num Vapocoolant

K202782 · 623 Medical, LLC · MLY · Dec 21, 2020 · PM

Device Facts

• Record ID: K202782
• Device Name: num Vapocoolant
• Applicant: 623 Medical, LLC
• Product Code: MLY · PM
• Decision Date: Dec 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

nüm is a sterile topical anesthetic spray - 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 (venipuncture, IV starts) and the temporary relief of minor sports injuries.

Device Story

nüm Vapocoolant is a sterile, single-use, prescription-only topical anesthetic spray. It contains a mixture of 95% 1,1,1,3,3-Pentafluoropropane (245fa) and 5% 1,1,1,2-Tetrafluoroethane (134a) stored in a pressurized canister. Operated by trained healthcare professionals in clinical settings, the user depresses a nozzle to dispense the mixture as a fine mist. The device uses the mixture's own vapor pressure as the propellant. Upon contact with the skin, the rapid evaporation of the volatile mixture provides localized cooling, creating an anesthetic effect. This cooling helps manage pain during minor procedures or injuries. The device is sterilized via electron beam radiation and maintained in a sterile state using protective lidstock and a base cap.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization), sterilization validation per ISO 11137 (parts 1-3), and performance testing covering actuation force, vapocoolant performance, spray production/duration, and sterile barrier efficacy.

Technological Characteristics

Single-use, sterile, pressurized aerosol canister. Composition: 95% 1,1,1,3,3-Pentafluoropropane and 5% 1,1,1,2-Tetrafluoroethane. Sterilization: Electron beam (SAL 10^-6). Standards: ISO 10993-1 (biocompatibility), ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017 (sterilization). Mechanical actuation via standard aerosol nozzle.

Indications for Use

Indicated for topical pain control during minor surgical procedures (lancing boils, abscess drainage), injections (venipuncture, IV starts), and temporary relief of minor sports injuries in patients requiring topical anesthesia.

Predicate Devices

• Gebauer's Skin Refrigerant, Mist and Medium Sprays (K031036)

Submission Summary (Full Text)

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December 21, 2020

623 Medical, LLC % James Fentress Director of Research and Development Gilero, LLC 635 Davis Drive, Suite 100 Morrisville, North Carolina 27560

Re: K202782

Trade/Device Name: num Vapocoolant™ Regulatory Class: Unclassified Product Code: MLY Dated: September 16, 2020 Received: September 22, 2020

Dear James Fentress:

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, 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202782

Device Name num Vapocoolant(TM)

Indications for Use (Describe)

nüm is a sterile topical anesthetic spray - 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 (venipuncture, IV starts) and the temporary relief of minor sports injuries.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|--|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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Image /page/3/Picture/0 description: The image shows the logo for 623 Medical. The logo consists of the number 623 inside of a circle that is made up of two rings. The word "MEDICAL" is to the right of the circle.

# 510(k) Summary

| Company Name: | Gilero, LLC |
|------------------|----------------------------------------------------|
| Company Address: | 635 Davis Drive Suite 100<br>Morrisville, NC 27560 |
| Company Phone: | [phone] |

Official Contact: Phone : E-mail:

Jim Fentress [phone] jfentress @ gilero.com

#### Submission Date :

September 17, 2020

### Device Identification:

| Trade Name: | num Vapocoolant™™ |
|--------------------|------------------------------------|
| Common Name: | Cold Spray |
| Device Class: | Unclassified |
| Regulation Number: | N/A - unclassified |
| Regulation Name: | Refrigerant, Topical (Vapocoolant) |
| Product Code: | MLY |
| Review Panel: | Physical Medicine |

### Predicate Device:

| Manufacturer: | Gebauer Company |
|---------------|----------------------------------------------------|
| Trade Name: | Gebauer's Skin Refrigerant, Mist and Medium Sprays |
| 510(k): | K031036 |

### De vice De scription:

num Vapocoolant is a sterile-fluid-path, single-use, prescription device that delivers a vapocoolant mixture of 95% r254fa (1,1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,1,2-Tetrafluoroethane). The vapocoolant is stored in a sealed canister within the Main Body of the device. When dispensed from the canister, this mixture self-propels itself from the delivery system using its vapor pressure as propellant leaving the device exits through the Nozzle which is engineered to produce a mist spray. When the vapocoolant reaches the skin, cooling achieved through rapid evaporation of the non-medicated volatile products, and through the cooling capacity of the low-temperature evaporating vapocoolant. Device sterility is achieved through electron beam sterilization and maintained through protective Tyvek lidstock on the top of the nozzle, and a Cap in the base of the Main Body.

