(214 days)
No
The summary describes a laser system for photocoagulation with pattern scanning capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the laser wavelengths and delivery methods.
Yes
The device is used to perform photocoagulation in the eye, which is a medical treatment.
No
The device is described as an ophthalmic scanning laser system intended for photocoagulation (treatment) of the eye, not for diagnosis.
No
The device is described as an "ophthalmic scanning laser system" and mentions hardware and software validation activities, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is a therapeutic device that uses laser energy to treat conditions in the eye. It directly interacts with the patient's tissue.
- Intended Use: The intended use clearly states it's for performing photocoagulation in the posterior and anterior segments of the eye. This is a treatment procedure, not a diagnostic test performed on a specimen.
- Device Description: The description details a laser system for performing photocoagulation, a therapeutic intervention.
- Lack of Specimen Handling: There is no mention of collecting or analyzing any biological specimens.
Therefore, the PASCAL® Synthesis™ TwinStar™ Ophthalmic Scanning Laser System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, HQF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment (retina, choroid), anterior segment (iris, trabecular meshwork), non-macular retina of the eye.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing - Bench:
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
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 (the 638 nm red treatment laser) relative to the PASCAL® Synthesis.
Grids of mild to moderate grade retinal lesions were delivered to rabbit retinae in vivo with both the subject device (with red treatment laser) and the reference predicate (the Novus Omni). 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.
Key results: 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
§ 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
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) |
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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
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.
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| 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