(93 days)
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.
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.
This FDA 510(k) summary describes a premarket notification for a Syringe Holder accessory (VM03000). The document aims to demonstrate that this accessory, when used with the Vapocoolshot Mist (primary predicate), is substantially equivalent to an existing predicate device called "Ouchless".
It is crucial to understand that this document does not describe an AI medical device or a study involving an algorithm's performance. The device in question is a physical accessory for a medical tool, not a software or AI product. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable to this submission.
Here's an attempt to extract and interpret the information based on the provided text, while acknowledging the limitations for an AI-centric request:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative manner for performance metrics (like sensitivity, specificity, accuracy). Instead, substantial equivalence is established by comparing technological characteristics and intended use. The "performance" described is about meeting the functional criteria set by the predicate device and being safe and effective.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be substantially equivalent to the predicate device. | The Syringe Holder accessory, when used with the Vapocoolshot Mist, facilitates the injection procedure following Vapocoolshot Mist application, targeting and minimizing cooling area for lessening pain associated with injections, minor surgical procedures, and minor sports injuries. This is deemed similar to the Predicate 1 (Ouchless) which "helps direct for topical application of refrigerant (cold like ice) to the skin with the attachment of a user supplied syringe." |
| Technological Characteristics | Must have similar technological characteristics to the predicate device, or differences must not raise new questions of safety or effectiveness. | The Syringe Holder accessory shares the basic principle of attaching (1cc (4.5mm) to 3cc (10.8mm) diameter) user-supplied syringes to a vapocoolant canister. It helps direct the refrigerant gas to a mist, targets the transient blanche site, allows one-handed use, keeps the syringe in the same path, and controls the amount of vapocoolant dispensed, thereby avoiding overspraying and maintaining the numbing effect. The comparison chart indicates similarities in: - Type (Rx)- Attaches a syringe (Yes)- Same Technology (Yes)- Syringe controlled by Practitioner (Yes)- Drug controlled by Practitioner (Yes)Differences noted: - Subject device attaches to a syringe by "one device," while predicate 1 attaches based on "3 colors." This difference is not deemed to raise new questions of safety or efficacy. - Design as a unit: Subject device is the accessory itself; Primary Predicate is the pressurized dispensing container. Predicate 1 includes the container, valve, and syringe attachment. The Syringe Holder accessory (subject device) combined with the Primary Predicate (Vapocoolshot Mist) forms a unit with similar technological characteristics to Predicate 1 (Ouchless). |
| Biocompatibility | Materials must be biocompatible. | The subject accessory device has no contact with the gas Blend or the patient, and its materials are reported as biocompatible. |
| Chemical Composition | Material composition must be consistent and verified. | The subject device's material is checked and verified upon receipt from the supplier to ensure the same chemical profile. |
| Structural Integrity | Must be equivalent to the predicate device(s). | 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 (DFU) | Must be substantially equivalent. | All key elements of the DFU between Predicate 1 and the subject device accessory attached to Primary predicate as a unit are similar. No significant differences exist. |
| Safety and Effectiveness | Must be safe and effective for its intended use, not raising new questions compared to predicates. | Based on the performance evaluations conducted (usability study, biocompatibility, chemical composition, structural integrity, DFU comparison, bench testing), the 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). It does not raise additional questions of safety, efficacy, and effectiveness different from the Predicate (Ouchless). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions a "Usability study was performed" and "Comparative performance testing was conducted." However, no specific sample sizes (e.g., number of participants, number of devices tested, number of observations) are provided for any of the performance evaluations.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the "bench testing" and "usability study" mentioned, it would typically be prospective, internally conducted testing, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a physical medical device accessory that is undergoing a substantial equivalence review. There is no "ground truth" establishment in the context of an AI algorithm's performance review. The evaluations are against engineering specifications, biocompatibility, and functional equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic results or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device or a diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted in #3, there is no "ground truth" in the AI/diagnosis sense. The "ground truth" for this device's performance would be engineering specifications, material standards, and the functional characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" in the machine learning sense.
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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
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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
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Indications for Use
510(k) Number (if known)
K201248
Device Name Syringe Holder accessory (VM03000)
Indications for Use (Describe)
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.
| 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)
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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:
-
- Subject device: Name/Classification Special Controls: Device Class: Review panel: Product code:
3. Trade Name of Subject Device:
-
- Primary Predicate:
Common Name
- Primary Predicate:
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
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I. 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.
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 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.
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:
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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 accessorySubject DeviceK201248 | Vapocoolshot MistK193349Primary Predicate | OuchlessK093951Predicate 1 |
| Type | Rx | Rx | Rx |
| ProductDesign as aunit | Syringe Holder accessory. | Pressurized dispensing container,which includes the vapocoolant,canister, valve, actuator, cap and anaccessory nozzle. | Pressurized dispensing container,which includes the vapocoolant,canister, valve, syringe attachment,and nozzle. (No canister cap, Noactuator) |
| Indication forUse | The Syringe Holder accessoryon the Nozzle of theVapocoolshot Mist allows theattachment of a user suppliedsyringe diameter 1cc (4.5mm)to 3 cc (10.8mm) for thepractitioner to focus on thetransient blanching effect forbest comfort and efficientresults in accordance with thebest judgment of thephysician under asepticconditions. | The Vapocoolshot Mist is intendedfor topical application to skin, intactmucous membrane (oral cavity, nasalpassageways, lips) and minor openwounds. The Vapocoolshot Mist isused to target and minimize coolingarea for lessening pain associatedwith injections (venipuncture, IVstarts, cosmetic procedures), minorsurgical procedures (such as lancingboils, incision, drainage of smallabscesses and sutures) and thetemporary relief of minor sportsinjuries (sprains, bruising, cuts, andabrasions)The Syringe Holder accessory isintended to be attached to the Nozzleof the Vapocoolshot Mist and allowsfor the attachment of a user suppliedsyringe 1cc (4.5mm) to 3 cc(10.8mm) in diameter to facilitate theinjection procedure followingVapocoolshot Mist application. | Used like ice for the temporaryrelief of minor pain. |
| Attaches asyringe | Yes | No | Yes |
| Gas Blendtype | N/A | 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% |
| EnergyDelivered | N/A | N/A | N/A |
| SameTechnology | Yes | Yes | Yes |
| Syringecontrolled byPractitioner | Yes | Yes | Yes |
| Drugcontrolled byPractitioner | Yes | Yes | Yes |
| SyringeAttachment | Attaches to the syringe byone device | N/A | Attaches to the specific syringebased on 3 colors. |
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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
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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).
N/A