(95 days)
Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body. The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.
The provided document is a 510(k) Premarket Notification for the Omni-Guide LISA Laser Surgical Fibers, determining its substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials and establishing new acceptance criteria based on human performance. Therefore, many of the typical elements of a study proving a device meets acceptance criteria for an AI/CAD system (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this document.
The document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance data, primarily bench testing and adherence to recognized standards.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:
1. A table of acceptance criteria and the reported device performance:
The document includes a "Substantial Equivalence Comparison Table" which compares the subject device (LISA Laser Surgical Fiber) with the predicate device (Laser Peripherals surgical fiber optic laser delivery devices K170366) across various characteristics and lists non-clinical performance data. Since this is a substantial equivalence submission for a traditional medical device (laser surgical fibers), the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate and compliance with relevant performance standards through bench testing.
| Acceptance Criteria (Implicitly from Predicate Equivalence & Standards) | Reported Device Performance (Bench Testing & Standards Compliance) |
|---|---|
| Technological Characteristics: | Subject Device Performance: |
| - Product Code: GEX | GEX (Same/Equivalent) |
| - Regulation Number: 21 CFR 878.4810 | 21 CFR 878.4810 (Same) |
| - Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology (Same/Equivalent) |
| - Components: Connector configurations suitable to multiple laser platforms | Connector configurations offered suitable to multiple laser platforms (Same/Equivalent) |
| - Fiber Material: High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm | High OH or Low OH silica material w/low attenuation of light wavelengths between 532nm - 2100nm (Same/Equivalent) |
| - Fiber Numerical Aperture (NA): between 0.22 - 0.48 | Fiber having a Numerical Aperture (NA) between 0.22 - 0.48 (Same/Equivalent) |
| - Fiber Distal Tip: Multiple configurations for suitable performance | Multiple configurations of distal tips offered to provide the most suitable performance for the application (Same/Equivalent) |
| - Core Diameters: Range of sizes suitable to user needs | Core diameters are offered in a range of sizes suitable to user needs (Same/Equivalent) |
| - Connectors: SMA 905, SMA 906, or manufacturer specific | SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors (Same/Equivalent) |
| - Fiber Construction: Core - Fused Silica; Clad – Fused Silica or Fluoropolymer Hard Cladding; Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate; Jacket - Nylon, Polyimide, or Teflon | Core - Fused Silica; Clad – Fused Silica or Fluoropolymer Hard Cladding; Buffer – Fluoropolymer Hard Cladding or Silicone Acrylate; Jacket - Nylon, Polyimide, or Teflon (Same/Equivalent) |
| - Peak and Continuous Wavelengths: 500nm-2200nm | 500nm-2200nm (Same/Equivalent) |
| - Power Ranges: 1-300 Watts | 1-300 Watts (Same/Equivalent) |
| - Compatibility with surgical laser systems | Fibers are compatible with any cleared laser system with an appropriate connection system (Same/Equivalent) |
| - Sterilization Method: EtO | EtO (Same/Equivalent) |
| Non-Clinical Performance: | Bench testing on the subject device has shown the device to perform as intended with the same technological principle, fit, form, function and method of operating, as the single use fibers of K170366. Tested for conformance to various performance standards (ISO 11135-1, ISO 11607-1, ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 14971, ASTM D4169, ASTM F88-09, ASTM F2096-11, ASTM F1980-07, ISO 14644-1, AAMI TIR12, ISO 17664, ISTA Project 2A, ASTM F56-13, ASTM F619-14). Specific performance tests included: Power & Energy input versus output, Homogeneity of output light (spot check, beam profile), High-power testing, Bend radius testing, Pull testing, Feature specific testing (e.g., Nav Tip traversing deflected endoscope), Scatter Free Fiber, Expanded transmission of laser wavelength/energy, and LaseGuide Nav distal tip configuration. These tests indicate passed testing of specific features or overall products, proving safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is for a traditional medical device, relying on bench testing and adherence to standards, not a diagnostic AI/CAD system that would typically have a "test set" of clinical data. The non-clinical performance data section describes "bench testing" without specifying sample sizes in this summary. The data provenance is laboratory-based testing conducted by the manufacturer, Omni-Guide Holdings, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth in the context of clinical expert review or diagnostic accuracy is not relevant for this device's submission type. Testing focused on engineering and material performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical studies involving human interpretation or diagnostic agreement, which is not the case here.
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 is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a laser surgical fiber, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Indirect. The "ground truth" for this type of device is implicitly defined by the safety and performance requirements of the predicate device and the relevant international and national standards (e.g., ISO, ASTM) that the device must meet through bench testing. For example, a successful bond strength test (per ASTM F88-09) or successful sterilization (per ISO 11135-1) serves as the "truth" that the device performs as intended in that particular aspect.
8. The sample size for the training set:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
9. How the ground truth for the training set was established:
- Not Applicable. This refers to machine learning algorithms, which are not involved here.
§ 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.