(30 days)
Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:
Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.
The provided text, K121938, describes Dornier's Medilas H RFID Laser Fibers, which is a modification of an already cleared device. This submission is a Special 510(k) notice, indicating that the device has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate devices, with only minor differences that do not raise new questions of safety or effectiveness.
Therefore, the submission primarily focuses on demonstrating that the modified device performs as safely and effectively as the predicate devices. This type of submission does not typically involve the extensive clinical studies with human subjects, ground truth establishment, or multi-reader, multi-case studies that would be associated with entirely new medical devices or software algorithms.
Based on the provided document, here is the information requested, with "N/A" for criteria not addressed in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates." Specific quantitative acceptance criteria and detailed performance metrics are not typically required or presented in this type of 510(k) summary for accessory modifications. The "performance data" likely refers to bench testing to ensure the fiber's physical and functional properties (e.g., power transmission, durability, RFID functionality) are comparable to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Performance data demonstrates safety equivalent to predicate devices. |
| Effectiveness equivalent to predicate devices | Performance data demonstrates effectiveness equivalent to predicate devices. |
| RFID functionality (implied) | The RFID functionality, as a new feature, would have been tested to ensure it operates as intended (e.g., communication with the laser system), but specific metrics are not detailed in this summary. |
| Physical and functional equivalence to predicate laser fibers (implied) | Likely demonstrated through bench testing, but specific metrics are not detailed in this summary. |
2. Sample size used for the test set and the data provenance: N/A (No human subject test set is described for this type of submission.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth established by experts is not applicable to this type of device modification submission.)
4. Adjudication method for the test set: N/A (No human subject test set or adjudication process 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: N/A (This is not an AI device, and no MRMC study was conducted.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (This is a physical medical device accessory, not an algorithm.)
7. The type of ground truth used: N/A (Not applicable. The equivalence is based on engineering design, bench testing, and comparison to existing predicate devices, not clinical ground truth in the context of diagnostic accuracy.)
8. The sample size for the training set: N/A (Not applicable, as this is a physical device accessory, not a machine learning algorithm.)
9. How the ground truth for the training set was established: N/A (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.