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PainFreeze II Medium Stream and Mist Spray are vapocoolants (skin refrigerants) intended for topical op skin. intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions).

The Subject Device consists of a chemical blend of 60% HFO-1233zd (Trans-1-chloro-3.3.3- trifluoropropene) and 40% HFO-1234ze (trans- 1.3.3.3-tetrafluoroprop-1- ene) that produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds. The product is delivered in the form of an aerosol in either a mist or stream spray. The device's delivery system controls the amount of chemical blend that is dispensed, the mist spray configuration produces very fine droplets that cools at the points of contact. The stream spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Upon contact with the skin, the product begins to evaporate immediately as it contacts the skin. The low evaporation rate of the product's chemical blend is what creates the coldness. The Subject Device is non- flammable and has a lower global warming potential than the predicate and provides equivalent performance.

The Subject Device is topically sprayed onto the skin. It creates a cooling effect on the surface of the application site by the immediate evaporation of the product from the skin surface.

With both product configurations, the evaporation creates the cold sensation. As the distance from the target surface is increased, the dispersion of the droplets in both the mist and stream is increased. Increasing the surface area of contact and decreasing the size of the droplets increases the evaporation rate. The increase in evaporation rate correlates to an increase in the cooling effect.

The chemical blend is incorporated in pressurized canisters, which will be offered in two (2) volumes 35 and 115 ml. The canister consists of a high-pressure canister, valve, and actuator.

The provided document is an FDA 510(k) Premarket Notification clearance letter for a medical device called "PainFreeze II," which is a vapocoolant (skin refrigerant). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced clinical effectiveness or accuracy via a traditional clinical trial or performance study typical for diagnostic/AI devices.

Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, study design for proving device performance, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies that would be present for a diagnostic device or an AI/ML algorithm. The "performance" being assessed here is primarily related to safety, physical characteristics, and equivalence to a predicate, not diagnostic accuracy or clinical outcome improvement.

Based on the provided text, here's what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing performed to demonstrate that the device is similar to its predicate and meets safety/performance requirements. The "criteria" are implied by the successful meeting of test requirements for each evaluation.

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For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.

The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance.

The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.

This document is a 510(k) summary for the CryoDose V50/50, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device, the Nuance Freeze Spray System (K130995). The primary difference highlighted is the cryogen composition, with the new device using a blend of HFC-32 and HFO-1234ze, which has a significantly lower Global Warming Potential (GWP) than the predicate's HFC blend (R-404a).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a clinical study, but rather a "Comparison of Technological Characteristics" that serves as the basis for demonstrating substantial equivalence. The "acceptance criteria" here are implied to be performance characteristics that are "similar" or "identical" to the predicate device, ensuring equivalent safety and effectiveness.

Here's a table based on the provided comparison, indicating the "acceptance criteria" (which are performance targets based on the predicate) and the "reported device performance":

The document states: "Technically, the Subject Device has similar mechanical properties to the predicate as well as its performance. The same patient population and use indications applies between the devices. Identical cannister components and applicators are used with both devices. The main differences between the Subject Device and predicate is that the global warning potential is significantly less with the Subject Device. The differences in the Subject Device does not impact safety, effectiveness, or performance."

Study Information

This 510(k) submission does not concern a clinical study involving human patients or complex AI algorithms necessitating large test sets, expert readers, or MRMC studies. Instead, it focuses on demonstrating substantial equivalence of a medical device (a cryosurgical unit) through non-clinical performance testing and comparison of technical specifications to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, and MRMC studies are not applicable to this type of device submission.

Here's the information that is applicable based on the document:

2. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated as a "test set" in the context of a clinical trial. The testing involved parameters like temperature, spray rate, pressure, flammability/ignition, and visual freezing. The sample size for these specific engineering/performance tests is not provided in this summary.
   • Data Provenance: The tests were "performed" on the subject device. The origin (e.g., country) of these performance test results is not specified, but it's presumed to be from the manufacturer's internal testing or a contracted lab. The data is from non-clinical, benchtop performance testing. It is not prospective or retrospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission relies on objective physical measurements (temperature, pressure, etc.) and comparison to a predicate device's established performance, rather than subjective expert interpretation of data points that would require "ground truth" establishment in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There was no human "adjudication" in the sense of resolving discrepancies in expert interpretation, as this was not a clinical or image-based diagnostic study.

