PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Device Facts
| Record ID | K170409 |
|---|---|
| Device Name | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System |
| Applicant | Topcon Medical Laser Systems, Inc. (Tmls) |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Sep 12, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
Device Story
Ophthalmic scanning laser system for photocoagulation; delivers laser energy to retina, choroid, iris, or trabecular meshwork. System utilizes 577 nm (yellow) and 638 nm (red) laser wavelengths. Physician operates system via slit lamp biomicroscope or indirect ophthalmoscope. Provides single-spot or selectable pattern-scanning delivery to enhance efficiency and reduce patient discomfort. Output is laser energy; healthcare provider uses visual feedback through microscope to guide treatment. Benefits include precise retinal/anterior segment photocoagulation for eye disease management.
Clinical Evidence
No clinical data. Evidence consists of bench performance testing and an in vivo animal study (rabbit retina) comparing the 638 nm red laser to the reference predicate. Study evaluated lesion morphology via ophthalmoscopy, fundus photos, and SD-OCT; results showed <20% difference in lesion width, supporting equivalence.
Technological Characteristics
Laser surgical instrument; Class II. Wavelengths: 577 nm (OPSL) and 638 nm (Diode). Top hat intensity profile. Spot diameter: 50-400 μm (577 nm), 60/200 μm (638 nm). Scan field: 4 mm x 4 mm. Aiming laser: 670 nm diode. Compliance: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-2-22, IEC 60825-1.
Indications for Use
Indicated for patients requiring photocoagulation in the posterior segment (retina, choroid) or anterior segment (iris, trabecular meshwork) of the eye. Includes single-spot and pattern-scanning delivery for non-macular retina.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2017
Topcon Medical Laser Systems, Inc. % Pamela Buckman. MSN Regulatory Consultant 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523
Re: K170409
Trade/Device Name: PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, HQF Dated: August 4, 2017 Received: August 7, 2017
Dear Pamela Buckman:
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.
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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,
# Denise L. Hampton -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
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# Indications for Use
510(k) Number (if known) K170409
Device Name
PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System
Indications for Use (Describe)
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(K) SUMMARY
#### K170409
#### 1. General Information
Submission
- Sponsor: Topcon Medical Laser Systems, Inc. 606 Enterprise Court Livermore CA- 94550 USA T 925 245 8300 F 925 245 7723 Contact Person: Sweta Srivastava
Submission Correspondent:
Pamela M. Buckman, MSN 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 T 925 980 7007 F 925 705 7381
Date Prepared: September 1, 2017
#### 2. Device Identification
| Device Name: | PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning<br>Laser System |
|-------------------------------|--------------------------------------------------------------------------------------------------------|
| Classification Name: | Laser Surgical Instrument for use in General and Plastic<br>Surgery and Dermatology; Laser, Ophthalmic |
| Classification<br>Regulation: | 21 CFR 878.4810<br>21 CFR 886.4390 |
| Classification Panel: | Ophthalmology/General and Plastic Surgery |
| Product Code: | GEX, HQF |
| Device Class: | Class II |
#### 3. Predicate Devices
Primary Predicate Device
PASCAL® Synthesis™Ophthalmic Scanning Laser System (K123542)
Reference Predicate Device
NOVUS Multiwavelength Omni (K932468)
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#### 4. Device Description
PASCAL® Synthesis™ TwinStar™ is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. At the physician's discretion, the system provides for a single laser spot treatment or the option of using a selectable pattern of delivering multiple laser spots simultaneously. Pattern scanning allows the physician to enhanced efficiency and reduced patient discomfort.
The PASCAL Synthesis™ Laser System (parent product to the PASCAL Synthesis Twinstar™) included 532 nm/577 nm wavelengths and was cleared via K123542. The subject device for this submission is a line extension named PASCAL Synthesis Twinstar and will include 577 nm/638 nm laser wavelengths.
### 5. Intended Use
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Singlespot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.
