(90 days)
The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.
The Laser Fiber GF500 is a disposable fiberoptic which is designed to deliver energy from the W.O.M. Laser U100 to the stone in lithotripsy. The fiber which is provided non-sterile is available in 3,5 and 5 meter in length.
The provided text describes a 510(k) summary for the Laser Fiber GF500. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical study with acceptance criteria.
Therefore, many of the requested categories for a study proving device performance (such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) are not applicable or available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: To be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode. | The Laser Fiber GF500 is similar in design, material, and technological characteristics to the predicate devices (Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber), which have the same intended use. Specifically, it's designed for use with the W.O.M. Laser U100 in lithotripsy in contact mode, just like the GF100. |
| Design, Material, and Technological Characteristics Equivalence: Similar to predicate devices. | The Laser Fiber GF500 is presented as similar to the Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber in these aspects. Differences are stated as "minor" and raising "no new questions of safety and effectiveness." |
| Safety and Effectiveness: No new questions of safety and effectiveness compared to predicate devices. | The submission asserts that the minor differences between the proposed device and predicate devices do not raise new questions of safety and effectiveness, implying it meets the same safety and effectiveness profile as already marketed devices. |
| Compliance with Standards: | The device has been tested in accordance with the European Standard EN 554 and EN 1174. It bears the CE mark in accordance with the Medical Device Directive 93/42/EEC. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This 510(k) submission relies on demonstrating substantial equivalence to existing devices, not on a new clinical study with a test set of patient data. The "performance data" mentioned refers to compliance with European standards, not clinical performance data from a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No clinical test set with expert-established ground truth was part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical 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:
- Not applicable/Not provided. This is a physical medical device (laser fiber), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "truth" in this submission relates to the functional and safety characteristics of the device being equivalent to predicate devices, and its compliance with relevant engineering and quality standards (EN 554, EN 1174, and CE marking).
8. The sample size for the training set:
- Not applicable/Not provided. No training set for an algorithm was used.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set.
Summary of the K021686 Submission's Approach:
The K021686 submission for the Laser Fiber GF500 is a 510(k) substantial equivalence submission. It aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device, thereby avoiding the need for a full Premarket Approval (PMA), which would involve extensive clinical trials. The core argument for acceptance is:
- Similarity in Intended Use: The device performs the same function (fiber optic delivery for lithotripsy with W.O.M. Laser U100) as a predicate device (Laser Fiber GF100).
- Similarity in Technological Characteristics: The design, materials, and overall technology are comparable to the identified predicate devices (Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber).
- No New Questions of Safety or Effectiveness: The manufacturer asserts that any differences are minor and do not introduce new risks or effectiveness concerns.
- Compliance with Recognized Standards: The device has undergone testing and certification against European standards (EN 554, EN 1174) and holds a CE mark, indicating adherence to certain quality and safety requirements.
This type of submission typically relies on bench testing, engineering analysis, and performance data relative to established standards, rather than de novo clinical trial data with patient samples or expert adjudication as would be seen in a more complex device or an AI/software algorithm submission.
§ 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.