(86 days)
No
The summary describes a laser surgical instrument for ophthalmology and does not mention any AI or ML capabilities.
Yes
The device is described as a surgical laser instrument used to perform procedures like iridotomy, posterior capsulotomy, posterior membranectomy, and Selective Laser Trabeculoplasty (SLT), which directly treat and manage medical conditions (glaucoma, opacities) in patients.
No
The device is described as a surgical laser instrument used for therapeutic procedures like iridotomy, posterior capsulotomy, and Selective Laser Trabeculoplasty (SLT), not for disease detection or diagnosis.
No
The device description explicitly lists multiple hardware components including a Delivery Head, Microscope, Slit lamp Illumination, Console, Table Top, Joystick fire button, Total solution table, and Display unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "slit lamp based surgical laser instrument" used by ophthalmologists to perform procedures directly on the patient's eye (e.g., iridotomy, capsulotomy, trabeculoplasty). It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use is for surgical procedures, not for analyzing biological samples for diagnostic purposes.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo):
-Iridotomy and iridectomy.
-Posterior capsulotomy.
-Posterior membranectomy.
In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)
Product codes (comma separated list FDA assigned to the subject device)
HOF
Device Description
These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.
There are 3 models in this device family and their differentiating characteristics are mentioned below:
| Models | Treatment beam/ mode | Aiming beam | Illumination mirror | Offset | Display on binocular | Energy control on joystick |
|---|---|---|---|---|---|---|
| Tango Neo | YAG (1064nm) | Red ,635nm | Fixed | 0 ± 500μ (anterior and posterior) | N/A | N/A |
| SLT (532 nm) | Red ,635nm | N/A | ||||
| Tango Reflex Neo | YAG (1064nm) | Green, 515nm | Reflex Coaxial | 0 to 500μ (anterior), 0 to 2mm (posterior) | Display of treatment energy | Adjusts laser energy |
| SLT (532 nm) | Red ,635nm | N/A | ||||
| Ultra Q Reflex Neo | YAG (1064nm) | Green, 515nm | Reflex Coaxial | 0 to 500μ (anterior), 0 to 2mm (posterior) | Display of treatment energy | Adjusts laser energy |
All these devices consist of the below main parts:
Delivery Head
The delivery head comprises an ophthalmic slit lamp microscope with an integrated treatment laser beam and a twin aiming laser beam system.
Microscope and Slit lamp Illumination
The microscope or biomicroscope comprises three main components, an objective lens, a magnification changer, and a binocular. The combination of these allows the physician to view into the patient's eye. The magnification changer allows for magnification adjustment between fixed magnification settings. The binocular can be adjusted to accommodate the physician's vision and pupillary distance. The right eye piece of the binocular for the Reflex Neo additionally includes the display of the treatment energy .The objective lens is fixed and determines the microscope focal distance. Microscope illumination light is provided from the slit lamp through a halogen or LED lamp. An illumination mirror is located above the slit lamp, near the microscope's visual axis. The mirror reflects the illumination from the source towards the focal plane and patient's eye. While the illumination mirror is fixed for Tango Neo, the mirror for Tango Reflex Neo and Ultra Q Reflex Neo is a flipping mirror as in the predicate Tango , Tango Reflex and Ultra Q Reflex devices respectively.
Console and Table Top: It consists of the Patient handles, the Key switch, Emergency stop switch and the Laser on-off push button. Main components such as a Power Supply Unit (DC PSU), a Y AG PSU, and voltage capacitors for initiating the laser beam generation are built inside the console.
Joystick fire button: It is used to trigger the emission of a laser pulse by pressing a button. The Reflex Neo additionally include the energy setting control on the joystick.
Total solution table: It is used to support the console and the tabletop. It also has the function to adjust the height of the tabletop.
Display unit: The operation of various functions is displayed on the tablet and the display unit controls and operates them.
