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.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification clearance letter for a medical device called "PainFreeze II," which is a vapocoolant (skin refrigerant). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical effectiveness or accuracy via a traditional clinical trial or performance study typical for diagnostic/AI devices.

Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies that would be present for a diagnostic device or an AI/ML algorithm. The "performance" being assessed here is primarily related to safety, physical characteristics, and equivalence to a predicate, not diagnostic accuracy or clinical outcome improvement.

Based on the provided text, here's what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing performed to demonstrate that the device is similar to its predicate and meets safety/performance requirements. The "criteria" are implied by the successful meeting of test requirements for each evaluation.

Acceptance Criteria (Implied)	Reported Device Performance
Temperature exiting canister similar to Predicate	Evaluation demonstrated the temperature exiting from the canister is similar to the Predicate.
Biocompatibility per ISO 10993-1 (for compromised skin, <24h): - Cytotoxicity - Sensitization - Irritation - Acute Systemic Toxicity - Material Mediated Pyrogenicity	All test criteria were successfully met for each evaluation.
Stability for stated shelf-life limits (24 months): - Visual Inspection - Total Delivery - Pressure - Spray Rate - Leakage/Weight Loss - Microbiological	Test criteria were met at each assessment interval, which demonstrated the Subject Device's stability.
Non-flammable	Non-flammable (listed as a similarity to predicate)
Mechanism has positive shut-off release	Mechanism has positive shut-off release (listed as a similarity to predicate)

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document refers to "evaluations" and "assessments" without quantification of the number of units or tests performed.
Data Provenance: Not specified. These are laboratory-based non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The ground truth for this device's "performance" is based on physical and chemical testing standards and comparison to a predicate, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

Not applicable and not provided. Similarly to point 3, there's no diagnostic component requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a vapocoolant, not a diagnostic AI system or a device intended to assist human readers. Therefore, no MRMC study was conducted. The document explicitly states "Clinical Testing: Not Applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for demonstrating the device's characteristics relies on:

Physical and chemical measurements (e.g., temperature exiting canister, pressure, spray rate, leakage, boiling point).
Standardized biocompatibility testing (ISO 10993-1).
Comparison to the characteristics of the legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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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).

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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

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Indications for Use

510(k) Number (if known) K232674

Device Name PainFreeze II

Indications for Use (Describe)

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).

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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K232674 - 510(K) SUMMARY

Submitter Information

Company Name:	Nuance Medical, Inc.
Company Address:	5931 Sea Lion Place, Suite 113Carlsbad, CA 92010
Company Phone:	(760) 585-9548
Company Facsimile:	(760) 235-4572
Contact Person:	Neal HartmanRegulatory Affairs/Quality Assurancenealenhartman@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	ProductCode	510(K)Number	ClearanceDate
Pain Freeze	Vapocoolant Device/ Unclassified	MLY	K162218	11/22/2016

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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
ComparisonFeature	Subject Device	Predicate Device	Similarities/Differences
Device name	PainFreeze II	PainFreeze
Manufacturer	Nuance Medical, Inc.	Nuance Medical, Inc.
Indications for Use	PainFreeze II Medium Streamand Mist Spray arevapocoolants (skinrefrigerants) intended fortopical application to skin,	Pain Freeze Mist Spray andMedium Stream Spray arevapocoolants (skin refrigerants)intended for topical applicationto skin, intact mucous	Same with the exceptionof removing thestatement "Pain FreezeMedium Stream Sprayis also intended for the
Table 10.1: Comparison Table – Subject & Predicate Devices
ComparisonFeature	Subject Device	Predicate Device	Similarities/Differences
	intact mucous membranes(oral cavity, nasalpassageways, and the lips)and minor open wounds.PainFreeze II's skin refrigerantcontrols pain associated withinjections (venipuncture, IVstarts, cosmetic procedures),minor surgical (lancing boils,incisions, drainage of smallabscesses, and sutures), andthe temporary relief of minorsports injuries (sprains,bruising, cuts and abrasions).	membranes (oral cavity, nasalpassageways, and the lips) andminor open wounds. PainFreeze controls pain associatedwith injections (venipuncture, IVstarts, cosmetic procedures),minor surgical procedures (suchas lancing boils, incisions,drainage of small abscessesand sutures) and the temporaryrelief of minor sports injuries(sprains, bruising, cuts andabrasions). Pain FreezeMedium Stream Spray is alsointended for the management ofmyofascial pain, restrictedmotion and muscle tension.	management ofmyofascial pain,restricted motion andmuscle tension." Thisdoes not impact thesafety and efficacy ofthe device.
ProductConfigurations	Mist sprayMedium stream spray	Mist sprayMedium stream spray	Same
ChemicalComposition	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 thedevice is different.Information incorporatedin the submissionsdemonstrates theformulation is safe andeffective.
Container Size	35ml, 115ml	103.5ml	Volume offered differs,however there is noimpact on safety orefficacy
Target Populations	Adults	Not Publicly Available	Safety and efficacy are notimpacted.
Patient Contact	Skin	Skin	Same
Energy Delivery	Thermal energy via refrigerantspray	Thermal energy via refrigerantspray	Same
VapocoolantDischarge Method	Handheld spray containers.Button on actuator is pressed.	Depress the Actuator Button torelease the vapocoolant	Same
Boiling Point	$-3.0±3°C$	Not Publicly Available	A comparisonevaluation wasconducted, which thetemperature exiting thecanister is similar to thepredicate. Safety andefficacy are notimpacted.
Mechanism ofAction & OperatingPrinciple	Cooling by application ofrefrigerant; Dispensing valveon canister is depressed torelease the refrigerant.	Depress the Actuator Button torelease the vapocoolant	Same
Flammability	Non-flammable	Non-flammable	Same
Mechanical Safety	Mechanism has positive shut-off release	Mechanism has positive shut-offrelease	Same
Shelf-Life	24 months	Not Publicly Available	Shelf-life may differ;however, stability testingis conducted, whichdemonstrates no impactto safety and efficacy.
Storage &Transportation	Not to exceed 49°C	Not Publicly Available	Storage conditions mayvary; however,restrictions areindicated on the productlabeling.

Summary of Technological Characteristics

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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 (<24 hours). Evaluations included:
- Cytotoxicity O
- Sensitization O
- Irritation O
- o Acute Systemic Toxicity
- Material Mediated Pyrogenicity o

All test criteria were successfully met for each evaluation.

Stability The following evaluations were conducted at various assessment ● intervals up to the stated shelf-life limits:
- o Visual Inspection
- Total Delivery O
- Pressure O
- Spray Rate o
- o Leakage/Weight Loss
- o Microbiological

Test criteria were met at each assessment interval, which demonstrated the Subject Device's stability.

Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use and the Predicate.

Clinical Testing

Not Applicable

Conclusions

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

Regulation Number and Section

N/A