(90 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like image processing, training sets, or specific performance metrics associated with AI/ML models. The device description focuses on hardware components and existing technologies like ultrasound and AquaLase.
Yes
The device is indicated for emulsification, separation, and removal of cataracts, removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection, all of which are therapeutic procedures.
No
The device is described as being 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." These are all surgical or therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "system" that incorporates hardware components like the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, and the AutoSert™ IOL Injector, in addition to software. The performance studies also reference testing against hardware standards (e.g., IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed on the patient's eye (emulsification, separation, removal of cataracts, vitreous aspiration, bipolar coagulation, IOL injection). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a surgical system with handpieces and tips designed for performing surgical procedures.
- Anatomical Site: The anatomical site is the eye, which is the site of the surgical intervention, not the source of a diagnostic specimen.
The device is a surgical system used for ophthalmic procedures, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Infinit® 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 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 AutoSert™ IOL Iniector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, 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 (comma separated list FDA assigned to the subject device)
HQC, HQR, MLZ, KYB
Device Description
The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Infinity Vision System have demonstrated its compliance with applicable requirements of the following standards:
11135-1:2007 ISO - Sterilization of health care products - Ethylene oxide - Requirements for development, validation, and routine control of a sterilization process for medical devices.
11979-3:2006 BS EN ISO - Ophthalmic implants - Intraocular Lenses - Part 3: Mechanical properties and test methods
14971:2007 EN ISO - Medical Devices: Application of Risk Management to Medical Devices
IEC 60601-1: 1988, A1:1991, A2:1995 - Medical Electrical Equipment - Part 1: General requirements for safety
IEC 60601-1-1: 2000 - Medical electrical equipment. Part 1-1: General requirement for safety - Collateral standard: Safety requirements for medical electrical systems
EN 60601-1-2: 2004 - Medical electrical equipment - Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-4: 2000 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems.
IEC 60601-1-6: 2006 - Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
IEC 60601-2-2: 2006 - Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment.
IEC 80601-2-58: 2008 - Medical electrical equipment -- Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
ISO 10993-1: 2009 - Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing within a Risk management Process
ISO 10993-5: 2009 - Biological Evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10: 2002/A1:2006 - Biological Evaluation of Medical Devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11: 2006 - Biological Evaluation of Medical Devices -- Part 11: Tests for systemic toxicity
ISO 10993-12: 2007 - Biological Evaluation of Medical Devices --Part 12: Sample Preparation and Reference Materials
Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate device.
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.
K021566, K082845, K091777, K093210, K063155
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
§ 886.4670 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
NOV 2 1 2011
PREMARKET NOTIFICATION 510(k) SUMMARY
The submitter of the 510(k) is:
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 this 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) Number | Device |
|---|---|
| K021566 | Infiniti® Vision System |
| K082845 | Infiniti® Vision System with OZil® IP |
| K091777 | Alcon UltraChopper Tip |
| K093210 | AquaLase Capsule Wash Tip |
| K063155 | Monarch III IOL Delivery System |
Device Description
The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.