The tablet interface provides the control for Patient Management system (PMS) database connection (DICOM compatibility) to facilitate export of treatment report to a network location and patient list viewing. The interface also provides control to initiate remote (restricted) access for service diagnosis of device faults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists in clinics or an outpatient facility in a hospital or surgery.
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)
The device has been evaluated for biocompatibility, as well as electrical, electromagnetic and laser safety, and has been found to conform to the applicable medical device safety standards. Electrical safety, EMC and laser safety tests were conducted on Ellex YAG/SLT, according to applicable federal and international safety and performance standards:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements for basic . safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for • safety-Collateral Standard Usability
- IEC 60601-1-8: 2006 (2nd Ed) + A1:2012 Medical electrical equipment Part 1-8: Collateral . Standard: General requirements, tests and guidance on alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-22: 2007 (Third Edition) + A1:2012 Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 2nd Edition Part I: Safety of laser products-Part I: Equipment classification and . requirements
Biocompatibility Testing: There are no direct patient components in Ellex Neo Lasers except for the chin rest and the head rest components of the slit lamp. These can be classified as "surface contacting devices in contact with intact skin" and as devices whose cumulative single, multiple or repeated use or contact is up to 24 hours. The Ellex slit lamps have been previously cleared by their manufacturers. The Takagi slit lamp has been FDA 510(k) cleared under K063352 and the CSO slit lamp under K992836.
Software Verification and Validation Testing: According to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)", the level of concern of Ellex Neo devices and its software is determined to be Major. The Software of these devices controls the delivery of laser energy. A failure of operation or latent flaw of these devices' software could directly result in serious injury to the patient or operator. The software verification and validation results confirm the fulfillment of software requirement specifications.
Risk Analysis Method Used: Ellex Medical Pty Ltd applied ISO-14971 to the design and development of the Ellex Neo Lasers. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 2, 2022
Ellex Medical Pty Ltd % Maureen OConnell President OConnell Regulatory Consultants, Inc. 44 Oak Street Stoneham, Massachusetts 02180
Re: K222395
Trade/Device Name: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: August 3, 2022 Received: August 8, 2022
Dear Maureen O`Connell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain -S
Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222395
Device Name
Ellex Neo Lasers (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo)
Indications for Use (Describe) In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.
In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)
| 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)
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3
510(k) Summary 21 CFR 807.92 K22395
I. Submitter
Ellex Medical Pty Ltd.
3-4 Second Avenue, Mawson Lakes, South Australia 5095,
AUSTRALIA
Contact Person: Rashmi Pillay
Telephone: 61 8 70748105
Email: rpillay@ellex.com
Date of preparation: 09/22/2022
II. Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: (978) 207-1245
III. Proposed Device
Trade Name: Ellex Neo Lasers (Tango Neo/Tango Reflex Neo /Ultra Q Reflex Neo)
Manufacturer: Ellex Medical Pty Ltd
Common or Usual Name: Ophthalmic laser
Classification:
| Class | Product
Code | Device
Classification
Name | Regulation
Number | Regulation Name | Reviewing
Branch |
|-------|-----------------|----------------------------------|----------------------|------------------|---------------------|
| II | HQF | Laser,
Ophthalmic | 21CFR
886.4390 | Ophthalmic Laser | Ophthalmic |
4
IV. Legally marketed Device /Predicate Device
Device name: Ellex YAG/SLT (Tango/Tango Reflex/Ultra Q/Ultra Reflex/Solo) Premarket Notification: K212630 Manufacturer: Ellex Medical Pty Ltd
V. Device Technological characteristics
These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.
