(89 days)
No
The device description and performance studies focus on the physical properties and delivery mechanism of a cooling spray, with no mention of AI or ML technologies.
Yes
The device is used for the temporary relief and reduction of minor pain and swelling, which aligns with the definition of a therapeutic device.
No.
The device description and intended use clearly state that CryoDose TA OTC is used for temporary relief and reduction of minor pain and swelling, acting like ice, and for muscle spasm. It does not perform any diagnostic function.
No
The device description clearly outlines a physical delivery system (canisters, valves, caps) and a chemical mixture (245fa and 134a) that is dispensed. This is a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief and reduction of pain and swelling from injuries, and for muscle spasm. This is a therapeutic use applied directly to the body, not for examining specimens taken from the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device delivers a mixture of propellants that cool the skin through rapid evaporation. This is a physical mechanism of action, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on laboratory results
The device is clearly intended for external, topical application for pain relief and cooling, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Mist Spray:
CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Stream Spray:
CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Product codes (comma separated list FDA assigned to the subject device)
MLY
Device Description
Nuance Medical's CryoDose TAOTC (subject device) is an over-the-counter (OTC) device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 1815) and Stream Spray (Model No. 1821). 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 CryoDose TA TTC mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
- Biocompatibility: Cytotoxicity (ISO 10993-5: 2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010). Biocompatibility testing met each evaluation's acceptance requirements, demonstrating the material's safety.
- Chemical Composition Confirmation: The subject device and predicate are composed of identical aerosols profiles, 245fa (1,1,1,3,3-Pentafluoropropane) at 95% and 134a (1,1,2-Tetrafluoroethane) at 5%. Checked and verified upon receipt from supplier.
- Structural and Parts Composition: Engineering verification measurements and visual inspections showed canisters, valves, and caps were equivalent to the predicate.
- Directions for Use (Clinical Use) Application and Methodology: All key elements of the Directions for Use (DFU) between the predicate and the subject device are equivalent including indication for use, intended use, precaution statements, warning statements, and contraindication statements, and treatment regiment.
- Side-by-Side Temperature & Output Bench Testing: Comparative performance testing for temperature output at the application surface and volume dispensed per actuation/total demonstrated equivalent results.
- Stability Protocol and Shelf Life Testing: Stability protocol developed to ensure identity, strength, quality, and purity. Testing under controlled and accelerated conditions met acceptance criteria.
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.
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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 18, 2017
Nuance Medical, LLC Marc Lieberman CEO 5931 Sea Lion Place, Suite 113 Carlsbad, California 92010
Re: K172203
Trade/Device Name: CryoDose TA OTC, Mist Spray and CryoDose TA OTC, Stream Spray Regulatory Class: Unclassified Product Code: MLY Dated: July 19, 2017 Received: July 21, 2017
Dear Marc Lieberman:
We have reviewed vour 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); medical device reporting of 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for 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) K172203
Device Name
CryoDose TA OTC (Mist Spray and Stream Spray)
Indications for Use (Describe)
Mist Spray:
CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Stream Spray:
CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for "CRYODOSE" by Nuance Medical. The word "CRYO" is in blue, and the word "DOSE" is in gray. Above the word "CRYODOSE" is a series of vertical lines in blue and gray.
K172203 – 510(k) Summary
Nuance Medical, LLC – CryoDose TAoTc
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
I. SUBMITTER
II.
III.
| 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: | October 17, 2017 |
| DEVICE | |
| Trade Name: | CryoDose TAOTC, Stream Spray, Model #1821
CryoDose TAOTC, Mist Spray, Model #1815 |
| 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 Instant Ice (Mist Spray & Stream Spray)
Gebauer Company.
K021726
Legally marketed medical device |
| Reference Device: | PainFreeze (Mist Spray & Stream Spray
Nuance Medical
K162218
Legally marketed medical device |
4
DEVICE DESCRIPTION IV.
The predicate is a legally marketed device.
Nuance Medical's CryoDose TAOTC (subject device) is an over-the-counter (OTC) device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 1815) and Stream Spray (Model No. 1821). 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 CryoDose TA TTC mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The 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.
CryoDose TAºTC, is substantially equivalent, if not identical, to the predicate device Gebauer's Instant Ice (Mist Spray and Stream Spray). Both devices are indicated for use to provide temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sport injuries.
INDICATIONS FOR USE V.
The Indications for Use is similar to the predicate device.
