Coventry ™ Mist Spray and Medium Stream Spray 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. Coventry ™ 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). Coventy ™ Medium Stream Spray is also intended for use the management of myofascial pain, restricted motion and muscle tension.

Device Description

Coventry™ Topical Anesthetic Spray HAZMAT FREE (subject device) is a non prescription device designed to deliver a standard mixture (1,1,1,3,3-245fa Pentafluoropane) and 134a (1.1.1.2-Tetrafluoroethane). which is being offered in two delivery configurations, Mist Spray Model No. 700-453 and Medium Stream Spray Model Number 700-454 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 Coventry "" 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.

AI/ML Overview

The document provided is a 510(k) Premarket Notification from the FDA for a medical device called "Coventry Topical Anesthetic Mist/Stream Spray HAZMAT FREE". This notification is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the document primarily focuses on comparing the subject device to its predicate, rather than providing a detailed study of the subject device against specific acceptance criteria for a novel device.

However, based on the provided text, I can extract information related to the demonstration of substantial equivalence, which serves as the "study" in this context.

Here's a breakdown of the requested information based on the document:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics. Instead, "performance" is demonstrated through the similarity to the predicate device. The acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device, demonstrated by having similar technological characteristics, indications for use, and a similar safety and effectiveness profile.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated through comparison to predicate)
Indications for Use: Similar to the predicate device.	Coventry™ Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for identical uses: topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips), and minor open wounds; controls pain associated with injections, minor surgical procedures, temporary relief of minor sports injuries. Medium Stream Spray also for myofascial pain, restricted motion, and muscle tension. (Identical to predicate)
Technological Characteristics: No technological differences (materials, design, energy source, other features).	Product Design: Pressurized dispensing container, including vapocoolant, canister, valve, actuator, and cap. (Identical to predicate) Vapocoolant Composition: 1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and 1,1,1,2-Tetrafluoroethane (HFC-134a) 5%. (Identical to predicate) Energy Delivered: Thermal Energy via Refrigerant Spray. (Identical to predicate) Vapocoolant Discharge Method: Depress Actuator Button to release vapocoolant. (Identical to predicate) Environmental Compatibility: Non-Flammable. (Identical to predicate) Mechanical Safety: Mechanism has positive shut-off release. (Identical to predicate) Structural and Parts Composition: Engineering verification measurements and visual inspections confirmed canisters, valves, and caps were substantially equivalent.
Chemical Composition: Identical chemical composition by type and percent of components as the predicate.	Both systems use identical aerosol profiles: 245fa (1,1,1,3,3-Pentafluoropropane) at 95% and 134a (1,1,1,2-Tetrafluoroethane) at 5%. The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate. (Identical to predicate)
Biocompatibility: Device biocompatibility is supported.	Evidence supporting the biocompatibility of the device was included in the submission.
Directions for Use (DFU): Key elements (indications, precautions, warnings, contraindications, treatment regimen) are substantially equivalent to the predicate device.	All key elements of the DFU for the predicate and subject device are substantially equivalent. No substantial differences exist. (Substantially equivalent to predicate)
Stability and Shelf Life: Product identity, strength, quality, and purity maintained throughout labeled dating period, meeting established acceptance criteria under controlled conditions.	A stability protocol was developed. Testing assessments under controlled conditions (room temperature and accelerated) confirmed all requirements met established acceptance criteria.
Safety and Effectiveness Profile: Similar, if not identical, to the predicate device.	Based on conducted testing performance, the Coventry™ device was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease. (Similar/Identical to predicate)

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

The document does not specify a "test set" in the traditional sense of a clinical trial with human subjects. The evidence for substantial equivalence primarily relies on comparative technical testing and verification of manufacturing parameters against the predicate device. Therefore, explicit sample sizes for a patient test set are not provided because a clinical study of that nature was not required for this 510(k) submission.

Data Provenance: The tests mentioned (Chemical Composition Confirmation, Structural and Parts Composition, Stability Protocol and Shelf Life Testing) were performed by the manufacturer, ITW Contamination Control Electronics. The location is Marietta, GA 30152, USA. The nature of these tests suggests they are prospective for the subject device.

