(185 days)
The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.
The Vizual™ Phacoemulsification system is a complete anterior segment surgical system, offering Irrigation, Phaco or Ultrasonic (U/S), Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation modes of operation. The device can be operated as a standalone unit, or connected to an optional cart with electric I/V pole where bottle height can be controlled by the software. The Vizual™ Phacoemulsification System includes the Phaco unit, U/S handpiece, tubing cartridge, and foot pedal. The device has been designed to work with commercially available (and 510k cleared) components and accessories including Phaco tips and sleeves, vit cutters, cautery pencils, and cautery forceps. The Vizual™ Phacoemulsification System utilizes a non-invasive vacuum sensing system including an external tubing cartridge that vents to the bottle versus air, thus minimizing the possibility of introducing contamination into the fluid path. The external tubing cartridge design is advantageous as the fluid path is visible to the user, and can be easily installed or removed in a single step. The Vizual™ Phacoemulsification System uses a LCD touch panel interface to allow access to all modes of operation. The system software allows for storing up to twenty-four different user profiles.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Vizual™ Phacoemulsification System, Model 551:
This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device, rather than specific performance metrics like those for AI algorithms. The "study" proving this substantial equivalence usually involves comparing the new device's technological characteristics and intended use to those of a legally marketed predicate device.
The provided document does not describe a study involving AI or machine learning algorithms. Therefore, questions related to AI-specific performance metrics (such as sample sizes for test/training sets, ground truth establishment methods, expert adjudication, or MRMC studies) are not applicable.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the primary "acceptance criterion" is demonstrable substantial equivalence to a predicate device. The device performance is assessed by comparing its characteristics to the predicate.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence: The new device must have the same intended use as the predicate device. | Vizual™ Phacoemulsification System: Intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy, a process known as phacoemulsification. Predicate Device (K020527): Implied to have the same intended use as the basis for substantial equivalence. |
| Technological Characteristics Equivalence: The new device must have the same or similar technological characteristics as the predicate device, or any differences must not raise new questions of safety or effectiveness. | Display: LCD Touch Screen (Same as Predicate) Pump: Peristaltic, low pulsation (Same as Predicate) Pump Vacuum Range: 0 to 500 mmHg (Same as Predicate) Aspiration Rate: 0 to 50 cc/min (Same as Predicate) Fluidics: External Fluid Path (Same as Predicate) System Tubing: Tubing/Cartridge unit (reusable and disposable models) (Same as Predicate) Vent: Fluid Vent (Same as Predicate) Modes: Irrigation, Phaco, Irrigation/Aspiration (I/A), Vitrectomy, and Coagulation (Same as Predicate) Programmable User Parameters: Yes (Same as Predicate) |
| Safety and Effectiveness Equivalence: The new device must be as safe and effective as the predicate device. | Based on the presented characteristics, the sponsor asserts that "The Vizual™ Phacoemulsification System has the same technological characteristics as the predicate device cleared under 510(k) K020527," implying no new questions of safety or effectiveness are raised. The FDA's 510(k) clearance letter (K080803) confirms this determination of substantial equivalence. |
Regarding the Study:
The "study" to prove the device meets the acceptance criteria is a 510(k) substantial equivalence comparison. This is a regulatory pathway, not a clinical trial or performance study in the AI sense. The manufacturer compares their new device (Vizual™ Phacoemulsification System) to a legally marketed predicate device (K020527, Horizon Phacoemulsification System) to demonstrate that it is equally safe and effective.
Here's why the subsequent questions are not applicable to the provided document:
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a surgical instrument (phacoemulsification system), not an AI algorithm that processes data. No "test set" of images or patient data is mentioned in this summary for performance evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "test set" or diagnostic ground truth being established as this is not an AI diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or human adjudication process is described for this type of device submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There is no "ground truth" in the AI sense required for this type of device. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.
