(173 days)
Not Found
No
The description focuses on mechanical modifications and performance testing according to standards, with no mention of AI or ML.
No.
The device is an insertion system for intraocular lenses, not a therapeutic device that directly treats a condition or disease.
No
This device is described as an "IOL insertion device" intended to "fold/hold and insert" intraocular lenses. Its function is to deliver a medical device (IOLs) into the eye, not to diagnose a condition or disease.
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, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a "disposable polypropylene cartridge and reusable titanium handpiece" designed to "fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the eye." This is a physical tool for implanting a medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for implantation.
N/A
Intended Use / Indications for Use
This Monarch® III C 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
MSS
Device Description
The Monarch® III IOL Delivery System (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the eye. The width of the loading zone has been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Posterior 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
The Monarch® III C Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver the AcrySof® Intraocular Lens in conformance with the requirements set forth in ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
March 2012 K112977
MAR 2 7 2012
6. 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 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: February 24, 2012
Device Subject to this 510(k):
| Trade Name: | Monarch® III IOL Delivery System |
|---|---|
| ( C 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 |
|---|---|
| K001157 | Monarch® II (C Cartridge) IOL Delivery System |
| K063155 | Monarch III (D Cartridge) IOL Delivery System |
2. Device Description:
The Monarch® III IOL Delivery System (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the width of the loading zone has
1
been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.
3. Indications for Use:
This Monarch® III C 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 C Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver the AcrySof® Intraocular Lens in conformance with the requirements set forth in ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971.
| Device Name | Proposed
Monarch® III IOL
Delivery System (C
Cartridge) | Monarch® II IOL
Delivery System (C
Cartridge) | Monarch® III IOL
Delivery System (D
Cartridge) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K112977 | K003768 | K063155 |
| Substantial Equivalence Characteristics | | | |
| Intended Use | Folding and injection
of AcrySof®
intraocular lenses into
the posterior chamber
of the eye | Folding and injection
of AcrySof®
intraocular lenses
into the posterior
chamber of the eye | Folding and injection
of AcrySof®
intraocular lenses into
the posterior chamber
of the eye |
| Anatomical Site of Use | Posterior chamber of
the eye | Posterior chamber of
the eye | Posterior chamber of
the eye |
| Components | Identical reusable
handpiece and single-
use, sterile coated
cartridge | Identical reusable
handpiece and single-
use, sterile coated
cartridge | Reusable handpiece
and single-use, sterile
coated cartridge |
| Device Name | Proposed
Monarch® III IOL
Delivery System (C
Cartridge) | Monarch® II IOL
Delivery System (C
Cartridge) | Monarch® III IOL
Delivery System (D
Cartridge) |
| 510(k) Number | K112977 | K003768 | K063155 |
| Substantial Equivalence Characteristics | | | |
| Handpiece (Identical) | | | |
| Material | Titanium alloy | Titanium alloy | Titanium alloy |
| Lens Injecting
Mechanism | Push and turn | Push and turn | Push and turn |
| Configuration | Barrel and plunger
assembly, the barrel
has a chamber to
accept the cartridge
and the plunger
advances the lens for
injection | Barrel and plunger
assembly, the barrel
has a chamber to
accept the cartridge
and the plunger
advances the lens for
injection | Barrel and plunger
assembly, the barrel
has a chamber to
accept the cartridge
and the plunger
advances the lens for
injection |
| Sterilization | Flash autoclave or
steam sterilization by
user | Flash autoclave or
steam sterilization by
user | Flash autoclave or
steam sterilization by
user |
| Cartridge | | | |
| Material | Polypropylene with a
polyvinylpyrolidione
(PVP) coating on the
inner lumen | 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 | Internal cartridge
geometry |
| Nozzle | Tapered lumen | 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 | Lens loading and
folding area
connected to a lens
injecting nozzle |
| Sterilization | EtO | EtO | EtO |
5. Comparison of Technological Characteristics to Predicate Device:
2
and the commended to the
:
.
. .
.
. .
.
ri
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Catherine Goble Assistant Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134
MAR 2 7 2012
Re: K112977
Trade/Device Name: Monarch® III IOL Delivery System (C Cartridge) Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, Reserved Product Code: MSS Dated: March 6, 2012 Received: March 7, 2012
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.
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
4
Page 2 - Ms. Catherine Goble
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.fda.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/ReportaProblem/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.
Sincerely yours.
Kesia Alexander
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Monarch III C Cartridge 510(k)
Page 1 of 1
5. INDICATIONS FOR USE STATEMENT
K112977 510(k) Number (if known):
Monarch III IOL Delivery System Device Name: (C Cartridge)
Indications for Use:
This Monarch® III C 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)
Jennifer H. Brown
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_KIJ 297