Search Results

Date Cleared

2008-08-07

(416 days)

Product Code

Regulation Number

Type

Panel

IRIDEX WIRELESS FOOTSWITCH

Reference & Predicate Devices

N/A

Predicate For

K091581,K091981,K111108,K111643,K120825,K121475,K133486,K141851,K143154,K151109,K170718,K201502,K230228

Intended Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 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™ 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
· Removal of Acoustic Neuromas
" Soft tissue Adhesion in Micro/Macro Otologic Procedures
Ophthalmology
Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:
· Retinal photocoagulation (RPC) for the treatment of

Diabetic retinopathy, including:
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal tears and detachments
Lattice degeneration
Age-related macular degeneration (AMD)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and branch retinal vein occlusion
· Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
Primary open angle/Closed angle

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 choroids including :

proliferative and nonproliferative diabetic retinopathy;
choroidal neovascularization;
branch retinal vein occlusion;
age-related macular degeneration
retinal tears and detachments
retinopathy of prematurity
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle . Glaucoma

630 - 670nm
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;
choroidal neovascularization;
branch retinal vein occlusion;
age-related macular degeneration
retinal tears and detachments
retinopathy of prematurity
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open . angle glaucoma

810nm
Opthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:
· Retinal photocoagulation for the treatment of:

Diabetic retinopathy including;
Nonproliferative retinopathy
Macular edema
Proliferative retinopathy
Retinal Tears, Detachments and Holes
Lattice degeneration
Age-related macular degeneration (AMD) with choroidal neovascularizations (CNV)
Retinopathy of prematurity
Sub-retinal (choroidal) neovascularization
Central and Branch Retinal Vein Occlusion
Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) . for the treatment of glaucoma, including;
Primary open angle
Closed angle
Refractory Glaucoma (recalcitrant/uncontrolled)

Device Description

The Family of IRIDEX IQ Laser Systems is comprised of the following main components:
Main console containing the major electrical components, including: .
A 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); A
A LIO illumination connection:
Smart key port for detecting/operating safety filters and/or accessory A identification:
A Emergency stop switch:
A Kev switch:
Connector ports for the footswitch, remote control, and power cord; A
A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); .
A Wired Remote Control that duplicates the control panel; .
Delivery Accessories including OtoProbe handpieces, EndoProbe handpieces, . G-Probe and DioPexy Probe Handpieces, Dermatology Handpieces, Microscope Adapters, and Laser Indirect Ophthalmoscopes.
. Optional Cart/Stand

AI/ML Overview

The provided 510(k) summary for the Family of IRIDEX IQ Laser Systems (K071687) does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria.

This document is a premarket notification for substantial equivalence, which primarily focuses on arguing that a new device is as safe and effective as a legally marketed predicate device. In such submissions, the manufacturer typically references existing performance standards and demonstrates that their device conforms to these rather than presenting a performance study with specific acceptance criteria.

The summary states:

Performance Standards: "The Family of IRIDEX® IQ Laser Systems ... conforms with: Federal Regulations; the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems: and, International Harmonized Standards." (Page 3)
Rationale for Substantial Equivalence: "The Family of IRIDEX IQ Laser Systems shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices." (Page 3)
Safety and Effectiveness Information: "The review of the indications for use and technical characteristics provided demonstrates that the Family of IRIDEX IQ Laser Systems is substantially equivalent to the predicate devices." (Page 3)

These statements indicate that the device's conformity is established by adherence to existing regulations and standards, and by demonstrating similarity to previously cleared devices. There is no mention of a specific study conducted by IRIDEX Corporation with defined acceptance criteria to "prove" device performance in the way one might expect for a novel or significantly different device requiring clinical data.

Therefore, I cannot populate the requested table and answer the specific questions below, as the information is not present in the provided text. The document is a regulatory submission focused on substantial equivalence rather than a detailed report of a performance study with acceptance criteria.

Ask a Question

Ask a specific question about this device

K Number

K062074

Device Name

Manufacturer

Date Cleared

2006-11-14

(116 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K020374,K031665,K050562,K964074,K041930,K050453,K033135,K053510

Predicate For

N/A

Intended 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.

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.

