(526 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically involve AI or ML, such as image processing for diagnosis or automated decision-making based on complex data analysis.
No
The device is described as an ophthalmic microsurgical system for performing surgical procedures, not for treating a disease or condition in a therapeutic manner.
No
The device is described as an "ophthalmic microsurgical system" used for surgical procedures like phacoemulsification, cataract removal, and vitreoretinal surgery. Its functions listed are related to performing surgical interventions (infusion, cutting, aspiration, illumination, irrigation, emulsification, fragmentation, cautery, diathermy), not diagnosing conditions.
No
The device description clearly states it is an "ophthalmic microsurgical system" and a "combined anterior and posterior procedure ophthalmic system" designed for surgical procedures requiring infusion, cutting, aspiration, illumination, emulsification, fragmentation, cautery, and diathermy. These are hardware-based functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Alcon Vision System is an ophthalmic microsurgical system used for surgical procedures (phacoemulsification, cataract removal, vitreoretinal surgery). IVDs are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical system with components for infusion, cutting, aspiration, illumination, emulsification, fragmentation, cautery, and diathermy. These are all surgical functions, not diagnostic tests performed on specimens.
- Anatomical Site: The device is used directly on the eye (ophthalmic), which is a surgical intervention, not an in vitro diagnostic test.
The information provided consistently describes a surgical device used for procedures on the eye, not a device used to test specimens outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Alcon Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
Product codes (comma separated list FDA assigned to the subject device)
HQC
Device Description
The Alcon Vision System is a combined anterior and postcrior procedure ophthalmic system that is modular in design and serves as an enhanced version of the current Alcon Accurus® system. The Alcon Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautcry and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.
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)
Not Found
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.
K911808, K961310, K021566, K981116, K032598
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
5. 510(K) SUMMARY
This summary is in accordance with 21 CFR 807.92(c).
MAY - 9 2008
The submitter of the 510(k) is:
Terry J. Dagnon Director, Regulatory Affairs Alcon, Inc. 6201 South Freeway Fort Worth, Texas 76134 Phone: (817) 551-4325 Fax: (817) 551 4630
Date Prepared: May 8, 2008
Device Subject to this 510(k):
| Trade Name: | Alcon Vision System |
|---|---|
| Common Name: | Vitreous Aspiration & Cutting Instrument |
| Classification Name: | Class II |
| Vitreous Aspiration & Cutting Instrument (21 CFR 886.4150) | |
| Phacofragmentation System (21 CFR 886.4670) |
5.1. Predicate Devices
| 510(k) Number | Device | |
|---|---|---|
| and and the program of the commend of the commend of the commend of the comments of the county of the county of the county of the county of the county of the county of the co |
| K911808 | Alcon Accurus® Surgical System (Gemini Ophthalmic Surgery System) |
|---|---|
| K961310 | Storz Premiere® II/Bausch and Lomb Millennium™ |
| K021566 | Alcon Infiniti® Vision System |
| K981116 | Allergan Sovereign® Cataract Extraction System |
| K032598 | Synergetics Photon Illuminator |
5.2. Device Description
The Alcon Vision System is a combined anterior and postcrior procedure ophthalmic system that is modular in design and serves as an enhanced version of the current Alcon Accurus® system. The Alcon Vision System is designed for use in anterior and posterior procedures
1
that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautcry and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.
5.3. Indications for Use
The Alcon Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.c. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
2
5.4. Brief Summary of Nonclinical Tests and Results
The device will comply with applicable sections of 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 AAMI | |
| / ANSI / ISO: | Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization |
| 10993-11:1993 AAMI | |
| / ANSI / ISO | Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity |
| 11135: 1994 | |
| AAMI/ISO | Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
| AAMI/ISO | |
| 11137:1994 | Sterilization of Healthcare Products - Requirements for Validation and Routine Control - Radiation Sterilization |
| 14971:2000 ISO | Medical Devices: Application of Risk Management to Medical Devices |
| 60601-1: 2003 UL | Medical Electrical Equipment, Part 1 - General Requirements for Safety |
| 60601-1:1988 IEC: | |
| A1:1991-11 + | |
| A2:1995 -03 | Medical Electrical Equipment, Part 1 - General Requirements for Safety. (Including A1:1992, A2:1995 and A13:1995) |
| 60601-1-2 :2001 IEC | Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. |
| 60601-1-4:1996 IEC | Medical Electrical Equipment, Part 1: General Requirements for Safety. 4. Collateral standard: Programmable electrical medical systems. (Including A1: 1999) |
| 60601-2-2: 1998 IEC | Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment |
| 60601-2-18: 1996 IEC | Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment |
| 60601-2-22: 1995 IEC | Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment |
The Alcon Vision System consumable products are provided sterile and intended for single use only. These products will be EtO or gamma sterilized and the process will be validated per the standards: AAMI/ISO 11135:1994: Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization or AAMVISO 11137:1994: Sterilization of Healthcare Products-Requirements for Validation and Routine Control-Radiation Sterilization.
3
Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning, sterilization and re-use will be provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Alcon Vision System will be developed and manufactured in compliance with FDA and ISO quality system requirements. Test data and documents were submitted that demonstrated the substantial equivalence of the IOP control features of the proposed and predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2008
Alcon Research, Ltd. c/o Terry J. Dagnon Senior Director, Regulatory Affairs 6201 South Freeway, R7-20 Fort Worth, TX 76134-2099
Re: K063583
Trade/Device Name: Alcon Vision System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: April 11, 2008 Received: April 14, 2008
Dear Mr. Dagnon:
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 (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.
5
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,
Malvina B. Eggleston, us
Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K063583
Device Name: Alcon Vision System
Indications for Use:
The Alcon Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.
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)
Dan L. Van
(Division Sign Off)
(Division sign-om)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K063583
Page 1 of 1