(683 days)
The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "EndoSerter™". It states that the device is substantially equivalent to legally marketed predicate devices.
However, this letter does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documents for AI/ML devices.
The provided text only includes:
- Device Name: EndoSerter™
- Regulation Number: 21 CFR 886.4300
- Regulation Name: Intraocular lens guide (though the Indications for Use state it's for corneal endothelial allograft tissue insertion)
- Regulatory Class: Class I, reserved
- Product Code: OTZ
- Indications for Use: "The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures."
Therefore, I cannot provide the requested table or answer the specific questions (2-9) because the necessary information is not present in the given document.
This type of FDA letter is primarily for regulatory clearance based on substantial equivalence to a predicate device, rather than a detailed performance study report. For performance criteria and study details, one would typically look for a separate clinical study report, a verification and validation report, or perhaps a more detailed summary of safety and effectiveness from the manufacturer.
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.