(50 days)
No
The device description focuses on mechanical components (vacuum ring, resistance joint, speculum) and physical principles (vacuum, friction) to achieve eye stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is intended to immobilize the eye during surgery, not to treat a disease or condition itself.
No.
The document describes a device used to immobilize the eye during medical procedures, not to diagnose a condition. Its function is mechanical stabilization rather than detecting, monitoring, or identifying disease or injury.
No
The device description clearly details physical components such as a scleral vacuum ring, plastic ophthalmic speculum, resistance joint, syringe, and elastomer ring, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized." This is a mechanical function performed directly on the patient's eye.
- Device Description: The description details a physical device (speculum, vacuum ring, syringe) that interacts with the eye to hold it steady.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device acts on the eye itself, not on a biological sample taken from the eye or elsewhere.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device is a surgical/procedural tool used on the body.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye / globe
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
DEC 1 7 1996
510(k) Summary
SUBMITTER:
Submitted on behalf of:
| Company Name: | eyeFix TM , Inc. |
|---|---|
| Address: | Suite 750 |
| Medical Arts Building | |
| 825 Nicollet Avenue | |
| Minneapolis, MN 55402 | |
| Phone: | 612-338-4861 |
| Fax: | 612-333-8306 |
| CONTACT PERSON: | Neal Sher, M.D., F.A.C.S. |
| OFFICAL 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: | 301-770-9590 |
| Fax: | 301-770-9584 |
| DATE SUMMARY PREPARED: | October 25, 1996 |
| TRADE NAME: | eyeFix TM , Inc. Eye Fixation Speculum |
| COMMON NAME: | ophthalmic speculum |
SUBSTANTIALLY EQUIVALENT TO: The Eye Fixation Speculum, by eyeFixTM, 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 opthalmic 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
1
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.