1
Indications for Use:
The Infinity 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 intraocular lens injection. The 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 AutoSert™ IOL Iniector Handpiece achieves the functionality of injection of । intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, 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 test and Results:
Safety tests of the Infinity Vision System have demonstrated its compliance with applicable requirements of the following standards:
| Standard # | Title |
|---|---|
| 11135-1:2007 | |
| ISO | Sterilization of health care products - Ethylene oxide - Requirements |
| for development, validation, and routine control of a sterilization | |
| process for medical devices. | |
| 11979-3:2006 | |
| BS EN ISO | Ophthalmic implants - Intraocular Lenses - Part 3: Mechanical |
| properties and test methods | |
| 14971:2007 | |
| EN ISO | Medical Devices: Application of Risk Management to Medical Devices |
| IEC 60601-1: | |
| 1988, A1:1991, | |
| A2:1995 | Medical Electrical Equipment - Part 1: General requirements for safety |
| IEC 60601-1-1: | |
| 2000 | Medical electrical equipment. Part 1-1: General requirement for safety - |
| Collateral standard: Safety requirements for medical electrical | |
| systems | |
| EN 60601-1-2: | |
| 2004 | Medical electrical equipment - Part 1: General requirements for safety 2. |
| Collateral Standard: Electromagnetic compatibility - Requirements and | |
| tests | |
| IEC 60601-1-4: | |
| 2000 | Medical electrical equipment - Part 1: General requirements for safety - |
- Collateral standard: Programmable electrical medical systems. |
| IEC 60601-1-6:
2006 | Medical electrical equipment - Part 1-6: General requirements for safety -
Collateral standard: Usability. |
| IEC 60601-2-2:
2006 | Medical electrical equipment - Part 2: Particular requirements for the
safety of high frequency surgical equipment. |
| IEC 80601-2-58:
2008 | Medical electrical equipment -- Part 2-58: Particular requirements for
basic safety and essential performance of lens removal devices and
vitrectomy devices for ophthalmic surgery |
2
Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:
| Standard # | Title |
|---|---|
| ISO 10993-1: | |
| 2009 | Biological Evaluation of Medical Devices -- Part 1: Evaluation and |
| Testing within a Risk management Process | |
| ISO 10993-5: | |
| 2009 | Biological Evaluation of medical devices -- Part 5: Tests for In Vitro |
| cytotoxicity | |
| ISO 10993-10: | |
| 2002/A1:2006 | Biological Evaluation of Medical Devices -- Part 10: Tests for irritation |
| and delayed-type hypersensitivity | |
| ISO 10993-11: | |
| 2006 | Biological Evaluation of Medical Devices -- Part 11: Tests for systemic |
| toxicity | |
| ISO 10993-12: | |
| 2007 | Biological Evaluation of Medical Devices --Part 12: Sample Preparation |
| and Reference Materials |
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 ISO 11135-1:2007: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are provided non-sterile. Validated reprocessing instructions for cleaning, sterilization, and re-use of the handpieces are provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Infiniti® Vision System has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate device.
Accessories Provided with the System (subject to change)
| Configurations of tips and sleeves currently used with the Irrigation/Aspiration Handpiece.
| Description |
|---|
| ASSY, SHIP, INTREPID POLYMER I/A TIP, STRAIGHT |
| ASSY, SHIP, INTREPID POLYMER I/A TIP, ANGLED |
| ASSY, SHIP, INTREPID POLYMER I/A TIP, CURVED |
| I/A Tip 0.5 mm |
| I/A Tip 0.2 mm |
| I/A Tip 0.3 mm Small Bore |
| I/A Tip 0.3 mm Small Bore Mod |
| I/A Tip 0.3 mm Bent |
| I/A Tip 0.3 mm Bent & Sand Blast |
| I/A Tip .033 OD, .3mm, Intrepid |
3
| Configurations of tips and sleeves currently used with the Irrigation/Aspiration Handpiece. | Description |
|---|---|
| I/A Tip .033 OD, .3mm Bent, Intrepid | |
| Silicone I/A Tip, Bent | |
| Silicone I/A Tip, Straight | |
| Ultraflow Tool/O-rings | |
| Ultraflow IA Handpiece Comp | |
| Ultraflow IA Handpiece Only | |
| Ultraflow IA Tip STR | |
| Ultraflow IA Tip CRVD | |
| Ultraflow IA 45 | |
| Ultraflow IA 90 | |
| Ultraflow IA 120 | |
| Ultraflow CNL STTL | |
| Ultraflow Luer | |
| Straight Tip, 3 mm | |
| Ultraflow Tip Protector, Standalone | |
| 45° Bent Tip, .3 mm | |
| 90° Bent Tip, .3mm | |
| Irrigation Only Luer | |
| Curved Tip, .3mm | |
| Threaded Tip - STTL | |
| Ultraflow I/A Box | |
| Replacement O-ring |
Configurations of Paks currently used with the Infiniti Vision System.