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

Not applicable for this type of 510(k) submission. The ground truth for this submission is the established safety and effectiveness of the predicate device, and the technical performance and composition of the subject device aligning with that. There's no mention of expert review of a "test set" in the context of clinical outcomes to establish ground truth.

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

Not applicable, as a clinical "test set" requiring adjudication of outcomes is not described in the document for this 510(k) clearance.

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 or assistive technology.

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

Not applicable. This device is a physical product (anesthetic spray), not an algorithm or AI.

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

The "ground truth" for this 510(k) is the established performance and safety profile of the predicate device, Gebauer's Pain Ease. The subject device is deemed substantially equivalent because its technical characteristics, formulation, indications for use, and manufacturing controls are identical or sufficiently similar such that it performs in the same way and raises no new safety or effectiveness concerns.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning. The "training" in manufacturing would involve process validation, which is implicitly covered by quality systems and the stability protocol.

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

Not applicable, as there is no "training set" in the context of machine learning for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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" in blue, with the word "ADMINISTRATION" underneath.

April 19, 2018

ITW Contamination Control Electronics Steve Cook Director of Product Technologv 8125 Cobb Center Drive Kennesaw, Georgia 30152

Re: K172598

Trade/Device Name: Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry™ Topical Anesthetic Stream Spray HAZMAT FREE

Regulatory Class: Unclassified Product Code: MLY Dated: January 29, 2018 Received: January 29, 2018

Dear Steve Cook:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172598

Device Name

Coventry TM Topical Anesthetic Mist/Stream Spray HAZMAT FREE

Indications for Use (Describe)

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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Electronic

510(k) Summary

Coventry ™ Topical Anesthetic Spray

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

I. SUBMITTER

Owner:	Illinois Tool Works Contamination ControlElectronics3125 Cobb Center DriveMarietta, GA 30152(770) 424 4888
Contact Person:	Steve CookITW CCE3125 Cobb Center DriveMareitta, GA 30152(770) 424-4888
Date Prepared:	August 25, 2017
DEVICE
Trade Name:	CoventryTM Topical Anesthetic SprayPart number - 700-453, 700-454
Common Name:	Cold Spray - 245fa (1,1,1,3,3-Pentafluoropropane) and134a (1,1,1,2-Tetrafluoroethane)
Classification Name:	Refrigerant Topical, Vapocoolant
Product Code:	MLY
PREDICATE DEVICE
Primary:	Gebauer's Pain Ease (Medium Stream Spray & Mist Spray)Gebauer Company.K032671Legally marketed medical device

III.

II.

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IV. DEVICE DESCRIPTION

The predicate is a legally marketed device.

Coventry™ Topical Anesthetic Spray HAZMAT FREE (subject device) is a non prescription device designed to deliver a standard mixture (1,1,1,3,3-245fa ------------------------------------------------------------------------------------------------------------------------------------------------------------------------Pentafluoropane) and 134a (1.1.1.2-Tetrafluoroethane). which is being offered in two delivery configurations, Mist Spray Model No. 700-453 and Medium Stream Spray Model Number 700-454 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 Coventry "" 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.

Coventry "", is substantially equivalent, if not identical, to the predicate device Gebauer's Pain Ease (Mist Spray and Medium Stream Spray). Both devices are indicated for use to control pain for pre-injection anesthesia, minor procedures, and minor sports injuries.

The distance and amount applied is determined by the user.

V. INDICATIONS FOR USE

The Indications for Use is similar to the predicate device.

