(122 days)
The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.
The Family of Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic. The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: 1) the fiber core, 2) fiber cladding and coating layers, and 3) the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material. The core is the main light pipe which offers a path for the light energy. The fiber cladding and coating layers are placed over the core and shield the fiber from losing energy over the length of the fiber and guide the energy to exit the distal tip. The material of the cladding and coating layer has a different index of refraction, which directs the light back into the core. This is typically another layer of silica, but may include a chemical layer (e.g., Fluoropolymer). Fiber selection is based on the ability to transmit the light wavelength that the laser is producing. The outside of the laser fiber is coated with a flexible material to offer abrasion and breakage resistance. This coating is typically an ETFE, but some models offer a Polyimide coating for superior resistance. The distal tip of the laser fiber offers the user an opportunity to configure the output energy to suit the needs of the application. The most predominate distal tip configuration is a flat, polished surface. The flat end face of the fiber allows the energy to exit the fiber unaltered. Other configurations manage the light in different ways. This allows the user to use the fiber where a different method of treatment is appropriate. Fibers can be divided into two categories: Contact and Non-contact. This refers to whether the distal tip is touching the subject matter at the worksite or whether it is held back, away from the target. Contact fibers are generally shaped into configurations intended to maximize the effectiveness of the procedure. These shapes include cone tips, ball tips, spherical tips, etc. A third type of distal tip offers further treatment of the laser energy as it exits the fiber. These distal tips utilize added components to either direct the laser light (i.e., ScatterFree™ (SideFire)) or lens the light (focus or dispersed).
The provided text describes a 510(k) premarket notification for "Laser Peripherals, Llc Family Of Bare Laser Fibers." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new, innovative device with a primary clinical outcome. Therefore, many of the requested details about acceptance criteria for device performance, especially in a comparative effectiveness study or involving expert ground truth, are not directly applicable or available in this document.
However, I can extract information related to what constitutes "acceptance" in the context of this 510(k) submission, which is primarily demonstrating substantial equivalence and meeting non-clinical performance and safety standards.
Here's an interpretation based on the provided text:
Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate devices and meeting relevant safety and performance standards. The reported device performance is that it meets these standards and is comparable to the predicates.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The device's intended use is substantially equivalent to predicate devices, potentially with more specificity but without raising new safety/efficacy concerns. | The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors. The intended uses are similar to predicate devices, with clarifying specificity (e.g., removing "Diode" for generic term of Laser Fiber based on light wavelength). This "does not raise any new issues of safety or efficacy." |
| Technological Characteristics Equivalence: The device shares the same fundamental scientific technology and characteristics as predicate devices. | The device's components (connector configurations, fiber materials like silica core with fluoropolymer hard cladding, acrylate, Teflon, nylon, or polyimide buffer; silica cladding with fluoropolymer coating) and jacket materials (Teflon, Peek) are "similar" to predicates. It utilizes high OH or Low OH silica material with low attenuation of light wavelengths between 500nm - 2200nm (predicate range 532nm - 2100nm, one predicate 500nm - 2200nm), and numerical apertures (NA) between 0.22 – 0.48, which are "similar." Multiple configurations of distal tips are offered, "similar" to predicates. Used with attachments (hand-pieces, endoscopes, cannulas, introducers) is "similar." Core diameters are offered in a range of sizes. Power ranges are 1-300 Watts (one predicate 30W/50W). Compatibility with surgical laser systems via appropriate connection is "similar." The fiber core and cladding are made from silica, the same material as in predicate devices. There are "no differences in technology" that raise new questions on safety or efficacy. Features like Scatter Free Fiber, expanded transmission of laser wavelength/energy, and the LaseGuide Nav distal tip configuration were tested and shown to be safe and effective. |
| Safety and Performance Standards Compliance: The device meets recognized consensus standards for medical devices and relevant performance testing. | The device complies with numerous ISO and ASTM standards related to sterilization (ISO 11135-1, ISO 10993-7), packaging (ISO 11607-1, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07), biocompatibility (ISO 10993-1, -5, -10, -11, ASTM F56-13, ASTM F619-14), risk management (ISO 14971), cleanrooms (ISO 14644-1), and reprocessing (AAMI TR12, ISO 17664). Bench testing was conducted for performance, biocompatibility, packaging and shipping, and sterilization. Specific performance tests include: Power & Energy input versus output, homogeneity of output light (spot check, beam profile), high-power testing, bend radius testing, pull testing, and feature-specific testing (e.g., Nav Tip ability to traverse deflected endoscope). These tests collectively demonstrated the device performs as intended with same or similar results as predicate device design and did "not raise new safety or efficacy questions." |
Study Details (as inferred from the 510(k) submission):
This submission primarily relies on non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study with diagnostic outcomes.
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Sample Size used for the test set and the data provenance:
- The document does not specify a "test set" in the sense of a clinical or expert-reviewed dataset. The testing was bench testing on physical device samples.
- The sample sizes for the various non-clinical engineering and bench tests (e.g., power output, bend radius, pull testing, biocompatibility, packaging) are not explicitly stated in this summary. These quantities would be detailed in the full test reports referenced (e.g., Section 18).
- Provenance: This is entirely laboratory/bench test data, likely conducted internally by Laser Peripherals, LLC, or by accredited labs per standards. It is retrospective in the sense that the test results confirm the design's performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on non-clinical engineering and performance testing, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these tests are objective measurements against defined engineering specifications and standard requirements.
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Adjudication method for the test set:
- Not applicable. There was no expert adjudication process involved, as the "test set" consists of objective measurements from physical bench tests.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a bare laser fiber, a surgical instrument, not an AI-assisted diagnostic tool or an imaging device. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
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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 medical device (laser fiber), not an algorithm or software. Its performance is inherent in its physical properties and how it delivers laser energy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's evaluation is primarily based on engineering specifications, compliance with recognized consensus standards (ISO, ASTM), and objective physical measurements from bench testing. For biocompatibility, it's defined by the outcomes of standard biological tests. For sterilization, it's meeting validated sterilization parameters.
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The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model, so there is no "training set" in the AI sense. The design and manufacturing process would involve internal development and verification cycles, but not a dataset for algorithm training.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 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.