AI/ML Overview

This document describes the IRIDEX Wireless Footswitch, seeking clearance as an accessory for existing IRIDEX laser systems. As an accessory that emulates the functionality of a wired footswitch, the submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.

Therefore, the requested information fields related to clinical efficacy studies, expert ground truth, and training data are largely not applicable in the context of this 510(k) submission. The FDA clearance is based on the device's functional similarity to predicate devices and its adherence to general controls for safety and effectiveness.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to a substantial equivalence submission for an accessory device:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an accessory (wireless footswitch) demonstrating substantial equivalence to wired and other wireless footswitches, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, acceptance is based on functional equivalence and safety to predicate devices. The document implies functional equivalence to existing wired and wireless footswitches as the primary criterion.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	The wireless footswitch must directly emulate the functionality of the current wired footswitch of IRIDEX laser consoles. It must provide input control of laser emission to compatible IRIDEX Laser Systems in the same manner as the wired footswitch. Its use should be cleared for the particular indications of the laser system to which it is attached.	"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."
Indications for Use	The device's indications for use must be similar to or the same as predicate devices and compatible with the existing IRIDEX laser systems.	"The IRIDEX Wireless Footswitch shares the same indications for use... with, and thus is substantially equivalent to, the predicate devices."
Safety and Effectiveness	The device must be demonstrated to be substantially equivalent to predicate devices in terms of technical characteristics and operation, implying it meets the same safety and effectiveness standards as those devices. This includes general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration). Compliance with applicable standards is usually demonstrated.	"The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX Wireless Footswitch is substantially equivalent to the predicate devices."
Design Features	The design features (e.g., wireless transmission) should be similar to other legally marketed wireless footswitches.	"The IRIDEX Wireless Footswitch shares... similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices."

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission is for substantial equivalence of an accessory device (wireless footswitch) based on functional emulation and comparison to predicate devices, not requiring a clinical performance study with a test set of patient data. The documentation does not mention such a study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No clinical test set or ground truth validation by experts is mentioned or required for this type of 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a hardware accessory (wireless footswitch), not an AI-powered diagnostic tool. MRMC studies are irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware accessory, not an algorithm. Performance is assessed based on its ability to emulate the wired footswitch function and comply with relevant standards (though not explicitly detailed in this summary).
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Not a clinical diagnostic device requiring ground truth for clinical performance. The "ground truth" for this device's functionality would be the successful and consistent control of the laser system, as performed by the wired equivalent.
The sample size for the training set
- Not Applicable. This is a hardware accessory, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm.

Ask a Question

Ask a specific question about this device

K Number

K062369

Device Name

IRIDEX OCULIGHT TX

Manufacturer

Date Cleared

2006-11-08

(86 days)

Product Code

Regulation Number

Type

Panel

K050562,K022327,K032220,K002296

Reference & Predicate Devices

Predicate For

N/A

Intended Use

The OcuLight TX is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. In otolaryngology it is indicated for stapedectomy, stapedotomy, myringotomy, lysis of adhesions, control of bleeding, removal of acoustic neuromas, and soft tissue adhesion in micro/macro otologic procedures. In dermatology it is indicated for the treatment of vascular and pigmented skin lesions. In ophthalmology it is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, and iridoplasty.

Device Description

The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532 nm) light for otolaryngologic, dermatology, and ophthalmic applications. The integrated system is comprised of the OcuLight TX laser console, various compatible optical fiber delivery devices, and a Footswitch. The laser console contains the laser head, imaging optics, power supplies, control electronics, and firmware. The electronic system is comprised of various sense and control electronics, user controls and displays, and an embedded microprocessor that monitors all system functions. The microprocessor interprets operator commands, formats displays and supervises laser emission. A visible red (630-650 nm) semiconductor diode laser is used for aiming.

AI/ML Overview

The provided text is a 510(k) summary for the IRIDEX OcuLight TX device. It outlines the device's general information, predicate devices, product description, and indications for use. However, it does not contain any information regarding acceptance criteria, study performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on similar indications for use, device operation, and technical characteristics. It states: "The OcuLight TX shares the same or similar indications for use, device operation, overall the Oculergit 12x shares the same ies and therefore is substantially equivalent to the predicate devices." and "The review of the indications for use and technical characteristics provided demonstrates that the OcuLight TX is substantially equivalent to the predicate devices."

Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria and study details.

Ask a Question

Ask a specific question about this device

K Number

K060905

Device Name

IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1

Manufacturer

Date Cleared

2006-05-31

(58 days)

Product Code

Regulation Number

Type

Panel

K990174,K943445,K980389,K952772

Reference & Predicate Devices

Predicate For

N/A

Intended Use

The IRIDEX OtoProbe is intended for use in surgical procedures for use in incision, excision, coagulation, and vaporization of soft and fibrous tissue including osseous tissue in the medical specialty of ENT surgery. The IRIDEX OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached.

Device Description

The IRIDEX OtoProbe is comprised of the following main components:

A glass fiber optic protected by a medical grade stainless steel needle and handle at the distal (patient) end and by a plastic jacket at the proximal (laser connection) end: and
. A universal SMA laser connector.

The IRIDEX OtoProbe is provided as a sterile, single use laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the IRIDEX OcuLight laser system or other 532 nm laser system with universal SMA compatibility that has been qualified by IRIDEX for use with the IRIDEX OtoProbe.

AI/ML Overview

This document is stating "substantial equivalence" of the IRIDEX OtoProbe to previously cleared predicate devices, rather than establishing new performance criteria through a study. Therefore, the traditional acceptance criteria and study data format you've requested for a device proving it meets acceptance criteria are not directly applicable here.

Here's how to interpret the provided information in the context of your request:

The core of this submission is about demonstrating that the new device, IRIDEX OtoProbe, is as safe and effective as existing, legally marketed devices, not about proving specific numerical performance targets.

The document doesn't report on a study designed to establish new performance metrics for the IRIDEX OtoProbe, nor does it provide a table of acceptance criteria and reported device performance in the way you've outlined. Instead, it relies on the established safety and effectiveness of its predicate devices.

Let's break down why your requested categories either aren't addressed or have a different interpretation in this context:

1. A table of acceptance criteria and the reported device performance

Not applicable in the direct sense. This document does not present a table of numerical acceptance criteria (e.g., sensibility, specificity thresholds) and corresponding measured performance for the IRIDEX OtoProbe.
Implicit "Acceptance Criteria": The implicit acceptance criteria here are that the IRIDEX OtoProbe:
- Shares the same or similar indications for use as the predicate devices.
- Has similar device operation, overall technical, and functional capabilities as the predicate devices.
- Is substantially equivalent in safety and effectiveness to the predicate devices.
Reported Device Performance: The document states that "The review of the indications for use and technical characteristics provided demonstrates that the IRIDEX OtoProbe is substantially equivalent to the predicate devices." This is the "reported performance" against the implicit acceptance criteria of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. There is no "test set" or clinical study data presented in this 510(k) summary that required a sample size for patient data or a specific provenance. The "test" here is a comparison of the device's design, indications, and functional features to those of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission doesn't involve clinical "ground truth" derived from expert consensus on patient data. The "ground truth" for substantial equivalence is the FDA's acceptance of the predicate devices' safety and efficacy, and a comparison of the new device to those established devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Since there's no clinical "test set" requiring ground truth establishment, no adjudication method was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (laser probe accessory), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. Again, this is a physical medical device, not an algorithm. Standalone performance studies in the AI sense are not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implicit "Ground Truth": The "ground truth" is the regulatory clearance and established safety/effectiveness profiles of the identified predicate devices (Lumenis EndoOto Probe, CeramOptec MegaBeam Fiber Optic Delivery System, Biolitec Megabeam Endo-ENT Probe). The IRIDEX OtoProbe is considered "equivalent" based on its design, intended use, and functional characteristics aligning with these already cleared devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or AI model for this device.

9. How the ground truth for the training set was established

Not applicable. As there's no training set, there's no ground truth establishment for one.

In summary:

The provided document is a 510(k) summary for a medical device accessory seeking clearance via the "substantial equivalence" pathway. This pathway does not typically involve new clinical studies to establish performance against new acceptance criteria. Instead, it relies on demonstrating that the new device is fundamentally similar in design, function, and intended use to devices already cleared by the FDA. Therefore, the detailed study-related information you requested is not present in this type of regulatory submission.

