(139 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on hardware and existing features.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation," which are all therapeutic procedures.
No
The device's intended use is for emulsification and removal of cataracts, vitreous aspiration and cutting, and bipolar coagulation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is a "System" and mentions hardware components like the "OZil® IP feature" and "Infiniti® UltraVit" Vitrectomy Probe," indicating it is not software-only.
Based on the provided information, the Infiniti® Vision System with OZil® IP is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation." These are surgical procedures performed directly on the patient's eye.
- Device Description: The description details a surgical system used for ophthalmic procedures.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectoriny, and bipolar coagulation.
Product codes (comma separated list FDA assigned to the subject device)
HOC
Device Description
The Infinitie Vision System with OZit® IP is an enhanced version of the Infinitie Vision System (K021566) that is modular in design and incorporates both the QZile IP feature and the Infiniti® UltraVit" Vitrectomy Probe and its associated software.
Mentions image processing
Infiniti® Vision System with OZU® IP
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 Infinit® Vision System with OZil® IP have demonstrated its compliance with applicable requirements of the following standards: 60601-1: 2003 UL (Equivalent to IEC 60601-1: 1998 with A1: 1991, A2: 1995) Medical Electrical Equipment, Part 1 -- General Requirements for Safety; 60601-1-2 :2001 IEC Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility-Requirements and test.; 60601-1-4:2000 IEC Medical Electrical Equipment, Part 1: General Requirements for Safety, 4. Collateral standard: Programmable electrical medical systems.; 60601-2-2: 1998 IEC Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards: 10993-1: 2003 AAMI / ANSI / ISO Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing; 10993-5: 1999 AAMI / ANSI / ISO Biological Evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity; 10993-7: 1995 AAMI / ANSI / ISO Biological Evaluation of Medical Devices -- Part 7: Ethylene Oxide Sterilization Residuals; 10993-10:2002/A1:2006 AAMI / ANSI / ISO Biological Evaluation of Medical Devices -- Part 10: Tests for irritation and delayed-type hypersensitivity; 10993-11:2006 AAMI / ANSI / ISO Biological Evaluation of Medical Devices -- Part 11: Tests for systemic toxicity; 10993-12:2007 AAMI / ANSI / ISQ Biological Evaluation of Medical Devices -- Part 12: Sample Preparation and Reference Materials.
The Infiniti® UltraVit" Vitrectorry Probe is provided sterile and intended for single use only. This product is EtO sterilized and the process has been validated per AAMV ISO 11135:2007: 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.
Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the 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, K981116, K063583, K911808
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
FEB 12 2009
Infiniti® Vision System with OZU® IP
Image /page/0/Picture/3 description: The image shows the word "Alcon" in a bold, sans-serif font. The letters are black and slightly pixelated, giving them a textured appearance. The word is horizontally oriented and appears to be a logo or brand name.
PREMARKET NOTIFICATION 510(k) SUMMARY 5.
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76132. Phone: (817) 551-6810 Fax: (817) 551-4630
Device Subject to this 510(k):
Infiniti® Vision System Trade Name: Phacofragmentation System Common Name: Classification Name: Phacofragmentation System (per 21 CFR 886.4670)
Predicate Devices : 5.1.
The legally marketed devices(s) to which we are claiming equivalence to are:
| 510(k) Number | Device |
|---|---|
| K021566 | Infiniti® Vision System |
| K981116 | Sovereign* Cataract Extraction System |
| K063583 | Alcon Vision System (Constellation) |
| K911808 | Gemini Ophthalmic Surgery System |
| (Marketed as the Series 20000® Legacy® (STTL) and Accurus®) |
5.2. Device Description
The Infinitie Vision System with OZit® IP is an enhanced version of the Infinitie Vision System (K021566) that is modular in design and incorporates both the QZile IP feature and the Infiniti® UltraVit" Vitrectomy Probe and its associated software.
1
Indications for Use: 5.3.
The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectoriny, and bipolar coagulation.
Brief Summary of Nonclinical test and Results: 5.4.
Safety tests of the Infinit® Vision System with OZil® IP have demonstrated its compliance with applicable requirements of the following standards:
| Standard | Title |
|---|---|
| 60601-1: 2003 UL | |
| (Equivalent to IEC 60601-1: | |
| 1998 with A1: 1991, A2: |
- | Medical Electrical Equipment, Part 1 -- General
Requirements for Safety |
| 60601-1-2 :2001 IEC | Medical electrical equipment Part 1: General
requirements for safety 2. Collateral Standard:
Electromagnetic compatibility-Requirements and test. |
| 60601-1-4:2000 IEC | Medical Electrical Equipment, Part 1: General
Requirements for Safety, 4. Collateral standard:
Programmable electrical medical systems. |
| 60601-2-2: 1998 IEC | Medical electrical equipment - Part 2-2: Particular
requirements for the safety of high frequency surgical
equipment |
Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:
| Standard # | Title |
|---|---|
| 10993-1: 2003 AAMI / ANSI / ISO | Biological Evaluation of Medical Devices -- |
| Part 1: Evaluation and testing | |
| 10993-5: 1999 AAMI / ANSI / ISO | Biological Evaluation of medical devices -- |
| Part 5: Tests for In Vitro cytotoxicity | |
| 10993-7: 1995 AAMI / ANSI / ISO | Biological Evaluation of Medical Devices -- |
| Part 7: Ethylene Oxide Sterilization Residuals | |
| 10993-10:2002/A1:2006 AAMI / ANSI / ISO | Biological Evaluation of Medical Devices -- |
| Part 10: Tests for irritation and delayed-type | |
| hypersensitivity | |
| 10993-11:2006 AAMI / ANSI / ISO | Biological Evaluation of Medical Devices -- |
| Part 11: Tests for systemic toxicity |
2
| Standard #19 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 | |
|---|---|
| 10993-12:2007 AAMI / ANSI / ISQ Biological Evaluation of Medical Devices -- | |
| Part 12: Sample Preparation and Reference | |
| Materials | |
| more forme four leases diving as as a prover a manager was | |
| Complete Company Controller of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Comments of Ch | |
| . | and and the contract of the county of the country of the country of the country of |
The Infiniti® UltraVit" Vitrectorry Probe is provided sterile and intended for single use only. This product is EtO sterilized and the process has been validated per AAMV ISO 11135:2007: 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 with OZil® IP has been developed and will be manufactured in compliance with section 21 CFR 820 and ISO 14971:2003. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the device is equivalent to the predicate device.
Trademark References:
*SOVEREIGN is a registered trademark of Allergan, Inc. Corp.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcon Research, Ltd. c/o Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Fort Worth, Texas 76134-2099
FEB 1 2 2009
Re: K082845
Trade/Device Name: Infiniti® Vision System with Ozil® IP Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HOC Dated: January 12, 2008 Received: January 13, 2008
Dear Mr. Buenger:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Evertins, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K082845 / Infiniti Vision System with Ozil IP Response to November 21, 2008 Deficiency Letter
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K082845
Device Name: Infiniti® Vision System with OZil® IP
Indications for Use:
The Infiniti® Vision System with OZil® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectorny, and bipolar coagulation.
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)
HZB histolass
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(Division Sign-Off) ovision of Ophthalmic and Ear, Jose and Throat Devices
510(k) Number K082845