(60 days)
Not Found
No
The document describes a laser system for tissue treatment and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the treatment of glaucoma and for soft and fibrous tissue incision, excision, coagulation, vaporization, ablation, and vessel hemostasis, which are all therapeutic medical procedures.
No
The device description and intended use clearly state that it is a surgical laser system designed to deliver laser energy for various therapeutic treatments (incision, excision, coagulation, vaporization, ablation, vessel hemostasis, and cyclophotocoagulation), not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a main console, control panel, fiber-optic connector ports, footswitch, remote control, and delivery accessories (handpieces). This indicates it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states that this device is a laser system used for surgical procedures (incision, excision, coagulation, vaporization, ablation, vessel hemostasis) directly on the patient's tissue. It delivers energy to the body, rather than analyzing samples taken from the body.
- Intended Use: The intended use is for treating conditions like glaucoma and performing procedures in dermatology, ENT, and ophthalmology by directly interacting with the patient's tissues.
Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & 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 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 | For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | CW |
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Iridex Cyclo G6 is 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-Probeand MicroPulse P3 probe Handpieces. ● Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
- Optional Cart/Stand ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft and fibrous tissue, including osseous tissue (general); Ciliary processes (specific to Glaucoma treatment with MicroPulse P3 and G-Probe).
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)
No clinical data was needed for these indications. They are identical to those on K071687.
The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble fabric or water.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2015
Iridex Corporation c/o Ms. Kathy Maynor Regulatory Consultant 26 Rebecca St. Homosassa, FL 34446
Re: K143154
Trade/Device Name: Iridex Cyclo G6 (with delivery devices) Regulation Number: 21 CFR 878.4810 Regulation Name: Power Laser Surgical Instruments Regulatory Class: Class II Product Code: GEX Dated: December 4, 2014 Received: December 5, 2014
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.
1
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 of medical device-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" (21CFR 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 yours.
Deborah L. Falls -S
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) K143154
Device Name
Family of IR.IDEX® IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810[IRIDEX Cyclo G6 Laser System])
Indications for Use (Describe)
The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:
810nm (IRIDEX Cyclo G6 Laser System)
Ophthalmology:
The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & 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 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 | 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)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Section 8 – Special 510(k) Summary
I. General Information
Submitter:
Iridex Corporation
Contact Person:
Kathy Maynor
352-586-3113 (cell)
Summary Preparation Date: October 31, 2014
II. Names
Device Name(s): Cyclo G6
Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories
III. Predicate Devices
- K071687 Family of Iridex IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, ● IQ 810)
4
IV. Product Description
The Iridex Cyclo G6 is 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-Probeand MicroPulse P3 probe Handpieces. ● Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
- Optional Cart/Stand ●
V. Indications for Use
lndications for Use (same as K071687):
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670mm]. IO 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse TM 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:
532 nm
Dermatology
- Pigmented Skin Lesions
- Vascular Lesions
Ear, Nose, and Throat (ENT)/ Otolaryngology
Otosclerotic Hearing loss and/or diseases of the inner ear:
- Stapedectomy
- Stapedotomy
- Myringotomies ●
- Lysis of Adhesions
- Control of Bleeding ●
5
- Removal of Acoustic Neuromas
- . Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:
- Retinal photocoagulation (RPC) for the treatment of ●
- Diabetic retinopathy, including: o
- Nonproliferative retinopathy .
- Macular edema
- I Proliferative retinopathy
- Retinal tears and detachments о
- Lattice degeneration O
- Age-related macular degeneration (AMD) O
- Retinopathy of prematurity O
- O Sub-retinal (choroidal) neovascularization
- Central and branch retinal vein occlusion O
- Diabetic retinopathy, including: o
- Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including ●
- Primary open angle/Closed angle O
577nm
Dermatology:
- Treatment of Vascular and pigmented lesions
Ophthalmology:
Indicated for use in photocoagulation of both anterior and posterior segments including:
- Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :
- proliferative and nonproliferative diabetic retinopathy; о
- choroidal neovascularization; O
- branch retinal vein occlusion; O
- age-related macular degeneration O
- O retinal tears and detachments
- retinopathy of prematurity O
- Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle ● glaucoma
810nm
Ophthalmoloqgy:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:
6
- Retinal photocoagulation for the treatment of: о
- Diabetic retinopathy, including: O
- Nonproliferative retinopathy .
- . Macular edema
- I Proliferative retinopathy
- Retinal Tears, Detachments and Holes o
- Lattice degeneration O
- Age-related macular degeneration (AMD) with choroidal neovascularization O (CNV)
- Retinopathy of prematurity O
- Sub-retinal (choroidal) neovascularization O
- Central and Branch Retinal Vein Occlusion O
- Diabetic retinopathy, including: O
-
o Laser trabeculoplasty, Iidotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
- Primary open angle o
- O Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled) O
No clinical data was needed for these indications. They are identical to those on K071687.
VI. Summary of Technological Characteristics
The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device.
| K071687 | ||
|---|---|---|
| Characteristic | Iridex Cyclo G6 | Iridex Family of IQ Lasers |
| Product Code | General & Plastic Surgery | General & Plastic Surgery |
| Regulation | • GEX, 21 CFR 878.4810 | • GEX, 21 CFR 878.4810 |
| Intended Use | Intended for use in dermatology, ear, | |
| nose and throat (ENT)/ | ||
| otolaryngology, and ophthalmology | Intended for use in | |
| dermatology, ear, nose and | ||
| throat (ENT)/ | ||
| otolaryngology, and | ||
| ophthalmology | ||
| Indications for | ||
| Use | Exactly the same as K071687 | See K071687 |
| Wavelength | 810nm | 532nm, 577nm, 630- |
| 670nm, 810nm | ||
| K071687 | ||
| Characteristic | Iridex Cyclo G6 | Iridex Family of IQ Lasers |
| Aiming beam | 630nm-650nm | 630nm-650nm |
| Power Watts | ≤ 5W | ≤ 5W |
| Pulse Duration | ||
| (usec) | 10µsec-60min | 10µsec-60min |
| Output Mode | CW (CW-Pulse, MicroPulse, Long | |
| Pulse) | CW (CW-Pulse, MicroPulse, | |
| Long Pulse) | ||
| Repetition rate | ≤ 1kHz | ≤ 1kHz |
| Laser media | Diode, Diode-pumped, frequency | |
| doubled, solid state | Diode, Diode-pumped, | |
| frequency doubled, solid | ||
| state | ||
| User interface | Manual & Remote Controls | Manual & Remote Controls |
| Laser | ||
| activation | footswitch | footswitch |
| Delivery devices, how | ||
| supplied | Delivery Devices provided Sterile | |
| packaged & non-sterile | Delivery Devices provided | |
| Sterile packaged & non- | ||
| sterile | ||
| Electrical | ||
| requirements | 90-130 VAC, 50/60 Hz | |
| 200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz | |
| 200-240 VAC, 50/60 Hz |
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VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated.
The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures.
8
VIII. Conclusion
The Iridex G6 Laser was found to be substantially equivalent to the predicate device.
The Iridex G6 Laser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device.