There are 3 models in this device family and their differentiating characteristics are mentioned below:
| Models | Treatment
beam/ mode | Aiming
beam | Illumination
mirror | Offset | Display on
binocular | Energy
control on
joystick |
|--------------------------|-------------------------|----------------|------------------------|-----------------------------------------------------|-----------------------------------|----------------------------------|
| Tango
Neo | YAG
(1064nm) | Red ,635nm | Fixed | 0 ± 500μ
(anterior and
posterior) | N/A | N/A |
| | SLT (532 nm) | Red ,635nm | | N/A | | |
| Tango
Reflex
Neo | YAG
(1064nm) | Green, 515nm | Reflex
Coaxial | 0 to 500μ
(anterior),
0 to 2mm
(posterior) | Display of
treatment
energy | Adjusts laser
energy |
| | SLT (532 nm) | Red ,635nm | | N/A | | |
| Ultra Q
Reflex
Neo | YAG
(1064nm) | Green, 515nm | Reflex
Coaxial | 0 to 500μ
(anterior),
0 to 2mm
(posterior) | Display of
treatment
energy | Adjusts laser
energy |
All these devices consist of the below main parts:
Delivery Head
The delivery head comprises an ophthalmic slit lamp microscope with an integrated treatment laser beam and a twin aiming laser beam system.
5
Microscope and Slit lamp Illumination
The microscope or biomicroscope comprises three main components, an objective lens, a magnification changer, and a binocular. The combination of these allows the physician to view into the patient's eye. The magnification changer allows for magnification adjustment between fixed magnification settings. The binocular can be adjusted to accommodate the physician's vision and pupillary distance. The right eye piece of the binocular for the Reflex Neo additionally includes the display of the treatment energy .The objective lens is fixed and determines the microscope focal distance. Microscope illumination light is provided from the slit lamp through a halogen or LED lamp. An illumination mirror is located above the slit lamp, near the microscope's visual axis. The mirror reflects the illumination from the source towards the focal plane and patient's eye. While the illumination mirror is fixed for Tango Neo, the mirror for Tango Reflex Neo and Ultra Q Reflex Neo is a flipping mirror as in the predicate Tango , Tango Reflex and Ultra Q Reflex devices respectively.
Console and Table Top: It consists of the Patient handles, the Key switch, Emergency stop switch and the Laser on-off push button. Main components such as a Power Supply Unit (DC PSU), a Y AG PSU, and voltage capacitors for initiating the laser beam generation are built inside the console.
Joystick fire button: It is used to trigger the emission of a laser pulse by pressing a button. The Reflex Neo additionally include the energy setting control on the joystick.
Total solution table: It is used to support the console and the tabletop. It also has the function to adjust the height of the tabletop.
Display unit: The operation of various functions is displayed on the tablet and the display unit controls and operates them.
The tablet interface provides the control for Patient Management system (PMS) database connection (DICOM compatibility) to facilitate export of treatment report to a network location and patient list viewing. The interface also provides control to initiate remote (restricted) access for service diagnosis of device faults.
6
VI. Principle of Operation
The Ellex Neo Lasers are surgical laser instruments designed for use by ophthalmologists for performing both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies and Selective Laser Trabeculoplasty (SLT) for the treatment of chronic open angle glaucoma. The instrument is capable of producing short, individual pulses of focused light with wavelengths of either 1064nm (YAG) or 532nm (SLT), depending on the mode of operation selected. The pulses can be accurately positioned on a structure within the patient's eye with the aid of a slit-lamp microscope and a 635nm (red) / 515 nm (green) aiming beam system.
When the YAG mode is selected, the treatment wavelength is 1064mm. A twin-aiming beam is used to position the treatment beam into the area where the tissue disruption process is to occur. The energy contained within a single short pulse is concentrated by focusing to a very small spot size (approximately 8 microns) so that plasma formation occurs at the focal point. This creates an acoustic shock wave that disrupts nearby tissue.
When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam is used to position the treatment beam onto the trabecular meshwork via an SLT gonioscope contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that selectively targets and damages only the pigmented cells in the trabecular meshwork of the resulting cellular activity restores the aqueous outflow through the trabecular meshwork and lowers the intraocular pressure.
