EYE FIXATION SPECULUM

K964289 · Eyefix, Inc. · HNC · Dec 17, 1996 · Ophthalmic

Device Facts

• Record ID: K964289
• Device Name: EYE FIXATION SPECULUM
• Applicant: Eyefix, Inc.
• Product Code: HNC · Ophthalmic
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1

Intended Use

The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.

Device Story

Device consists of low-profile scleral vacuum ring attached to medical-grade plastic ophthalmic speculum via six-degrees-of-freedom resistance joint. Physician retracts eyelids, secures speculum, and places concentric elastomer ring on sclera. Vacuum applied via spring-loaded syringe secures ring to sclera; resistance joint holds eye steady against ocular muscle movement. Allows physician to adjust globe position within joint range. Luminescent plastic aids visualization in low-light conditions. Used in clinical settings by physicians to immobilize eye during procedures; benefits patient by preventing involuntary eye movement, improving surgical/procedural precision.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: medical-grade plastic, elastomer ring. Principle: vacuum-assisted scleral fixation combined with mechanical resistance joint. Form factor: low-profile ring with attached speculum arm. Sterilization: provided sterile, single-use disposable.

Indications for Use

Indicated for patients requiring globe immobilization during ophthalmic procedures to reduce eye movement.

Regulatory Classification

Identification

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Predicate Devices

• Lid-Set Eyelid Retractor (K903322)
• Hessburg-Barron Vacuum Trephine (K864520)

Reference Devices

• K843048
• K923540

Submission Summary (Full Text)

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DEC 17 1996
K964289

510(k) Summary

SUBMITTER:

Submitted on behalf of:

Company Name: eyeFix™, Inc.
Address: Suite 750
Medical Arts Building
825 Nicollet Avenue
Minneapolis, MN 55402
Phone: [phone]
Fax: [phone]

CONTACT PERSON: Neal Sher, M.D., F.A.C.S.

OFFICIAL CORRESPONDENT: Richard E. Lippman, O.D., F.A.A.O.
Firm Name: C.L. McIntosh & Associates, Inc.
Address: 12300 Twinbrook Parkway, Suite 625
Rockville, MD 20852
Phone: [phone]
Fax: [phone]

DATE SUMMARY PREPARED: October 25, 1996

TRADE NAME: eyeFix™, Inc. Eye Fixation Speculum

COMMON NAME: ophthalmic speculum

SUBSTANTIALLY EQUIVALENT TO: The Eye Fixation Speculum, by eyeFix™, Inc. is substantially equivalent to two products currently legally marketed in the U.S. The Eye Fixation Speculum is substantially equivalent to the indication for use of the Lid-Set Eyelid Retractor manufactured by Universi, S.A. This device was determined by FDA to be exempt from 510(k) notification per K903322. The Eye Fixation Speculum is substantially equivalent to the stabilization method (technology) used in numerous manual ophthalmic instruments such as the Hessburg-Barron Vacuum Trephine as manufactured by Precision Instruments, Inc. This device was cleared by FDA in K864520. Additional products in the same family line were cleared under K843048 and K923540.

DESCRIPTION of the DEVICE: The Eye Fixation Speculum, by eyeFix, Inc., consists of a low profile scleral vacuum ring attached to a medical quality plastic ophthalmic speculum using a six-degrees of freedom resistance joint. After retracting the eyelids, and securing the speculum, the vacuum ring is attached to the sclera by locating the medical quality concentric elastomer-ring to the cornea. Vacuum is applied

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K964289

by way of the attached spring-loaded syringe. When vacuum is applied, the flexible elastomer portion of the ring sucks down on the scleral region of the eye securing the ring to the eye. The frictional forces within the resistance joint of the attaching arm of the speculum, together with the vacuum ring, hold the eye steady against the tendency of the eye muscles to the move the globe. Although this resistance is high enough to prevent the eye from moving, the force is not so high that the physician is prevented from conveniently moving the ring within the range of motion that the joint allows. Luminescent plastic on the upper portion of the ring helps in visualization of the eye under low examination lighting.

INDICATIONS FOR USE: The Eye Fixation Speculum, by eyeFix™, Inc. is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and is disposable for single use only.

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