Nüm Vapocoolant is intended to be used by trained nurses, healthcare professionals, and pharmacists, in professional healthcare facilities.

#### Indications for Use:

nüm is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils,

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incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries.

### Technological Characteristics and Substantial Equivalence :

The following chart presents an overview of comparisons between the subject device (num Vapocoolant), and the predicate device (Gebauer's Skin Refrigerant):

| Device Attribute | SUBJECT: [Gilero]<br>num Vapocoolant™ | PREDICATE: [Gebauer]<br>Skin Refrigerant | Assessment of Equivalence |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Unclassified | Unclassified | Equivalent |
| Device<br>Classification<br>Name | Refrigerant, Topical<br>(Vapocoolant) | Refrigerant, Topical<br>(Vapocoolant) | Equivalent |
| Regulation<br>Number | N/A - unclassified | N/A - unclassified | Equivalent |
| Product Code | MLY | MLY | Equivalent |
| Indications for<br>Use and Intended<br>Use | nümis a sterile topical<br>anesthetic spray –<br>vapocoolant (skin refrigerant)<br>intended for topical<br>application to to control pain<br>associated with minor<br>surgical procedures (such as<br>lancing boils, incisions and<br>drainage of small abscesses),<br>injections (venipuncture, IV<br>starts) and the temporary<br>relief of minor sports injuries. | Gebauer's Skin Refrigerant<br>(Mist Spray and Medium<br>Spray) Topical Anesthetic: a<br>vapocoolant (skin refrigerant)<br>intended for topical<br>application to control pain<br>associated with minor<br>surgical procedures (such as<br>lancing boils, incisions and<br>drainage of small abscesses),<br>injections (venipuncture, IV<br>starts) and the temporary<br>relief of minor sports injuries.<br>The Medium Spray is also<br>intended for the treatment of<br>restricted motion associated<br>with myofascial pain caused<br>by trigger points | Equivalent<br>The indications for use and<br>intended use of the subject<br>device and predicate device<br>are equivalent.<br>Since the numdevice only<br>exists as a mist spray,<br>additional indications for a<br>medium spray (with its<br>different spray pattern) do not<br>apply.<br>Although the numdevice is<br>provided sterile, this is<br>descriptive and does not alter<br>the indications or intended<br>use. |
| Intended Users | Licensed healthcare<br>practitioners | Licensed healthcare<br>practitioners | Equivalent.<br>Both devices are sold by<br>prescription only and<br>intended to be used by<br>medical practitioners. |
| Principles of<br>Operation | The user applies pressure to<br>the nozzle to dispense the<br>aerosol product onto the skin.<br>The material is contained in a<br>can, filled under pressure, and<br>dispensed using standard<br>aerosol nozzle technology. | The user applies pressure to<br>the nozzle to dispense the<br>aerosol product onto the skin.<br>The material is contained in a<br>can, filled under pressure, and<br>dispensed using standard<br>aerosol nozzle technology. | Equivalent |
| Vapocoolant<br>Composition | 95% 254fa (1,1,1,3,3-<br>Pentafluoropropane) and 5% | 95% 254fa (1,1,1,3,3-<br>Pentafluoropropane) and 5% | Equivalent |
| Device Attribute | SUBJECT: [Gilero] num Vapocoolant™<br>(Tetrafluoroethane) | PREDICATE: [Gebauer] Skin Refrigerant<br>(Tetrafluoroethane) | Assessment of Equivalence |
| Technology and Design | The numdevice provides a vapocoolant mixture consisting of a 95% 245fa and 5% 134a. The mixture provides a positive pressure relative to the surrounding environment so the vapocoolant itself is also the propellant necessary to dispense the vapocoolant from the container. The num device is provided sterile single-dose container.<br><br>When the spray actuator is depressed by theend user, the vapocoolant mixture travels through the misting nozzle under its own pressure. The nozzle separates the mixture into a fine mist which is directed towards the area of the patient where an anesthetic effect is desired.<br><br>Upon reaching the skin, cooling occurs through the rapid evaporation of the non-medicated volatile mixture. This localized cooling creates an anesthetic effect. | The Gebauer Mist device provides a vapocoolant mixture consisting of a 95% 245fa and 5% 134a. The mixture provides a positive pressure relative to the surrounding environment so the vapocoolant itself is also the propellant necessary to dispense the vapocoolant from the container. The Gebauer Mist is provided non-sterile in a multidose container.<br><br>When the spray actuator is depressed by theend user, the vapocoolant mixture travels through the misting nozzle under its own pressure. The nozzle (in the case of the Mist Spray) separates the mixture into a fine mist which is directed towards the area of the patient where an anesthetic effect is desired.<br><br>Upon reaching the skin, cooling occurs through the rapid evaporation of the non-medicated volatile mixture. This localized cooling creates an anesthetic effect. | Equivalent.<br><br>The vapocoolant mixture which reaches the patient consists of an identical mixture of non-medicated volatiles.<br><br>The numdevice contains only a single dose compared to the Gebauer device, however, the numdevice still produces an equivalent cooling effect when both devices are used in accordance with their IFUs,<br><br>Sterilization of the num device does not alter the chemistry of the volatiles.<br><br>These differences in technology and design raise no new types of safety or effectiveness questions with the subject device when compared to the predicate device. |
| Biocompatibility | Acceptable biological risk established by demonstrating that the device meets ISO 10993. See Section 15-Biocompatibility. | Acceptable biological risk established by demonstrating that the device meets ISO 10993 | Equivalent. |
| Environmental Compatibility | Non-Flammable | Non-Flammable | Equivalent |
| Sterilization | Sterile SAL 10-6 | Non-sterile | Although the numdevice is offered in a sterile configuration, the vapocoolant chemistry remains unaltered after sterilization. The vapocoolant composition reaching the patient is the same between the sterile num device and the non-sterile |

