(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and delivery mechanism of a vapocoolant spray, with no mention of AI or ML technologies.
Yes.
The device is intended to control pain, which is considered a therapeutic effect, and is used for temporary relief of minor sports injuries.
No
This device is a topical anesthetic spray/vapocoolant used for pain control and temporary relief of minor injuries by cooling the skin. It does not collect or analyze any physiological data to diagnose a condition.
No
The device description clearly outlines a physical device with a canister, nozzle, and delivery system for a vapocoolant mixture. It also mentions sterilization and physical performance testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to control pain associated with minor surgical procedures, injections, and temporary relief of minor sports injuries. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device delivers a vapocoolant mixture to the skin for cooling. This mechanism of action is physical and topical, not involving the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnostic purposes. This device's function is entirely external and related to pain management through cooling.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MLY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nüm Vapocoolant is intended to be used by trained nurses, healthcare professionals, and pharmacists, in professional healthcare facilities.
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)
Non-clinical tests were conducted including:
- Biocompatibility: Cytotoxicity, Sensitization
- Sterilization Validation: In accordance with ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017
- Performance Testing: Device sterility, Sterile barrier efficacy, Sterile barrier usability, Actuation force, Vapocoolant performance, Spray Production and Duration
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 shows 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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
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
1
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
2
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) | |
|---|---|
| ☑ 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 100 |
| Morrisville, 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:
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,
4
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 |
| Device
Classification
Name | Refrigerant, Topical
(Vapocoolant) | Refrigerant, Topical
(Vapocoolant) | Equivalent |
| Regulation
Number | N/A - unclassified | N/A - unclassified | Equivalent |
| Product Code | MLY | MLY | Equivalent |
| Indications for
Use and Intended
Use | nümis a sterile topical
anesthetic spray –
vapocoolant (skin refrigerant)
intended for topical
application to 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. | Gebauer's Skin Refrigerant
(Mist Spray and Medium
Spray) Topical Anesthetic: a
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 Medium Spray is also
intended for the treatment of
restricted motion associated
with myofascial pain caused
by trigger points | Equivalent
The indications for use and
intended use of the subject
device and predicate device
are equivalent.
Since the numdevice only
exists as a mist spray,
additional indications for a
medium spray (with its
different spray pattern) do not
apply.
Although the numdevice is
provided sterile, this is
descriptive and does not alter
the indications or intended
use. |
| Intended Users | Licensed healthcare
practitioners | Licensed healthcare
practitioners | Equivalent.
Both devices are sold by
prescription only and
intended to be used by
medical practitioners. |
| Principles of
Operation | The user applies pressure to
the nozzle to dispense the
aerosol product onto the skin.
The material is contained in a
can, filled under pressure, and
dispensed using standard
aerosol nozzle technology. | The user applies pressure to
the nozzle to dispense the
aerosol product onto the skin.
The material is contained in a
can, filled under pressure, and
dispensed using standard
aerosol nozzle technology. | Equivalent |
| Vapocoolant
Composition | 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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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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- 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.