K Number
K121475
Device Name
TXCELL SCANNING LASER DELIVERY SYSTEM
Manufacturer
Date Cleared
2012-11-28

(194 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When the TxCell Scanning Laser Delivery System is connected to the IQ 532 (532 nm), the IQ 577 (577 nm) or the IQ 810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye. 532 nm: 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) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma. 577 nm: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy; Choroidal neovascularization; Branch retinal vein occlusion; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Retinal tears and detachments; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma. 810 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including: Retinal photocoagulation for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy; Retinal tears, detachments and hole; Lattice degeneration; Age-related macular degeneration (AMD) with choroidal neovascularization (CNV); Sub-retinal (choroidal) neovascularization; Central and branch retinal vein occlusion; Laser trabeculoplasty for the treatment of: Primary open angle glaucoma; Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma.
Device Description
The TxCell™ Scanning Laser Delivery System is a slit lamp adapter laser delivery system which is installed by the customer on existing slit lamps in their office or clinic and is used by ophthalmologists to deliver laser energy to various ocular targets. The TxCell™ delivery system delivers laser applications in both single spot mode and multi-spot mode. The TxCell™ Scanning Laser Delivery System adds the use of multi-spot pattern scanning technology when coupling with commercially available IRIDEX laser systems. This offers existing IRIDEX laser systems the ability to deliver, in addition to standard single spot applications, a full spectrum of multi-spot pattern scanning options through a variety of customer owned slit lamps. The TxCell™ Scanning Laser Delivery System consists of the following system components: TxCell™ Scanning Slit Lamp Adapter (SSLA) that may be coupled to Zeiss-style or Haag Streit-style slit lamps or the IRIDEX Laser Workstations. TxCell™ Control Box with power supply, scanner controller, drive electronics and electrical connections. The Control Box is paired with an SSLA. Cables to connect the SSLA to the Control Box and the Control Box to the laser console. The TxCell Scanning Laser Delivery System requires connection to a TxCell compatible Laser Console from the IRIDEX Family of IQ Laser Systems (IQ 532, IQ 577, IQ 810). The touchscreen on the TxCell compatible IQ Family Laser Console accesses a Pattern Selection Screen and the knobs on the Laser Console set the pattern parameters. All other user interface screens and menus are unchanged and operate the same as on the standard IQ Family Laser Console.
More Information

Not Found

No
The summary describes a laser delivery system with multi-spot pattern scanning technology, but there is no mention of AI or ML being used for image processing, diagnosis, treatment planning, or any other function. The performance studies focus on laser output consistency, not algorithmic performance.

Yes
The device is clearly indicated for the "treatment of ocular pathology" and specifically lists numerous conditions it treats, such as diabetic retinopathy and glaucoma. This falls under the definition of a therapeutic device designed to treat medical conditions.

No
The device is described as a laser delivery system for treating ocular pathology, not for diagnosing it. It delivers laser energy for therapeutic procedures, such as retinal photocoagulation and laser trabeculoplasty, indicating a treatment function.

No

The device description clearly outlines multiple hardware components including a Slit Lamp Adapter, Control Box, and cables, in addition to requiring connection to existing laser consoles. While it includes software for pattern selection and control, it is not solely software.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.
  • Device Function: The TxCell Scanning Laser Delivery System is a laser delivery system used by ophthalmologists to deliver laser energy directly to the eye for the treatment of various ocular pathologies. It is a therapeutic device, not a diagnostic one.
  • Intended Use: The intended use clearly states it is for the treatment of ocular pathology. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
  • Device Description: The description details a system that delivers laser energy to the eye via a slit lamp adapter. This is a direct intervention on the patient, not an in vitro test.

