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K Number
K082460
Device Name
CENEFOM PVA SURGICAL SPEAR
Manufacturer
LONGTEK SCIENTIFIC CO., LTD.
Date Cleared
2008-12-15

(111 days)

Product Code
HOZ
Regulation Number
886.4790
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cenefom PVA Surgical Spear is indicated for short-term transient use in ophthalmic surgical procedures for absorbing excess fluids from the operative field.

Device Description

Not Found

AI/ML Overview

The provided FDA document (K082460) is a 510(k) clearance letter for the Longtek Cenefom PVA Surgical Spear and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

This document solely focuses on:

  • The FDA's determination of substantial equivalence to a predicate device.
  • The device's regulation number, name, and regulatory class.
  • General controls and other regulations that apply to the device.
  • The indications for use for the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or AI performance, as this document does not pertain to those aspects.

§ 886.4790 Ophthalmic sponge.

(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.