K Number

Device Name

Syringe Holder accessory

Manufacturer

Vapocoolshot, Inc.

Date Cleared

2020-08-12

(93 days)

Product Code

MLY PRE

Regulation Number

N/A

Intended Use

The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions) The Syringe Holder accessory is intended to be attached to the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.

Device Description

The Syringe Holder accessory (K201248) on the Nozzle of the Primary predicate Vapocoolshot Mist (K193349), allows the attachment of a user supplied syringe diameter 1cc (4.5mm) to 3 cc (10.8mm) for the practitioner to focus on the transient blanching effect for the best rapid, targeted, comfortable and efficient use of the gas Blend misting action onto the skin surface accordance with the best judgment of the physician under aseptic conditions. The Primary predicate Vapocoolshot Mist (K193349) is a vapocoolant (skin refrigerant) canister with standard gas Blend 245fa (1,1,3,3 Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane) that is designed to spray onto the skin surface for a comfort injection procedure. The vapocoolant cools the skin through rapid evaporation of the non-medicated propellants. The subject device, Syringe Holder accessory (K201248) helps direct the site with the following efficient use of the gas Blend with the syringe: configures refrigerant gas to a mist, targets the transient blanche site, one handed use, keeps the syringe in the same path, and controls the amount of the vapocoolant mixture that is dispensed for the practitioner. Thus, the accessory device avoids over spraying and having to switch from a canister spray effect to a syringe injection technique that may have dissipated the transient numbing effect for comfort results.

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

K193349, K093951

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on a mechanical accessory for a vapocoolant spray and do not mention any computational or learning capabilities.

Therapeutic

Yes.
The device is intended to lessen pain associated with medical procedures and injuries by cooling the skin, which is a therapeutic effect.

Diagnostic

The Vapocoolshot Mist and its accessory are intended for topical application to cool the skin and provide temporary pain relief, not to identify or monitor a medical condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly details a physical accessory (Syringe Holder) and its interaction with a physical vapocoolant canister, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Vapocoolshot Mist and its Syringe Holder accessory are used for topical application to the skin and mucous membranes to provide temporary cooling for pain relief during procedures and injuries. They do not analyze samples taken from the body.
Intended Use: The intended use clearly describes a topical application for pain management, not diagnostic testing.

Therefore, this device falls under the category of a medical device used for pain management and procedural assistance, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Syringe Holder accessory is intended to be attached to the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.

Product codes (comma separated list FDA assigned to the subject device)

MLY

Device Description

The subject device, Syringe Holder accessory (K201248) helps direct the site with the following efficient use of the gas Blend with the syringe: configures refrigerant gas to a mist, targets the transient blanche site, one handed use, keeps the syringe in the same path, and controls the amount of the vapocoolant mixture that is dispensed for the practitioner. Thus, the accessory device avoids over spraying and having to switch from a canister spray effect to a syringe injection technique that may have dissipated the transient numbing effect for comfort results.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Practitioner / Not specified, but implied to be a medical setting (e.g., clinic, hospital) due to procedures like venipuncture, IV starts, minor surgical procedures.

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)

Usability study was performed with the attachment of a user supplied syringe to the Nozzle with the Syringe Holder accessory (K201248).
Comparative performance testing was conducted as it related to attachment of a user supplied syringe as an accessory device. Usability testing performed on subject device as a unit for efficacy and safety as an accessory introducer.
Results: Syringe Holder Accessory (K201248) when used with the Primary Predicate Vapocoolshot Mist (K193349) were found to be safe and effective to the Predicate 1 (Ouchless).

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.

K193349, K093951

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

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

August 12, 2020

Vapocoolshot, Inc. % Neil Ross Chief Scientific officer. Ouality Affairs N2Pharma, LLC 1071 Nandina Dr Weston, Florida 33327

Re: K201248

Trade/Device Name: Syringe Holder accessory (VM03000) Regulatory Class: Unclassified Product Code: MLY Dated: May 11, 2020 Received: May 14, 2020

Dear Neil Ross:

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. 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 located 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.

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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

Amber Ballard. PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine 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)

K201248

Device Name Syringe Holder accessory (VM03000)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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."

510(k) Summary

Traditional

Vapocoolshot Inc. - Syringe Holder accessory

Type of 510(k) submission:

1. Submitter:

510(k) submitter/ Owner:

Vapocoolshot, Inc. 1155 Main St, Suite 105 Jupiter, Fl. 33458 561-427-0420 (main) 561-420-8330 (fax)

Neil Ross Chief scientist neildonaldross@gmail.com

June 12, 2020

Contact person:

Date Prepared:

1. Subject device: Name/Classification Special Controls: Device Class: Review panel: Product code:

3. Trade Name of Subject Device:

1. Primary Predicate:
  Common Name

Device: Device Class: Review panel: Product code:

Predicate 1:

Basis for Submission:

Syringe Holder accessory for K193349 None unclassified Physical Medicine MLY

Syringe Holder Accessory (VM03000)

Vapocoolshot Mist (Model VM11000) Vapocoolshot, Inc. K193349

Cold Spray - 245fa (1,1,1,3,3-Pentafluropropane) and 134a (1,1,1,2-Tetrafluroethane) Refrigerant, Topical (Vapocoolant) Unclassified Physical Medicine MLY

Ouchless Occam Design LLC K093951

New accessory Device

I. DEVICE DESCRIPTION

The Syringe Holder accessory (K201248) is equivalent to the predicate 1 device, Ouchless. Both devices help direct for topical application of refrigerant (cold like ice) to the skin with the attachment of a user supplied syringe. Primary predicate Vapocoolshot Mist (K193349) is used for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Primary predicate Vapocoolshot Mist (K193349) is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions). Ouchless and Syringe Holder devices attach to a user supplied syringe with the same exact blend of The Syringe Holder accessory is the attachment of the "introducer" of the user vapocoolant. supplied syringe to the vapocoolant.

