Pain Freeze™ Mist Spray and Medium Stray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Freeze™ controls pain associated with injections (venipuncture, IV starts, cosmetic 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.

Device Description

Nuance Medical's Pain Freeze™ (subject device) is a prescription device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 2102) and Medium Stream Spray (Model No. 2101). This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the Pain Freeze™ mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Medium Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Pain Freeze™," a vapocoolant. The document focuses on demonstrating that the subject device is substantially equivalent to a legally marketed predicate device, "Gebauer's Pain Ease."

Here's a breakdown of the acceptance criteria and the study (or, rather, the testing performed to demonstrate substantial equivalence) according to the provided text:

Key Takeaway: This submission is for a vapocoolant (skin refrigerant) and the entire premise of the "study" is to prove substantial equivalence to a predicate device, not to prove clinical efficacy of a novel AI-powered diagnostic/treatment device. Therefore, many of the typical acceptance criteria and study design elements you might expect for an AI/ML device (e.g., AUC, sensitivity/specificity, expert consensus for ground truth, MRMC studies) are not applicable here. The "proof" is based on the devices being nearly identical in composition and performance parameters.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a vapocoolant asserting substantial equivalence), the "acceptance criteria" are based on matching the predicate device's characteristics and performance, rather than achieving specific clinical efficacy metrics.

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (Pain Freeze™)
Chemical Composition: Identical to predicate (95% 245fa, 5% 134a)	Confirmed: "Both systems use identical aerosols profiles: 245fa (1,1,3,3-Pentafluoropropane) at 95% of the total and 134a (1,1,1,2-Tetrafluoroethane) at 5% of the total mixture. The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate."
Structural & Parts Composition: Substantially equivalent canisters, valves, caps	Confirmed: "Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were substantially equivalent between the predicate and the subject device."
Directions for Use (DFU): Substantially equivalent indications, precautions, warnings	Confirmed: "All key elements of the Directions for Use (DFU) for the predicate device and the subject device are all substantially equivalent including indication for use, intended use, precaution statements, warning statements, and contraindication statements, and treatment regiment. No substantial differences exist between the predicate and subject device's Directions for Use."
Temperature & Output Performance: Comparable to predicate in bench testing	Confirmed: "Comparative performance testing was conducted to determine the temperature and output of the predicate and subject devices." (Implied to be comparable; the summary states overall safety and effectiveness profile is similar/identical).
Stability & Shelf Life: Maintain identity, strength, quality, purity over dating period	Confirmed: "A stability protocol was developed to ensure that the identity, strength, quality, and purity of the product is maintained throughout its labeled dating period. Testing assessments were conducted under controlled conditions at room temperature and under accelerated conditions. All requirements were confirmed to meet established acceptance criteria." (Specific numerical criteria not provided, but confirmed to be met.)
Overall Safety and Effectiveness Profile: Similar/identical to predicate	Concluded: "Based on the testing performance conducted the subject device, Pain Freeze™, was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease."
Labeling: Substantially equivalent to predicate	Concluded: "Also, the labeling is substantially equivalent to the predicate device."

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

The document does not describe a test set in the conventional sense of a clinical or image-based study. The "tests" performed are primarily bench testing and material/composition analyses comparing the subject device directly to the predicate device.

Sample Size: Not explicitly stated numerically for each test. For chemical composition, it refers to "the subject device's aerosol" being checked, implying multiple samples would be tested to confirm consistency. For structural composition, "measurements were taken and visual inspections were made," again, not indicating a specific n. For temperature and output bench testing, it states "comparative performance testing was conducted," implying multiple measurements for both devices.
Data Provenance: The data originates from bench testing and material analysis of the manufactured subject device and the predicate device. This is not patient-derived data; it's product performance data. There's no mention of country of origin of data in this context. It's a retrospective comparison to the established predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable. For this type of device (a vapocoolant asserting substantial equivalence), there is no "ground truth" established by human experts in a clinical interpretation sense. The ground truth for chemical composition is determined by analytical instruments. The ground truth for physical characteristics is determined by engineering measurements and visual inspection. The "truth" of comparability is established by the direct measurements against the known characteristics of the predicate device.

4. Adjudication Method for the Test Set

This section is not applicable. Since there are no human interpretations or classifications that require adjudication for a diagnostic or AI algorithm, no adjudication method was used.

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

No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (especially those involving image interpretation by human readers) to assess how human performance is altered by an AI assistant. The Pain Freeze™ device is a topical vapocoolant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

This section is not applicable. There is no algorithm or AI component to the Pain Freeze™ device. It is a physical medical device (a spray vapocoolant).

7. Type of Ground Truth Used

The "ground truth" in this context refers to the established physical and chemical characteristics and performance profiles of the legally marketed predicate device, Gebauer's Pain Ease.