Therefore, the TxCell Scanning Laser Delivery System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

When the TxCell Scanning Laser Delivery System is connected to the IQ 532 (532 nm), the IQ 577 (577 nm) or the IQ 810 (810 nm) Laser Console, from the IRIDEX Family of IQ Laser Systems and used to deliver laser energy in CW-Pulse, MicroPulse or LongPulse mode, it is intended to be used by a trained ophthalmologist for the treatment of ocular pathology of both the anterior and posterior segments of the eye.
532 nm: 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 Aqe-related macular degeneration (AMD) with choroidal neovascularization (CNV) Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion - Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma
577 nm: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation of vascular and structure abnormalities of the retina and choroid including: Proliferative and nonproliferative diabetic retinopathy Choroidal neovascularization Branch retinal vein occlusion Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Retinal tears and detachments Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma
810 nm: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy including: Retinal photocoagulation for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal tears, detachments and hole Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion Laser trabeculoplasty for the treatment of: Primary open angle glaucoma Laser iridotomy, iridoplasty for the treatment of: Angle closure glaucoma

Product codes

GEX

Device Description

The TxCell™ Scanning Laser Delivery System is a slit lamp adapter laser delivery system which is installed by the customer on existing slit lamps in their office or clinic and is used by ophthalmologists to deliver laser energy to various ocular targets. The TxCell™ delivery system delivers laser applications in both single spot mode and multi-spot mode. The TxCell™ Scanning Laser Delivery System adds the use of multi-spot pattern scanning technology when coupling with commercially available IRIDEX laser systems. This offers existing IRIDEX laser systems the ability to deliver, in addition to standard single spot applications, a full spectrum of multi-spot pattern scanning options through a variety of customer owned slit lamps. The TxCell™ Scanning Laser Delivery System consists of the following system components: - TxCell™ Scanning Slit Lamp Adapter (SSLA) that may be coupled to Zeiss-style 1. or Haag Streit-style slit lamps or the IRIDEX Laser Workstations. - TxCell™ Control Box with power supply, scanner controller, drive electronics and 2. electrical connections. The Control Box is paired with an SSLA. - . 3. Cables to connect the SSLA to the Control Box and the Control Box to the laser console. The TxCell Scanning Laser Delivery System requires connection to a TxCell compatible Laser Console from the IRIDEX Family of IQ Laser Systems (IQ 532, IQ 577, IQ 810). The touchscreen on the TxCell compatible IQ Family Laser Console accesses a Pattern Selection Screen and the knobs on the Laser Console set the pattern parameters. All other user interface screens and menus are unchanged and operate the same as on the standard IQ Family Laser Console.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior and posterior segments of the eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained ophthalmologist

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)

Bench testing was performed to compare the laser output variations of single spot and multispot scanned applications using the TxCell Scanning Laser Delivery System and a compatible Laser Console. Variations in continuous wave and MicroPulse laser applications were also assessed for both single spot and multi-spot delivery. Results showed that the laser system controls pulse to pulse power variations for both single spot and multi-spot scanning modes to better than 0.5%; and that the duration variability for both single spot and multi-spot scanning modes was less than 0.25%. The test confirmed that the output energy from the TxCell Scanning Laser Delivery System was consistently delivered in both single spot and multi-spot modes while delivering either continuous wave or MicroPulse laser applications. Pulse to pulse variations are controlled by the laser console and are independent of spatial positioning due to changes in spot location by the scanner.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pulse to pulse power variations for both single spot and multi-spot scanning modes to better than 0.5%; and that the duration variability for both single spot and multi-spot scanning modes was less than 0.25%.

Predicate Device(s)

K071687, K100678, K111108

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K121475

510(k) Summary Section 5: TxCell™ Scanning Laser Delivery System

NOV 2 8 2012

Trade Name A.

TxCellTM Scanning Laser Delivery System

B. Common Name

Scanning Photocoagulator Slit Lamp Adapter Delivery System

C. Device Classification

Laser Instrument, Surgical, Powered (21CFR 878.4810)

D. Product Code:

GEX

E. Establishment Registration Number

2939653

Manufacturer's Identification F.

IRIDEX Corporation 1212 Terra Bella Ave. Mountain View, CA 94043-1824 (650) -962-8848 Ext. 8872 (650) 940-4710 (FAX)

Official Correspondent

Paul Hardiman Vice President Regulatory Affairs/Quality Assurance phardiman@iridex.com

G. Performance Standards

Bench testing was performed to compare the laser output variations of single spot and multispot scanned applications using the TxCell Scanning Laser Delivery System and a compatible Laser Console. Variations in continuous wave and MicroPulse laser applications were also assessed for both single spot and multi-spot delivery. Results showed that the laser system controls pulse to pulse power variations for both single spot and multi-spot scanning modes to better than 0.5%; and that the duration variability for both single spot and multi-spot scanning modes was less than 0.25%. The test confirmed that the output energy from the TxCell Scanning Laser Delivery System was consistently delivered in both single spot and multi-spot modes while delivering either continuous wave or MicroPulse laser applications. Pulse to pulse variations are controlled by the laser console and are independent of spatial positioning due to changes in spot location by the scanner.