VII. Indications for Use
In the YAG mode (Tango Neo, Ultra Q Reflex Neo, Tango Reflex Neo):
-Iridotomy and iridectomy.
-Posterior capsulotomy.
-Posterior membranectomy
In the SLT mode (Tango Neo, Tango Reflex Neo): -Selective Laser Trabeculoplasty (SLT)
7
VIII. Summary of Non-Clinical Tests
The device has been evaluated for biocompatibility, as well as electrical, electromagnetic and laser safety, and has been found to conform to the applicable medical device safety standards as below:
Safety and Product Specific testing: ●
Electrical safety, EMC and laser safety tests were conducted on Ellex YAG/SLT, according to applicable federal and international safety and performance standards:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements for basic . safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for • safety-Collateral Standard Usability
- IEC 60601-1-8: 2006 (2nd Ed) + A1:2012 Medical electrical equipment Part 1-8: Collateral . Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-22: 2007 (Third Edition) + A1:2012 Medical Electrical Equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 2nd Edition Part I: Safety of laser products-Part I: Equipment classification and . requirements
Biocompatibility Testing ●
There are no direct patient components in Ellex Neo Lasers except for the chin rest and the head rest components of the slit lamp. These can be classified as "surface contacting devices in contact with intact skin" and as devices whose cumulative single, multiple or repeated use or contact is up to 24 hours. The Ellex slit lamps have been previously cleared by their manufacturers. The Takagi slit lamp has been FDA
510(k) Summary
8
cleared under K063352 and the CSO slit lamp under K992836.
Software Verification and Validation Testing
According to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)", the level of concern of Ellex Neo devices and its software is determined to be Major. The Software of these devices controls the delivery of laser energy. A failure of operation or latent flaw of these devices' software could directly result in serious injury to the patient or operator. The software verification and validation results confirm the fulfillment of software requirement specifications.
Risk Analysis Method Used ●
Ellex Medical Pty Ltd applied ISO-14971 to the design and development of the Ellex Neo Lasers. The conclusion from the risk analysis was the device was safe for its intended use and does not pose any unacceptable risks.
IX. Summary of Clinical Tests
Since the Ellex Neo devices use the same technology and principles as the predicate device, clinical data is not required.
X. Substantial Equivalence Discussion
The predicate device is the Ellex YAG/SLT cleared in K212630.
The Indications for Use for Ellex Neo Lasers are exactly the same, as the predicate Ellex YAG/SLT. Technological characteristics of the Ellex Neo Lasers are similar with respect to the basic design and function of the predicate device. Both the subject and predicate device are based on the same photo disruption and selective photothermolysis principles. The major technological aspects are in common between the predicate Ellex YAG/SLT device and the Ellex Neo Lasers:
- Same wavelength, laser class, pulse duration, energy, pulse setting , repetition rate, spot . size for the treatment beam.
- Same beam safety class, wavelength, and power for the aiming beams. ●
- Same slit lamp microscope, magnification settings, slit lamp working length, slit lamp .
9
controls, illumination mirror, chinrest and controls, slit lamp joystick and laser firing mechanism (fire switch).
-
. The systems have been designed in compliance with approved electrical and physical safety standards.
There are some technological /usability advancements with respect to user preferences for: -
. Enhanced offset, additional display in the right binocular, energy control on the joystick, for the Reflex Neo devices.
-
. Reflex Coaxial illumination mirror positioning, below optical axis in SLT mode for the Tango Reflex Neo.
-
DICOM facilitating Physician worklist viewing and remote access for system fault . diagnosis.
In terms of the required treatment regimen, these are prescription devices and under the control of trained ophthalmologist; none of these modifications have any impact on safety and effectiveness of the product.
These modifications have been verified through the Non-Clinical testing mentioned above.
XI. Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing. the subject Ellex Neo Lasers met the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to its predicate Ellex YAG/SLT device.