Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a chemical spray for topical anesthesia, with no mention of AI or ML technology. The performance studies focus on biocompatibility and antimicrobial effectiveness, not algorithmic performance.

Therapeutic

Yes
The device is intended to control pain, relieve pain, and treat myofascial pain, which are therapeutic claims.

Diagnostic

No

This device is a topical anesthetic spray used to control pain and is not described as diagnosing any condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a spray delivered from a bottle or can with nozzles, indicating it is a physical product containing a chemical, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a "vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections, minor surgical procedures, and the temporary relief of minor sports injuries." It also mentions treatment of myofascial pain. These are all applications directly on or to the body surface for therapeutic or anesthetic purposes.
Device Description: The description details a spray that cools the skin through rapid evaporation of a propellant. This is a physical effect on the body surface.
Anatomical Site: The anatomical sites listed are "Topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds." These are all external or surface applications.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens in vitro (outside of the body) to provide information about a physiological state, disease, or condition.

IVD devices are used to test samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device's function is to provide topical anesthesia and pain relief through cooling, which is a direct application to the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

MLY

Device 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 Antimicrobial Effectiveness Testing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ( Antimicrobial Effectiveness Testing (Preservative Effectiveness): Testing was performed in accordance with USP 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K991514, K032671

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 Company
4444 East 153rd Street
Cleveland, OH 44128
(216) 581-3030 |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Brittney Cooper
Gebauer Company
4444 East 153rd Street
Cleveland, OH 44128
(216) 581-3030 |
| Date Prepared: | May 6, 2019 |
| DEVICE | |
| Trade Name: | Gebauer's Ethyl Chloride Topical
Anesthetic Spray |
| Common Name: | Cold Spray |
| Classification Name: | Refrigerant Topical, Vapocoolant |
| Product Code: | MLY |
| PREDICATE DEVICE: | |
| Primary: | Gebauer's Ethyl Chloride (Fine Spray and
Medium Spray)
K991514 |

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

4

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 Antimicrobial Effectiveness Testing.

V. INDICATIONS FOR USE OF DEVICE

The Indications for Use is similar to the predicate devices.

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.

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:

5

	Comparison Chart – Technological Characteristics
Trade Name	Gebauer's Ethyl
Chloride Predicate
Device	Gebauer's Pain
Ease Skin
Refrigerant (Mist
Spray and Medium
Spray) Topical
Anesthetic
Predicate Device	Gebauer's Ethyl
Chloride Topical
Anesthetic Spray
New Device
Product Design	Pressurized
dispensing
container which
includes the
vapocoolant, steel
aerosol can, or
pharmaceutical
glass bottle, valve
(if a can) and
actuator.	Pressurized
dispensing
container which
includes the
vapocoolant,
aerosol can, valve
and actuator.	Pressurized
dispensing container
which includes the
vapocoolant, steel
aerosol can, or
pharmaceutical glass
bottle, valve (if a
can) and actuator.
Indication for Use
and Intended Use	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.	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 Pain
Ease Skin
Refrigerant
controls pain
associated with
minor surgical
procedures
(such as
lancing boils,
incisions,
drainage of
small
abscesses, and	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
		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.	myofascial pain
caused by trigger
points, restricted
motion and muscle
tension.
Product Fill Volume	3.5 fl. oz. (103.5
mL)	3.5 flo. Oz. (103.5
mL)	3.9 fl. oz. (116 mL)
Vapocoolant
Composition	Ethyl Chloride
(100%)	1,1,1,3,3
Pentafluoropropane
(HFC 245fa high
purity) and
1,1,1,2
Tetrafluoroethane
(HFC 134a
pharmaceutical
grade).	Ethyl Chloride
(100%)
Energy Delivered	Thermal energy
via Refrigerant
Spray.	Thermal energy via
Refrigerant Spray.	Thermal energy via
Refrigerant Spray.
Vapocoolant
Discharge Method	Depress the
actuator to release
the vapocoolant.	Depress the
actuator to release
the vapocoolant.	Depress the actuator
to release the
vapocoolant
Method of
Application	Direct spray
application to
intact skin	Direct spray
application to
intact skin, intact	Direct spray
application to intact
skin.
		membranes and
minor open
wounds.
Environmental
Compatibility	Flammable.	Non-Flammable.	Flammable.
Mechanical Safety	Mechanism has
positive shut-off
release.	Mechanism has
positive shut-off
release.	Mechanism has
positive shut-off
release.

6

7

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 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 ( Antimicrobial Effectiveness Testing (Preservative Effectiveness) Testing was performed in accordance with USP 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.