## 6. Comparison of Technological Characteristics
The technological characteristics of PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System are substantially equivalent to those of the Primary predicate and the Reference predicate devices.
The Pascal Synthesis Twinstar that is the subject of k170409 is a modification of Pascal Synthesis (primary predicate) with an added option of red treatment wavelength. Pascal Synthesis Twinstar is a combination wavelength device that offers two treatment wavelengths, i.e., 577nm and 638 nm.
Using red laser for the treatment of eye disease, the Pascal Synthesis Twinstar uses 638 nm red laser to perform single-spot photocoagulation. The Novus Multiwavelength (reference predicate) has been cleared for the use of similar red laser wavelength (647 nm) for the treatment of eye disease.
The following Table compares the technological characteristics of the Pascal Synthesis Twinstar to the Primary Predicate as well as the Reference Predicate.
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| ITEM | NOVUS Multi-<br>Wavelength<br>(K932468)<br>Reference Predicate | PASCAL® Synthesis™<br>(K123542)<br>Primary Predicate | PASCAL Synthesis<br>TwinStar<br>(K170409) |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | Treatment Laser:<br>Coherent super<br>INNOVA Ceramic<br>CoolDisk, Aiming<br>Laser: InGaAIP Diode | OPSL- Optically<br>Pumped Semiconductor<br>Laser; Diode Pumped;<br>Solid State | OPSL - Optically<br>Pumped Semiconductor<br>Laser; Diode Pumped;<br>Solid State (577)<br>Diode Laser (638) |
| Output<br>Wavelength3 | 521 and 531 nm<br>(Green)<br>647 nm (Red)<br>568 nm (Yellow)<br>521, 531 and 568 nm<br>(Yellow-Green) | 532 nm (Green)<br>577 nm (Yellow) | 577 nm (Yellow)<br>638 nm (Red) |
| Power Output4 | Green: 50 - 900 mW<br>Red: 50 – 1000 mW<br>Yellow: 75 - 600 mW<br>Yellow-Green: 75 -<br>1500 mW | 0, 30 mW - 2000 mW | 0, 30 mW - 2000 mW<br>(577)<br>0 to 600mW (638) |
| Duty Cycle | 100% | 100% | 100% |
| Exposure Time | 10 ms - 1000 ms, and<br>continuous | 2ms -1000 ms | 2ms -1000 ms |
| Repetition Rate<br>(Available with<br>single-spot<br>pattern only) | Available settings<br>range from 1 Hz to 9<br>Hz depending on rate<br>and exposure time<br>settings | Off, 1.0 Hz, 1.5 Hz, 2.0<br>Hz, 3.0 Hz, 4.0 Hz, 5.0<br>Hz, 6.0 Hz, 7.0 Hz, 8.0<br>Hz | Off, 1.0 Hz, 1.5 Hz, 2.0<br>Hz, 3.0 Hz, 4.0 Hz, 5.0<br>Hz, 6.0 Hz, 7.0 Hz, 8.0<br>Hz |
| Pulse Counter | 0 - 9999, reset<br>available | 0-99,999, reset available | 0-99,999, reset available |
| CDRH<br>Classification | Class IV | Class IV | Class IV |
| European<br>Classification | Class 4 | Class 4 | Class 4 |
| Aiming Laser<br>Type | InGaAIP<br>Diode<br>(Direct Diode) | Direct Diode | Direct Diode |
| Wavelength | 670 nm | 635 nm | 670 nm |
| Power Output | Adjustable to <1mW | Adjustable to <1mW | Adjustable to <1mW |
| CDRH<br>Classification | Class IIIa | Class II | Class II |
| MDD<br>Classification | Class 3a | Class 2 | Class 2 |
| ITEM | NOVUS Multi-Wavelength<br>(K932468)<br>Reference Predicate | PASCAL® Synthesis™<br>(K123542)<br>Primary Predicate | PASCAL Synthesis<br>TwinStar<br>(K170409) |
| Level of<br>Concern | Unknown | Major | Major |
| Spot Diameter | 50 μm – 500 μm<br>delivered to the focal<br>plane of the slit lamp<br>in the air (with<br>LaserLink Z Slit Lamp<br>Adapter) There is a<br>laser diameter<br>magnification factor for<br>the contact lens<br>utilized. | 50 μm – 400 μm<br>delivered to the focal<br>plane of the slit lamp in<br>the air. There is a laser<br>diameter magnification<br>factor for the contact<br>lens utilized. | 50 μm – 400 μm (577);<br>60, 200um (638)<br>delivered to the focal<br>plane of the slit lamp in<br>the air. There is a laser<br>diameter magnification<br>factor for the contact<br>lens utilized. |
| Intensity Profile | Top Hat | Top Hat | Top Hat |
| Spot Spacing | Not applicable (non-<br>scanning) | Adjustable, with a<br>minimum center-to-<br>center spacing of 1 spot<br>diameter. | Adjustable, with a<br>minimum center-to-<br>center spacing of 1 spot<br>diameter. |
