Source: http://www.boydtech.com/device-finder/ophthalmic
Timestamp: 2019-02-18 00:37:04
Document Index: 569277658

Matched Legal Cases: ['art 886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', 'art 807', 'art 820', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', 'art 807', 'art 820', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', 'art 807', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', 'art 807', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886']

Ophthalmic | Boyd Technologies
Ophthalmology is an area of medicine concerned with the structure, function, and diseases of the eye. The FDA regulates ophthalmological devices under CFR Title 21 Part 886, and the devices are categorized into four subparts.
Ophthalmic Prosthetic Devices
Ophthalmic Therapeutic Devices
Ocular esthesiometer.
§886.1040
Adaptometer (biophotometer).
§886.1050
§886.1070
§886.1090
Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.
§886.1120
Ophthalmic chair.
§886.1140
§886.1150
Color vision plate illuminator.
§886.1160
§886.1170
§886.1190
§886.1200
Corneal electrode.
§886.1220
§886.1250
§886.1270
§886.1290
Afterimage flasher.
§886.1300
Identification. An afterimage flasher is an AC-powered light that automatically switches on and off to allow performance of an afterimage test in which the patient indicates the positions of afterimages after the light is off. The device is intended to determine harmonious/anomalous retinal correspondence (the condition in which corresponding points on the retina have the same directional value).
§886.1320
§886.1330
Haploscope.
§886.1340
§886.1342
Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination). (2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated: (i) Verification of lowest detectable amount of deviation; and (ii) Validation of the accuracy and precision at the lowest detectable amount of deviation. (3) Software verification, validation, and hazard analysis must be performed. (4) Optical radiation safety testing must demonstrate the device is safe per the directions for use. (5) Performance testing must demonstrate the electromagnetic compatibility of the device. (6) Performance testing must demonstrate the electrical safety of the device. (7) Labeling must include the following: (i) Summaries of non-clinical and clinical performance testing; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanation of all user-interface components; and (iv) Information related to electromagnetic compatibility and optical radiation classification.
§886.1350
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files
Visual field laser instrument.
§886.1360
§886.1375
§886.1380
Polymethylmethacrylate (PMMA) diagnostic contact lens.
§886.1385
§886.1390
§886.1395
§886.1400
Ophthalmic trial lens set.
§886.1405
Ophthalmic trial lens clip.
§886.1410
§886.1415
Ophthalmic lens gauge.
§886.1420
Lens measuring instrument.
§886.1425
Ophthalmic contact lens radius measuring device.
§886.1430
Maxwell spot.
§886.1435
Identification. A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.
Corneal radius measuring device.
§886.1450
§886.1460
§886.1500
Eye movement monitor.
§886.1510
§886.1570
§886.1605
AC-powered photostimulator.
§886.1630
Ophthalmic preamplifier.
§886.1640
Identification. An ophthalmic preamplifier is an AC-powered or battery-powered device intended to amplify electrical signals from the eye in electroretinography (recording retinal action currents from the surface of the eyeball after stimulation by light), electrooculography (testing for retinal dysfunction by comparing the standing potential in the front and the back of the eyeball), and electromyography (recording electrical currents generated in active muscle).
§886.1650
Identification. An ophthalmic bar prism is a device that is a bar composed of fused prisms of gradually increasing strengths intended to measure latent and manifest strabismus (eye muscle deviation) or the power of fusion of a patient&#39;s eyes.
§886.1655
Gonioscopic prism.
§886.1660
§886.1665
Ophthalmic isotope uptake probe.
§886.1670
Identification. An ophthalmic isotope uptake probe is an AC-powered device intended to measure, by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye.
Ophthalmic projector.
§886.1680
Pupillograph.
§886.1690
Identification. A pupillograph is an AC-powered device intended to measure the pupil of the eye by reflected light and record the responses of the pupil.
§886.1700
Skiascopic rack.
§886.1750
Ophthalmic refractometer.
§886.1760
§886.1770
§886.1780
Classification. (1) Class II (special controls) for the AC-powered device. (2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
§886.1790
Schirmer strip.
§886.1800
Identification. A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient&#39;s lower eyelid to stimulate and evaluate formation of tears.
§886.1810
Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient&#39;s visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.
§886.1840
§886.1850
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient&#39;s eye through a control diaphragm a thin, intense beam of light.
Ophthalmic instrument stand.
§886.1860
§886.1870
Identification. A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient&#39;s corrective exercises of eye muscles.
