K Number

Device Name

PainFreeze II

Manufacturer

Nuance Medical, LLC

Date Cleared

2024-02-12

(164 days)

Product Code

MLY

Regulation Number

N/A

Intended Use

PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Device Description

The Subject Device consists of a chemical blend of 60% HFO-1233zd (Trans-1-chloro-3.3.3- trifluoropropene) and 40% HFO-1234ze (trans- 1.3.3.3-tetrafluoroprop-1- ene) that produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds. The product is delivered in the form of an aerosol in either a mist or stream spray. The device's delivery system controls the amount of chemical blend that is dispensed, the mist spray configuration produces very fine droplets that cools at the points of contact. The stream spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Upon contact with the skin, the product begins to evaporate immediately as it contacts the skin. The low evaporation rate of the product's chemical blend is what creates the coldness. The Subject Device is non- flammable and has a lower global warming potential than the predicate and provides equivalent performance. The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface. With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect. The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162218

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the chemical composition and physical delivery mechanism of a vapocoolant, with no mention of AI or ML technologies. The performance studies are related to temperature, biocompatibility, and stability, not algorithmic performance.

Therapeutic

Yes.
The device is intended to control pain, a medical condition, by producing a cooling effect for temporary relief, which is a therapeutic function.

Diagnostic

Explanation: The device is described as a "vapocoolant (skin refrigerant)" intended for pain control and temporary relief of minor injuries. Its mechanism of action is producing a cooling effect through evaporation for symptomatic relief, not for diagnosing any condition.

SaMD (Software as a Medical Device)

The device is a chemical blend delivered via a pressurized canister with a valve and actuator, which are hardware components. The description focuses on the chemical composition and physical delivery mechanism, not software.

IVD (In Vitro Diagnostic)

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 the skin, intact mucous membranes, and minor open wounds to control pain and provide temporary relief. This is a direct therapeutic or palliative effect on the body.
Device Description: The device is a chemical blend delivered as an aerosol that creates a cooling effect through evaporation on the body surface. It's a physical interaction with the body.
Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

IVD devices are specifically designed to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose or monitor a medical condition. This device acts on the body surface.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

PamFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Product codes

MLY

Device Description

The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface.

With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect.

The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

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 passageways and the lips) and minor open wounds

Indicated Patient Age Range

Adults

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

Non-Clinical Testing:

Study type: Temperature Comparison
Sample size: Not specified
Key results: Evaluation demonstrated the temperature exiting from the canister is similar to the Predicate.
Study type: Biocompatibility Evaluations (per ISO 10993-1)
Sample size: Not specified
Key results: All test criteria were successfully met for each evaluation, including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Material Mediated Pyrogenicity.
Study type: Stability
Sample size: Not specified
Key results: Test criteria were met at each assessment interval, which demonstrated the Subject Device's stability, including Visual Inspection, Total Delivery, Pressure, Spray Rate, Leakage/Weight Loss, and Microbiological.

Clinical Testing:
Not Applicable

Conclusions: The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate.

Key Metrics

Not Found

Predicate Device(s)

K162218

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2024

Nuance Medical, LLC Neal Hartman Regulatory Affairs/Quality Assurance 5931 Sea Lion Place, Suite 113 Carlsbad, California 92010

Re: K232674

Trade/Device Name: PainFreeze II Regulatory Class: Unclassified Product Code: MLY Dated: August 31, 2023 Received: September 1, 2023

Dear Neal Hartman:

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 (the 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 available 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, 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,

Lauren E. Woodard -S

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K232674

Device Name PainFreeze II

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)

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."

Image /page/3/Picture/0 description: The image shows the logo for Nuance Medical. The word "NUANCE" is written in large, bold, dark blue letters. Below it, the word "MEDICAL" is written in smaller, orange letters. The logo is framed by thin orange lines on the left and right sides.

K232674 - 510(K) SUMMARY

Submitter Information

Company Name:	Nuance Medical, Inc.
Company Address:	5931 Sea Lion Place, Suite 113
Carlsbad, CA 92010
Company Phone:	(760) 585-9548
Company Facsimile:	(760) 235-4572
Contact Person:	Neal Hartman
Regulatory Affairs/Quality Assurance
nealenhartman@gmail.com
Date:	January 29, 2024

Device Identification

Device Trade Name:	PainFreeze II
Common Name:	Cold Spray (Skin Refrigerant)
Models:	#1830 - Mist Stray, 115ml
#1831 - Medium Stream, 115ml
#1832 - -Mist Spray, 35ml
#1833 - Medium Stream, 35ml
Classification Name(s):	Vapocoolant Device
Regulation(s):	Unclassified
Device Class:	Unclassified
Product Code(s):	MLY

ldentification of Predicate Devices

The System Device is substantially equivalent to the following device:

| Device Name | Classification Name/Regulation | Product
Code | 510(K)
Number | Clearance
Date |
|-------------|----------------------------------|-----------------|------------------|-------------------|
| Pain Freeze | Vapocoolant Device/ Unclassified | MLY | K162218 | 11/22/2016 |

Common Name: Cold Spray – 245fa (1.1.1.3.3-Pentafluorpropane) and 134a (1.1.1.2-Tetrafluoroethane)

Device Description

The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface.

