Search Results
Found 2 results
510(k) Data Aggregation
(334 days)
Hydrozid Precise contains 1.1.1.2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of vertuca (warts), including plantar warts, seborrheic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatits, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Hydrozid Precise™ is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells to induce necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, single-patient application templates which are disposed after use.
The provided text describes a 510(k) premarket notification for the Hydrozid Precise™ device. The submission aims to establish substantial equivalence to a predicate device, Hydrozid®. The document focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing detailed acceptance criteria and a study to prove a predetermined performance outcome. The study described is a bench test comparing the thermal profile of the new device to the predicate device.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds for a specific clinical performance metric (e.g., sensitivity, specificity, accuracy) for Hydrozid Precise™. Instead, the "acceptance criterion" in this context is demonstrating substantial equivalence to the predicate device Hydrozid® in terms of its thermal profile (surface temperature, duration of surface temperature, and ice-ball formation).
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Hydrozid Precise™) |
|---|---|
| Capable of reaching the minimum desired temperature for cell destruction and vascular stasis in both minimum and maximum treatment time, equivalent to the predicate device. | Confirmed that the cryogen R134a was capable of reaching the minimum desired temperature for cell destruction and vascular stasis in both the minimum and maximum treatment time. Performed equivalently to the predicate device Hydrozid®. |
| Thermal profile (surface temperature, duration of surface temperature, and ice-ball) is equivalent to the predicate device. | The bench test determined that Hydrozid Precise™ performed equivalently to the predicate device Hydrozid® in terms of its thermal profile. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "bench test" to analyze the thermal profile. For this type of test, "sample size" typically refers to the number of devices or test conditions evaluated. However, the specific sample size used for the bench test is not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, though it is likely a prospective bench study conducted by the manufacturer, BIBAWO Medical A/S, based in Denmark.
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 information is not applicable as the described study is a non-clinical bench test analyzing the thermal profile of the device, not a study involving human subjects or expert assessment of clinical outcomes. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the described study is a non-clinical bench test. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or AI-powered devices involving human interpretation, which is not the case for this cryosurgical unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human intervention. The Hydrozid Precise™ is a medical device (cryosurgical unit), not an artificial intelligence (AI) algorithm. Therefore, a standalone algorithm performance study was not done. The "standalone" performance here would refer to the device's physical function in the bench test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical bench test, the "ground truth" would be the measured physical properties (surface temperature, duration of surface temperature, and ice-ball characteristics) of the cryogen (R134a) under controlled experimental conditions, often established using calibrated measurement equipment. These measurements are then compared to the established performance of the predicate device.
8. The sample size for the training set
This information is not applicable. Cryosurgical devices are not typically "trained" in the way AI algorithms are. No training set was used.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set.
Ask a specific question about this device
(377 days)
Hydrozid (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Hydrozid® is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, singlepatient application templates which are disposed after use.
The provided document is a 510(k) Premarket Notification for the medical device Hydrozid®, a portable aerosol cryosurgery device. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, Cool Renewal®. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating substantial equivalence rather than a clinical trial with specific performance metrics for a novel device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are not explicit performance thresholds in the typical sense for a new device's efficacy/accuracy. Instead, the acceptance criteria are met if the new device (Hydrozid®) demonstrates comparable performance to the predicate device (Cool Renewal®) in areas related to its mechanism of action and intended use, and does not raise new questions of safety and effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Hydrozid®) |
|---|---|
| Cryogen Comparison: The cryogen used in Hydrozid® should achieve a thermal profile comparable to the predicate device's cryogen. | Bench Test 1: "A bench test was performed to analyze the thermal profile (surface temperature, duration of the surface temperature and iceball geometry and size) of the cryogen R134A and the predicate device cryogen. The bench test determined that Hydrozid® cryogen performed equivalently to the cryogen of the predicate device." |
| Cryogen Efficacy: The cryogen should be able to reach the minimum desired temperature for cell destruction and vascular stasis. | Bench Test 2: "A second temperature testing performed on Hydrozid® confirmed that the cryogen R134A could reach the minimum desired temperature for cell destruction and vascular stasis in both the minimum and maximum treatment time." |
| Overall Safety and Effectiveness: The device should not introduce new safety or effectiveness concerns compared to the predicate. | The submission asserts: "Testing and argumentation rationale were provided to support the equivalence of the Hydrozid® and shows that no new questions of safety and effectiveness have been introduced with this device. The safety and effectiveness of the Hydrozid® are adequately supported by the testing rationale, substantial equivalence information, materials information, and comparison of technical characteristics provided within this premarket notification." Additionally, the comparison table (Table 5.3-1) highlights that despite a difference in cryogen composition (Hydrozid® uses R134A, predicate uses R404A which contains R134A, Pentafluoroethane, and 1,1,1,-trifluoroethane), the performance data showed Hydrozid® achieves a thermal profile comparable to the predicate, thus raising "no new safety or efficacy concerns." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "bench tests" being performed. These are laboratory-based tests on the device's physical properties (thermal profile, temperature reach) rather than tests on biological samples or patients.
- Data Provenance: The tests are "bench tests," so the data provenance is internal laboratory testing rather than data from human subjects or clinical settings (e.g., country of origin of data is not applicable in this context). The document states, "There was no clinical testing required to support the medical device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this type of submission is typically based on established scientific principles of cryosurgery (e.g., temperatures required for cell necrosis) and comparison against the performance of a legally marketed predicate device. There is no mention of experts required to establish ground truth for the bench tests.
4. Adjudication Method for the Test Set
Not applicable. This was not a study involving human interpretation of data where adjudication would be necessary. The "tests" were bench tests measuring physical parameters.
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/imaging device. It's a cryosurgical unit. 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 not an algorithm-based device. No standalone performance was evaluated in this context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the bench tests appears to be based on:
- Established scientific understanding of cryosurgery, specifically the minimum temperatures required for cell destruction and vascular stasis.
- The thermal profile and performance of the legally marketed predicate device (Cool Renewal®).
8. The Sample Size for the Training Set
Not applicable. This is not an algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
Ask a specific question about this device
Page 1 of 1