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 device is a cryosurgical unit, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth," if one can use the term loosely here, for this type of submission is the established performance characteristics of the legally marketed predicate device and accepted engineering/physical standards for the measured parameters. The goal is to show that the subject device's performance metrics are "similar" or "equivalent" to those of the predicate device, implying comparable safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. This is a hardware device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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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.

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.

This document is a 510(k) Summary for the CryoDose TA OTC (Mist Spray and Stream Spray) device, which is a vapocoolant for temporary pain relief. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested categories related to AI/software performance studies (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the device's characteristics and the types of tests performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on a physical medical device (vapocoolant spray) and not an AI/software product, the "acceptance criteria" are related to demonstrating similarity to a predicate device rather than numerical performance thresholds for diagnostic accuracy. The "reported device performance" is essentially that the device was found to be "substantially equivalent" and met the requirements outlined for physical and chemical characteristics.

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" of medical images or patient data for an AI/software device. The testing involved laboratory and bench testing of the physical properties and chemical composition of the device, utilizing data from an identical reference device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing diagnostic performance against a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 device is a vapocoolant spray, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a vapocoolant spray.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the "ground truth" was the established standards and acceptance criteria of ISO 10993. For chemical and structural composition, the "ground truth" was the known composition and structure of the predicate device. For performance characteristics, the "ground truth" was the expected performance and temperature/volume output of the predicate/reference device.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established
Not applicable.

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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.

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.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

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

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

8. Sample Size for the Training Set

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

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

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

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The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.

The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.

The provided document describes the acceptance criteria and study for the Nuance Medical, LLC CryoDose H device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

The Nuance Freeze Spray System is used in the practice of dermatology in the treatment of skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions.

This 510(k) summary for the Nuance Freeze Spray System does not contain a study that proves the device meets specific acceptance criteria in the way a traditional clinical study with defined endpoints and statistical analysis would. Instead, the submission relies on the concept of substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested elements regarding acceptance criteria and study design are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific acceptance criteria (e.g., a specific percentage reduction in lesion size, a cure rate, or a predefined safety profile) nor does it report performance metrics from a dedicated study against such criteria for the Nuance Freeze Spray System itself. The device's "performance" is implicitly assumed to be equivalent to the predicate devices.

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

Not applicable. There was no specific test set or clinical study conducted for the Nuance Freeze Spray System described in this document. The device relies on comparing its characteristics to predicate devices that have already demonstrated safety and effectiveness through their past clearances.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable, as no dedicated test set or ground truth establishment process is described for this specific submission. The established practices and efficacy of cryogen spray for dermatological conditions, as supported by the predicate devices, serve as the foundational "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as no test set or adjudication process is described.

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 a medical device (cryogen spray system), not an AI/imaging device. Therefore, MRMC studies and AI effectiveness are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" implicitly relied upon is the established clinical efficacy and safety of cryogen spray systems, particularly those using the specified chemical composition, for the treatment of various skin lesions, as evidenced by the predicate devices. This can be considered accepted clinical practice and outcomes data from previously cleared devices and general medical knowledge.

8. The Sample Size for the Training Set

Not applicable. The Nuance Freeze Spray System is a physical device, and its clearance is based on substantial equivalence rather than a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this device.

Summary of the Basis for Clearance:

The Nuance Freeze Spray System gained 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices:

• Primary Predicate: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K982506)
• Secondary Predicates: Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System (K881349) and (K944221)

The "study" that proves the device meets the acceptance criteria is effectively this comparison demonstrating substantial equivalence. The core arguments for substantial equivalence are:

• Identical Indications for Use: The Nuance Freeze Spray System is intended for the treatment of the same specific skin lesions as the predicate devices.
• Identical Technical Characteristics (Cryogen Composition): The cryogen used (1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane, also known as R-404a) is stated to be the "exact same chemical composition and formulation as the predicate device."
• Similar Delivery Method: The methods for delivering the cryogen are described as "similar to the predicate."
• No New Issues of Safety or Efficacy: The statement explicitly says, "Nuance Freeze Spray System and its predicate devices do not raise any new issues of safety or efficacy."

Therefore, the "acceptance criteria" for the Nuance Freeze Spray System's clearance were met by demonstrating that it is fundamentally the same in terms of composition, intended use, and operational principles as already cleared devices, thereby inferring equivalent safety and effectiveness without requiring a new clinical performance study.

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