(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 coagulation 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,
- o ENT.
- General Surgery.
The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device. Additionally, the fiber is manufactured and tested in the identical fashion as the company's predicate device and functions in an equivalent manner.
The medical device described in the document is the "Dornier Medilas H RFID Gentle Flex Laser Fiber," an accessory for the Dornier Medilas H Holmium Laser. This device is a modification of a previously cleared device (K152591), with the primary change being the addition of a rounded, ball-tip distal end.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Result) |
|---|---|
| Emission pattern of the distal tip from the laser colored aiming beam is equivalent to the predicate device. | Confirmed as equivalent to the predicate device. |
| Power transmission of the laser fibers when used with a Dornier Medilas H30 Holmium Laser is equivalent to the predicate device. | Confirmed as equivalent to the predicate device. |
| Tip fracture resistance of the ball tip fiber is equivalent to the predicate device. | Confirmed as equivalent to the predicate device. |
| Ability of the ball tip laser fibers to be introduced into a deflected scope with minimal resistance. | Confirmed as having minimal resistance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each functional performance test. The data provenance is also not explicitly stated in terms of country of origin, nor whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance tests appear to be engineering/technical evaluations rather than clinical studies requiring expert consensus on ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or provided, as the tests described are functional performance tests rather than assessments requiring human adjudication of clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was mentioned or performed. The studies were non-clinical functional performance tests comparing the modified device to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This question is not applicable as the device is a medical accessory (laser fiber) and not an AI or algorithm-based device.
7. The Type of Ground Truth Used
For the functional performance tests, the "ground truth" was established by comparing the performance characteristics of the modified (subject) device against the established performance characteristics of the predicate device (Dornier Medilas H RFID Laser Fiber - K1525591). These are objective measurements related to physical and optical properties.
8. The Sample Size for the Training Set
This question is not applicable as the device is not an AI or algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is not an AI or algorithm-based device.
§ 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.