(142 days)
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.