Mist Spray:
CryoDose TA TC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Stream Spray:
CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
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 | Nuance Medical's | ||
| CryoDose TAOTC | |||
| Subject Device | Gebauer's Instant Ice | ||
| Predicate | Nuance Medical's PainFreeze | ||
| Reference Device | |||
| Type | OTC | OTC | Rx |
| 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 | Pressurized dispensing | ||
| container, which includes the | |||
| vapocoolant, canister, valve, | |||
| actuator, and cap | |||
| Indication for | |||
| Use/ Intended | |||
| Use | Mist Spray: | ||
| CryoDose TA OTC is | |||
| used like ice for the | |||
| temporary relief and | |||
| reduction of minor pain | |||
| and swelling from sprains, | |||
| strains, | |||
| bruising, contusions and | |||
| minor sports injuries. |
Stream Spray:
CryoDose TA OTC is
used like ice for muscle
spasm and for the
temporary relief and
reduction of minor pain
and
swelling from sprains,
strains, bruising,
contusions and minor
sports injuries. | Clinical conditions that
may respond to the
cooling effect's of
Gebauer's Instant IceTM
Mist Spray are to use
like ice for temporary
relief and reduction of
minor pain and swelling
from sprains, strains,
bruising, contusions or
minor sport injuries. For
Gebauer's Instant IceTM
Stream spray they are to
use like ice for the
temporary relief and
reduction of minor pain
and swelling from
sprains, strains, bruising,
contusions or minor
sports injuries and
muscle spasms. | PainFreeze™ 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.
PainFreezeTM 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). PainFreezeTM
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) | 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% | 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 | Thermal Energy via Refrigerant
Spray |
| Energy
Deposited | N/A | N/A | N/A |
| Vapocoolant
Discharge
Method | Depress the Actuator
Button to release the
vapocoolant | Depress the Actuator
Button to release the
vapocoolant | Depress the Actuator Button to
release the vapocoolant |
| Environmental
Compatibility | Non-Flammable | Non-Flammable | Non-Flammable |
| Mechanical
Safety | Mechanism has positive
shut off release | Mechanism has positive
shut off release | Mechanism has positive shut-
off release |
6
Substantial Equivalence:
The predicate and reference device are legally marketed devices. The subject device has similar intended use (Indications for Use) as the predicate device. The reference device's Indications for Use is similar in that it is topically applied for temporary relief of minor sports injuries, however is also associated with injections and minor surgical procedures that is conducted by healthcare professionals. 21 CFR 807.107(b)(1)
The subject device is for Over-The-Counter (OTC) like the predicate. The reference device is the Rx version of the subject device.
The subject device has the same technological characteristics as the predicate and reference 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 or reference device. 21 CFR 800.107(b)(2)(i)
The subject, predicate, and reference devices use 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 (1,1,2-Tetrafluoroethane) at 5% of the total mixture.
The subject, predicate, and reference devices use the same materials, design, energy source and other features.
The subject device is a reverse-engineering of its predicate and identical to the reference device.
Differences between the subject, predicate, and reference device, if any, would be limited to discussion and promotion of product, marketing materials, and cosmetic labeling as well as the reference device is for prescription use while the subject device and predicate are OTC.
The subject device does not raise questions of safety and effectiveness efficacy different from the predicate or the reference 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: CryoDose TAOTC is substantially equivalent and no technological differences exist to the predicate device. 21 CFR 800.107(b)(2)(i)
VII. PERFORMANCE DATA
The subject, predicate, and reference 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:
Biocompatibility
Since the reference device is identical to the subject device's composition and indication for use, the biocompatibility results of the reference device were utilized. The subject/reference
7
device is categorized as a surface-contacting/breached or compromised surface with limited contact duration (≤ 24 hours). The biocompatibility test program is based on ISO 10993-1:2009, which the following evaluations were conducted:
- Cytotoxicity (ISO 10993-5: 2009) ●
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010)
Biocompatibility testing met each evaluation's acceptance requirements, which demonstrated the material's safety.
Chemical Composition Confirmation
The subject device and predicate are composed of identical aerosols profiles, which is 245fa (1,1,1,3,3-Pentafluoropropane) at 95% of the total and 134a (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
Since the reference device is identical to the subject device's construction, engineering verification results for the reference device were utilized. Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were equivalent to the predicate.
Directions for Use (Clinical Use) Application and Methodology:
All key elements of the Directions for Use (DFU) between the predicate and the subject device are 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
Since the reference device is identical to the subject device's construction and composition, the performance results for the reference device were utilized. Comparative performance testing was conducted as it related to temperature output at the application surface and volume dispensed per actuation/total and equivalent results were demonstrated.
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 performance evaluations conducted as it relates to the subject device, as compared to the predicate, it was found to be safety and effectiveness and similar, if not identical, to the predicate. The following was demonstrated for substantial equivalence:
- Material safety through biocompatibility
8
- Identical chemical composition ●
- Identical canister volume and construction ●
- Identical clinical use, application and methodology
- Equivalent temperature at application surface and volume dispersed from canister ●
VIII. CONCLUSION
Based on the information provided in the submission, it is concluded that the CryoDose TAOTC is safe and effective for its intended use and has demonstrated substantially equivalent to the predicated device.