(116 days)
No
The device description and intended use clearly state that the device is a wireless footswitch that emulates the functionality of a wired footswitch. There is no mention of AI or ML in the description, intended use, or the "Mentions AI, DNN, or ML" section. The device acts as a simple input control accessory.
No
The device is an accessory (wireless footswitch) intended to control compatible IRIDEX Laser Systems, which are therapeutic devices. However, the footswitch itself does not directly perform any therapeutic function.
No
The device is an accessory (footswitch) that provides input control for laser emission to compatible laser systems. It does not perform any diagnostic functions.
No
The device description explicitly states it consists of two discreet parts: a footswitch/transmitter and a receiver, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases or other conditions.
- Device Function: The IRIDEX Wireless Footswitch is an accessory that controls the emission of a laser system. It provides input to the laser, not analysis of biological samples.
- Intended Use: The intended use clearly states it's for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities to provide input control of laser emission. There is no mention of analyzing biological samples.
- Device Description: The description details its function as an alternate to a wired footswitch, emulating its functionality to control the laser. This aligns with controlling a medical device, not performing a diagnostic test.
Therefore, the IRIDEX Wireless Footswitch is a medical device accessory, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.
The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.
Product codes
HQF
Device Description
The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.
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
hospital or outpatient facilities
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)
IRIS Medical OcuLight SL/SLx Laser System (K020374), IRIS Medical OcuLight GL/GLx Laser System (K031665), IRIS Medical OcuLight GL/GLx Laser System (K050562), IRIDEX DioLite Laser System (K964074), IRIDEX VariLite Laser System (K041930), Ivoclar Vivadent Odyssey 2.4G Pedal -- Accessory for: Odyssey 2.4G Diode Laser (K050453), Stryker Wireless Universal Footswitch (K033135), Linemaster IR Wireless Footswitch ( K053510)
Reference Device(s)
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
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Section 5 - 510(k) Summary or 510(k) Statement
NOW 1 4 2006
I. General Information
| Submitter: | IRIDEX Corporation
1212 Terra Bella Avenue
Mountain View, CA 94043-1824
USA |
|---------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | John Jossy
Director of Regulatory Affairs and Quality Assurance |
| Summary Preparation Date: | July 17, 2006 |
II. Names
| Device Names: | IRIDEX Wireless Footswitch |
|---|---|
| Primary Classification Names: | Accessory for, Laser Powered Surgical Instruments and |
| Lasers, Ophthalmic |
III. Predicate Devices
IRIDEX Standard Footswitch - Accessory for:
- IRIS Medical OcuLight SL/SLx Laser System (K020374) .
- IRIS Medical OcuLight GL/GLx Laser System (K031665, K050562) .
- IRIDEX DioLite Laser System (K964074) .
- IRIDEX VariLite Laser System (K041930) .
Ivoclar Vivadent Odyssey 2.4G Pedal -- Accessory for:
Linemaster IR Wireless Footswitch ( K053510)
IV. Product Description
The Wireless Footswitch is an alternate option to the existing cabled footswitch for users of IRIDEX laser consoles. It consists of two discreet parts - a footswitch/transmitter and receiver. The wireless footswitch receiver connects to the laser through the same connector as the current wired footswitch, and operates with the console by directly emulating the functionality of the current wired footswitch.
V. Indications for Use
The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.
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1
The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for the particular indications of the laser system to which it is attached ..
VI. Rationale for Substantial Equivalence
The IRIDEX Wireless Footswitch shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX Wireless Footswitch is substantially equivalent to the predicate devices.
VIII. Conclusion
The IRIDEX Wireless Footswitch was found to be substantially equivalent to the predicate devices.
The IRIDEX Wireless Footswitch shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IRIDEX, Corporation % Mr. John Jossy Director, Regulatory Affairs and Quality Assurance 1212 Terra Bella Avenue Mountain View, California 94043-1824
Re: K062074
Trade/Device Name: IRIDEX Wireless Footswitch Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: October 17, 2006 Received: October 19, 2006
Dear Mr. Jossy:
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.
NUV 1 4 2006
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
3
Page 2 - Mr. John Jossy
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
For
Mark N. Melkerson
DEPU
O.L
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K06207 510(k) Number (if known):
IRIDEX Wireless Footswitch Device Name:
Indications for Use:
The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities.
The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached.
Prescription Use (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)
Mark A. Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062074 /Page 1 of 1