Ask a Question

Ask a specific question about this device

K Number

K050562

Device Name

OCULIGHT GL/GLX

Manufacturer

Date Cleared

2005-04-14

(42 days)

Product Code

Regulation Number

Type

Panel

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR

Reference & Predicate Devices

N/A

Predicate For

K062074,K062369

Intended Use

The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
Diabetic Retinopathy (Nonproliferative Retinopathy, Macular Edema, Proliferative Retinopathy): Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments
Glaucoma (Primary Open Angle, Closed Angle): Laser Trabeculoplasty; Iridotomy, Iridoplasty
Retinal Tears and Detachments: RPC; Focal and Grid Laser Treatments
Lattice Degeneration: RPC; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD): RPC; Focal and Grid Laser Treatments
Intra-Ocular Tumors (Choroidal Hemangioma, Choroidal Melanoma, Retinoblastoma): RPC; Focal and Grid Laser Treatments
Retinopathy of Prematurity: RPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovascularization: RPC; Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion: RPC; Focal and Grid Laser Treatments
Dermatology (Pigmented Skin Lesions, Vascular lesions): Focal Laser Treatments
Ear, Nose and Throat (Otosclerotic hearing loss and/or diseases of the inner ear): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft tissue Adhesion in Micro/Macro Otologic Procedures

Device Description

The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

AI/ML Overview

This looks like a 510(k) summary for a medical device seeking clearance, rather than a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, which often relies on demonstrating similar technological characteristics and comparable performance without necessarily conducting extensive de novo clinical studies with predefined acceptance criteria.

Based on the provided document:

A table of acceptance criteria and the reported device performance:
- The document does not provide a table of acceptance criteria or reported device performance in the way one would see for a clinical study with specific performance metrics (e.g., sensitivity, specificity, accuracy).
- Instead, it states that the device, IRIS Medical OcuLight GL/GLx, is "substantially equivalent" to legally marketed predicate devices, specifically the OcuLight SL/SLx systems and the Lumenis Novus Spectra (K022327).
- The basis for this substantial equivalence is primarily rooted in the device's intended use, technological characteristics (wavelength, pulse duration, spot size, energy densities), and the expansion of indications for use not requiring changes to hardware or firmware.
  - Key comparative points mentioned:
    - OcuLight GL/GLx: True continuous wave green laser (532 nm).
    - Lumenis Novus Spectra: Delivers the same 532nm wavelength, pulses of equivalent duration, treatment spots of equivalent size, and equivalent energy densities to the OcuLight GL/GLx.
    - OcuLight SL/SLx: Uses 810 nm wavelength diode laser. The comparison here is largely about the existence of similar devices for ophthalmic and other applications, rather than direct numerical performance comparison for the 532nm device against the 810nm device. The expansion of indications for GL/GLx to include ENT applications is justified by the existence of Lumenis Novus Spectra with similar technology for these applications.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The submission explicitly states "Non-Clinical performance Data: None" and "Clinical performance Data: None." This indicates that no new clinical or non-clinical studies with test sets were conducted for this 510(k) submission to demonstrate performance against specific criteria. The argument for substantial equivalence relies on existing knowledge of the predicate devices and the physical characteristics of the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no test set performance data was provided, there was no need for experts to establish ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical laser device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth data was generated or used in this submission as no new clinical or non-clinical performance studies were conducted.
The sample size for the training set:
- Not applicable. This is a hardware device; machine learning training sets are not relevant here.
How the ground truth for the training set was established:
- Not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a laser surgical instrument. It demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined acceptance criteria and performance results. Therefore, most of the requested information regarding study design, sample sizes, and ground truth establishment is not present in this type of submission.

Ask a Question

Ask a specific question about this device

K Number

K040209

Device Name

Manufacturer

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

Date Cleared

2004-09-20

(234 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K020374

Predicate For

K032676,K072643,K081623

Intended Use

The IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cvclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810 laser systems.

