(68 days)
InnoVoyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue.
The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.
This device is a Laser Surgical Instrument. The device is a Class II device with product code GEX.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table format common for AI/ML devices. Instead, the performance is demonstrated through non-clinical performance testing against recognized consensus standards, which essentially serve as the acceptance criteria for safety and effectiveness for this type of device.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ISO 14971:2007 (Medical devices - Application of risk management) | Compliance demonstrated through testing and adherence to design control practices. |
| ISO-10993-10:2010 (Biological evaluation - Tests for irritation & skin sensitization) | Compliance demonstrated through non-clinical testing. |
| ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals) | Compliance demonstrated through non-clinical testing. |
| USP (Medical Devices - Bacterial Endotoxin and Pyrogen Tests) | Compliance demonstrated through non-clinical testing. |
| ISO 11135:2014/Amd.1:2018 (Sterilization of health-care products - Ethylene oxide) | Compliance demonstrated through non-clinical testing. |
| ISO 11138-2:2017 (Sterilization - Biological indicators for ethylene oxide) | Compliance demonstrated through non-clinical testing. |
| ISO 11737-1:2018 (Sterilization - Microbiological methods) | Compliance demonstrated through non-clinical testing. |
| ISO 11607-1:2019 (Packaging for sterilized devices - Materials) | Compliance demonstrated through non-clinical testing. |
| ISO 11607-2:2019 (Packaging for sterilized devices - Validation) | Compliance demonstrated through non-clinical testing. |
| Intended Use, Technological Characteristics, Requirement Specifications, Risk Management Results | "The subject device was tested in accordance with Verification and Validation processes in accordance with design control practices. Testing has been performed to address intended use, the technological characteristics, requirement specifications, and the risk management results." (Conclusion: Sufficient to support intended use and demonstrate safety/effectiveness.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an AI/ML device. For this type of medical device (laser fiber), the "test set" would encompass the physical units subjected to the non-clinical performance and biological evaluation tests. The document indicates that "Non-clinical testing was performed on InnoVoyce Laser Fiber."
- Data Provenance: Not applicable in the same way as AI/ML software. The data provenance would refer to the materials and methodology used in the laboratory and bench testing, which are governed by the listed ISO and USP standards. This is not retrospective or prospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The "ground truth" for this device is established by adherence to recognized international and FDA standards for medical device safety and performance (e.g., biocompatibility limits, sterilization efficacy, material properties). These standards are developed through consensus by experts in various fields. The testing itself is conducted by qualified personnel in accredited laboratories.
- Qualifications of Experts: Not explicitly stated for specific individuals involved in this submission, as the "experts" are the collective bodies that establish the standards and the qualified personnel performing the laboratory tests.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is not a study requiring expert adjudication of interpretations (like imaging studies). Compliance with the performance standards is typically determined by objective measurements and analyses performed during bench and laboratory testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical surgical tool, not an AI/ML diagnostic aid that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Not applicable. This is not an algorithm or software device. The "performance" is inherent to the physical device's characteristics and its ability to deliver laser energy safely and effectively as intended.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for this device is established by objective measurements against predefined scientific and engineering specifications and consensus standards. This includes physical properties, biological safety (e.g., lack of irritation, endotoxin levels), and sterilization efficacy, as outlined by the ISO and USP standards. It is not expert consensus on interpretations of images or pathology.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 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.