(106 days)
Not Found
No
The device description and performance studies focus solely 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, a therapeutic effect, and is also described as managing myofascial pain, restricted motion, and muscle tension, which are all therapeutic uses.
No
The device is a vapocoolant intended for topical pain relief and myofascial pain management, not for diagnosing medical conditions.
No
The device description clearly states it is a "prescription device designed to deliver a standard mixture" of chemical propellants and describes a "delivery system" with "configurations" (Mist Spray and Medium Stream Spray) that control the dispensing of this mixture. This indicates a physical hardware component for delivery, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for topical application to the skin, mucous membranes, and minor open wounds for pain control and temporary relief of minor injuries. This is a direct application to the body for a therapeutic effect (pain relief through cooling).
- Device Description: The description details a spray that delivers a mixture of propellants that cool the skin through rapid evaporation. This is a physical mechanism acting on the body's surface.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are used in vitro (outside the body) to analyze biological samples.
The device is a topical pain relief product that works through a physical cooling mechanism, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
MLY
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.
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 passage ways and the lips)
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Summary: 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.
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
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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.
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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)
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.
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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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 113
Carlsbad, CA 92010
(760) 585-4849 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marc S. Lieberman
Nuance Medical, LLC.
5931 Sea Lion Place, Suite 113
Carlsbad, CA 92010
(760) 585-4849 |
| Date Prepared: | November 21, 2016 |
DEVICE
| Trade Name: | Pain Freeze TM , Medium Stream Spray, Model #2101
Pain Freeze TM , Mist Spray, Model #2102 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cold Spray - 245fa (1,1,1,3,3-Pentafluoropropane) and
134a (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.
K032671
Legally marketed medical device |
---------- | -------------------------------------------------------------------------------------------------------------------------- |
---|
II.
III.
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IV. DEVICE DESCRIPTION
The predicate is a legally marketed device.
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.
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:
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Comparison Chart – Technological Characteristics | ||
---|---|---|
Trade Name | Gebauer's Pain EaseTM | |
Predicate | Nuance Medical's Pain FreezeTM | |
Subject Device | ||
Product Design | Pressurized dispensing container, | |
which includes the vapocoolant, | ||
canister, valve, actuator, and cap | Pressurized dispensing container, which | |
includes the vapocoolant, canister, | ||
valve, actuator, and cap | ||
Indication for Use | ||
and Intended Use | Gebauer's Pain Ease Mist Spray and | |
Medium Stream Spray are | ||
vapocoolants (skin refrigerant) | ||
intended for topical application to skin, | ||
intact mucous, and minor open | ||
wounds. Pain Ease 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 Ease Medium | ||
Stream Spray is also intended for the | ||
treatment of myofascial pain caused by | ||
trigger points, restricted motion and | ||
muscle tension. | Pain FreezeTM 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 FreezeTM 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 FreezeTM Medium | ||
Stream Spray is also intended for use | ||
the management of myofascial pain, | ||
restricted motion and muscle tension. | ||
Product Fill | ||
Volume | 3.5oz (103.5mL) | 3.5oz (103.5mL) |
Vapocoolant | ||
Composition | 1,1,1,3,3-Pentafluoropropane (HFC- | |
245fa) 95% and | ||
1,1,1,2-Tetrafluoroethane (HFC-134a) | ||
5% | 1,1,1,3,3-Pentafluoropropane (HFC- | |
245fa) 95% and | ||
1,1,1,2-Tetrafluoroethane (HFC-134a) | ||
5% | ||
Energy delivered | Thermal Energy via Refrigerant Spray | Thermal Energy via Refrigerant Spray |
Energy Deposited | N/A | N/A |
Vapocoolant | ||
Discharge Method | Depress the Actuator Button to release | |
the vapocoolant | Depress the Actuator Button to release | |
the vapocoolant | ||
Environmental | ||
Compatibility | Non-Flammable | Non-Flammable |
Mechanical Safety | Mechanism has positive shut-off | |
release | 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)
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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.
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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.