(31 days)
The ophthalmic laser endoscope is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, visualization of the internal ocular structures in retinal detachment, and for visualization of the anterior segment which do not allow a posterior view.
Glaucoma
This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or other cyclodestructive procedures.
The endophotocoagulation of ciliary processes under direct endoscopic view is a recognized procedure and has been demonstrated to be effective in the treatment of glaucoma.
Vitreoretinal Surgery
The endoscopically controlled endophotocoagulation that is possible with the MicroProbe is also useful for endophotocoagulation:
- To produce chorioretinal scar around retinal breaks or retinotomy sites
- To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies
- To perform intraoperative retinal photocoagulation on a scleral buckle
- To perform intraoperative photocoagulation around focal neovascularization
The Endo Optiks E2 MicroProbe™ is the principal component in a new portable laser and endoscopy system. The complete system consists of the therapeutic laser, the endoscope, the monitor and the footswitch. This compact unit creates the opportunity to simultaneously image and photocoagulate the ciliary processes through a corneal incision. It is especially indicated for the safe and effective treatment of glaucoma in combination with cataract surgery. Important vitreo-retinal applications can be realized. It can be used for the contact and non-contact excision, hemostatis, incision and vaporization of soft tissue. The E2 MicroProbe is a modification to the packaging of the original MicroProbe.
Based on the provided documents for the Endo Optiks E2 MicroProbe, here's a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| System specifications are satisfied. | The nonclinical tests showed that "all system specifications are satisfied." (Page 2) |
| Performance is substantially equivalent to predicate device. | "The testing of the modified device demonstrates that the performance is substantially equivalent to the predicate device." (Page 2) |
| Image quality meets requirements for endoscopic visualization. | While not explicitly stated as an "acceptance criterion" in a table within the document, the device description and intended use imply adequate imaging. The device is a "principal component in a new portable laser and endoscopy system" and creates "the opportunity to simultaneously image and photocoagulate." (Page 1) The intended use specifies "video imaging" for endoscopic procedures. The fact that the device was found substantially equivalent to the predicate (which performs these functions) means it met these implied criteria. |
| Laser output meets requirements for photocoagulation. | The intended use specifies "photocoagulation using up to 1.2 watt of continuous wave radiation for endoscopic procedures." (Page 2) The nonclinical testing found all system specifications satisfied and substantial equivalence to the predicate, which also performs photocoagulation. This indicates the device met its specified laser output for its intended therapeutic procedures. |
| Conformity with recognized standards. | The E2 MicroProbe "has also been tested and found to be in conformity with recognized standards." (Page 2) Specific standards are not listed. |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify a test set sample size or data provenance (e.g., country of origin, retrospective or prospective data) for any clinical or nonclinical studies. The assessment for this 510(k) relies on nonclinical testing to demonstrate substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the documents. The submission emphasizes nonclinical testing and substantial equivalence, not clinical validation based on expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the documents. As the submission focuses on nonclinical testing for substantial equivalence, a clinical adjudication method is not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned in the provided documents. The submission relies on nonclinical testing for substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the E2 MicroProbe is a medical device (laser and endoscopy system), not an AI algorithm. Its performance is inherent in its physical and functional capabilities, not in an independent algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission appears to be engineering specifications and established performance characteristics of the predicate device. The testing demonstrated that the E2 MicroProbe satisfied its own system specifications and that its performance was substantially equivalent to the legally marketed predicate device (Uram Ophthalmic Laser Endoscope - MicroProbe).
8. The Sample Size for the Training Set
This information is not applicable as the E2 MicroProbe is a medical device, not an AI or machine learning model that requires a training set. The evaluation is based on the device's physical and functional performance, not learned data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.