(30 days)
Not Found
No
The document describes a laser system with various control parameters and delivery devices. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The changes described relate to hardware modifications (illumination fibers) and standard performance testing.
Yes
The device is described as a laser system used for medical treatments in ophthalmology, specifically for glaucoma, which indicates its therapeutic purpose.
No
The device is a therapeutic laser system used for treatment (incision, excision, coagulation, vaporization, ablation, and hemostasis of tissue, specifically for glaucoma treatment), not for diagnostic purposes. While it aids in probe placement by revealing internal ocular structures, this is a procedural aid, not a diagnosis.
No
The device is a laser system with multiple hardware components including a main console, footswitch, remote control, and delivery accessories (handpieces and probes). While it has a control panel and display which likely involve software, the core function and components are hardware-based. The submission also details hardware testing (sterilization, biocompatibility, illumination, shelf life, transit testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for treating glaucoma by applying laser energy to the ciliary processes. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a laser system, handpieces, and accessories used to deliver laser energy. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Measuring analytes in a sample.
The device is a therapeutic medical device used for surgical intervention.
N/A
Intended Use / Indications for Use
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (The IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:
MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. CW/μP: μP
G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW/μP: CW
Product codes
GEX
Device Description
The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:
- . Main console containing the major electrical components, including:
- Control Panel including control knobs (power, interval, duration or software assigned ● function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time); ●
- . LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification; ●
- Emergency stop switch;
- Key switch; ●
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); ●
- A Wired Remote Control that duplicates the control panel;
- Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the ● G-Probe Illuminate
- Optional Cart/Stand
The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.
The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).
The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.
The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ciliary processes (of the 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)
Clinical trial data was not required for this product change. This product change did not require any additional EMC (electromagnetic compatibility) or IEC 60601 safety testing. There were no software changes to the product.
The product change did require the following tests, which were successfully completed to the relevant standards:
Sterilization:
ISO 11135: 2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
Biocompatibility:
ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for Irritation and Skin Sensitization
Illumination:
ISO 15004-2:2007 Ophthalmic Instruments -Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection
Shelf Life:
ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Transit Testing:
ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packing Components for Testing
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
BS EN ISO 11607-1: 2009 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with a stylized design that suggests flowing hair or water beneath the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
Iridex Corporation Ms. Kathy Maynor Acting VP of Regulatory/Quality 1212 Terra Bella Avenue Mountain View, CA 94043
Re: K162416
Trade/Device Name: Iridex Cyclo G6 Laser System, G-Probe Illuminate Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 27, 2016 Received: August 30, 2016
Dear Ms. Maynor:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kesia Alexander
for 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
2
Indications for Use
510(k) Number (if known) K162416
Device Name
Cyclo G6 Laser System with Illumination
Indications for Use (Describe)
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (The IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:
| Condition (Indicated | Treatment (Intended Use) | CW/μP | |
|---|---|---|---|
| MicroPulse P3 | |||
| Device | For the treatment of | ||
| Glaucoma including: | |||
| • Primary Open-Angle | |||
| • Closed-Angle | |||
| • Refractory | Transscleral Cyclophotocoagulation | ||
| (TSCPC) of the ciliary processes | μP | ||
| G-Probe & | |||
| G-Probe Illuminate | For the treatment of | ||
| Glaucoma including: | |||
| • Primary Open-Angle | |||
| • Closed-Angle | |||
| • Refractory | Transscleral | ||
| cyclophotocoagulation | |||
| (TSCPC) of the ciliary | |||
| processes | CW |
Type of Use (Select one or both, as applicable)
[≥] Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Section 8 - Special 510(k) Summary
I. General Information
Submitter:
Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Contact Person: Kathy Maynor kmaynor@iridex.com 352-586-3113
Summary Preparation Date: September 28, 2016
II. Names
Device Name(s): Cyclo G6 Laser System with Illumination
Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories
Predicate Devices III.
K143154 -Iridex Cyclo G6 Laser System
IV. Product Description
The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:
- . Main console containing the major electrical components, including:
- Control Panel including control knobs (power, interval, duration or software assigned ● function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time); ●
- . LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification; ●
- Emergency stop switch;
- Key switch; ●
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); ●
- A Wired Remote Control that duplicates the control panel;
- Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the ● G-Probe Illuminate
- Optional Cart/Stand
4
The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.
The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).
The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.
The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.
V. Indications for Use
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (The IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:
5
| Condition (Indicated for) | Treatment (Intended Use) | CW/μP | |
|---|---|---|---|
| MicroPulse P3 | |||
| Device | For the treatment of | ||
| Glaucoma including: | |||
| • Primary Open-Angle | |||
| • Closed-Angle | |||
| • Refractory | Transscleral | ||
| cyclophotocoagulation | |||
| (TSCPC) of the ciliary | |||
| processes | μP | ||
| G-Probe & | |||
| G-Probe Illuminate | For the treatment of | ||
| Glaucoma including: | |||
| • Primary Open-Angle | |||
| • Closed-Angle | |||
| • Refractory | Transscleral | ||
| cyclophotocoagulation | |||
| (TSCPC) of the ciliary | |||
| processes | CW |
VI. Performance Testing
Clinical trial data was not required for this product change. This product change did not require any additional EMC (electromagnetic compatibility) or IEC 60601 safety testing. There were no software changes to the product.
The product change did require the following tests, which were successfully completed to the relevant standards:
Sterilization:
ISO 11135: 2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
Biocompatibility:
ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for Irritation and Skin Sensitization
Illumination:
ISO 15004-2:2007 Ophthalmic Instruments -Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection
Shelf Life:
ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Transit Testing:
ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers
6
and Systems
ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packing Components for Testing
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
BS EN ISO 11607-1: 2009 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
7
VII. Summary of Technological Characteristics
The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device.
| K143154 | ||
|---|---|---|
| Charact | ||
| eristic | Iridex Cyclo G6 Laser | |
| System | Iridex Cyclo G6 Laser System | |
| Product | ||
| Code | General & Plastic | |
| Surgery | General & Plastic Surgery | |
| Regulation | • GEX, 21 CFR 878.4810 | • GEX, 21 CFR 878.4810 |
| Intended | ||
| Use | Intended for use for the | |
| treatment of Glaucoma | ||
| including: | ||
| • Primary Open-Angle | ||
| • Closed-Angle | ||
| • Refractory | ||
| (see section V above) | Intended for use for the | |
| treatment of Glaucoma | ||
| including: | ||
| • Primary Open-Angle | ||
| • Closed-Angle | ||
| • Refractory | ||
| (see section V above) | ||
| Indications for | ||
| Use | Transscleral | |
| cyclophotocoagulation | ||
| (TSCPC) of the ciliary | ||
| processes | Transscleral | |
| cyclophotocoagulation | ||
| (TSCPC) of the ciliary | ||
| processes | ||
| Wavelength | 810nm - Infrared (IR) Diode | 810nm – Infrared (IR) Diode |
| Aiming | ||
| beam | 630-670 nm – red | |
| (nominal) – variable | ||
| intensity from 0 to |