(90 days)
The Side Firing Needle with Vent Sheath is intended for superficial or interstitial incision. excision, resection, ablation, vaporization, coagulation and hemostasis and may be used with any cleared Holmium laser that has a compatible connector.
Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.
The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.
The provided text describes a medical device, the Trimedyne Side Firing Needle with Vent Sheath, and its 510(k) submission to the FDA. It does not include information about acceptance criteria or a study using the device with acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which is typically found for AI/ML or diagnostic devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and nonclinical testing.
Therefore, many of the requested sections about acceptance criteria, sample sizes, ground truth, experts, and MRMC studies are not applicable to the information provided in this 510(k) summary.
Here's an analysis based on the provided text, indicating where information is present or absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatible | The Side Firing Needle with Vent Sheath is biocompatible. |
| Performs as intended (superficial/interstitial incision, excision, etc. using Holmium laser) | Performs as intended (based on verification and validation tests). |
| Acceptable mechanical properties | Has acceptable mechanical properties (based on verification and validation tests). |
| Substantial equivalence to predicate devices (K992230, K010041, K990851) | "The Side Firing Needle with Vent Sheath differs... in the addition of a pointed tip, a silver reflector... and a vent sheath..." but is deemed substantially equivalent implying overall comparable safety and effectiveness. |
Note: The acceptance criteria are inferred from the "Conclusions Drawn From Testing" and the nature of a 510(k) submission, which aims to demonstrate substantial equivalence to previously cleared devices. Specific numerical performance targets are not provided.
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. The submission states "No clinical tests were submitted in this Premarket Notification." The nonclinical data involved "verification and validation tests, including performance and tissue affect studies," but specific sample sizes or provenance for these tests are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No clinical data was submitted, and thus no expert-adjudicated ground truth for a test set is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical data or test set requiring adjudication is described.
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 fiber accessory, not an AI or diagnostic device that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Given the lack of clinical studies, no "ground truth" in the diagnostic sense was established. The nonclinical "tissue affect studies" would have relied on direct observation of the laser's interaction with tissue, but details are not provided.
8. The sample size for the training set
- Not Applicable. As a physical device, there is no "training set" in the context of machine learning or AI models. The device was likely designed and optimized through engineering and bench testing.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.