Condition	Treatment
Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy	Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments
Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma(recalcitrant/uncontrolled)	Laser Trabeculoplasty; Iridotomy;Transscleral Cyclophotocoagulation(TSCPC)
Retinal Tears, Detachments, and Holes	Transscleral Retinal Photocoagulation(TSRPC); Focal and Grid LaserTreatments
Lattice Degeneration	PRP; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD)with Choroidal Neovascularization (CNV)	Focal and Grid Laser Treatments
Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma	Focal and Grid Laser Treatments
Retinopathy of Prematurity	PRP; TSRPC; Focal and Grid LaserTreatments
Sub-Retinal (choroidal) Neovascularization	Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion	PRP; Focal and Grid Laser Treatments

Device Description

The IQ 810 is a semiconductor diode laser system that delivers infrared 810 nm laser light intended to be used for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the IRIS Medical® IQ 810 Diode Laser. This type of document establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

No acceptance criteria table or reported device performance is present.
No sample sizes for test sets, data provenance, or details about the ground truth establishment for a study are provided. This is because no such study is described.
No information on experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is included.
No training set details are mentioned.

The document states:

"Non-Clinical performance Data: None"
"Clinical performance Data: None"

The substantial equivalence determination is based on the device's technological characteristics and its intended use being similar to predicate devices, namely the IRIDEX Corporation's IRIS Medical OcuLight SLx Laser Photocoagulator (K020374). The letter concludes that the IQ 810 is "substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy."

Ask a Question

Ask a specific question about this device

K Number

K031665

Device Name

Manufacturer

FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES

Date Cleared

2003-08-27

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K960971,K982031,K020374,K022327,K962592

Predicate For

K062074,K062624,K111460

Intended Use

The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.

Condition	Treatment
Diabetic Retinopathy	Retinal Photocoagulation (RPC); Focaland Grid Laser Treatments
• Nonproliferative Retinopathy
• Macular Edema
• Proliferative Retinopathy
Glaucoma	Laser Trabeculoplasty; Iridotomy,Iridoplasty
• Primary Open Angle
• Closed Angle
• Refractory Glaucoma
Retinal Tears and Detachments	RPC; Focal and Grid Laser Treatments
Lattice Degeneration	RPC; Focal and Grid Laser Treatments
Age-related Macular Degeneration (AMD)	RPC; Focal and Grid Laser Treatments
Intra-Ocular Tumors	RPC; Focal and Grid Laser Treatments
• Choroidal Hemangioma
• Choroidal Melanoma
• Retinoblastoma
Retinopathy of Prematurity	RPC; Focal and Grid Laser Treatments
Sub-Retinal (choroidal) Neovascularization	RPC; Focal and Grid Laser Treatments
Central and Branch Retinal Vein Occlusion	RPC; Focal and Grid Laser Treatments
Dermatology	Focal Laser Treatments
• Pigmented Skin Lesions
• Vascular lesions
Ear, Nose and Throat	Stapedotomy
• Otosclerotic hearing loss

Device Description

AI/ML Overview

The IRIS Medical® OcuLight® GL/GLx device is a laser system indicated for various medical treatments, primarily in ophthalmology (retinal photocoagulation, laser trabeculoplasty) and also for vascular/pigmented skin lesions and other laser treatments.

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance & 3. Number and Qualifications of Experts & 4. Adjudication Method & 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study & 6. Standalone Performance & 7. Type of Ground Truth & 8. Sample Size for Training Set & 9. How Ground Truth for Training Set was Established

Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through substantial equivalence to predicate devices, rather than through specific performance metrics from a clinical study on the OcuLight GL/GLx itself.

The document explicitly states:

"Non-Clinical performance Data: None"
"Clinical performance Data: None"

Therefore, the following information cannot be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the OcuLight GL/GLx within this document. The "acceptance criteria" presented here are implicitly the FDA's determination of substantial equivalence based on the device's technological characteristics and intended use being similar to legally marketed predicate devices.
Sample Size Used for the Test Set and Data Provenance: No test set or associated data is described.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as no ground truth establishment for a test set is described.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or referenced.
Standalone Performance: No standalone performance data (algorithm-only) is presented as this is a physical laser device, not an AI or algorithmic diagnostic tool.
Type of Ground Truth Used: Not applicable, as no external ground truth was established for the device's performance in this filing.
Sample Size for the Training Set: Not applicable as this is not an AI/ML device that requires a training set in the conventional sense.
How the Ground Truth for the Training Set was Established: Not applicable.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" that proves the OcuLight GL/GLx meets the acceptance criteria of the FDA is the application for 510(k) Pre-market Notification, demonstrating Substantial Equivalence (SE) to legally marketed predicate devices.

