(206 days)
The INTRAcel Premium Fractional RF Micro Needle is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The INTRAcel Premium consists of the following components:
- INTRAcel Premium (Main Frame)
- Active Accessory
- : 10xINTRAcelTip 1011 1x Power cable 1x Foot switch 1xHandpiece 1xHandpiece hanger 1x User's manual
This document is a 510(k) Premarket Notification for the INTRAcel Premium Fractional RF Micro Needle (FRM) System. It demonstrates the device's substantial equivalence to a legally marketed predicate device (Lutronic – INFINI, K121481) for electrocoagulation and hemostasis in dermatological and general surgical procedures.
Based on the provided text, here is a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" often refers to meeting these standards during testing.
| Acceptance Criteria (What was tested for) | Reported Device Performance (Did it pass?) | Comments |
|---|---|---|
| Electrical Safety (IEC 60601-1:2012, IEC 60601-2-2:2009) | Met all acceptance criteria. | Device is electrically safe. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2007) | Met all acceptance criteria. | Device operates without electromagnetic interference and is not susceptible to it. |
| Performance Testing (Dimensional Inspection, Accuracy of Measurement) | Met all acceptance criteria. | Physical dimensions and measurement accuracy are within specifications. |
| Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity) | Active electrodes are biocompatible. | Materials in contact with the patient are safe. |
| Sterilization & Shelf Life Testing (Ethylene Oxide Residues, Bioburden, Sterility, Bacteriostasis/Fungistasis, Shelf Life) | Met all acceptance criteria. | Device can be safely sterilized and maintains sterility over its shelf life. |
| Software Design Testing (IEC 62304:2006) | Met all acceptance criteria. | Software functions as intended and safely; development adhered to standards. |
| Preclinical Performance (In-vivo Micropig Model) - Wound Healing Response | Histologically, thermally coagulated collagen after treatment was replaced by new collagen. | Demonstrates biological effect of the treatment (tissue remodeling). |
| Preclinical Performance (Ex-vivo Animal Tissue) - Power Delivery Characteristics Effect on Tissue | Both subject device and predicate device created conical diamond-shaped tissue coagulation in the dermis and show similar coagulated columns. | Demonstrates similar biological effect and mechanism of action to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Preclinical In-vivo Study: The text mentions "in-vivo micropig model" and "porcine subjects" but does not specify the number of subjects (i.e., the sample size).
- Sample Size for Preclinical Ex-vivo Study: The text mentions "ex-vivo animal tissue testing" but does not specify the number of tissue samples or animals from which they were derived.
- Data Provenance: Not explicitly stated in terms of country of origin for the preclinical studies. However, the manufacturer is in Korea (Jeisys Medical, Inc., Seoul, Korea), and the submission correspondent is in the USA (LK Consulting Group USA, Inc., Fullerton, CA), suggesting international collaboration or trials conducted in either location.
- Retrospective or Prospective: The preclinical studies described (in-vivo micropig model, ex-vivo animal tissue testing) are inherently prospective as they involve conducting new experiments to gather data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not specify the number or qualifications of experts used to establish ground truth for the preclinical studies. "Histologic evaluation was done by H&E and Trichrome" implies a histopathologist, but no details are provided.
- For the non-clinical testing (Electrical Safety, EMC, Software, etc.), these are typically assessed against pre-defined engineering standards by qualified test engineers/laboratories, but expert details are not provided.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the preclinical test sets. Histological evaluation is typically performed by a pathologist, and sometimes a second review is done for quality control, but this is not mentioned.
- For the non-clinical (engineering) tests, adjudication is usually not applicable; rather, the results are objectively measured against defined criteria.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is an electrocoagulation and hemostasis system, not an AI-assisted diagnostic or therapeutic device that involves human readers interpreting medical images or data. Therefore, this type of study is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a medical instrument for electrocoagulation and hemostasis, not an AI algorithm. Its performance is evaluated through physical and electrical characteristics, and its effect on tissue.
7. The Type of Ground Truth Used
- Preclinical In-vivo Study: The ground truth for the wound healing response was histopathological examination (H&E and Trichrome staining) after varying time points. This is a direct biological and histological ground truth.
- Preclinical Ex-vivo Study: The ground truth for comparing power delivery characteristics was also histopathological examination (H&E and Trichrome staining) of the tissue after immediate treatment. This serves as a direct, objective measure of the device's effect on tissue.
- Non-Clinical (Engineering) Testing: The "ground truth" for these tests is adherence to established international and national standards (e.g., IEC 60601 series for electrical safety and EMC, IEC 62304 for software).
8. The Sample Size for the Training Set
- This device is not an AI/machine learning device that requires a "training set." Therefore, this concept is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As the device does not employ AI/machine learning requiring a training set, this concept 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.