(267 days)
The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds.
The EPIC 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10 laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.
The provided document is a 510(k) premarket notification for the Biolase Epic 10 laser surgical instrument, seeking to expand its Indications for Use to include "Debridement of wounds."
Here's an analysis of the acceptance criteria and study information, based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) submission process for a device that is substantially equivalent to a predicate device generally focuses on demonstrating that the new device is as safe and effective as the predicate. In this specific case, the submission is about expanding the Indications for Use for an already cleared device (Epic 10, cleared under K130465). Therefore, the "acceptance criteria" here are to demonstrate substantial equivalence to predicate devices that already have the "Debridement of wounds" indication.
| Acceptance Criteria (Demonstrated Substantial Equivalence for "Debridement of wounds") | Reported Device Performance (Epic 10) |
|---|---|
| Technological Characteristics: Comparable to predicate devices with the desired indication. | The Epic 10 shares similar descriptive information, laser classification, operating voltage, laser medium (InGaAsP vs. Diode Laser/GaAlAs), wavelength range (940 +/- 10nm vs. 980nm +/- 10%), current frequency, output power range (10W vs. up to 120W in predicates), power mode, pulse repetition rate, pulse duration, aiming beam, and materials with the predicate devices. |
| Intended Use: Consistent with predicate devices for the expanded indication. | The Epic 10's expanded indication for "Debridement of wounds" is explicitly listed among the indications for use of all three predicate devices. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | The document states that non-clinical and clinical testing were not performed on this device because the purpose was to expand indications based on already cleared predicate devices. The conclusion is that the clinical performance for the expanded indication is "deemed to be substantially equivalent" to the predicates. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. The submission explicitly states, "Clinical testing was not conducted on this device." Instead, substantial equivalence is claimed based on a comparison to predicate devices that already have the "Debridement of wounds" indication.
- Data Provenance: Not applicable, as no new clinical or non-clinical studies were performed for this specific 510(k) submission. The data provenance implicitly refers to the prior FDA clearances of the predicate devices (K100558, K072779, K060114), which would have involved their own testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No new test set (clinical or otherwise) was generated for this expanded indication submission. The "ground truth" for the predicate devices' indications would have been established during their original clearance processes.
4. Adjudication Method for the Test Set
- Not applicable, as no new test set was used.
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
- Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a surgical instrument operated by a human, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for this specific submission as no new testing was performed. The basis for clearance relies on the established "ground truth" and safety/effectiveness demonstrations of the predicate devices for the "Debridement of wounds" indication. For a surgical device, ground truth in design would typically involve engineering specifications, biocompatibility, electrical safety, and performance characteristics (e.g., power output, beam quality), validated against regulatory standards and possibly preclinical models. Clinical ground truth for efficacy would come from clinical trials or established medical practice.
8. The Sample Size for the Training Set
- Not applicable. The device is a surgical laser, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria for this specific 510(k):
The "study" in this context is a comparison to legally marketed predicate devices that already carry the expanded indication. Biolase demonstrated that its Epic 10 device is "substantially equivalent" to these predicates for the indication "Debridement of wounds" by showing that:
- Predicate Devices: QUANTA Diode Laser Family (K100558), Ceralas D980 Diode Laser (K072779), and Vectra Laser System and Accessories (K060114) all include "Debridement of wounds" in their Indications for Use.
- Technological Characteristics: The Epic 10 shares similar fundamental technological characteristics (laser type, power delivery, general operating principles) with these predicate devices. The document includes a table comparing these characteristics, highlighting that while there might be differences in specific parameters (e.g., maximum power output), these are not considered to raise new questions of safety or effectiveness regarding the expanded indication when compared to the range and functionality of the predicate devices.
- Lack of New Testing: The submission explicitly states that "Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearance... The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices..." and "Clinical testing was not conducted on this device."
Therefore, the "proof" is the argument of substantial equivalence based on the established safety and effectiveness of the identified predicate devices for the specified expanded indication.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.