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K Number
K031023
Device Name
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10
Manufacturer
PEREGRINE SURGICAL LTD.
Date Cleared
2003-06-27

(88 days)

Product Code
HQF
Regulation Number
886.4390
Type
Traditional
Panel
OP
Reference & Predicate Devices
K024061,K931784
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip

Device Description

The Peregrine Illuminated Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Peregrine Illuminated Laser Probe). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

The document details:

  • Device Description: What the device is composed of and its function.
  • Intended Use: For photocoagulation and illumination during ophthalmic surgery.
  • Substantial Equivalence Comparison: A comparison of the Peregrine Illuminated Laser Probe to two predicate devices, highlighting similarities and differences in components and specifications. This is a regulatory comparison to justify substantial equivalence, not a performance study.
  • Sterility Information: States the device will be ETO sterilized and the validation method (AAMI Overkill Method).
  • FDA Clearance Letter: Confirms substantial equivalence to predicate devices and allows marketing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.