| Description |
|---|
| Ultrasound FMS, Basic |
| Ultrasound FMS, Tipless, 0.9mm |
| Ultrasound FMS, Tipless, 1.1mm |
| Ultrasound FMS, Tipless, 0.9mm HIS |
| Ultrasound FMS, Tipless, 1.1mm HIS |
| Ultrasound FMS, 30° Round, 0.9 mm ABS |
| Ultrasound FMS, 45° Round, 0.9 mm ABS |
| Ultrasound FMS, 30° Kelman, 0.9 mm ABS |
| Ultrasound FMS, 45° Kelman, 0.9 mm ABS |
| Ultrasound FMS, 30° Round, 1.1 mm ABS |
| Ultrasound FMS, 45° Round, 1.1 mm ABS |
| Ultrasound FMS, 30° Kelman, 1.1 mm ABS |
| Ultrasound FMS, 45° Kelman, 1.1 mm ABS |
| Ultrasound FMS, 30° Round, 0.9 mm MicroTip Flared ABS |
| Ultrasound FMS, 45° Round, 0.9 mm MicroTip Flared ABS |
| Ultrasound FMS, 30° Kelman, 0.9 mm MicroTip Flared ABS |
| Ultrasound FMS, 45° Kelman, 0.9 mm MicroTip Flared ABS |
| Description |
| Ultrasound FMS, 30° Round, 1.1 mm Flared ABS |
| Ultrasound FMS, 45° Round, 1.1 mm Flared ABS |
| Ultrasound FMS, 30° Kelman, 1.1 mm Flared ABS |
| Ultrasound FMS, 45° Kelman, 1.1 mm Flared ABS |
| Ultrasound FMS, 30° Round, 0.9 mm Mackool |
| Ultrasound FMS, 45° Round, 0.9 mm Mackool |
| Ultrasound FMS, 30° Kelman, 0.9 mm Mackool |
| Ultrasound FMS, 45° Kelman, 0.9 mm Mackool |
| Ultrasound FMS, 30° Round, 1.1 mm Mackool Flared ABS |
| Ultrasound FMS, 45° Round, 1.1 mm Mackool Flared ABS |
| Ultrasound FMS, 30° Kelman, 1.1 mm Mackool Flared ABS |
| Ultrasound FMS, 45° Kelman, 1.1 mm Mackool Flared ABS |
| Ultrasound FMS, 30° Round, 0.9 mm Tapered ABS |
| Ultrasound FMS, 45° Round, 0.9 mm Tapered ABS |
| Ultrasound FMS, 30° Kelman, 0.9 mm Tapered ABS |
| Ultrasound FMS, 45° Kelman, 0.9 mm Tapered ABS |
| Ultrasound FMS, Tipless, 0.9 Ultra |
| Ultrasound FMS, 30° Kelman, 0.9 mm Mini Flared ABS, Ultra |
| Ultrasound FMS, 45° Kelman, 0.9 mm Mini Flared ABS, Ultra |
| Ultrasound FMS, 30° OZil 12, 0.9 mm Mini Flared ABS, Ultra |
| Ultrasound FMS, 45° OZil 12, 0.9 mm Mini Flared ABS, Ultra |
| Ultrasound FMS, 30° Kelman, 0.9 mm Mini Flared ABS |
| Ultrasound FMS, 45° Kelman, 0.9 mm Mini Flared ABS |
| Ultrasound FMS, 30° OZil 12, 0.9 mm Mini Flared ABS |
| Ultrasound FMS, 45° OZil 12, 0.9 mm Mini Flared ABS |
| Ultrasound FMS, Tipless, 0.9mm J |
| Ultrasound FMS, Tipless, 1.1mm J |
| Ultrasound FMS, Tipless, 0.9mm HIS J |
| Ultrasound FMS, Tipless, 1.1mm HIS J |
| Ultrasound FMS, Tipless, 0.9 Ultra J |
| Ultrasound FMS, Intrepid, Basic |
| Ultrasound FMS, Intrepid, Tipless, 0.9 Ultra |
| Ultrasound FMS, Intrepid, Tipless, 1.1 Ultra |
| Ultrasound FMS, Intrepid, Tipless, 0.9 Nano |
| Ultrasound FMS, Intrepid, Tipless, 1.1 Nano |
| Ultrasound FMS, Intrepid, 30° Kelman, 0.9 mm Mini-Flared ABS, Ultra |
| Ultrasound FMS, Intrepid, 45° Kelman, 0.9 mm Mini-Flared ABS, Ultra |
| Ultrasound FMS, Intrepid, Tipless, 0.9 |
| Ultrasound FMS, Intrepid, 30° Kelman, 0.9 mm Mini Flared ABS, Nano |
| Ultrasound FMS, Intrepid, 45° Kelman, 0.9 mm Mini Flared ABS, Nano |
| Ultrasound FMS, Intrepid, 30° OZil 12, 0.9 mm Mini Flared ABS, Nano |
| Ultrasound FMS, Intrepid, 45° OZil 12, 0.9 mm Mini Flared ABS, Nano |
| Ultrasound FMS, Intrepid, 30° OZil 12, 0.9 mm Mini Flared ABS, Ultra |
| Description |
| Ultrasound FMS, Intrepid, 45° OZil 12, 0.9 mm Mini Flared ABS, Ultra |
