(52 days)
The UltraLase Flexible CO2 Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthalmology, oral surveology, podiatry, gyneology, and urology procedures. It is used to deliver laser energy for incision, ablation, vaportzation, and coagulation of soft tissues.
The UltraLase Flexible CO2 Laser Waveguide can be used in open surgical procedures and endoscopic procedures.
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached
The UltraLase Flexible CO2 Laser Waveguides are laser delivery systems for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue.
The wavequide consists of a flexible silica capillary who's inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a protective sleeve.
The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6um and has a broad enough transmission band to accommodate any laser operating in this region.
The laser energy is coupled into the waveguide using the correct focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.
The laser waveguides have either a 905 SMA connector or a 953 ST connector attached and can therefore be used with any CO2 Laser that is compatible with one of these connectors. The wavequides are 2 meters long.
It is recommended that a purge gas be used to flow a gas through the wavequide to keep the inner channel of the wavequide free of debris.
The waveguides delivery systems are supplied sterile for single use.
The provided text describes a 510(k) premarket notification for a medical device called the "UltraLase Flexible CO2 Laser Waveguide." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new studies. Therefore, many of the requested categories for a typical medical device study that proves predefined acceptance criteria are not applicable in this context.
However, I can extract the information that is present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical tests performed are listed, along with their acceptance criteria. The document states that the new device met these criteria, implying its performance aligns with them.
| Test Performed | Acceptance Criteria (K211761 - New Device) | Reported Device Performance (Implied by document's conclusion of meeting criteria) |
|---|---|---|
| Epoxy strength Test | 15 Newtons for 15 seconds | Met 15 Newtons for 15 seconds |
| Intracutaneous Study | No evidence of irritation | No evidence of irritation |
| Muscle Implant Study | Microscopic reaction not significant | Microscopic reaction not significant |
| Systemic Toxicity Study | No mortality or systemic toxicity | No mortality or systemic toxicity |
| Sterilization Validation | Sterility assurance level of 10^-6 | Sterility assurance level of 10^-6 |
| ETO Residual | Meets requirements of ISO 10993-7 | Met requirements of ISO 10993-7 |
| Bioburden | Less than 100 | Less than 100 |
| Shelf-Life | 1 Year | 1 Year |
| Package Integrity | Visual Inspection, Bubble Leak Test, Seal Strength Test | Met Visual Inspection, Bubble Leak Test, Seal Strength Test |
| Performance Testing | Meets 70% transmission criteria after sterilization | Met 70% transmission criteria after sterilization |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the non-clinical tests. It refers to these as generic "tests." The data provenance is not explicitly stated, but these are non-clinical tests, meaning they were likely conducted in a laboratory setting by the manufacturer, Laser Engineering, in the US (Milford, MA). The tests are retrospective, as they were conducted to support a premarket notification for a device modified from a previously cleared one.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For non-clinical tests like material biocompatibility or mechanical strength, "ground truth" would typically be defined by established international standards (e.g., ISO for ETO residual) or internal product specifications rather than expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving diagnostic interpretations by multiple human readers, not for non-clinical engineering or biological safety tests.
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 passive surgical tool (a laser waveguide), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and no AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm-only performance testing was done.
7. The type of ground truth used
For the non-clinical tests:
- Performance Testing (Power Transmission): The ground truth is the engineering specification of greater than 70% transmission after sterilization.
- Biocompatibility (Intracutaneous, Muscle Implant, Systemic Toxicity): The ground truth is established by specific biological endpoints (e.g., "no evidence of irritation," "microscopic reaction not significant," "no mortality or systemic toxicity") as defined by relevant biocompatibility standards (e.g., ISO 10993 series).
- Sterilization & Residuals (Sterilization Validation, ETO Residual, Bioburden): The ground truth is defined by specific quantitative targets or compliance with standards (e.g., "sterility assurance level of 10^-6", "Meets requirements of ISO 10993-7", "Less than 100").
- Mechanical (Epoxy Strength, Package Integrity): The ground truth is based on engineering specifications (e.g., "15 Newtons for 15 seconds") or visual/physical inspection criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.