(233 days)
Not Found
No
The device description and performance studies focus on the chemical composition, delivery system, and physical effects of the spray, with no mention of AI or ML.
Yes
The device is intended to control pain, relieve minor sports injuries, and manage myofascial pain, restricted motion, and muscle tension, which are all therapeutic purposes.
No
The device is a vapocoolant intended for pain relief and management of myofascial pain, restricted motion, and muscle tension, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical delivery system (spray can) containing a chemical mixture, which is a hardware component.
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 for topical application to the skin, mucous membranes, and minor open wounds to control pain and provide temporary relief. This is a direct application to the body surface for a therapeutic effect (cooling and pain relief).
- Device Description: The device description explains that it's a spray containing propellants that cool the skin through rapid evaporation. This mechanism of action is physical and applied externally.
- Lack of In Vitro Activity: An IVD is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). This device does not involve collecting samples or performing tests on them in a laboratory setting.
The device is a topical anesthetic/vapocoolant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MLY
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.
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 passage ways 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)
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, Biocompatibility, Structural and Parts Composition, Directions for Use Application and Methodology, and Stability Protocol and Shelf Life Testing.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.