II. INDICATIONS FOR USE

The Syringe Holder accessory is intended to be attached to the Nozzle of the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) to 3 cc (10.8mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.

III. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device Syringe Holder accessory (K201248) has similar technical characteristics as the Predicate 1 device (Ouchless). Refer to the following table for the comparison between the subject device Syringe Holder accessory, Primary Predicate Vapocoolshot Mist, and the Predicate 1, Ouchless:

The basic principle of attaching a canister to a user supplied syringe is similar with the Predicate 1
Ouchless and the Syringe Holder accessory as a unit.

Comparison Chart – Technological Characteristics
Trade Name	Syringe Holder accessory
Subject Device
K201248	Vapocoolshot Mist
K193349
Primary Predicate	Ouchless
K093951
Predicate 1
Type	Rx	Rx	Rx
Product
Design as a
unit	Syringe Holder accessory.	Pressurized dispensing container,
which includes the vapocoolant,
canister, valve, actuator, cap and an
accessory nozzle.	Pressurized dispensing container,
which includes the vapocoolant,
canister, valve, syringe attachment,
and nozzle. (No canister cap, No
actuator)
Indication for
Use	The Syringe Holder accessory
on the Nozzle of the
Vapocoolshot Mist allows the
attachment of a user supplied
syringe diameter 1cc (4.5mm)
to 3 cc (10.8mm) for the
practitioner to focus on the
transient blanching effect for
best comfort and efficient
results in accordance with the
best judgment of the
physician under aseptic
conditions.	The Vapocoolshot Mist is intended
for topical application to skin, intact
mucous membrane (oral cavity, nasal
passageways, lips) and minor open
wounds. The Vapocoolshot Mist is
used to target and minimize cooling
area for lessening pain associated
with injections (venipuncture, IV
starts, cosmetic procedures), minor
surgical procedures (such as lancing
boils, incision, drainage of small
abscesses and sutures) and the
temporary relief of minor sports
injuries (sprains, bruising, cuts, and
abrasions)
The Syringe Holder accessory is
intended to be attached to the Nozzle
of the Vapocoolshot Mist and allows
for the attachment of a user supplied
syringe 1cc (4.5mm) to 3 cc
(10.8mm) in diameter to facilitate the
injection procedure following
Vapocoolshot Mist application.	Used like ice for the temporary
relief of minor pain.
Attaches a
syringe	Yes	No	Yes
Gas Blend
type	N/A	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	N/A	N/A	N/A
Same
Technology	Yes	Yes	Yes
Syringe
controlled by
Practitioner	Yes	Yes	Yes
Drug
controlled by
Practitioner	Yes	Yes	Yes
Syringe
Attachment	Attaches to the syringe by
one device	N/A	Attaches to the specific syringe
based on 3 colors.

Equivalence:

The subject device as a unit has similar intended use as the Predicate 1, Ouchless.

The accessory "introducer" in the subject device, Syringe Holder Accessory attachment helps direct the user supplied syringe onto the refrigerant target blanche site similar to the predicate 1, Ouchless.

The subject device is a prescription device as well as Primary Predicate and Predicate 1.

The subject device combined with the Primary predicate has the same technological characteristics as the Predicate 1, Ouchless. There are no technological differences of the device as a unit from those of the Predicate 1, Ouchless. The similarities between the subject device and Predicate 1 (Ouchless), are the ability to attach a user supplied syringe to the canister through an accessory attachment on the nozzle.

Labeling:

The labeling of subject device has been prepared to ensure the medical professional has adequate and clear instructions for safety and usage. The Syringe Holder accessory (K201248) attachment to the Nozzle of the Primary predicate, Vapocoolshot Mist (K193349) are equivalent to the Predicate 1 (Ouchless).

IV. PERFORMANCE DATA

Usability study was performed with the attachment of a user supplied syringe to the Nozzle with the Syringe Holder accessory (K201248) .

Biocompatibility:

The subject accessory device, Syringe Holder, has no contact with the gas Blend or the patient. The materials are biocompatible.

Chemical Composition Confirmation:

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

Structural and Parts Composition:

Engineering verification measurements were taken, and visual inspections were made to determine the Syringe Holder accessory (K201248) when used with the Primary predicate were equivalent to the Predicate 1 (Ouchless).

Directions for Use (Clinical Use) Application and Methodology:

All key elements of the Directions for Use (DFU) between the Predicate 1 (Ouchless) and the subject device accessory attached to Primary predicate as a unit are similar. No significant differences exist

between the Predicate 1 (Ouchless) and subject device's Directions for Use as a unit.

Bench Testing:

Tests were selected and performed to ensure the subject device's performance, when attached to Vapocoolshot Mist (K193349), results are similar. Comparative performance testing was conducted as it related to attachment of a user supplied syringe as an accessory device. Usability testing performed on subject device as a unit for efficacy and safety as an accessory introducer.

Summary:

Based on the performance evaluations conducted, Syringe Holder Accessory (K201248) when used with the Primary Predicate Vapocoolshot Mist (K193349) were found to be safe and effective to the Predicate 1 (Ouchless).

CONCLUSION V.

Based on the information provided in the submission, it is concluded that the Syringe Holder accessory (K201248) is safe and effective for its intended use. The Syringe Holder accessory (K201248) attached to the Predicate Vapocoolshot Mist (K193349) as a unit does not raise additional questions of safety, efficacy and effectiveness different from the Predicate (Ouchless).