Coventry TM Mist Spray and -Medium Stream Spray (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Coventry "" controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical 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). Coventry "" Medium Stream Spray is also intended for use the management of myofascial pain, restricted motion and muscle tension.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The subject 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 submitted device. Refer to the following table for the comparison between the subject device and the predicate:

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Comparison Chart – Technological Characteristics
Trade Name	Gebauer's Pain EasePredicate	Coventry ™ Topical Anesthetic Spraysubject device
Product Design	Pressurized dispensing container,which includes the vapocoolant,canister, valve, actuator, and cap	Pressurized dispensing container, whichincludes the vapocoolant, canister,valve, actuator, and cap
Indication for Useand Intended Use	Gebauer's Pain Ease Mist Spray andMedium Stream Spray arevapocoolants (skin refrigerant)intended for topical application to skin,intact mucous, and minor openwounds. Pain Ease controls painassociated with injections(venipuncture, IV starts, cosmeticprocedures), minor surgical procedures(such as lancing boils, incisions,drainage of small abscesses, andsutures), and the temporary relief ofminor sports injuries (sprains, bruising,cuts and abrasions). Pain Ease MediumStream Spray is also intended for thetreatment of myofascial pain caused bytrigger points, restricted motion andmuscle tension.	Coventry ™ Topical Anesthetic SprayMedium Stream and Mist Sprays arevapocoolants (skin refrigerants)intended for topical application to skin,intact mucous membranes (oral cavity,nasal passage ways and the lips) andminor open wounds. Coventry ™controls pain associated with injections(venipuncture, IV starts, cosmeticprocedures), minor surgical procedures(such as lancing boils, incisions,drainage of small abscesses andsutures) and the temporary relief ofminor sports injuries (sprains, bruising,cuts and abrasions). Coventry ™Medium Stream Spray is also intendedfor use the management of myofascialpain, restricted motion, muscle tension
Product FillVolume	3.5oz (103.5mL)	3.5oz (103.5mL)
VapocoolantComposition	1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and1,1,1,2-Tetrafluoroethane (HFC-134a)5%	1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and1,1,1,2-Tetrafluoroethane (HFC-134a)5%
Energy delivered	Thermal Energy via Refrigerant Spray	Thermal Energy via Refrigerant Spray
Energy Deposited	N/A	N/A
VapocoolantDischarge Method	Depress the Actuator Button to releasethe vapocoolant	Depress the Actuator Button to releasethe vapocoolant
EnvironmentalCompatibility	Non-Flammable	Non-Flammable
Mechanical Safety	Mechanism has positive shut-offrelease	Mechanism has positive shut-off release

Substantial Equivalence:

The predicate device is a legally marketed device. The subject device has similar intended use (Indications for Use) as the predicate device. 21 CFR 807.107(b)(1)

The subject device has the same technological characteristics as the predicate device. There are no technological differences, including no changes in the materials, design, energy source, or other features of the device from those of the predicate device. 21 CFR 800.107(b)(2)(i)

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The subject device and the predicate device use an identical (substantially equivalent) chemical composition by type and percent of components: 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 and the predicate device use the same materials, design, energy source and other features.

The subject device is a reverse-engineering of its predicate.

Differences, if any, would be limited to discussion and promotion of product, marketing materials, cosmetic labeling, only.

The subject device does not raise questions of safety and effectiveness efficacy different from the predicate device.

Labeling:

The labeling of subject device has been prepared to ensure the medical professional has adequate and clear instructions for safety and usage. The canister labeling, directions for use, safety and warning statements are substantially equivalent to the predicate.

Summary: Coventry ™ is substantially equivalent and no technological differences exist to the predicate device. 21 CFR 800.107(b)(2)(i)

VII. PERFORMANCE DATA

The predicate and the subject devices use the same materials, design and energy source and no technological differences exist. Tests were selected and performed to ensure the subject device's output performance are the same as its predicate. The following tests were performed in support of substantial equivalence:

Chemical Composition Confirmation

Both systems use identical aerosols profiles: 245fa (1,1,1,3,3-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.

Biocompatibility

The submission included evidence supporting the biocompatibility of the device

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Structural and Parts Composition

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 Application and Methodology:

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 statement , and treatment regiment. No substantial differences exist between the predicate and subject device's Directions for Use.

Stability Protocol and Shelf Life Testing

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.

Summary

Based on the testing performance conducted the subject device, Coventry ™ was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease.

VII. CONCLUSION

Based on the information presented above and within this submission, it is concluded that the Coventry ™ is safe and effective for its intended use and is substantially equivalent to the predicated device. Also, the labeling is substantially equivalent to the predicate device.

Regulation Number and Section

N/A