(81 days)
No
The summary describes a surgical system for cataract removal and IOL injection, focusing on mechanical and fluidic functionalities (ultrasound, AquaLase, injector handpiece). There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on safety and compatibility with different lenses, not on algorithmic performance.
Yes
The device is indicated for medical procedures such as the removal of cataracts and cortical material, vitreous aspiration, and intra-ocular lens injection, which are all therapeutic interventions.
No
The device is indicated for surgical procedures such as emulsification, separation, and removal of cataracts, and injection of intraocular lenses, which are treatment functions, not diagnostic ones.
No
The device description explicitly mentions hardware components like the "INFINITI® Vision System," "UltraChopper tip," "AquaLase Capsule Wash Tip," and "INTREPID® AutoSert™ IOL Injector Handpiece," indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The INFINITI® Vision System is used for surgical procedures within the eye (emulsification, separation, removal of cataracts, etc.) and for injecting intraocular lenses. These are direct interventions on the patient's body, not tests performed on samples outside the body.
- Intended Use: The intended use clearly describes surgical procedures and device delivery within the eye. There is no mention of analyzing biological samples.
Therefore, the INFINITI® Vision System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Product codes
HQC, HQR, MLZ, KYB
Device Description
The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.
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)
Safety tests of the INFINIT!® Vision System have been demonstrated its compliance with all applicable requirements that were covered in K112425. Additional testing that covers the additional AcrySoft intraocular lenses SN6AT3 through SN6AT9 was completed per EN ISO 11979-3, Section 5. Each AcrySoft iens was tested with the Monarch® II C Cartridge and the Monarch® III D Cartridge. This submission makes no changes whatsoever to the INFINITI® Vision System console, Sterilization parameters, Biocompatibility of materials, System Software, or the Electromagnetic and Electrical Safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112425, K093210, K091777, K082845, K063155, K021566
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
510/1): K120912
PREMARKET NOTIFICATION 510(k) SUMMARY
The submitter of the 510(k) is
JUN 1 5 2012
r
Martin A. Kaufman Director, Regulatory Affairs Alcon Research Ltd. 18500 Alton Parkway Irvine, CA 92618 Phone: (949) 753-6250 Fax: (949) 753-6237
Device Subject to the 510(k)
Trade Name: Common Name: Classification Name: INFINITI® Vision System Phacofragmentation System Phacofragmentation System
per 21 CFR 886.4670
Predicate Devices:
The legally marketed devices(s) to which we are claiming equivalence to are:
510(k) numberDevice
| K112425 | INFINITI® Vision System (Evergreen II) |
|---|---|
| K093210 | AquaLase Capsule Wash Tip |
| K091777 | Alcon UltraChopper Tip |
| K082845 | INFINITI® Vision System with OZil® IP |
| K063155 | Monarch III Delivery System (includes C & D cartridges) |
| K021566 | INFINITI® Vision System |
Device Description
The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.
1
Indications for use:
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Brief Summary of Nonclinical Tests and Results:
Safety tests of the INFINIT!® Vision System have been demonstrated its compliance with all applicable requirements that were covered in K112425. Additional testing that covers the additional AcrySoft intraocular lenses SN6AT3 through SN6AT9 was completed per EN ISO 11979-3, Section 5. Each AcrySoft iens was tested with the Monarch® II C Cartridge and the Monarch® III D Cartridge. This submission makes no changes whatsoever to the INFINITI® Vision System console, Sterilization parameters, Biocompatibility of materials, System Software, or the Electromagnetic and Electrical Safety.
2
| Standard # | Title |
|---|---|
| EN ISO 11979-3: | |
| 2006 | Ophthalmic implants - Intraocular lenses-Part 3: Mechanical |
| Properties and Test Methods, Section 5. |
Accessories
Many INFINITI® accessories are provided sterile and are intended for single use only. These products are EtO sterilized and the process has been validated per AAMI/ISO 11135-1:2007: Medical Devices – Validation and routine control of Ethylene Oxide Sterilization. Reusable Handpieces are provided non-sterile. Validated reprocessing instruction for cleaning, sterilization, and re-use of the Handpieces are provided in the Directions for Use provided with the product.
Conclusions
Technological characteristics affecting the clinical performance are unchanged to that of the predicate devices previously listed. The INFINITI® Vision System has been developed and will be manufactured in compliance with 21CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that functional requirements have been met and that this device is equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the logo in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alcon Research, Ltd. c/o Mr. Martin Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine. CA 92816
Re: K120912
Trade/Device Name: Infiniti Vision System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: II Product Codes: HQC, HQR, MLZ, KYB Dated: March 21, 2012 Received: March 26, 2012
Dear Mr. Kaufman:
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. Iisting 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
JUN 1 5 2012
4
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 (OS) 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/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
ﺎﻝ
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known) _ ★ / 209 / 2 Device Name: INFINITI® Vision System
Indications for Use:
The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectorny, bipolar coagulation, and intraocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.
The following system modalities additionally support the described indications:
- Ultrasound with UltraChopper Tip achieves the functionality of cataract separation. -
- AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
- The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.
Prescription use X AND/OR Over-The-Counter (21 CFR 801 Subpart C) (Pat 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
120912
510(k) Number