Who is the manufacturer of PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

Topcon Medical Laser Systems, Inc. (Tmls) filed the 510(k) submission for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System (K170409).

What is the FDA product code for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

PASCAL® Synthesis™ Ophthalmic Scanning Laser System (K123542); NOVUS Multiwavelength Omni (K932468).

Who can help prepare an FDA 510(k) submission like PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

K170409 · Topcon Medical Laser Systems, Inc. (Tmls) · GEX · Sep 12, 2017 · General, Plastic Surgery

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

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. 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

PASCAL® Synthesis™ Ophthalmic Scanning Laser System (K123542)
NOVUS Multiwavelength Omni (K932468)

Related Devices

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K100678 — SUPRA SCAN DELIVERY SYSTEM · Quantel Medical · Jul 21, 2010
K170302 — YELLOW LASER PHOTOCOAGULATOR YLC-500 · Nidek Co., Ltd. · Jun 23, 2017
K103056 — VISULAS TRION LASER SYSTEM WITH THE VITE OPTION · Carl Zeiss Meditec, AG · Feb 1, 2011
K120825 — SUPRA SCAN DELIVERY SYSTEM · Quantel Medical · Sep 14, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (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 {2}------------------------------------------------ # 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) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 Laser System | |-------------------------------|--------------------------------------------------------------------------------------------------------| | Classification Name: | Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology; Laser, Ophthalmic | | Classification Regulation: | 21 CFR 878.4810 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) {4}------------------------------------------------ #### 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. {5}------------------------------------------------ | ITEM | NOVUS Multi- Wavelength (K932468) Reference Predicate | PASCAL® Synthesis™ (K123542) Primary Predicate | PASCAL Synthesis TwinStar (K170409) | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type | Treatment Laser: Coherent super INNOVA Ceramic CoolDisk, Aiming Laser: InGaAIP Diode | OPSL- Optically Pumped Semiconductor Laser; Diode Pumped; Solid State | OPSL - Optically Pumped Semiconductor Laser; Diode Pumped; Solid State (577) Diode Laser (638) | | Output Wavelength3 | 521 and 531 nm (Green) 647 nm (Red) 568 nm (Yellow) 521, 531 and 568 nm (Yellow-Green) | 532 nm (Green) 577 nm (Yellow) | 577 nm (Yellow) 638 nm (Red) | | Power Output4 | Green: 50 - 900 mW Red: 50 – 1000 mW Yellow: 75 - 600 mW Yellow-Green: 75 - 1500 mW | 0, 30 mW - 2000 mW | 0, 30 mW - 2000 mW (577) 0 to 600mW (638) | | Duty Cycle | 100% | 100% | 100% | | Exposure Time | 10 ms - 1000 ms, and continuous | 2ms -1000 ms | 2ms -1000 ms | | Repetition Rate (Available with single-spot pattern only) | Available settings range from 1 Hz to 9 Hz depending on rate and exposure time settings | Off, 1.0 Hz, 1.5 Hz, 2.0 Hz, 3.0 Hz, 4.0 Hz, 5.0 Hz, 6.0 Hz, 7.0 Hz, 8.0 Hz | Off, 1.0 Hz, 1.5 Hz, 2.0 Hz, 3.0 Hz, 4.0 Hz, 5.0 Hz, 6.0 Hz, 7.0 Hz, 8.0 Hz | | Pulse Counter | 0 - 9999, reset available | 0-99,999, reset available | 0-99,999, reset available | | CDRH Classification | Class IV | Class IV | Class IV | | European Classification | Class 4 | Class 4 | Class 4 | | Aiming Laser Type | InGaAIP Diode (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 Classification | Class IIIa | Class II | Class II | | MDD Classification | Class 3a | Class 2 | Class 2 | | ITEM | NOVUS Multi-Wavelength (K932468) Reference Predicate | PASCAL® Synthesis™ (K123542) Primary Predicate | PASCAL Synthesis TwinStar (K170409) | | Level of Concern | Unknown | Major | Major | | Spot Diameter | 50 μm – 500 μm delivered to the focal plane of the slit lamp in the air (with LaserLink Z Slit Lamp Adapter) There is a laser diameter magnification factor for the contact lens utilized. | 50 μm – 400 μm delivered to the focal plane of the slit lamp in the air. There is a laser diameter magnification factor for the contact lens utilized. | 50 μm – 400 μm (577); 60, 200um (638) delivered to the focal plane of the slit lamp in the air. There is a laser diameter magnification factor for the contact lens utilized. | | Intensity Profile | Top Hat | Top Hat | Top Hat | | Spot Spacing | Not applicable (non- scanning) | Adjustable, with a minimum center-to- center spacing of 1 spot diameter. | Adjustable, with a minimum center-to- center spacing of 1 spot diameter. | | Scan Field | Not applicable (non- scanning) | 4 mm X 4 MM (in air) | 4 mm X 4 mm (in air) | | Scan Rate | Not applicable (non- scanning) | ≤ 100 Hz | ≤ 100 Hz | | Electrical Requirements: | | | | | Voltage | 200-240 VAC or 380 to 415 VAC | 100-230 VAC ± 10% | 100-230 VAC ± 10% | | Frequency | 50/60 Hz, single phase or three- phase | 50,60 Hz, single-phase | 50,60 Hz, single-phase | | Current | 20, 35, or 60 A | < 10 Amperes | < 10 Amperes | {6}------------------------------------------------ #### 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. {7}------------------------------------------------ #### 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). {8}------------------------------------------------ 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.