Predicate Devices asserted by IRIDEX Corporation:

IRIDEX Corporation's IRIS Medical OcuLight GL Laser (K960971 and K982031)
IRIDEX Corporation's IRIS Medical OcuLight SL/SLx Laser (K020374)
Lumenis Novus Spectra (K022327)
Alcon Ophthalas® 532 Laser (K962592)

Reasoning for Substantial Equivalence (as described in the document):

Intended Use: The OcuLight GL/GLx shares the same intended uses as the predicate devices, including retinal photocoagulation, laser trabeculoplasty, treatment of vascular and pigmented skin lesions, and other laser treatments. The document lists numerous specific conditions and treatments, implicitly asserting that these are within the scope of the predicate devices.
Technological Characteristics:
- The OcuLight GL/GLx is described as a "semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments."
- The document explicitly states that "The expansion of the indications for use for the proposed OcuLight does not result in a change to the hardware or firmware for the currently marketed OcuLight GL/GLx." This implies the underlying technology is consistent with previous versions.
- Comparisons to specific predicates highlight shared characteristics:
  - Lumenis Novus Spectra: "delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." (Note: there seems to be a minor inconsistency here, as OcuLight GL/GLx is described as 532 nm green laser by IRIDEX, and Lumenis Novus Spectra delivers "infrared wavelength" in this comparison. This might suggest the comparison is more general, or a slight error in wording in the summary provided for the Lumenis device description).
  - Alcon Ophthalas 532 Laser: "delivers a similar wavelength [532 nm], pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx." Both use a variety of delivery systems like slit lamps, indirect ophthalmoscopes, and endoprobe handpieces.
  - IRIS Medical OcuLight SL/SLx Laser: Indicated for similar ophthalmic treatments, but uses an 810 nm diode laser. This comparison points to the similarity in intended use for ophthalmic applications, even with a different wavelength for some predicate devices cited.

In conclusion, the 'study' demonstrating the device meets "acceptance criteria" (defined as substantial equivalence to legally marketed devices) is the submission of a 510(k) premarket notification. This notification asserts and provides evidence for the device's similarity in intended use and technological characteristics to existing devices, without presenting new clinical or non-clinical performance data for the OcuLight GL/GLx itself. The FDA reviewed this submission and determined the device was substantially equivalent.

Ask a Question

Ask a specific question about this device

K Number

K022228

Device Name

Manufacturer

Date Cleared

2002-10-08

(90 days)

Product Code

Regulation Number

Type

Panel

APEX 800 LASER SYSTEM, MODEL APEX 800

Reference & Predicate Devices

K020374,K962592,K931784,K925663,K921488,K946135

Predicate For

K133019

Intended Use

The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

Device Description

The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.

AI/ML Overview

This 510(k) premarket notification for the IRIS Medical® EndoProbe® Handpieces does not describe a study that uses acceptance criteria and reports device performance.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their device is as safe and effective as existing legally marketed devices, primarily by comparing their intended use, materials, and performance characteristics to those predicates.

Therefore, I cannot provide the requested information about acceptance criteria, a performance study, sample sizes, ground truth, or MRMC studies, as these elements are not presented in this 510(k) summary.

The document states: "The family of IRIS Medical EndoProbe handpieces shares similar indications for use, materials, and similar performance characteristics as, and thus is substantially equivalent to, the currently marketed predicate devices." This is the core argument for clearance, rather than presenting a performance study against specific acceptance criteria.

Ask a Question

Ask a specific question about this device

K Number

K020849

Device Name

Manufacturer

Date Cleared

2002-05-20

(66 days)

Product Code

Regulation Number

Type

Panel