(59 days)
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No
The device description details a mechanical cleaning process using a figure-eight motion and disposable pads. There is no mention of any computational or algorithmic components that would suggest the use of AI or ML.
No
The device is a contact lens cleaning accessory, not a therapeutic device. It is intended to aid in cleaning contact lenses and does not treat or prevent any medical condition.
No
The device is described as a cleaning accessory for contact lenses, mimicking a manual cleaning motion. Its purpose is to physically clean lenses, not to diagnose any condition or disease.
No
The device description clearly outlines physical components such as a plastic case, disposable foam pads, hinge-mounted base and cover, receptacles, mounting posts, motion plate, cleaning head domes, and a hinged latch. These are all hardware components, not software.
Based on the provided information, the ACU-CLENS™ Cleaning Accessory is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for cleaning contact lenses, which are medical devices themselves, but the cleaning process is a physical action to remove debris and deposits. It does not involve testing a biological sample from the human body to provide diagnostic information.
- Device Description: The description details a mechanical cleaning method using a physical motion and cleaning solution. It doesn't describe any components or processes that would analyze biological samples.
- Lack of IVD Characteristics: The document 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 biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
The device is a cleaning accessory for contact lenses, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device ands in cleaning by minimizing hand contact with lenses.
Product codes
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Device Description
ACU-CLENS™ Cleaning Accessory for Contact Lens Cleaning is a method of cleaning contact lenses that mimics the figure-eight hand-in-palm motion. The ACU-CLENS™ Cleaning Accessory can be used with hard (gas permeable) and soft (hydrophilic) lenses. ACU-CLENSTM Cleaning Accessory features a durable plastic case and disposable foam pads for use with professionally recommended daily cleaning solutions. The hinge mounted base and cover contain right and left lens receptacles and four mounting posts which secures the disposable pad to the base. The cover provides a motion plate, cleaning head domes and a hinged latch to secure the disposable pad to the cleaning head domes. Daily cleaning solution (recommended by an eye care professional or physician) is applied to the disposable pad secured to the cleaning head domes and the right and left receptacle and the lenses are placed on the disposable pad above the right and left receptacle. After closing the case the motion plate on the cover is moved in a figure-8 motion to create the scrubbing effect necessary to clean both top and bottom of each lens simultaneously. Lenses should be thoroughly disinfected using solution recommended by physicians or eye-care professionals. The disposable pad should be removed and the Cleaning Case disinfected after each use.
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)
The foam pads used in the ACU-CLENS™ Cleaning Accessory have been tested for cytotoxicity and eye irritation and have been found to be non-toxic and non-irritating. The CLENSER Corporation has tested lenses with the ACU-CLENS™ Cleaning Accessory, the results of which are represented by Scanning Electron Microscope photographs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
K 964222 DEC 2 0 1996
510(k) Summary
,
DATE SUMMARY REVISED: November 27, 1996
SUBMITTER:
Submitted on behalf of:
The CLENSER Corporation Address: 7100 Boyd Avenue Eden Prairie, MN 55346-3534 Telephone: 612-934-1616 by:
Paladin Medical, Inc. P. O. Box 560 Stillwater, MN 55082 Elaine Duncan CONTACT PERSON:
| TRADE NAME: | ACU-CLENST™ Cleaning Accessory |
|---|---|
| COMMON NAME: | Contact Lens Cleaning Accessory |
SUBSTANTIALLY EQUIVALENT TO: The CLEANER™ Accessory by Easy Eyes, Eaton Medical Corporation
DESCRIPTION: ACU-CLENS™ Cleaning Accessory for Contact Lens Cleaning is a method of cleaning contact lenses that mimics the figure-eight hand-in-palm motion. The ACU-CLENS™ Cleaning Accessory can be used with hard (gas permeable) and soft (hydrophilic) lenses. ACU-CLENSTM Cleaning Accessory features a durable plastic case and disposable foam pads for use with professionally recommended daily cleaning solutions. The hinge mounted base and cover contain right and left lens receptacles and four mounting posts which secures the disposable pad to the base. The cover provides a motion plate, cleaning head domes and a hinged latch to secure the disposable pad to the cleaning head domes. Daily cleaning solution (recommended by an eye care professional or physician) is applied to the disposable pad secured to the cleaning head domes and the right and left receptacle and the lenses are placed on the disposable pad above the right and left receptacle. After closing the case the motion plate on the cover is moved in a figure-8 motion to create the scrubbing effect necessary to clean both top and bottom of each lens simultaneously. Lenses should be thoroughly disinfected using solution recommended by physicians or eye-care professionals. The disposable pad should be removed and the Cleaning Case disinfected after each use.
INDICATIONS FOR USE: ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device ands in cleaning by minimizing hand contact with lenses.
SUPPORTING INFORMATION: The ACU-CLENSTM Cleaning Accessory is intended for use with a fresh pad each use, whereas THE CLEANER ACCESSORY™ by Easy Eyes® recommends cleaning and reuse of the pads. The CLENSER Corporation does not recommend reuse of the cleaning pads. Labeling instructions for use of the ACU-CLENS™ Cleaning Accessory state that the cleaning pads should not be reused. Replacement pads are available, sold separately. The foam pads used in the ACU-CLENS™ Cleaning Accessory have been tested for cytotoxicity and eye irritation and have been found to be non-toxic and non-irritating. The ACU-CLENS™ Cleaning Accessory has been designed to minimize the hand contact with lenses normally associated with cleaning instructions accompanying cleaning solutions. The CLENSER Corporation has tested lenses with the ACU-CLENS™ Cleaning Accessory, the results of which are represented by Scanning Electron Microscope photographs.