(42 days)
Dornier's Medilas H RFID Reusable 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, cystoscopes, 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 basic technological characteristics of the subject device are:
- Use of a Silica-glass Fiber to transmit the laser energy; .
- Use of a plastic SMA 905 connector for connection to the laser; .
- t Other materials used in the manufacturing of the product: Natural Quartz Ferrule; Heat Shrink tubing; and SMA connector strain relief boot;
- . All fibers are 3 meters (nominal) in length;
- The fibers are sold in core diameter sizes of 272, 365, 550 and 940 microns. .
The basic principal of operation of the Laser Fibers is to transmit laser energy when connected to a Holmium Laser. The Laser Fibers that are the subject of this submission are identical to the predicate fibers (K121938) with the exception of being able to be reused.
This is a 510(k) premarket notification for a reusable medical device, specifically laser fibers. The submission focuses on demonstrating substantial equivalence to previously cleared devices through performance data, largely related to the reprocessing capabilities and the integrity of the fiber after multiple uses.
Here's a breakdown of the requested information based on the provided text, with an important caveat: This document describes a medical device, not an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or relevant to this type of regulatory submission. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of a medical device's performance testing for reusability and safety.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Text) | Reported Device Performance (from Text) |
|---|---|---|
| Intended Use/Indications | Device performs cutting, vaporization, ablation, and coagulation of soft tissue in specified medical specialties. | Same intended use/indications as predicate devices. The device functions as an accessory to transmit laser energy. |
| Technological Characteristics | Use of Silica-glass Fiber, plastic SMA 905 connector, Natural Quartz Ferrule, Heat Shrink tubing, SMA connector strain relief boot. Fibers are 3 meters (nominal) in length, with core diameter sizes of 272, 365, 550, and 940 microns. | Basic technological characteristics are identical to predicate devices. |
| Safety and Effectiveness (after reprocessing) | Maintain safety and effectiveness after undergoing reprocessing. (Implicit: such as maintaining laser energy transmission capabilities, structural integrity, and sterility where applicable, after multiple cycles of cleaning and sterilization). | "Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates." (This statement implies tests were conducted to support reusability, but specific details of those tests are not provided in this excerpt). |
| Substantial Equivalence | Device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and principles of operation, without raising new questions of safety or effectiveness. | Stated to be substantially equivalent. "The minor differences in the technological characteristics do not raise any new questions of safety or effectiveness." |
Study Details (or why they are not applicable for this device type)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not explicitly stated in the provided text. For a device like this, testing would typically involve a certain number of fiber samples subjected to multiple reprocessing cycles. The documentation does not specify these numbers or the origin of the test data.
- Data Provenance: Not specified. Testing for reusability is typically conducted in a laboratory setting.
- Retrospective or Prospective: Not applicable in the context of this device's performance testing. This would be controlled lab testing or simulated-use testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission describes a physical medical device (laser fiber) and its reusability, not a diagnostic or AI/ML algorithm that requires expert "ground truth" to evaluate its output. Evaluation would rely on objective physical, chemical, and functional performance metrics.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
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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, not an AI/ML system. There are no "human readers" or "AI assistance" involved in its direct function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for reusable medical devices is typically established through recognized standards for cleaning, disinfection, sterilization, material compatibility, and functional performance testing (e.g., laser transmission efficiency, optical integrity, structural integrity, sterility assurance levels) after specified numbers of reprocessing cycles. The "performance data" mentioned would be derived from such objective measurements.
-
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the AI/ML context.
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
Summary for this specific device:
The regulatory approval for the Dornier Medilas H RFID Reusable Laser Fibers is based on demonstrating substantial equivalence to existing predicate devices (Dornier Medilas H RFID Laser Fiber K121938 and Dornier Medilas H Laser Fiber Cables K022544). The key modification is the addition of reprocessing instructions to allow for reusability. The "study" that proves the device meets acceptance criteria would be a series of performance tests confirming that the fibers maintain their safety and effectiveness (e.g., laser energy transmission, structural integrity, biocompatibility, and sterility after multiple reprocessing cycles) despite being reused and going through the specified cleaning and sterilization processes. The document states "Performance data demonstrates that the Dornier Medilas H RFID Reusable Laser Fibers are as safe and effective as the listed predicates," implicitly confirming that these tests were conducted and the criteria met, though the specific details of these tests (like sample sizes, methods, and acceptance thresholds) are not provided in this specific excerpt.
§ 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.