(379 days)
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.
Here's a breakdown of the acceptance criteria and study information for the Intensif Applicator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance | Description / Reported Performance |
|---|---|
| Safety | Compliance with IEC 60601-1:2005 / EN 60601-1:2006 (Medical electrical equipment - General requirements for basic safety and essential performance, 3rd edition for basic safety and essential performance). Compliance with IEC/EN 60601-1-2 (Electromagnetic compatibility (EMC)). Lab performance tests, design validation, software verification and validation. Ex Vivo studies (laboratory and animal) showed similar thermal and biological effects to previously FDA cleared fractional skin hemostasis and coagulation devices. |
| Efficacy | Lab performance tests, design validation, software verification and validation. Ex Vivo studies (laboratory and animal) showed similar thermal and biological effects to previously FDA cleared fractional skin hemostasis and coagulation devices. Device performs according to its specifications. |
| Operational Performance | Intensif Applicator's power control and accuracy. Intensif Applicator's safety features functionality. Intensif Applicator needle depth validation. |
| Intended Use | For use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis. The results of preclinical testing indicate it offers a "minimally invasive, effective, safe device for skin hemostasis and coagulation." |
| Substantial Equivalence | The device has the same intended use and similar indications as predicate devices (Primaeva Medical System K080145, EndyMed FSR K101510, EndyMed Imagine TC Skin Treatment System K083461). Technology is similar. Power and frequency envelopes covered by predicate devices. Minor differences in human interface/accessories do not raise new safety/effectiveness issues, as verified by performance and ex vivo testing. |
Study Information
This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
- Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.
4. Adjudication Method for the Test Set
- Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
- Evaluating thermal and biological effects.
- Measuring power control and accuracy.
- Testing safety features functionality.
- Validating needle depth.
8. The Sample Size for the Training Set
- Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there was no "training set" in the context of AI/machine learning 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.