The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

Indications for Use

PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with iniections (venipuncture, IV starts, cosmetic procedures). minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

Table 10.1: Comparison Table - Subject & Predicate Devices
Comparison
Feature	Subject Device	Predicate Device	Similarities/
Differences
Device name	PainFreeze II	PainFreeze
Manufacturer	Nuance Medical, Inc.	Nuance Medical, Inc.
Indications for Use	PainFreeze II Medium Stream
and Mist Spray are
vapocoolants (skin
refrigerants) intended for
topical application to skin,	Pain Freeze Mist Spray and
Medium Stream Spray are
vapocoolants (skin refrigerants)
intended for topical application
to skin, intact mucous	Same with the exception
of removing the
statement "Pain Freeze
Medium Stream Spray
is also intended for the
Table 10.1: Comparison Table – Subject & Predicate Devices
Comparison
Feature	Subject Device	Predicate Device	Similarities/
Differences
	intact mucous membranes
(oral cavity, nasal
passageways, and the lips)
and minor open wounds.
PainFreeze II's skin refrigerant
controls pain associated with
injections (venipuncture, IV
starts, cosmetic procedures),
minor surgical (lancing boils,
incisions, drainage of small
abscesses, and sutures), and
the temporary relief of minor
sports injuries (sprains,
bruising, cuts and abrasions).	membranes (oral cavity, nasal
passageways, and the lips) and
minor open wounds. Pain
Freeze 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 Freeze
Medium Stream Spray is also
intended for the management of
myofascial pain, restricted
motion and muscle tension.	management of
myofascial pain,
restricted motion and
muscle tension." This
does not impact the
safety and efficacy of
the device.
Product
Configurations	Mist spray
Medium stream spray	Mist spray
Medium stream spray	Same
Chemical
Composition	HFO-1233zd (Trans-1-chloro-
3,3,3- trifluoropropene) 60%
and HFO-1234ze (trans-
1,3,3,3-tetrafluoroprop-1- ene)
40%	1,1,1,3,3-Pentafluoropropane
(HFC-245fa) 95% and 1,1,1,2-
Tetrafluoroethane (HFC-134a)
5%	The formation of the
device is different.
Information incorporated
in the submissions
demonstrates the
formulation is safe and
effective.
Container Size	35ml, 115ml	103.5ml	Volume offered differs,
however there is no
impact on safety or
efficacy
Target Populations	Adults	Not Publicly Available	Safety and efficacy are not
impacted.
Patient Contact	Skin	Skin	Same
Energy Delivery	Thermal energy via refrigerant
spray	Thermal energy via refrigerant
spray	Same
Vapocoolant
Discharge Method	Handheld spray containers.
Button on actuator is pressed.	Depress the Actuator Button to
release the vapocoolant	Same
Boiling Point	$-3.0±3°C$	Not Publicly Available	A comparison
evaluation was
conducted, which the
temperature exiting the
canister is similar to the
predicate. Safety and
efficacy are not
impacted.
Mechanism of
Action & Operating
Principle	Cooling by application of
refrigerant; Dispensing valve
on canister is depressed to
release the refrigerant.	Depress the Actuator Button to
release the vapocoolant	Same
Flammability	Non-flammable	Non-flammable	Same
Mechanical Safety	Mechanism has positive shut-
off release	Mechanism has positive shut-off
release	Same
Shelf-Life	24 months	Not Publicly Available	Shelf-life may differ;
however, stability testing
is conducted, which
demonstrates no impact
to safety and efficacy.
Storage &
Transportation	Not to exceed 49°C	Not Publicly Available	Storage conditions may
vary; however,
restrictions are
indicated on the product
labeling.

Summary of Technological Characteristics

Non-Clinical Testing

Assessments were performed that includes the following:

Temperature Comparison - Evaluation demonstrated the temperature exiting from the canister is similar to the Predicate.
Biocompatibility Evaluations were conducted per ISO 10993-1 Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process for devices in contact with compromised skin and a limited exposure (