(86 days)
The bipolar applicator, in combination with the compatible electrosurgical generator, is indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The CELON ProCurve V is a bipolar applicator that uses Radiofrequency Induced Thermotherapy (RFITT) technology for treating varicose veins. The medical purpose of the Radiofrequency Induced Thermotherapy is to achieve controlled tissue coagulation. The CELON ProCurve V is used in conjunction with a compatible generator.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Bipolar applicator "CELON ProCurve V"
Intended Use: Endovascular coagulation of blood vessels in patients with superficial vein reflux, in combination with a compatible electrosurgical generator.
Acceptance Criteria and Reported Device Performance
The provided document describes various performance tests conducted to establish substantial equivalence. These tests serve as the basis for the acceptance criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards for: | Successfully tested or assessed for all listed biocompatibility and hemocompatibility tests. |
| - Cytotoxicity | ||
| - Chemical Analysis | ||
| - Sensitization (biological-toxicological eval) | ||
| - Irritation (biological-toxicological eval) | ||
| - Acute systemic toxicity (biological-toxicological eval) | ||
| - In vitro Hemocompatibility (thrombogenicity) | ||
| - Hemolysis | ||
| Electrical Safety & EMC | Compliance with recognized 60601 standards (e.g., AAMI/ANSI ES 60601-1:2005, IEC 60601-1-2) | Complies with recognized 60601 standards. |
| Thermal Safety | Compliance with recognized standard IEC 60601-2-2. | Complies with recognized standard IEC 60601-2-2. |
| Functional Performance | Device functions as intended and meets design specifications. | Verification and comparison bench studies conducted; results confirm functionality and design specification adherence. |
| Stability/Shelf-life | Maintains functionality and meets specifications over stated shelf-life. | Accelerated age testing successful, demonstrating stability for the stated shelf-life (3.25 years). Real-time testing in progress. |
| Environmental/Shipping | Tolerates environmental conditions and shipping. | Samples subjected to environmental conditioning and ship testing; implicit success as "all tests passed." |
| Tissue Effects | Comparable performance and tissue effects to the predicate device in relevant aspects. | Ex vivo bench tests demonstrated comparable performance and tissue effects to the predicate device across various generator modes, power settings, and tissue types (porcine muscle, liver, kidney, intraluminal animal tissue). All tests passed. |
| Usability/Risk Management | User interface assessed, hazardous situations mitigated, residual risk acceptable. | Assessed according to risk management plan; use-related hazardous situations assessed, risk mitigation defined, and residual risk evaluated as acceptable (based on ISO 14971:2007). |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6^ for sterilization. | Sterilization (ionizing radiation/GAMMA rays) validated to ISO 11137-1, achieving a SAL of 10^-6^. Packaging conforms to ISO 11607-1. |
Study Details
The primary study supporting the "CELON ProCurve V" is a series of non-clinical and preclinical performance tests.
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Sample Size used for the test set and the data provenance:
- Biocompatibility: Not explicitly stated as a "sample size" in terms of number of devices, but rather the tests performed on "patient contacting materials." The provenance is indicated by compliance with ISO 10993 international standards and FDA guidance.
- Electrical Safety, EMC, Thermal Safety: Compliance with standards is stated, implying testing against those criteria. Sample size for these electrical/physical tests is typically a representative number of devices, but not specified in the document.
- Performance (Functional): Verification and comparison bench studies were conducted. Sample size not specified.
- Stability: "Sterile samples" were subjected to accelerated aging; "samples" were also subjected to environmental conditioning and ship testing. Specific numbers not provided.
- Preclinical (Simulated Use/Tissue Effects):
- "three generator modes and three power settings which were applied five times to each of three different types of tissue" (porcine muscle, liver, and kidney). This means 3 x 3 x 5 x 3 = 135 applications to tissue.
- "ten ex vivo bench tests based on three generator modes and three power settings were applied to intraluminal animal tissue." This means 10 x 3 x 3 = 90 applications to intraluminal animal tissue.
- Data Provenance: The tissue types specified are porcine (pig) and generic "animal tissue" for intraluminal use. This indicates ex-vivo (outside a living organism) animal tissue studies. The document does not specify a country of origin for the data, but the manufacturer is German.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes "quantitative and qualitative assessment" for tissue effects and "assessment of non-clinical performance data" for substantial equivalence. It also mentions "risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971:2007."
- Not explicitly stated. The evaluation of tissue effects and comparison to the predicate device would typically involve trained personnel in a laboratory setting, but the number and specific qualifications (e.g., histology technicians, engineers, medical professionals assessing tissue changes) are not provided. The assessment of risk and usability would involve different experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None explicitly stated. The document refers to "assessment" and "comparing" performance to the predicate. This suggests laboratory-based evaluations against defined metrics rather than a multi-reader adjudication process typically seen in image analysis or diagnostic studies.
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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:
- No, an MRMC study was NOT done. This device is an electrosurgical applicator, not an AI-powered diagnostic or assistive tool. The studies focused on the performance of the device itself, not human interaction with an AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was assessed for the device. The primary performance testing (biocompatibility, electrical, thermal, functional, stability, tissue effects) evaluated the device's intrinsic characteristics and output without direct continuous human intervention during the "use" phase of the test (though humans operate the device for the test). The device itself (CELON ProCurve V) does not contain software and thus isn't an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and comparative performance to a legally marketed predicate device. For tissue effects, the ground truth was the observed effect on various tissue types (e.g., coagulation pattern, lesion size, thermal spread) which was then compared to the effects produced by the predicate device. For other tests (electrosurgical, biocompatibility), the ground truth was compliance with recognized international standards and internal design specifications.
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The sample size for the training set:
- Not applicable. This device is a hardware medical device and does not involve machine learning or AI models that require a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.