(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.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.