(100 days)
The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The CELFIRM™ includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the hand-piece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, CELFIRM™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
The provided text describes a 510(k) premarket notification for the CELFIRM™ device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (INFINI Radiofrequency System) through various non-clinical performance tests.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the CELFIRM™ device. Instead, it describes various non-clinical tests conducted and generally states that the "test results met the pre-set criteria" or that the device is "substantially equivalent."
However, we can infer some criteria and reported performance from the "Performance Tests (Non-clinical)" section:
| Test Type | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterility Assurance Level (SAL) of 10^-6 for EtO sterilization, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2012. | Validation and biological indicator (BI) overkill method used, implying the SAL of 10^-6 was met. |
| Shelf-life Validation | Device maintains functionality and safety for its proposed shelf life, using accelerated aging method in accordance with ASTM F1980-07 (2011) and referenced standards ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USP-NF . | Tests conducted using specified methods, implying the proposed shelf life was validated. |
| Biocompatibility | Patient-contacting components (Consumable Tip) must be biocompatible, in accordance with ISO 10993-4, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and USP 39. | Tests conducted according to specified standards, implying the device met biocompatibility requirements. |
| Software Validation | Software (firmware) functions as intended for a moderate level of concern, compliant with relevant validation practices. | Software validation tests were performed. |
| EMC & Electrical Safety | Compliance with IEC 60601-1:2005, IEC 6061-1-6:2010, IEC 60601-2-2:2009, EN 60601-1-2:2007, EN 6100-3-2:2006, and EN 6100-3-3:2008. | All tests met the pre-set criteria. |
| Max Output Energy | Max energy per electrode should meet pre-set criteria/specifications for CELFIRM™. | Test results met the pre-set criteria and validated the device performance specifications for max energy. |
| Preclinical (Animal) Test | Safety and effectiveness comparable to predicate devices, with acceptable tissue response (e.g., transient and resolving erythema, minimal/mild necrosis within expected stages of healing, dermal fibrosis as expected for healing). | Application resulted in transient very slight to well-defined erythema (3-4h post-application, resolved by Day 3). Minimal to mild necrosis noted (Days 1 and 5). Dermal fibrosis at applied sites on Day 22. No other application-related findings. Histology data demonstrated substantial equivalence to predicate devices for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions "Yucatan Mini-pigs" for the preclinical (animal) test. However, it does not specify the number of mini-pigs used as the sample size. It refers to "Animal were euthanized 3 h after application on Day 1, Day 4, and Day 22," implying multiple animals or multiple applications on different animals over time points, but no precise count is given. For other tests (sterilization, shelf-life, biocompatibility, software, EMC/electrical safety, max output energy), the sample sizes of the components or units tested are not specified.
- Data Provenance: The preclinical animal study was conducted as part of the device's development by VIOL Co., Ltd., based in South Korea. Therefore, the data provenance is likely prospective (generated specifically for this submission) and from South Korea (or the location where the animal study was conducted under the company's purview).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number or qualifications of experts used to establish a "ground truth" for the test set. The evaluation of test results (e.g., histology data from the animal study) would implicitly involve experts (e.g., veterinary pathologists), but these details are not provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The results appear to be based on direct measurements and observations from the non-clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical evaluation of the device's safety and performance characteristics, primarily against standards and a predicate device. It does not involve human readers interpreting cases with or without AI assistance.
6. Standalone Performance Study
Yes, the studies described are essentially standalone evaluations of the algorithm/device (CELFIRM™) without a human-in-the-loop performance component in the context of diagnostic interpretation. The tests assess the device's physical, electrical, and biological effects independently.
7. Type of Ground Truth Used
For the preclinical animal test, the ground truth was established through:
- Direct observation of tissue responses (erythema, necrosis).
- Histology data (microscopic examination of tissue samples).
For other tests (sterilization, shelf-life, biocompatibility, EMC/electrical safety, max output energy), the ground truth is based on established scientific and engineering standards and specifications (e.g., ISO, ASTM, IEC, EN standards).
8. Sample Size for the Training Set
The document does not mention any training set or machine learning model. The CELFIRM™ is an electrosurgical device, not an AI or imaging device that would typically involve a "training set" in the context of machine learning. The studies described are hardware and bio-compatibility related.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set or machine learning in the provided document, this question is not applicable.
§ 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.