Chemical Composition: Verified by analytical testing of the chemical mixture.
Physical/Structural Design: Verified by engineering measurements and visual inspection.
Performance (Temperature & Output): Verified by direct bench testing measurements.
Stability: Verified by controlled environmental testing over time.
Labeling and Indications: Verified by direct comparison of text and statements.

8. Sample Size for the Training Set

This section is not applicable. There is no AI or machine learning algorithm in the Pain Freeze™ device, and therefore no training set. The device is a "reverse-engineering of its predicate," meaning its design and composition are based directly on the predicate, not learned from a dataset.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and are arranged in a way that suggests a sense of unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

Nuance Medical, LLC Marc Lieberman CEO 5931 Sea Lion Place, Suite 113 Carlsbad, California 92008

Re: K162218

Trade/Device Name: Pain Freeze™, Medium Stream Spray, Model 2101 Pain Freeze™, Mist Spray, Model 2102 Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: MLY Dated: October 21, 2016 Received: October 25, 2016

Dear Marc Lieberman:

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. 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.

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 and Part 809); medical device reporting (reporting of

{1}------------------------------------------------

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Image /page/1/Picture/8 description: The image shows the name "William J. Heetderks -A" in large, bold font on the left side. On the right side, there is a digital signature block that includes information such as the signer's name, organizational details (DN: c=US, o=U.S. Government, ou=HHS, ou=NIH, ou=People), and a specific identifier (0.9.2342.19200300.100.1.1=0010149848). The signature block also includes the date and time of the signature: 2016.11.22 12:58:11-05'00'.

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162218

Device Name

Pain Freeze™, Medium Stream Spray, Model #2101 Pain Freeze™, Mist Spray, Model #2102

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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for "CRYODOSE by Nuance Medical". The word "CRYODOSE" is written in a large, bold font, with "CRYO" in blue and "DOSE" in gray. Above the word "CRYODOSE" is a series of vertical lines that are blue on the left and gray on the right. Below the word "CRYODOSE" is the phrase "by Nuance Medical" in a smaller font.

510(k) Summary – K162218

Nuance Medical, LLC – Pain Freeze™

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

I. SUBMITTER

Owner:	Nuance Medical, LLC.5931 Sea Lion Place, Suite 113Carlsbad, CA 92010(760) 585-4849
Contact Person:	Marc S. LiebermanNuance Medical, LLC.5931 Sea Lion Place, Suite 113Carlsbad, CA 92010(760) 585-4849
Date Prepared:	November 21, 2016

DEVICE

Trade Name:	Pain Freeze TM , Medium Stream Spray, Model #2101Pain Freeze TM , Mist Spray, Model #2102
Common Name:	Cold Spray - 245fa (1,1,1,3,3-Pentafluoropropane) and134a (1,1,1,2-Tetrafluoroethane)
Classification Name:	Refrigerant Topical, Vapocoolant
Product Code:	MLY

PREDICATE DEVICE

Primary:	Gebauer's Pain Ease (Medium Stream Spray & Mist Spray)Gebauer Company.K032671Legally marketed medical device
----------	--------------------------------------------------------------------------------------------------------------------------

II.

III.

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

The predicate is a legally marketed device.

Pain Freeze™, is substantially equivalent, if not identical, to the predicate device Gebauer's Pain Ease (Mist Spray and Medium Stream Spray). Both devices are indicated for use to control pain for pre-injection anesthesia, minor procedures, and minor sports injuries.

The distance and amount applied is determined by the using physician.

V. INDICATIONS FOR USE

The Indications for Use is similar to the predicate device.

Pain Freeze 10 Mist Spray and Medium Stream Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways 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 use the management of myofascial pain, restricted motion and muscle tension.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device has the same technical characteristics as the predicate device including materials, design, and energy source. There are no technological differences between the predicate and the submitted device. Refer to the following table for the comparison between the subject device and the predicate:

