Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE

Q: Who is the manufacturer of Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE?

Itw Contamination Control Electronics filed the 510(k) submission for Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE (K172598).

Q: What is the FDA product code for Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE?

MLY. as a Class U device in the PM panel.

Q: What is the regulatory pathway for Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K172598 · Itw Contamination Control Electronics · MLY · Apr 19, 2018 · PM

Device Facts

Record ID	K172598
Device Name	Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
Applicant	Itw Contamination Control Electronics
Product Code	MLY · PM
Decision Date	Apr 19, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

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 Story

Coventry Topical Anesthetic Spray is a non-prescription, pressurized dispensing container (canister, valve, actuator, cap) delivering a vapocoolant mixture of 95% 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 5% 1,1,1,2-Tetrafluoroethane (HFC-134a). The device is operated by a clinician or user who depresses an actuator button to release the mixture. The Mist Spray configuration produces fine droplets; the Medium Stream Spray produces a pinpoint stream. Cooling occurs via rapid evaporation of the non-medicated propellants upon contact with skin, intact mucous membranes, or minor open wounds. The cooling effect provides topical anesthesia for injections, minor surgical procedures, and sports injuries, or manages myofascial pain. The device is used in clinical or point-of-care settings. It is a mechanical, non-powered device requiring no external energy source.

Clinical Evidence

Bench testing only. Evidence includes chemical composition verification, biocompatibility assessment, structural/parts inspection, and stability/shelf-life testing under room temperature and accelerated conditions. No clinical data presented.

Technological Characteristics

Pressurized dispensing container (canister, valve, actuator, cap). Vapocoolant composition: 95% 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 5% 1,1,1,2-Tetrafluoroethane (HFC-134a). Non-flammable. Mechanical operation via manual actuator button. No external energy source. Standalone device.

Indications for Use

Indicated for patients requiring topical anesthesia or pain relief. Used for pre-injection anesthesia (venipuncture, IV starts), cosmetic procedures, minor surgical procedures (lancing boils, incisions, drainage of abscesses, sutures), and temporary relief of minor sports injuries (sprains, bruising, cuts, abrasions). Medium Stream Spray also indicated for myofascial pain, restricted motion, and muscle tension. Applicable to skin, intact mucous membranes, and minor open wounds.

Predicate Devices

Gebauer's Pain Ease (Medium Stream Spray & Mist Spray) (K032671)

Related Devices

K162218 — Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 · Nuance Medical, LLC · Nov 22, 2016
K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 · Gebauer Co. · Mar 17, 2004
K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray · Nuance Medical, LLC · Oct 18, 2017
K172028 — Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) · Gebauer Company · Oct 27, 2017
K193349 — Vapocoolshot Mist · Vapocoolshot, Inc. · Apr 14, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172598 Device Name Coventry TM Topical Anesthetic Mist/Stream Spray HAZMAT FREE Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | <input type="checkbox"/> 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 ITW Contamination Control. The logo consists of the letters "ITW" in a bold, sans-serif font, with the "IT" in a dark red color and the "W" outlined in the same color. Below the letters, the words "Contamination Control" are written in a smaller, black, sans-serif font. # 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 Control Electronics 3125 Cobb Center Drive Marietta, GA 30152 (770) 424 4888 | |----------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Steve Cook ITW CCE 3125 Cobb Center Drive Mareitta, GA 30152 (770) 424-4888 | | Date Prepared: | August 25, 2017 | | DEVICE | | | Trade Name: | CoventryTM Topical Anesthetic Spray Part number - 700-453, 700-454 | | Common Name: | Cold Spray - 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (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. K032671 Legally marketed medical device | III. II. {4}------------------------------------------------ #### 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: {5}------------------------------------------------ | Comparison Chart – Technological Characteristics | | | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Gebauer's Pain Ease Predicate | Coventry ™ Topical Anesthetic Spray subject device | | Product Design | Pressurized dispensing container, which includes the vapocoolant, canister, valve, actuator, and cap | Pressurized dispensing container, which includes the vapocoolant, canister, valve, actuator, and cap | | Indication for Use and Intended Use | Gebauer's Pain Ease Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerant) intended for topical application to skin, intact mucous, and minor open wounds. Pain Ease 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). Pain Ease Medium Stream Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension. | Coventry ™ Topical Anesthetic Spray Medium Stream and Mist Sprays 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), 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, muscle tension | | Product Fill Volume | 3.5oz (103.5mL) | 3.5oz (103.5mL) | | Vapocoolant Composition | 1,1,1,3,3-Pentafluoropropane (HFC- 245fa) 95% and 1,1,1,2-Tetrafluoroethane (HFC-134a) 5% | 1,1,1,3,3-Pentafluoropropane (HFC- 245fa) 95% and 1,1,1,2-Tetrafluoroethane (HFC-134a) 5% | | Energy delivered | Thermal Energy via Refrigerant Spray | Thermal Energy via Refrigerant Spray | | Energy Deposited | N/A | N/A | | Vapocoolant Discharge Method | Depress the Actuator Button to release the vapocoolant | Depress the Actuator Button to release the vapocoolant | | Environmental Compatibility | Non-Flammable | Non-Flammable | | Mechanical Safety | Mechanism has positive shut-off release | 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) {6}------------------------------------------------ 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 {7}------------------------------------------------ #### 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.