(218 days)
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Not Found
No
The summary describes a basic surgical illumination system and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device's intended use is to "Provide illumination at surgical site," which is a supportive function, not a direct therapeutic intervention. It's a component of a phacofragmentation system, but its described function here is illumination.
No
The device's sole stated intended use is to "Provide illumination at surgical site," which is a functional purpose, not a diagnostic one.
No
The device description explicitly mentions hardware components like "fiber optic light guides," "fluid channels," and "infusion sleeve," indicating it is a physical system, not software-only.
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 performed on or within the patient during surgery, not a test performed on a sample taken from the patient.
- Device Description: The description mentions a "Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve." This describes a surgical instrument used for a procedure, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, this device falls under the category of a surgical instrument or system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Provide illumination at surgical site.
Product codes
78FCW, 86HQC
Device Description
Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image is a black and white drawing of a circular target-like design. The design features a central black circle surrounded by a white ring. Four rectangular shapes extend outward from the white ring, dividing the circle into quadrants. The bottom right corner of the image has the letters 'SM' written in a small font.
1301 - 20th Street #260 Santa Monica, California 90404 (310) 453-0551
OCT - 2 1996
960811
510(k) Summary per section 807.92(c)
Submitters Name: Michael Reynard, M.D. Address: 1301 - 20th Street #260, Santa Monica, CA 90404 FAX: 310-315-0133 Telephone: 310-453-0551 Contact Person: Michael Reynard, M.D. Date of Summary: 02/12/1996
Name of Device: Fiber Optic Phacofragmentation System
Tradename of Device: Phacoscopers
Equivalence: The subject device combines predicate phacofragmentation system and fiber optic light guides for transmitting visible light.
Description of Device: Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.
Intended Use of Device: Provide illumination at surgical site.
Comparison with predicate devices: Medical grade fiber optic guides consistent with Class II classification devices used for intraocular illumination (Classification number 876-1500; Product Code 78FCW) are combined with a phacofragmentation handpiece. Electrical power and light sources for the fiber optic phacofragmentation handpiece (Class II; Classification number 886.4670; Product Code 86HQC) are identical with those currently used. Construction materials are identical with phacofragmentation handpieces and fiber optic devices that are legally marketed devices currently in use. Colors are identical to those in legally marketed devices currently in use.
Sterilization Method: 1) Autoclave for fiber optic phacofragmentation handpiece incorporating quartz fiber optics, or 2) sterilizers customarily used for fiber optic instruments incorporating quartz or plastic fiber optics.
Image /page/0/Picture/14 description: The image shows a circular stamp with the text "FEB 1996" in the center. The stamp also includes the phrases "EPA VALIDATED" and "CDS/CRLB REGISTRATION YR 40". The outer ring of the stamp features numbers from 12 to 31, likely representing dates.