PHACOSCOPE

K960811 · Saint John'S Plaza Medical Group · HQC · Oct 2, 1996 · Ophthalmic

Device Facts

• Record ID: K960811
• Device Name: PHACOSCOPE
• Applicant: Saint John'S Plaza Medical Group
• Product Code: HQC · Ophthalmic
• Decision Date: Oct 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Provide illumination at surgical site.

Device Story

Phacoscope™ combines phacofragmentation handpiece with integrated fiber optic light guides; guides routed through fluid channels and infusion sleeve. Device provides illumination at surgical site during ophthalmic procedures. Operates using existing electrical power and light sources identical to predicate phacofragmentation systems. Used by ophthalmologists in surgical settings. Benefits include simultaneous fragmentation and illumination, reducing need for separate light pipe instruments.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on identical materials and design to legally marketed predicate devices.

Technological Characteristics

Phacofragmentation handpiece with integrated quartz or plastic fiber optic light guides. Materials identical to legally marketed phacofragmentation and fiber optic devices. Sterilization via autoclave or standard fiber optic instrument sterilizers.

Indications for Use

Indicated for use during ophthalmic surgery requiring phacofragmentation and intraocular illumination.

Regulatory Classification

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.

Predicate Devices

• Phacofragmentation system (Class II, 886.4670, 86HQC)
• Fiber optic light guides (Class II, 876-1500, 78FCW)

Submission Summary (Full Text)

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MICHAEL REYNARD, M.D.
Saint John's Plaza Eye Medical Group
1301 - 20th Street #260
Santa Monica, California 90404
[phone]
OCT - 2 1996
K960811

# 510(k) Summary per section 807.92(c)

Submitters Name: Michael Reynard, M.D.
Address: 1301 - 20th Street #260, Santa Monica, CA 90404
Telephone: [phone] FAX: [phone]
Contact Person: Michael Reynard, M.D.
Date of Summary: 02/12/1996

**Name of Device:** Fiber Optic Phacofragmentation System
**Tradename of Device:** Phacoscope™
**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.

RECEIVED
02/12/1996
9661 811