(66 days)
Not Found
No
The description focuses on mechanical delivery and folding of the lens, with no mention of AI/ML terms or functions.
No.
The device is described as a delivery system for intraocular lenses, which are therapeutic, but the device itself is a tool for delivery rather than a device with a therapeutic effect on the body.
No
The device is described as an IOL delivery system used for folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. Its function is mechanical delivery, not diagnosis.
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® intraocular lenses into the eye for replacement of the human crystalline lens." This describes a surgical procedure involving the delivery of a medical device (an intraocular lens) into the body.
- Device Description: The description details a system for physically handling and inserting a lens into the eye. It's a mechanical delivery system.
- 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 about a patient's health status or disease. IVDs are used for diagnostic purposes, not for delivering therapeutic devices.
The device is clearly intended for a surgical procedure to implant a lens, which falls under the category of a surgical instrument or delivery system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.
Product codes
86 KYB
Device Description
The MONARCH IOL Delivery System consists of two parts: an autoclavable, reusable titanium handbiece 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the overall diameter, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely in a controlled fashion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MONARCH IOL Delivery System, K981571, ChiroFlex Lens Microsert, Softrans Injector
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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K 98/57/
JUL - 9 1998
LABORATORIES
ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134 -2099 (817)293-0450
May 1, 1998
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)
MONARCH IOL Delivery System Trade Name: IOL Delivery System Common Name: Classification Name: Intraocular lens Guide, 21 CFR 886.4300
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1. Predicate Device
The predicate device(s) to which we are claiming equivalence to are:
- MONARCH IOL Delivery System, (Alcon Laboratories, Inc.) a.
- ChiroFlex Lens Microsert, (Chiron Ophthalmics Inc.) b.
- Softrans Injector, (STAAR Surgical Company) C.
2. Device Description
The MONARCH IOL Delivery System consists of two parts: an autoclavable, reusable titanium handbiece 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 intraocular 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 diameter, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely 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 Alcon MONARCH IOL Delivery System, the Softrans Injector (Model ET), or the ChiroFlex Lens Microsert system.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 1998
Mr. Martin A. Kaufman Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099
Re: K981571
Trade Name: MONARCH™ IOL Delivery System Regulatory Class: I Product Code: 86 KYB Dated: May 1, 1998 Received: May 4, 1998
Dear Mr. Kaufman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes.compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Martin A. Kaufman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3. Indication for Use
510(k) Number (if known):
Device Name: MONARCH™ IOL Delivery System
Indications For Use:
The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens
(PLEASE DO NOT WRITE BELQWITHIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) . .
Lawrence Romrell
DRL
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981571
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96).