(97 days)
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No
The device description and performance studies focus on the mechanical function of folding an intraocular lens and do not mention any computational or learning-based processes.
No
The device's intended use is to fold an intraocular lens for insertion, not to treat or cure a disease or condition. It is a tool for preparing another medical device.
No
The device is described as an intraocular lens folder used to fold existing lenses prior to insertion into the eye. Its purpose is mechanical preparation, not diagnosis or analysis of patient conditions.
No
The device description explicitly states it is a "sterile, single-use IOL folder," which is a physical, hardware device used to fold intraocular lenses. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fold an intraocular lens prior to insertion into the eye. This is a surgical/procedural device used to prepare a medical implant.
- Device Description: The description reinforces its function as a tool for manipulating a lens.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical accessory.
N/A
Intended Use / Indications for Use
The intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.
Product codes
HAR
Device Description
The AcryPak® Folder is a sterile, single-use IOL folder that allows the user to load and fold ACRYSOF® lenses in 6-12, 3-9, or 4-10 orientation. This lens folder is easy to use and does not require user cleaning and resterilization. The AcryPak® Folder is supplied separately from the IOL.
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 performance of the AcryPak® Folder was tested using low, medium and high diopter ACRYSOF® lenses. The test results demonstrated that the AcryPak® Folded all the lenses evenly in all three folding orientations. All the test lenses possessed acceptable focal length, resolution, haptic angle, overall length and cosmetic quality after testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
0
Alcon Laboratories, Inc.
K965185 AcryPak® Folder
HAR 3 | 1997
510(K) SUMMARY
Submitted by:
Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)
Trade Name: Common Name Classification Name
11 - 11 - 11 -
AcryPak® Folder IOL Len Folder Intraocular Lens Guide, 21 CFR 886.4300
1
Alcon Laboratories, Inc. K965185 AcryPak® Folder
1. Predicate Device
The legally marketed device(s) to which we are claiming equivalence to is:
- K913626, Softrans The Injector, (STAAR Surgical Company) 1.
- K903574, ChiroFlex® Lens Microsert®, (Chiron Ophthalmics Inc.) 2.
2. Device Description
The AcryPak® Folder is a sterile, single-use IOL folder that allows the user to load and fold ACRYSOF® lenses in 6-12, 3-9, or 4-10 orientation. This lens folder is easy to use and does not require user cleaning and resterilization. The AcryPak® Folder is supplied separately from the IOL.
3. Intended Use of the Device
The intended use of this device is to fold the Alcon ACRYSOF® intraocular lens prior to its insertion into the eye. The AcryPak Folder is used as the folding forceps. A pair of implantation forceps is used to remove the folded lens from the AcryPak® Folder for lens implantation.
4. Summary of the Technological Characteristics of the Device
The folding of the ACRYSOF® lens is typically done using conventional metal forceps which requires great dexterity of the user to fold the lens evenly. In addition, folding metal forceps require time to properly clean and re-sterilize for each use.
The AcryPak® Folder is a sterile, single use folder molded from polypropylene. The folder allows the user to load the ACRYSOF® lens for 6-12, 3-9, or 4-10 folding. Use of the AcryPak® Folder will not affect the incision size, which is determined by the lens and the implantation forceps.
The lens folding function of the AcryPak® Folder is equivalent to that of the cartridges of lens injectors used for other types of lenses. However, AcryPak® Folders provide the capability of multi-axis lens folding which cartridges do not provide.
5. Summary of the Performance Data
The performance of the AcryPak® Folder was tested using low, medium and high diopter ACRYSOF® lenses. The test results demonstrated that the AcryPak® Folded all the lenses evenly in all three folding orientations. All the test lenses possessed acceptable focal length, resolution, haptic angle, overall length and cosmetic quality after testing.
6. Conclusions
The AcryPak® Folder is easy to use, performs reliably, and is effective in folding ACRYSOF® IOLs without compromising the quality of the lens. It is supplied sterile and eliminates the need for user cleaning and resterilization.