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 Description

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "num Vapocoolant™" device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance "acceptance criteria" and a "study" in the traditional sense of a clinical trial proving performance against those criteria. In 510(k) submissions for devices like this vapocoolant, the "acceptance criteria" are implicitly met by demonstrating equivalence to a legally marketed predicate device, especially for unclassified devices.

The "study" here is a series of non-clinical tests and comparisons to establish this substantial equivalence. There is no information about an AI/ML component, human readers, expert consensus for ground truth on patient data, MRMC studies, or training/test sets as these concepts typically apply to AI/ML device evaluations.

Therefore, the response below will interpret "acceptance criteria" in the context of a 510(k) submission for a non-AI/ML device seeking substantial equivalence, and the "study" as the set of non-clinical tests and comparisons performed.

Acceptance Criteria and Device Performance for num Vapocoolant™

For the num Vapocoolant™ device, the "acceptance criteria" are implicitly met by demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, Gebauer's Skin Refrigerant. The performance criteria for such a device largely revolve around safety, the intended mechanism of action (cooling through rapid evaporation), and equivalence in composition and application compared to the predicate. The "study" proving acceptance is the detailed comparison and non-clinical testing outlined in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implicit in 510(k) SE)	Specific Criterion (as demonstrated by SE)	Reported Device Performance (as per 510(k) submission)
Indications for Use (IFU)	Equivalent IFU to predicate device.	`num Vapocoolant™` shares identical indications for use with the predicate: "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." The only difference noted is that since `num vapocoolant` is only a mist spray, additional indications for a medium spray (which the predicate has) do not apply to the subject device.
Intended Users	Equivalent intended users to predicate device.	Both devices are intended to be used by "Licensed healthcare practitioners" and are sold by prescription only.
Principles of Operation	Equivalent mechanism of action for cooling.	Both devices operate by the user applying pressure to the nozzle, dispensing an aerosol product onto the skin. The material is contained in a can, filled under pressure, and dispensed using standard aerosol nozzle technology. Cooling is achieved through rapid evaporation of non-medicated volatile products.
Vapocoolant Composition	Identical chemical composition of the cooling agent.	Both devices use a mixture of 95% 254fa (1,1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,1,2-Tetrafluoroethane).
Technology and Design	No new types of safety or effectiveness questions raised by differences.	The `num` device provides the same vapocoolant mixture and mechanism of dispensing and cooling. Differences and Assessment:- `num` is a sterile, single-dose container; predicate is non-sterile, multi-dose.- Assessment: Sterilization does not alter chemistry of volatiles. The single-dose design of `num` still produces an equivalent cooling effect when used as per IFU. These differences do not raise new safety or effectiveness questions.
Biocompatibility	Acceptable biological risk for patient contact.	Demonstrated compliance with ISO 10993, including Cytotoxicity and Sensitization testing. This established acceptable biological risk.
Sterilization (if applicable)	Validated sterilization process and maintenance of sterility.	`num Vapocoolant™` is sterile (SAL 10⁻⁶) via radiation, validated per ISO 11137 series. This differs from the predicate (non-sterile), but the vapocoolant chemistry is unaltered by sterilization.
Performance Testing (Mechanism & Delivery)	Ensures safety, reliability, and efficacy of product delivery and function, similar to predicate.	Non-clinical performance tests included: Device sterility, Sterile barrier efficacy, Sterile barrier usability, Actuation force, Vapocoolant performance, and Spray Production and Duration. These tests would ensure the device consistently delivers the vapocoolant as intended.
Environmental Compatibility	Non-flammable.	Both devices are Non-Flammable.

