(247 days)
INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.
The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body. Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer). The INTRAgen consists of the following components: INTRAgen (Main Frame), Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece, Miscellaneous Accessories : Foot Switch and Power Cable.
The provided document describes the INTRAgen, an electrosurgical cutting and coagulation device and its accessories. The document focuses on demonstrating its substantial equivalence to a predicate device (Thermage ThermaCool System) for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed as a separate table but are implied by the types of tests performed and the statement "The INTRAgen met all the acceptance criteria." The performance is reported in the summary tables and discussed in the text.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC Testing | Compliance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. | Met all acceptance criteria in accordance with IEC 60601-1:2009, IEC 60601-2-2:2009, and IEC 60601-1-2:2007. |
| Biocompatibility Testing | Compliance with ISO 10993-1 for patient-contacting parts. | The active electrodes (made of PCB and ABS) are biocompatible, as per cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogen tests. |
| Bench Data (Performance Testing) | Accurate dimensional measurements, impedance, energy output, current density, on/off time, output waveform, and skin temperature control. | Met all acceptance criteria for dimensional inspection, accuracy of measurement (impedance), energy output, current density, on/off time, and output waveform. Demonstrated that skin surface temperature does not cause damage even without a cooling system. |
| Pre-Clinical Trial | Demonstrate substantial equivalence to the predicate device in terms of biological effects (wound healing, neocollagenesis, neoelastogenesis). | Evaluated effects on porcine tissue using different joule energy levels and active electrodes. Showed vigorous wound healing, progressive inflammatory cell infiltration, profound neocollagenesis, and neoelastogenesis up to 10 weeks post-treatment. Concluded substantial equivalence to the predicate device. |
| Sterilization | Compliance with ISO 11135-1:2007 for EtO sterilization. | Met all acceptance criteria in accordance with ISO 11135-1:2007 for the EtO sterilization of active electrodes (KT-07 and KT-15). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Pre-clinical Study: "a porcine tissue model." The exact number of animals or tissue samples is not specified.
- For Electrical Safety, Biocompatibility, Bench Data, and Sterilization, the "sample size" refers to the tested device units/materials. The document states "The tests were performed on the INTRAgen" and "The active electrodes... Biocompatibility test has been conducted..." without indicating the number of units.
- Data Provenance: The document does not specify the country of origin for the data collection, but the manufacturing company is based in Korea. The studies are described as "pre-clinical" and "bench tests", implying controlled laboratory settings rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Pre-clinical Study:
- Number of Experts: Not specified.
- Qualifications: "Histology evaluation" and "immune histochemical and PCR studies" would imply evaluation by qualified scientists or pathologists. However, specific qualifications (e.g., "radiologist with X years of experience") are not provided.
- For other tests (Electrical Safety, Biocompatibility, Bench Data, Sterilization), ground truth is established by meeting recognized standards (e.g., IEC, ISO) and internal specifications, which are assessed by qualified engineers/testers rather than external domain experts in the clinical sense.
4. Adjudication Method for the Test Set
- No adjudication method is described. For the pre-clinical study, the evaluation was stated as "histologically and by RT-PCR," implying objective lab analyses rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- No MRMC comparative effectiveness study was done. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. The study primarily focuses on the device's technical specifications and biological effects in a pre-clinical model.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. The INTRAgen is a hardware electrosurgical device, not an algorithm or AI. Its performance is inherent to its physical operation, not an algorithm's output.
7. The Type of Ground Truth Used
- Pre-clinical Trial: The ground truth was based on objective biological markers and histological evaluations:
- Histological evaluation of wound healing response.
- Immune histochemical and PCR studies for neocollagenesis and neoelastogenesis.
- Other Tests: Ground truth was based on established industry standards (IEC, ISO), internal engineering specifications, and measurement accuracy.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve an AI algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for traditional medical devices like electrosurgical units.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a traditional medical device, there is no training set for which ground truth would be established.
§ 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.