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The sample size for the training set
- Not applicable. This is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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SEP 2 2 2008
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510(k) Summary
| 510(k) Submitter/Owner | Herbert Cameron IIIPresidentAmerican Optisurgical, Inc.Email: cameron@optisurgical.com |
|---|---|
| Contact person | David SalzbergDirector of Regulatory AffairsAmerican Optisurgical, Inc.Email: regulatory@optisurgical.com |
| Date prepared | 03/20/2008 |
| Trade name | Vizual™ Phacoemulsification System, Model 551 |
| Common name | Phacoemulsification System |
| Classification | Phacofragmentation system (21 CFR 886.4670, ProductCode HQC) |
| Predicate device | K020527, Horizon Phacoemulsification System(manufactured by American Optisurgical, Inc.) |
| Device description | The Vizual™ Phacoemulsification system is a completeanterior segment surgical system, offering Irrigation, Phacoor Ultrasonic (U/S), Irrigation/Aspiration (I/A),Vitrectomy, and Coagulation modes of operation. Thedevice can be operated as a standalone unit, or connected toan optional cart with electric I/V pole where bottle heightcan be controlled by the software.The Vizual™ Phacoemulsification System includes thePhaco unit, U/S handpiece, tubing cartridge, and foot pedal.The device has been designed to work with commerciallyavailable (and 510k cleared) components and accessoriesincluding Phaco tips and sleeves, vit cutters, cauterypencils, and cautery forceps.The Vizual™ Phacoemulsification System utilizes a non-invasive vacuum sensing system including an externaltubing cartridge that vents to the bottle versus air, thus |
| minimizing the possibility of introducing contaminationinto the fluid path. The external tubing cartridge design isadvantageous as the fluid path is visible to the user, and canbe easily installed or removed in a single step. | |
| The Vizual™ Phacoemulsification System uses a LCDtouch panel interface to allow access to all modes ofoperation. The system software allows for storing up totwenty-four different user profiles. | |
| Intended use | The Vizual™ Phacoemulsification System is intended foruse in the disruption and extraction of cataractous lensmaterial from the eye with ultrasonic energy, a processknown as phacoemulsification. |
| Technologicalcharacteristics | The Vizual™ Phacoemulsification System has the sametechnological characteristics as the predicate device clearedunder 510(k) K020527. A summary is as follows: |
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| DeviceCharacteristics | Subject Device | Predicate Device |
|---|---|---|
| Display | LCD Touch Screen | LCD Touch Screen |
| Pump | Peristaltic, low pulsation | Peristaltic, low pulsation |
| Pump VacuumRange | 0 to 500 mmHg | 0 to 500 mmHg |
| Aspiration Rate | 0 to 50 cc/min | 0 to 50 cc/min |
| Fluidics | External Fluid Path | External Fluid Path |
| System Tubing | Tubing/Cartridge unit (reusableand disposable models) | Tubing/Cartridge unit (reusableand disposable models) |
| Vent | Fluid Vent | Fluid Vent |
| Modes | Irrigation, Phaco,Irrigation/Aspiration (I/A),Vitrectomy, and Coagulation | Irrigation, Phaco,Irrigation/Aspiration (I/A),Vitrectomy, and Coagulation |
| Programmable UserParameters | Yes | Yes |
Table II – Summary of Device Characteristics
:
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2008
American Optisurgical, Inc. c/o David Salzberg 25501 Arctic Ocean Lake Forest, CA 92630
Re: K080803
Trade/Device Name: Vizual™ Phacoemulsification System, Model 551 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification System Regulatory Class: II Product Code: HQC Dated: August 20, 2008 Received: August 20, 2008
Dear Mr. Salzberg:
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 10gally marketed predicate device results in a classification for your device and thus, perror to 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 Presmarket 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 on 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,
Maling B. Egleston, und
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
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Indications for Use Statement
510(k) Number (if known): K080803
Device Name: Vizual™ Phacoemulsification System
Indications for Use: The Vizual™ Phacoemulsification System is intended for use in the disruption and extraction of cataractous lens material from the eye with ultrasonic energy; a process known as phacoemulsification.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K080803
Page 4-1
§ 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.