§886.1880
§886.1905
Identification. Nystagmus tape is a device that is a long, narrow strip of fabric or other flexible material on which a series of objects are printed. The device is intended to be moved across a patient&#39;s field of vision to elicit optokinetic nystagmus (abnormal and irregular eye movements) and to test for blindness.
§886.1910
§886.1925
Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Ability of the device to detect diurnal changes. (ii) Tolerability of the system at the corneoscleral interface in the intended use population. (2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure. (3) Patient-contacting components must be demonstrated to be biocompatible. (4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life. (5) Software verification, validation, and hazard analysis must be performed. (6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device. (7) Performance testing must demonstrate electrical safety of the device. (8) Labeling must include the following: (i) Warning against activities and environments that may put the user at greater risk. (ii) Specific instructions for the safe use of the device, which includes: (A) Description of all device components and instructions for assembling the device; (B) Explanations of all available programs and instructions for their use; (C) Instructions and explanation of all user-interface components; (D) Instructions on all safety features of the device; and (E) Instructions for properly maintaining the device. (iii) A summary of nonclinical testing information to describe EMC safety considerations. (iv) A summary of safety information obtained from clinical testing. (v) Patient labeling to convey information regarding appropriate use of device.
Tonometer and accessories.
§886.1930
Tonometer sterilizer.
§886.1940
§886.1945
Ophthalmic tantalum clip.
§886.3100
Ophthalmic conformer.
§886.3130
§886.3200
Identification. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient&#39;s eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
Absorbable implant (scleral buckling method).
§886.3300
§886.3320
Extraocular orbital implant.
§886.3340
§886.3400
Classification. Class II. The special controls for this device are FDA&#39;s: (1) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (2) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), and (3) Guidance on 510(k) Submissions for Keratoprostheses.
§886.3600
Scleral shell.
§886.3800
§886.3920
Classification. Class II. The special controls for this device are FDA&#39;s: (1) Use of International Standard ISO 10993 Biological Evaluation of Medical DevicesPart I: Evaluation and Testing, (2) 510(k) Sterility Review Guidance of 2/12/90 (K90-1), and (3) Aqueous Shunts510(k) Submissions.
§886.4070
Radiofrequency electrosurgical cautery apparatus.
§886.4100
Thermal cautery unit.
§886.4115
§886.4150
§886.4155
Identification. A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.
Classification. Class II (special controls). The special controls for the scleral plug are as follows: (1) 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 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; and (iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. (2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; (iii) Characterization of the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and (vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
Cryophthalmic unit.
§886.4170
§886.4230
§886.4250
Intraocular gas.
§886.4270
Intraocular fluid.
§886.4275
Intraocular pressure measuring device.
§886.4280
Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.
§886.4300
§886.4335
Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user&#39;s head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.
§886.4350
Ocular surgery irrigation device.
§886.4360
§886.4370
Ophthalmic laser.
§886.4390
§886.4392
§886.4400
§886.4440
§886.4445
Ophthalmic surgical marker.
§886.4570
Ocular pressure applicator.
§886.4610
§886.4670
Ophthalmic photocoagulator.
§886.4690
§886.4750
§886.4770
§886.4790
§886.4855
§886.5100
Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
§886.5120
§886.5200
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.
Classification. Class II (special controls). The special controls for this device are: (1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions; (3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components; (4) The device should be demonstrated to be biocompatible; and (5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.
Contact lens inserter/remover.
§886.5420
§886.5540
§886.5600
§886.5700
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). (1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid.
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 886.9. The special controls for the external eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.
§886.5800
§886.5810
§886.5820
§886.5838
Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
§886.5840
§886.5842
§886.5844
§886.5850
§886.5870
Electronic vision aid.
§886.5900
Oral electronic vision aid.
§886.5905
Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.
Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability. (3) Software verification, validation, and hazard analysis must be performed. (4) Analysis/testing must validate electromagnetic compatibility. (5) Analysis/testing must validate electrical safety. (6) Analysis/testing must assess and validate wireless coexistence concerns. (7) Any elements of the device that contact the patient must be demonstrated to be biocompatible. (8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use. (9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use).
§886.5910
Optical vision aid.
§886.5915
§886.5916
Classification. (1) Class II if the device is intended for daily wear only. (2) Class III if the device is intended for extended wear.
§886.5918
Classification. Class II (Special Controls) Guidance Document: Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.
§886.5925
§886.5928