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Image /page/5/Picture/1 description: The image shows the logo for 623 Medical. The logo consists of the number 623 inside of a circle that is partially blue. To the right of the circle is the word MEDICAL in all capital letters.

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Image /page/6/Picture/0 description: The image shows the logo for 623 Medical. The number 623 is inside of a circle that is partially completed. The word "MEDICAL" is to the right of the circle.

### Substantial Equivalence Discussion:

num Vapocoolant™ is substantially equivalent to the predicate: Gebauer's Skin Refrigerant. The subject device and the predicate device have similar indications for use and intended use. Both devices are single-use devices that contain the same mixture of 95% 254fa (1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,2-Tetrafluoroethane) with the operation principles being equivalent.

Differences are limited to external packaging, which is for aesthetic and marketing purposes only, and sterilization, which has been shown not to affect material composition. Any difference in materials between the two products has been evaluated through ISO 10993 testing, which demonstrates material safety. The information provided in this submission supports the safety and effectiveness of the subject device for its intended use and demonstrates substantial equivalence with the predicate device.

#### Discussion of Non-clinical Tests:

The following non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.

#### Biocompatibility:

The num Vapocoolant, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (type and duration), in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:

- . Cytotoxicity
- . Sensitization

### Sterilization Validation:

Num Vapocoolant is sterilized using radiation in accordance with a validated sterilization cycle. The following standards were referenced during the sterilization validation process:

- ISO 11137-1:2006 - Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013 Sterilization of Health Care Products-Radiation-Part 2: ● Establishing the sterilization dose
- ISO 11137-3:2017 Sterilization of health care products Radiation Part ● 3: Guidance on dosimetric aspects of development, validation and routine control

### Performance Testing:

Num Vapocoolant is tested to ensure the safety, reliability, and efficacy of the product:

- Device sterility .
- Sterile barrier efficacy

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Image /page/7/Picture/0 description: The image shows the logo for 623 Medical. The number 623 is inside of a circle that is partially blue and partially dark blue. The word "MEDICAL" is to the right of the circle and is in dark blue.

- Sterile barrier usability ●
- Actuation force
- Vapocoolant performance ●
- Spray Production and Duration ●

### Conclusion

The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The num Vapocoolant™ differences in external materials, technology and operation from the predicate device do not raise new questions about safety and effectiveness.