| Scan Field | Not applicable (non-<br>scanning) | 4 mm X 4 MM (in air) | 4 mm X 4 mm (in air) |
| Scan Rate | Not applicable (non-<br>scanning) | ≤ 100 Hz | ≤ 100 Hz |
| Electrical Requirements: | | | |
| Voltage | 200-240 VAC or<br>380 to 415 VAC | 100-230 VAC ± 10% | 100-230 VAC ± 10% |
| Frequency | 50/60 Hz, single<br>phase or three-<br>phase | 50,60 Hz, single-phase | 50,60 Hz, single-phase |
| Current | 20, 35, or 60 A | < 10 Amperes | < 10 Amperes |
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#### 7. Substantial Equivalence
PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System shares the same indications for use, device operation, overall technical and functional capabilities and therefore is substantially equivalent to the predicate devices. Performance and animal testing confirmed that the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is substantially equivalent to the identified predicates.
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#### Safety and Effectiveness information 8.
The review of the indications for use and technical characteristics as well as animal study results and performance testing demonstrate that the PASCAL® Synthesis™ Twinstar™ Ophthalmic Scanning Laser System is substantially equivalent to the predicate devices. No new safety and effectiveness questions are applicable.
## 9. Non Clinical Testing
### Performance Testing - Bench
Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:
• AAMI/ANSI ES60601-1:2005/(R) 2012 + A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-2:2007: 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 62366-1 Medical Devices-Part 1: Application of usability engineering to medical devices • 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 1: Safety of laser products-Part 1: Eguipment classification and requirements Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Major level of concern was provided.
### Performance Testing - Animal
An animal study was performed for the novel features of the subject device relative to the PASCAL® Synthesis: the 638 nm red treatment laser. In the study grids of mild to moderate grade retinal lesions were delivered to rabbit retinae in vivo with both the subject device and the reference predicate (the Novus Omni compared with the red treatment laser).
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In the case of the red laser study, both 60um and 200um spot-sizes were used. Ophthalmoscopic evaluation, fundus photos, and SD-OCT measurements were taken in vivo immediately after treatment, prior to euthanasia. No difference in lesion morphology between predicate and subject device was observed funduscopically or in OCT for equivalent lesion ophthalmoscopic grade. In an analysis of OCT width measurements, the difference in lesion width for predicate and subject device was <20% in all statistically significant single-eye comparative cases. The similarity in lesion character and size under matching delivery conditions supports substantial equivalence between predicate and subject devices for the red treatment laser.
### 10. Clinical Performance
There was no clinical testing required to support this medical device as the indications for use and technology are equivalent to those of the predicate devices.
### 11. Statement of Substantial Equivalence
A device is substantially equivalent when the subject device has the same intended use and the same technological characteristics as the previously cleared predicate device(s). The addition of the red laser to the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System does not alter either of these characteristics and does not raise any new questions of safety or efficacy as compared to the predicates.
## 12. Conclusion
The PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System was found to be substantially equivalent to the predicate devices. It shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
