(476 days)
Not Found
No
The document describes a mechanical device for inserting intraocular lenses and makes no mention of AI, ML, image processing, or any related concepts.
No
The device is described as an "IOL insertion device" and a "delivery system" for intraocular lenses, indicating it is an accessory used for the implantation of a therapeutic device (IOLs) rather than being therapeutic itself.
No
Explanation: The device is an insertion system for intraocular lenses, designed to fold, hold, and insert IOLs. Its stated purpose involves delivery and implantation, not the diagnosis of any medical condition.
No
The device description explicitly states it consists of a disposable polypropylene cartridge and a reusable titanium handpiece, which are physical 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/hold and insert Alcon IOLs" into the eye. This is a surgical procedure performed on a patient, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a system for delivering an intraocular lens (IOL) into the anterior chamber of the eye. This is a medical device used for a surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical insertion of an implant into the eye.
N/A
Intended Use / Indications for Use
This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior chamber of the 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 Monarch® III P Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver Alcon IOL in conformance with the requirements set forth in ISO 11979-3, section 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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OCT 1 3 2011
5. 510(K) SUMMARY
510(k) Summary
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Catherine G. Goble Assistant Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-6816 Fax: (817) 551-4630
Date Summary Prepared: May 4, 2010
Device Subject to this 510(k):
| Trade Name: | Monarch® III IOL Delivery System
(P Cartridge) |
|----------------------|---------------------------------------------------|
| Common Name: | Intraocular Lens Guide |
| Classification Name: | 21 CFR 886.4300 |
1. Predicate Devices:
The legally marketed device(s) to which we are claiming substantial equivalence are:
510(k) Number Device K063155 Monarch® III IOL Delivery System (D Cartridge)
2. Device Description:
The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses
1
into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.
3. Indications for Use:
This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.
4. Brief Summary of Nonclinical Test and Results:
The Monarch® III P Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver Alcon IOL in conformance with the requirements set forth in ISO 11979-3, section 5.
| Device Name | Monarch® III IOL Delivery System (P Cartridge) | Monarch® III IOL Delivery System (D Cartridge) |
|---|---|---|
| 510(k) Number | N/A | K063155 |
| Substantial Equivalence Characteristics | ||
| Intended Use | Folding and injection of the | |
| Alcon intraocular lens into the | ||
| anterior chamber of the eye | Folding and injection of | |
| AcrySof® intraocular lenses | ||
| into the posterior chamber of | ||
| the eye | ||
| Anatomical Site of Use | Anterior chamber of the eye | Anterior chamber of the eye |
| Components | Monarch® III reusable | |
| handpiece and single-use, | ||
| sterile coated cartridge | Monarch® III reusable | |
| handpiece and single-use, | ||
| sterile coated cartridge | ||
| Material | Polypropylene with a | |
| polyvinylpyrolidione (PVP) | ||
| coating on the inner lumen | Polypropylene with a | |
| polyvinylpyrolidione (PVP) | ||
| coating on the inner lumen | ||
| Lens Folding Mechanism | Internal cartridge geometry | Internal cartridge geometry |
| Nozzle | Tapered lumen | Tapered lumen |
| Configuration | Lens loading and folding area | |
| connected to a lens injecting | ||
| nozzle | Lens loading and folding area | |
| connected to a lens injecting | ||
| nozzle | ||
| Sterilization | EtO | EtO |
5. Comparison of Technological Characteristics to Predicate Device:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 3 2011
Alcon Research, Ltd. c/o Ms. Catherine G. Goble Assistant Director, Regulatory Affairs 6201 South Freeway (R3-48) Fort Worth. TX 76134
Re: K101774
Trade/Device Name: Monarch® III Intraocular Lens Delivery System (P Cartridge) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: August 11, 2011 Received: August 12, 2011
Dear Ms. Goble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Catherine G. Goble
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.ida.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.tda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.
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Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
K101774 510(k) Number (if known):
Monarch III IOL Delivery System Device Name: (P Cartridge)
Indications for Use:
This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Sivision Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
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