaused by triggerpoints.	A vapocoolant(skinrefrigerant)intended fortopicalapplication toskin, intactmucousmembranes(oral cavity,nasalpassagewaysand the lips)and minor openwounds.Gebauer's PainEase SkinRefrigerantcontrols painassociated withminor surgicalprocedures(such aslancing boils,incisions,drainage ofsmallabscesses, and	Gebauer's EthylChloride TopicalAnesthetic Spray(Mist Spray, FineSpray and MediumSpray): Avapocoolant (skinrefrigerant) intendedfor topicalapplication to controlpain associated withinjections (startingIV's andvenipuncture), minorsurgical procedures(such as lancingboils, or incision anddrainage of smallabscesses), and thetemporary relief ofminor sportsinjuries. The Fineand Medium Spraysare also intended forthe treatment of
		sutures),injections(venipuncture,IV starts,cosmeticprocedures)and thetemporaryrelief of minorsports injuries(sprains,bruising, cutsand abrasions).The MediumSpray is alsointended for thetreatment ofmyofascial paincaused bytrigger points,restrictedmotion andmuscle tension.	myofascial paincaused by triggerpoints, restrictedmotion and muscletension.
Product Fill Volume	3.5 fl. oz. (103.5mL)	3.5 flo. Oz. (103.5mL)	3.9 fl. oz. (116 mL)
VapocoolantComposition	Ethyl Chloride(100%)	1,1,1,3,3Pentafluoropropane(HFC 245fa highpurity) and1,1,1,2Tetrafluoroethane(HFC 134apharmaceuticalgrade).	Ethyl Chloride(100%)
Energy Delivered	Thermal energyvia RefrigerantSpray.	Thermal energy viaRefrigerant Spray.	Thermal energy viaRefrigerant Spray.
VapocoolantDischarge Method	Depress theactuator to releasethe vapocoolant.	Depress theactuator to releasethe vapocoolant.	Depress the actuatorto release thevapocoolant
Method ofApplication	Direct sprayapplication tointact skin	Direct sprayapplication tointact skin, intact	Direct sprayapplication to intactskin.
		membranes andminor openwounds.
EnvironmentalCompatibility	Flammable.	Non-Flammable.	Flammable.
Mechanical Safety	Mechanism haspositive shut-offrelease.	Mechanism haspositive shut-offrelease.	Mechanism haspositive shut-offrelease.

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VII. DETERMINATION OF SUBSTANTIAL EQUIVELANCE

This premarket notification 510(k) "change being effected" is being submitted to revise, remove or include specific information on the labeling identified and addressed within this pre-market submission. There is demonstrated equivalency in basic product design and technology, in indications for use, target population, and risk factors.

As stated above, the new device is identical in formulation, delivery system and packaging to the predicate device Gebauer's Ethyl Chloride, 510(k) K991514.

Labeling

The new device has revised, removed or added information on the device labeling. The predicate device contained precautions and warnings not representative of clinical use of the device whereas the new device is labeled in accordance with the biocompatibility requirements of ISO 10993-1. Additionally, the labeling of the new device was revised to include information regarding USP <51> Antimicrobial Effectiveness Testing. Both the new and predicate devices are indicated for use 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. The stream applications are also intended for use as a counterirritant in the management of myofascial pain, restricted motion and muscle tension. The new device labeling is substantially equivalent to the predicate device.

VIII. PERFORMANCE DATA

The predicate and new devices use the same materials, design and energy source and no technological differences exist. No changes were made to the device, use of the device, production of the device or output of the device. To support the labeling changes and to demonstrate that changes do not impact substantial equivalence, the following tests were performed:

Biocompatibility

Gebauer's Ethyl Chloride Topical Anesthetic Spray is categorized according to ISO 10993-1 as a surface device that has limited (< 24 hours) contact with intact skin.

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The relevant endpoints for the device are cytotoxicity, sensitization and irritation. Testing included in the submission support the biocompatibility of the device.

USP <51> Antimicrobial Effectiveness Testing (Preservative Effectiveness) Testing was performed in accordance with USP <51> to demonstrate that the product acts as its own preservative and does not support growth of microorganisms during use. All test method acceptance criteria were met.

IX. CONCLUSION

Based on the information above and within this submission, it is concluded that the new Ethyl Chloride device is safe and effective for its intended use and is substantially equivalent to the predicate device.

Regulation Number and Section

N/A