IRIDEX Corporation 510(k) Submission for: TxCell Scanning Laser Delivery System

Section 5: 510(k) Summary - Page 5-1

1

H. Predicate Devices:

Family of IRIDEX IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) (K071687) Quantel SUPRA SCANTM Delivery System (K100678) Topcon PASCAL Streamline 577 (K111108)

I. Product Description:

'

The TxCell™ Scanning Laser Delivery System is a slit lamp adapter laser delivery system which is installed by the customer on existing slit lamps in their office or clinic and is used by ophthalmologists to deliver laser energy to various ocular targets. The TxCell™ delivery system delivers laser applications in both single spot mode and multi-spot mode.

The TxCell™ Scanning Laser Delivery System adds the use of multi-spot pattern scanning technology when coupling with commercially available IRIDEX laser systems. This offers existing IRIDEX laser systems the ability to deliver, in addition to standard single spot applications, a full spectrum of multi-spot pattern scanning options through a variety of customer owned slit lamps.

The TxCell™ Scanning Laser Delivery System consists of the following system components:

  • TxCell™ Scanning Slit Lamp Adapter (SSLA) that may be coupled to Zeiss-style 1. or Haag Streit-style slit lamps or the IRIDEX Laser Workstations.
  • TxCell™ Control Box with power supply, scanner controller, drive electronics and 2. electrical connections. The Control Box is paired with an SSLA.
  • . 3. Cables to connect the SSLA to the Control Box and the Control Box to the laser console.

The TxCell Scanning Laser Delivery System requires connection to a TxCell compatible Laser Console from the IRIDEX Family of IQ Laser Systems (IQ 532, IQ 577, IQ 810). The touchscreen on the TxCell compatible IQ Family Laser Console accesses a Pattern Selection Screen and the knobs on the Laser Console set the pattern parameters. All other user interface screens and menus are unchanged and operate the same as on the standard IQ Family Laser Console.

IRIDEX Corporation 510(k) Submission for: TxCell Scanning Laser Delivery System

Section 5: 510(k) Summary - Page 5-2

2

Summary of Technological Characteristics દ્વાન

The technological characteristics of the TxCell Scanning Laser Delivery System when coupling with commercially available IRIDEX laser systems (IQ 532, IQ 577 & IQ 810) are substantially equivalent to those of the predicate devices.

| Manufacturer | IRIDEX Corporation | IRIDEX Corporation | QUANTEL MEDICAL | TOPCON
Corporation |
|---------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Device
Description | TxCellTM
Scanning Laser Delivery
System w/ IQ Family Laser
(IQ 532, IQ 577, IQ 810) | EasyFitTM
Slit Lamp Adapter
w/ IQ Family Laser
(IQ 532, IQ 577, IQ 810) | SUPRA SCANTM
Delivery System
w/ SUPRA 532 | PASCAL® Streamline
577 |
| 510 (k) Number | K121475 | K071687 | K100678 | K111108 |
| Treatment Laser
Wavelengths | 532 nm,577 nm, 810 nm | 532 nm,577 nm,810 nm | 532 nm | 577 nm |
| Treatment Laser
Sources | Frequency doubled solid-state
(532 nm, 577 nm) and direct
diode (810 nm) | Frequency doubled solid-
state (532 nm, 577 nm) and
direct diode (810 nm) | Frequency doubled solid-
state | Frequency doubled
solid-state |
| Treatment Laser
Power | Up to 2 W | Up to 5 W | Up to 2 W | Up to 2 W |
| Duty Cycle | Variable | Variable | Not reported | 100% |
| Repetition Mode | Available with single spot
mode only | Available with single spot
mode only | Not reported | Available with single
spot mode only |
| Aiming Beam λ
(power output) | 635 nm; Direct diode
(adjustable to