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510(k) Data Aggregation
(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 <8mm diameter subgroups.- Study 3: Efficacy, adverse events, occlusion rates, patient satisfaction, and VCSS scores comparable to radiofrequency (RF) energy for very large diameter (>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.
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(73 days)
The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System. Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.
The provided text is a 510(k) summary for the Twister™ Side-Firing Fiber Optic Delivery System. It describes the device, its intended use, and its technological characteristics. However, it explicitly states that no performance testing was included in the submission because the performance of the device on soft tissue is "well established and documented."
Therefore, based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented in the document.
- Sample sized used for the test set and the data provenance: No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was analyzed.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no performance data was collected.
- The sample size for the training set: Not applicable as this is a physical medical device.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing substantial equivalence to a predicate device (Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System, K112987) based on technological characteristics and identical components/patient contact materials. The key difference noted is a change in the numerical aperture (NA) of the fiber for better coupling efficiency, which is presented as an improvement rather than a factor requiring new performance testing for soft tissue applications.
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