| Ultrasound FMS, Intrepid, 30° Kelman, 0.9 mm Mini Flared ABS, 0.9 |
| Ultrasound FMS, Intrepid, 45° Kelman, 0.9 mm Mini Flared ABS, 0.9 |
| Ultrasound FMS, Intrepid, 30° OZil 12, 0.9 mm Mini Flared ABS, 0.9 |
| Ultrasound FMS, Intrepid, 45° OZil 12, 0.9 mm Mini Flared ABS, 0.9 |
| Ultrasound FMS, Intrepid, Basic, J |
| Ultrasound FMS, Intrepid, Tipless, 0.9 Ultra, J |
| Ultrasound FMS, Intrepid, Tipless, 1.1 Ultra, J |
| Ultrasound FMS, Intrepid, Tipless, 0.9 Nano, J |
| Ultrasound FMS, Intrepid, Tipless, 1.1 Nano, J |
| Ultrasound FMS, Intrepid, Tipless, 0.9 J |
| INFI, Multipak, Basic Pak |
| INFI, Multipak, 0.9mm Tipless |
| INFI, Multipak, 1.1mm Tipless |
| INFI MP Procedural Pouch Basic |
| INFI MP Procedural Pouch 0.9mm |
| INFI MP Procedural Pouch 1.1mm |
| Infiniti MP Drain Bags |
| INFI Multi-Pak Basic Stand Alone |
| INFI Multi-Pak 0.9 Tipless Stand Alone |
| INFI Multi-Pak 1.1 Tipless Stand Alone |
| Ultrasound FMS, Intrepid Plus, Basic |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Tipless Ultra |
| Ultrasound FMS, Intrepid Plus, 1.1 MM Tipless Ultra |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Tipless Nano |
| Ultrasound FMS, Intrepid Plus, 1.1 MM Tipless Nano |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30K, Ultra |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45K, Ultra |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Tipless |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30K, Nano |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45K, Nano |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30 OZil, Nano |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45 OZil, Nano |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30 OZil, Ultra |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45 OZil, Ultra |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30K |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45K |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 30 OZil |
| Ultrasound FMS, Intrepid Plus, 0.9 MM Mini-Flared ABS 45 OZil |
4
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5
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 1 2011
Alcon Research, Ltd. c/o Mr. Martin Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine, CA 92816
Re: K112425
Trade/Device Name: Infiniti Vision System (Evergreen II) Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: II Product Codes: HQC, HQR, MLZ, KYB Dated: August 19, 2011 Received: August 23, 2011
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, 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
7
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.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
8
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ k1/2 425
Device Name: Infiniti® Vision System
Indications for Use:
The Infinit® 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 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 AutoSert ™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, 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 × AND/OR (Part 21 CFR 801 Subpart D)
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)
R
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices
510(k) Number f/12425