K Number
K964018
Device Name
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
Date Cleared
1997-02-26

(142 days)

Product Code
Regulation Number
886.4670
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Provide illumination at surgical site.
Device Description
Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.
More Information

predicate silicone infusion sleeve

Not Found

No
The device description and intended use are purely mechanical/optical, and there are no mentions of AI, ML, or image processing.

No
The device provides illumination and does not treat or prevent disease.

No

Explanation: The device's intended use is to "Provide illumination at surgical site," and its description indicates it's a "Clear silicone sleeve that transmits light." These functions are for illumination, not for detecting, diagnosing, treating, or preventing disease, which are characteristics of a diagnostic device.

No

The device description clearly states it is a "Clear silicone sleeve" which is a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Provide illumination at surgical site." This is a direct action on the patient during a surgical procedure, not an analysis of a sample taken from the body.
  • Device Description: The device is described as a "Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece." This is a physical component used for illumination during surgery.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information about a patient's health status based on in vitro analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for surgical illumination.

N/A

Intended Use / Indications for Use

Provide illumination at surgical site.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

surgical site

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

predicate silicone infusion sleeve

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.

0

FEB 2 6 1997

CONFIDENTIAL AND PROPRIETARY INFORMATION

Page Three

510(k) Summary per section 807.92(c)

Submitter Name: Michael Reynard, M.D. Address: 1301 - 20th Street #260, Santa Monica, CA 90404 Telephone: 310-453-0551 FAX: 310-315-0133 Contact Person: Michael Reynard, M.D. Date of Summary: 9/30/1996

Name of Device: Accessory Illuminating Infusion Sleeve

Tradename of Device: Phacoilluminator™

Equivalence: The subject device is a predicate silicone infusion sleeve without opaque or tint additives.

Description of Device: Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.

Intended Use of Device: Provide illumination at surgical site.

Comparison with predicate devices: Construction material is identical with currently manufactured silicone infusion sleeve except that opaque additives are omitted to allow for light transmission.