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) submission does not involve a "test set" in the context of an AI/ML device evaluated on patient data. The "tests" here are non-clinical, laboratory-based evaluations of the device's physical and chemical properties and performance characteristics, as well as a direct comparison to a predicate device. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

3. Number of Experts and Qualifications for Ground Truth

This submission does not mention the use of experts to establish "ground truth" for a test set of patient data, as it is not an AI/ML device evaluating medical images or patient outcomes. The determination of substantial equivalence is made by the FDA based on the submission's evidence, often relying on established standards and testing protocols rather than multi-expert consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient cases requiring adjudication by multiple readers or experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a vapocoolant spray and not an AI/ML diagnostic or assistive tool where human reader performance would be measured with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable, as this device is a physical medical device (vapocoolant spray), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established by demonstrated compliance with recognized standards and direct comparison to a legally marketed predicate device.

Predicate Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate device (Gebauer's Skin Refrigerant), which the num Vapocoolant™ aims to be substantially equivalent to.
Non-clinical Test Standards: "Ground truth" for specific parameters (e.g., biocompatibility, sterilization, spray performance) is derived from ISO 10993 (biocompatibility), ISO 11137 series (sterilization), and other implicit engineering and performance standards for medical spray devices.

8. Sample Size for the Training Set

Not applicable. The described device is a physical product, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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510(k) Summary

Company Name:	Gilero, LLC
Company Address:	635 Davis Drive Suite 100Morrisville, NC 27560
Company Phone:	+1 (919) 595-8220

Official Contact: Phone : E-mail:

Jim Fentress +1 (919) 595-8236 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:

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]num Vapocoolant™	PREDICATE: [Gebauer]Skin Refrigerant	Assessment of Equivalence
Device Class	Unclassified	Unclassified	Equivalent
DeviceClassificationName	Refrigerant, Topical(Vapocoolant)	Refrigerant, Topical(Vapocoolant)	Equivalent
RegulationNumber	N/A - unclassified	N/A - unclassified	Equivalent
Product Code	MLY	MLY	Equivalent
Indications forUse and IntendedUse	nümis a sterile topicalanesthetic spray –vapocoolant (skin refrigerant)intended for topicalapplication to to control painassociated with minorsurgical procedures (such aslancing boils, incisions anddrainage of small abscesses),injections (venipuncture, IVstarts) and the temporaryrelief of minor sports injuries.	Gebauer's Skin Refrigerant(Mist Spray and MediumSpray) Topical Anesthetic: avapocoolant (skin refrigerant)intended for topicalapplication to control painassociated with minorsurgical procedures (such aslancing boils, incisions anddrainage of small abscesses),injections (venipuncture, IVstarts) and the temporaryrelief of minor sports injuries.The Medium Spray is alsointended for the treatment ofrestricted motion associatedwith myofascial pain causedby trigger points	EquivalentThe indications for use andintended use of the subjectdevice and predicate deviceare equivalent.Since the numdevice onlyexists as a mist spray,additional indications for amedium spray (with itsdifferent spray pattern) do notapply.Although the numdevice isprovided sterile, this isdescriptive and does not alterthe indications or intendeduse.
Intended Users	Licensed healthcarepractitioners	Licensed healthcarepractitioners	Equivalent.Both devices are sold byprescription only andintended to be used bymedical practitioners.
Principles ofOperation	The user applies pressure tothe nozzle to dispense theaerosol product onto the skin.The material is contained in acan, filled under pressure, anddispensed using standardaerosol nozzle technology.	The user applies pressure tothe nozzle to dispense theaerosol product onto the skin.The material is contained in acan, filled under pressure, anddispensed using standardaerosol nozzle technology.	Equivalent
VapocoolantComposition	95% 254fa (1,1,1,3,3-Pentafluoropropane) and 5%	95% 254fa (1,1,1,3,3-Pentafluoropropane) and 5%	Equivalent
Device Attribute	SUBJECT: [Gilero] num Vapocoolant™(Tetrafluoroethane)	PREDICATE: [Gebauer] Skin Refrigerant(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.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.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.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.Upon reaching the skin, cooling occurs through the rapid evaporation of the non-medicated volatile mixture. This localized cooling creates an anesthetic effect.	Equivalent.The vapocoolant mixture which reaches the patient consists of an identical mixture of non-medicated volatiles.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,Sterilization of the num device does not alter the chemistry of the volatiles.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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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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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.

Regulation Number and Section

N/A