(301 days)
The device is intended for endovascular coagulation of blood vessels. Th indicated for the endovascular coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.
The ELVeS kit with 2 Ring Radial Fibers contain the following components: (1) 2 ring radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712 and K112299 except for the 2 ring radial tip design. The design provides 2 adjacent points of radial emission.
This submission describes the Endovascular Laser Venous System Kit (ELVeS®) with 2 Ring Radial Fiber. The information provided focuses on the device's substantial equivalence to predicate devices rather than establishing novel acceptance criteria through a specific study with a test set, experts, and ground truth.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the document defines "acceptance criteria" through compliance with voluntary consensus standards and clinical equivalence to predicate devices, rather than specific numerical targets for a new performance study.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance |
|---|---|
| Compliance with Voluntary Consensus Standards: | Device complies with: |
- 21 C.F.R. § 1040.10 & 1040.11 (Performance Standards for Light-Emitting Products)
- ANSI/AAMI ES1 (Medical Electrical Equipment - General Requirements for Safety)
- IEC 601-2-22 (Medical Electrical Equipment - Particular Requirements for the Safety of Surgical Lasers)
- EN 60825-1 (Safety of Laser Products)
- ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Ethylene Oxide Sterilization Residuals) |
| Clinical Effectiveness Equivalent to Predicate Devices: | Evidenced by several clinical evaluations showing: - Study 1: Reduction in recanalization rates, reduction in applied Watt/LEED, reduction in adverse events (bruising, pain, induration, numbness). Concluded EVLA with 2 ring radial fiber is effective and safe, decreasing energy and providing good occlusion rates with lowered side effects.
- Study 2: Effective for large insufficient GSV (>8mm), less energy needed, optimal homogenous radiation, high patient satisfaction, improved modified CEAP severity after 1 & 2 days. No significant difference in occlusion rate between >8mm and 12 mm) GSV. No statistically significant difference in VCSS scores or patient satisfaction between groups. 2-ring radial fiber resulted in almost no pain. |
| Acceptable Sterility: | Sterilization cycle parameters and validation reports showed an acceptable sterility was achieved. |
| Substantial Equivalence: | The ELVeS with 2 Ring Radial Fiber is substantially identical to K101712 and K112299, and has the same intended use and indications for use as cleared Evolve HPD and Ceralas ELVeS kits. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "several clinical evaluations" but does not provide specific sample sizes for these studies, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective) for each study. The nature of the studies (e.g., comparison of outcomes, patient satisfaction) suggests they were prospective clinical studies, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for any of the mentioned clinical evaluations. The outcomes measured (recanalization rates, adverse events, patient satisfaction, CEAP severity, VCSS scores) would have been assessed by treating physicians and/or study personnel, but their specific roles as "ground truth" experts or their qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
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 MRMC comparative effectiveness study was done. This device is a surgical laser system, not an imaging or diagnostic AI-powered device that would typically involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm-only performance was done. This is a medical device (a laser system), not an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in the clinical evaluations refers to various clinical outcomes data, including:
- Recanalization rates (likely based on ultrasound follow-up)
- Adverse events (clinically observed and reported)
- Applied Watt/LEED (objective measurement of energy delivery)
- Patient satisfaction (patient reports)
- Modified CEAP severity (clinical assessment by physicians)
- VCSS scores (clinical assessment by physicians)
- Occlusion rates (likely based on ultrasound follow-up)
8. The Sample Size for the Training Set
This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The clinical evaluations mentioned are for validating the device's performance, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this point is not applicable.
§ 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.