(526 days)
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.
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.
Acceptance Criteria and Study Details for Alcon Vision System (K063583)
This 510(k) summary for the Alcon Vision System focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance, and details of a clinical study proving those criteria, are not present in the provided document in the typical sense of a new technology submission.
The document states that "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed" and "Test data and documents were submitted that demonstrated the substantial equivalence of the IOP control features of the proposed and predicate devices." This implies that the 'acceptance criteria' were met by demonstrating that the new device performs equivalently to existing, legally marketed devices.
However, based on the provided text, we can infer the approach taken to meet regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" and direct "reported device performance" are not presented for a de novo evaluation, the table below reflects the stated goal of the submission: substantial equivalence to predicate devices. The "Performance" column indicates the documented approach used to demonstrate this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (as per document) |
|---|---|
| Compliance with relevant medical device standards | The device will comply with applicable sections of numerous standards including biological evaluation (ISO 10993 series), sterilization (AAMI/ISO 11135, 11137), risk management (ISO 14971), and electrical safety/EMC (UL/IEC 60601 series). Consumables are sterile (EtO or gamma), and reusable handpieces have validated reprocessing instructions. |
| Substantial equivalence of clinical performance to predicates | "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed." "Test data and documents were submitted that demonstrated the substantial equivalence of the IOP control features of the proposed and predicate devices." |
| Substantial equivalence of Indications for Use | The indications for use for the Alcon Vision System ("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") are considered substantially equivalent to those of the predicate devices for vitreous aspiration & cutting and phacofragmentation. |
| Compliance with Quality System Requirements | "The Alcon Vision System will be developed and manufactured in compliance with FDA and ISO quality system requirements." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trial data with a specified sample size. The substantial equivalence argument relies on comparing the technological characteristics and intended use to already-marketed predicate devices.
The "test data and documents" mentioned for IOP control features are not detailed, so their provenance (country, retrospective/prospective) and sample size are unknown from this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the nature of a 510(k) summary focused on substantial equivalence based on technological characteristics and safety standards, there is no mention of a "test set" requiring expert-established ground truth in a clinical performance measurement sense. The evaluation appears to be based on engineering and manufacturing compliance, as well as a comparison of device specifications and intended use against predicates.
4. Adjudication Method for the Test Set
Not applicable, as no external "test set" requiring expert adjudication for clinical performance is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study typically evaluates the improvement in human reader performance (e.g., diagnostic accuracy) with or without AI/device assistance. Since this device is an ophthalmic surgical system, not a diagnostic imaging AI, such a study would not be relevant.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Alcon Vision System is a physical surgical system, not a standalone algorithm. Its performance is intrinsically linked to the human operator during surgery.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by:
- Regulatory Standards: Compliance with an extensive list of AAMI/ISO, UL, and IEC standards for biological evaluation, sterilization, risk management, and electrical/medical equipment safety.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (Alcon Accurus® Surgical System, Storz Premiere® II/Bausch and Lomb Millennium™, Alcon Infiniti® Vision System, Allergan Sovereign® Cataract Extraction System, Synergetics Photon Illuminator) serves as the benchmark against which the new device's "similar technological characteristics" and "substantial equivalence of IOP control features" are compared.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
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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 IIVitreous 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
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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.
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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: 1994AAMI/ISO | Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
| AAMI/ISO11137:1994 | 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.
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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.
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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.
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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
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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
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§ 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.