(90 days)
Not Found
No
The document describes a remote control for a phacoemulsification system, focusing on its function as a wireless/wired interface. There is no mention of AI, ML, image processing, or any data analysis/learning capabilities.
No
The device is a remote control for a phacoemulsification system, which itself is a therapeutic device. However, the remote control only controls the functions of the main system and does not directly provide a therapeutic effect or interact with the patient.
No
The device is described as a remote control for a phacoemulsification system, used to control the main functions of the system from a distance. Its purpose is operational control, not to diagnose medical conditions or analyze patient data.
No
The device description explicitly states it is a "combination wireless and hard-wired hand-held device," indicating it includes hardware components (hand-held device, wireless/hard-wired capabilities, battery).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control a phacoemulsification system during surgery. This is a surgical device used in vivo (on a living patient), not in vitro (outside the body, typically on biological samples).
- Device Description: The description details a remote control for a surgical system, focusing on its function in controlling the system's operation. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Mentor® Phacoemulsification SIStem Remote Control is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mentor® Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.
Product codes
86 HQC
Device Description
The Mentor® Phacoemulsification SIStem Remote Control is an accessory to the Mentor Phacoemulsification SIStem. It is a combination wireless and hard-wired hand-held device that allows the operator to control certain aspects of the Mentor Phacoemulsification SIStem's operation from a distance. When using the remote in a wireless mode, signals are transmitted to the console via IR (infrared) signals. When using the remote in the hard-wired mode, signals are transmitted to the console directly through the wire. The remote can be powered either by battery (when used in the wireless mode) or from the SIStem console itself (when the hard-wired mode is used).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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
Not Found
Key Metrics
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
1-17-4-46-4
FEB 2 4 1998
(805) 681-6000
Image /page/0/Picture/1 description: The image shows the logo for Mentor Corporation. The logo consists of a symbol resembling a four-pointed star or compass rose on the left. To the right of the symbol is the word "MENTOR" in bold, sans-serif font. Below "MENTOR" is the word "CORPORATION" in a smaller, sans-serif font.
Date:
Executive Offices
| 5425 Hollister Avenue | Santa Barbara, CA 93111 |
|---|---|
| ----------------------- | ------------------------- |
510(k) SUMMARY
February 3, 1998
| Submitter: | Donna A. Crawford, |
|---|---|
| Manager, Corporate Regulatory Affairs | |
| Mentor Corporation | |
| 5425 Hollister Avenue | |
| Santa Barbara, CA 93111 | |
| Phone: 805-681-6000 | |
| Fax: 805-681-6004 |
| Trade or Proprietary Name: | Mentor ® Phacoemulsification SIStem Remote Control |
|---|---|
| Common or usual name: | Remote Control |
| Classification name: | Phacofragmentation system (accessory), 21 CFR 886.4670 |
Description and Intended Use of Device:
The Mentor® Phacoemulsification SIStem Remote Control is an accessory to the Mentor Phacoemulsification SIStem. It is a combination wireless and hard-wired hand-held device that allows the operator to control certain aspects of the Mentor Phacoemulsification SIStem's operation from a distance. When using the remote in a wireless mode, signals are transmitted to the console via IR (infrared) signals. When using the remote in the hard-wired mode, signals are transmitted to the console directly through the wire. The remote can be powered either by battery (when used in the wireless mode) or from the SIStem console itself (when the hard-wired mode is used).
The Mentor Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.
Substantial Equivalence:
The Mentor Phacoemulsification SIStem Remote Control has the same intended use and the same technological characteristics, and is therefore substantially equivalent to, the remote controls used with the Alcon Series 2000 Legacy
1
phacoemulsification system and the Chiron Vision Catalyst phacoemulsification system. The Alcon Legacy remote control and the Chiron Vision Catalyst remote control are full function, wireless, infrared remote controls. Please see the comparison table below.
| Feature | Alcon Legacy
Remote Control
510(k) K952213 | Chiron Vision
Catalyst Remote
Control
510(k) K925828 | Mentor
Phacoemulsification
SIStem Remote Control |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------|
| Wireless Infrared
Remote Control | YES | YES | YES, also may be hard-
wired |
| Controls I.V.
Pole Height | YES | YES | YES |
| Memory Access | YES | ? | YES |
| Mode Changes | YES | YES | YES |
| Performance
Parameter
Adjustments | YES | YES | YES |
| Hand motion
sensor which
initiates remote
backlight for
visibility in the
dark | YES | ? | NO |
| Optional sterile
cover | YES | ? | NO |
COMPARISON TABLE
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol is three stylized human profiles facing to the right, with flowing lines suggesting movement or connection. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Donna A. Crawford Manager, Corporate Regulatory Affairs Mentor Corporation 5425 Hollister Ave. Santa Barbara, Ca 93111
Re: K974469
Trade Name: Mentor Phacoemulsification SIStem Remote Control Regulatory Class: II Product Code: 86 HQC Dated: November 24, 1997 Received: November 26, 1997
Dear Ms. Crawford:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through_542 of the Act for devices under . the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Donna Crawford
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roepk. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(K) Number : K974469
Device Name:
Mentor® Phacoemulsification SIStem Remote Control
Indications for Use:
The Mentor® Phacoemulsification SIStem Remote Control is intended to be used by operating room personnel to control the main functions of the Mentor Phacoemulsification SIStem from a distance.
Prescription Use
(Per 21 CFR 801.109)
Thaselia L. Dusk. hi oklaos
Division of Ophthalmic Devices 510(k) Number_K974469