(185 days)
Not Found
No
The description focuses on standard phacoemulsification technology and operational modes, with no mention of AI or ML capabilities.
Yes
The device is intended for the disruption and extraction of cataractous lens material using ultrasonic energy, which is a direct treatment of a medical condition.
No
The device is described as a "surgical system" for the "disruption and extraction of cataractous lens material," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists hardware components such as the Phaco unit, U/S handpiece, tubing cartridge, and foot pedal, indicating it is a physical system with software control, not a software-only device.
Based on the provided information, the Vizual™ Phacoemulsification System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "disrupt and extract cataractous lens material from the eye with ultrasonic energy." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical system with various modes of operation (Irrigation, Phaco, I/A, Vitrectomy, Coagulation) and components used in surgery (handpiece, tubing cartridge, foot pedal, tips, sleeves, cutters, cautery pencils/forceps). These are all tools for performing a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Vizual™ Phacoemulsification System is a surgical device used to treat a condition within the eye.
N/A
Intended Use / 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.
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.
Product codes
HQC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 2 2008
. . . . .
:
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:
510(k) Summary
| 510(k) Submitter/
Owner | Herbert Cameron III
President
American Optisurgical, Inc.
Email: cameron@optisurgical.com |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | David Salzberg
Director of Regulatory Affairs
American 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, Product
Code HQC) |
| Predicate device | K020527, Horizon Phacoemulsification System
(manufactured by American Optisurgical, Inc.) |
| Device description | 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. |
| Intended 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. |
| Technological
characteristics | The Vizual™ Phacoemulsification System has the same
technological characteristics as the predicate device cleared
under 510(k) K020527. A summary is as follows: |
1
| Device
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Display | LCD Touch Screen | LCD Touch Screen |
| Pump | Peristaltic, low pulsation | Peristaltic, low pulsation |
| Pump Vacuum | ||
| Range | 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 (reusable | |
| and disposable models) | Tubing/Cartridge unit (reusable | |
| and 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 User | ||
| Parameters | Yes | Yes |
Table II – Summary of Device Characteristics
:
2
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.
3
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
4
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
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