(110 days)
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No
The description focuses on the mechanical function of folding and delivering lenses and does not mention any computational or learning capabilities.
No
The device is a delivery system for intraocular lenses, not a device that directly or by itself provides therapy or treatment.
No
The device is used to fold and deliver intraocular lenses, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of a reusable titanium handpiece and a single-use cartridge, which are hardware components.
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 and deliver Alcon ACRYSOF® intraccular lenses into the eye for replacement of the human crystalline lens." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "MONARCH™ IOL Delivery System" consisting of a handpiece and cartridge used for "folding and delivering ACRYSOF intraocular lenses into the eye." This further reinforces its use in a surgical context.
- Anatomical Site: The anatomical site is the "eye," indicating a direct interaction with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to perform tests in vitro (outside the body) to diagnose diseases or conditions.
This device is clearly designed for a surgical procedure to implant an intraocular lens, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraccular lenses into the eye for replacement of the human crystalline lens.
Product codes
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Device Description
The MONARCH™ IOL Delivery System consists of two parts: an autoclavable, reusable titanium handpiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF® intraocular lens into the capsular bag.
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
eye
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 test demonstrated that the MONARCH™ IOL Delivery System can be used to deliver ACRYSOF® IOLs without affecting the overall length, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely within 30 seconds in a controlled fashion.
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
Image /page/0/Picture/0 description: The image shows the logo for Alcon Laboratories. Above the logo is the number K470033. The Alcon logo is in bold, black letters. Below the Alcon logo is the word "LABORATORIES" in smaller, black letters.
APR 2 3 1997
ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450
January 2, 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 MONARCH™ IOL Delivery System IOL Delivery System Intraocular lens Guide, 21 CFR 886.4300
1
1. Predicate Device
The legally marketed device(s) to which we are claiming equivalence to are:
- K903574, ChiroFlex Lens Microsert™, (Chiron Ophthalmics Inc.) a.
- K913626, Softrans The Injector, (STAAR Surgical Company) b.
2. Device Description
The MONARCH™ IOL Delivery System consists of two parts: an autoclavable, reusable titanium handpiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF® intraocular lens into the capsular bag.
3. Intended Use of the Device
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraccular lenses into the eye for replacement of the human crystalline lens.
4. Summary of the Technological Characteristics of the Device
The MONARCH™ IOL Delivery System utilizes a sterile, single use cartridge and a reusable handpiece to deliver ACRYSOF® lenses. The cartridge is designed for easy loading and reliable folding of ACRYSOF lenses. The handpiece accepts the cartridge and delivers the lens by using a plunger to express the lens. The plunger head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by a screw mechanism to ensure a smooth and well controlled lens delivery.
5. Summary of the Performance Data
The performance test demonstrated that the MONARCH™ IOL Delivery System can be used to deliver ACRYSOF® IOLs without affecting the overall length, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely within 30 seconds in a controlled fashion.
6. Conclusions
The MONARCH™ IOL Delivery System is easy to use, properly delivers the Alcon ACRYSOF® intraocular lens, and is substantially equivalent to devices such as the Softrans' " Injector (Model ET) or the ChiroFlex Lens Microsert™ system.