{5}------------------------------------------------

Comparison Chart – Technological Characteristics
Trade Name	Gebauer's Pain EaseTMPredicate	Nuance Medical's Pain FreezeTMSubject Device
Product Design	Pressurized dispensing container,which includes the vapocoolant,canister, valve, actuator, and cap	Pressurized dispensing container, whichincludes the vapocoolant, canister,valve, actuator, and cap
Indication for Useand Intended Use	Gebauer's Pain Ease Mist Spray andMedium Stream Spray arevapocoolants (skin refrigerant)intended for topical application to skin,intact mucous, and minor openwounds. Pain Ease controls painassociated with injections(venipuncture, IV starts, cosmeticprocedures), minor surgical procedures(such as lancing boils, incisions,drainage of small abscesses, andsutures), and the temporary relief ofminor sports injuries (sprains, bruising,cuts and abrasions). Pain Ease MediumStream Spray is also intended for thetreatment of myofascial pain caused bytrigger points, restricted motion andmuscle tension.	Pain FreezeTM Mist Spray and MediumStream Spray are vapocoolants (skinrefrigerants) intended for topicalapplication to skin, intact mucousmembranes (oral cavity, nasal passageways and the lips) and minor openwounds. Pain FreezeTM controls painassociated with injections(venipuncture, IV starts, cosmeticprocedures), minor surgical procedures(such as lancing boils, incisions,drainage of small abscesses and sutures)and the temporary relief of minor sportsinjuries (sprains, bruising, cuts andabrasions). Pain FreezeTM MediumStream Spray is also intended for usethe management of myofascial pain,restricted motion and muscle tension.
Product FillVolume	3.5oz (103.5mL)	3.5oz (103.5mL)
VapocoolantComposition	1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and1,1,1,2-Tetrafluoroethane (HFC-134a)5%	1,1,1,3,3-Pentafluoropropane (HFC-245fa) 95% and1,1,1,2-Tetrafluoroethane (HFC-134a)5%
Energy delivered	Thermal Energy via Refrigerant Spray	Thermal Energy via Refrigerant Spray
Energy Deposited	N/A	N/A
VapocoolantDischarge Method	Depress the Actuator Button to releasethe vapocoolant	Depress the Actuator Button to releasethe vapocoolant
EnvironmentalCompatibility	Non-Flammable	Non-Flammable
Mechanical Safety	Mechanism has positive shut-offrelease	Mechanism has positive shut-off release

Substantial Equivalence:

The predicate device is a legally marketed device. The subject device has similar intended use (Indications for Use) as the predicate device. 21 CFR 807.107(b)(1)

The subject device has the same technological characteristics as the predicate device. There are no technological differences, including no changes in the materials, design, energy source, or other features of the device from those of the predicate device. 21 CFR 800.107(b)(2)(i)

{6}------------------------------------------------

The subject device and the predicate device use an identical (substantially equivalent) chemical composition by type and percent of components: 245fa (1,1,1,3,3-Pentafluoropropane) at 95% of the total and 134a (1,1,1,2-Tetrafluoroethane) at 5% of the total mixture.

The subject device and the predicate device use the same materials, design, energy source and other features.

The subject device is a reverse-engineering of its predicate.

Differences, if any, would be limited to discussion and promotion of product, marketing materials, cosmetic labeling, only.

The subject device does not raise questions of safety and effectiveness efficacy different from the predicate device.

Labeling:

The labeling of subject device has been prepared to ensure the medical professional has adequate and clear instructions for safety and usage. The canister labeling, directions for use, safety and warning statements are substantially equivalent to the predicate.

Summary: Pain Freeze™ is substantially equivalent and no technological differences exist to the predicate device. 21 CFR 800.107(b)(2)(i)

VII. PERFORMANCE DATA

The predicate and the subject devices use the same materials, design and energy source and no technological differences exist. Tests were selected and performed to ensure the subject device's output performance are the same as its predicate. The following tests were performed in support of substantial equivalence:

Chemical Composition Confirmation

Both systems use identical aerosols profiles: 245fa (1,1,3,3-Pentafluoropropane) at 95% of the total and 134a (1,1,1,2-Tetrafluoroethane) at 5% of the total mixture.

The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate.

Structural and Parts Composition

Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were substantially equivalent between the predicate and the subject device.

{7}------------------------------------------------

Directions for Use (Clinical Use) Application and Methodology:

All key elements of the Directions for Use (DFU) for the predicate device and the subject device are all substantially equivalent including indication for use, intended use, precaution statements, warning statements, and contraindication statements, and treatment regiment. No substantial differences exist between the predicate and subject device's Directions for Use.

Side-by-Side Temperature & Output Bench Testing

Comparative performance testing was conducted to determine the temperature and output of the predicate and subject devices.

Stability Protocol and Shelf Life Testing

A stability protocol was developed to ensure that the identity, strength, quality, and purity of the product is maintained throughout its labeled dating period. Testing assessments were conducted under controlled conditions at room temperature and under accelerated conditions. All requirements were confirmed to meet established acceptance criteria.

Summarv

Based on the testing performance conducted the subject device, Pain Freeze™, was found to have a safety and effectiveness profile that is similar, if not identical, to the predicate device, Gebauer's Pain Ease.

VIII. CONCLUSION

Based on the information presented above and within this submission, it is concluded that the Pain Freeze™ is safe and effective for its intended use and is substantially equivalent to the predicated device. Also, the labeling is substantially equivalent to the predicate device.

Regulation Number and Section

N/A