(189 days)
No
The description focuses on fixed pattern application and computer guidance, not adaptive or learning algorithms.
Yes
The device is described as software used for "procedures in trabeculoplasty in open angle glaucoma," which directly addresses a medical condition, making it a therapeutic device.
No
The device is described as software used for laser trabeculoplasty procedures to treat open angle glaucoma by applying a fixed pattern of laser locations to the trabecular meshwork. Its purpose is therapeutic intervention (treatment) rather than diagnosis.
No
The device is described as a "software option" for existing laser systems (PASCAL Streamline K100019 and K111108). While it is software, it is explicitly stated to be an enhancement for a hardware device (the laser system) and its function is to control the application of a laser, which is a hardware component. Therefore, it is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "procedures in trabeculoplasty in open angle glaucoma." This describes a surgical or therapeutic procedure performed directly on the patient's eye.
- Device Description: The device is a software option for a laser system used to apply patterns to the trabecular meshwork. This is a treatment modality, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device is used to deliver a therapeutic intervention.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.
Product codes
HQF, GEX
Device Description
Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K100019 and K111108). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trabeculoplasty in open angle glaucoma (referring to 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
A clinical study was conducted to evaluate safety and efficacy of the PSLT for PASCAL Streamline to for procedures in trabeculoplasty in patients with open angle glaucoma. The study was a prospective, randomized, controlled study of patients with open angle glaucoma that required bilateral laser trabeculoplasty for intraocular pressure control.
Clinical Endpoints: (primary endpoint) change in IOP from baseline to 1-month post-surgery as measured by tonometry and (secondary endpoint) success at 1-month post-surgery as measured by tonometry and CLS derived parameters.
Subject Criteria: The target population includes subjects fulfilling the standard criteria of the investigational site, who have given informed consent to participate in the study.
Subject Inclusion/Exclusion:
Inclusion - diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma; patients requiring bilateral laser trabeculoplasty for IOP control; structural glaucomatous damage and/or documented glaucomatous VF damage (in the previous 12 months with mean defect (MD) > 2.5 dB; no or stable anti-glaucomatous drug therapy since at least 3 months.
Exclusion – refractory glaucoma, patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma; corneal or conjunctival abnormality precluding contact lens adaptation; or severe dry eve syndrome.
Study Monitoring: primary endpoints were evaluated at the 1, 3, 6, and 12-month endpoint
Data Analysis: the modified intent to treat was used in the analysis to the data. Data were analyzed statistically using a 2-tailed unpaired t test, chi-square test, Mann-Whitney U test, repeated-measures analysis of variance. Kaplan-Meier survival analysis with Mantel-Cox logrank test was used to compare outcomes between groups. The sample size of 58 eyes was calculated to have sufficient power (at least 80% and two-sided alpha of 0.05) to detect to reject the null hypothesis of an inter-group IOP difference of 3 mmHg with a standard deviation of 3.5 mmHg at 1 month. The chief outcome measure was absolute change in IOP from baseline.
Results: Results of the clinical investigation support the indications for use of the PSLT for PASCAL Streamline to for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Both laser modalities had similar safety and efficacy profiles. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use.
Key Metrics
change in IOP from baseline to 1-month post-surgery
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2017
Topcon Medical Laser Systems, Inc. Sweta Srivastava Manager, Regulatory and Clinical Affairs 606 Enterprise Ct. Livermore, CA 94550
Re: K171488
Trade/Device Name: PSLT for PASCAL Streamline Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: October 11, 2017 Received: October 16, 2017
Dear Sweta Srivastava:
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.
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.
1
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 (reporting of medical devicerelated 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K171488
Device Name PSLT for PASCAL Streamline
Indications for Use (Describe)
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.
X 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
PSLT for PASCAL Streamline
1. Submission Sponsor
Topcon Medical Laser Systems, Inc.
606 Enterprise Ct.,
Livermore,
CA, 94550
USA
| Contact: | Sweta Srivastava |
|---|---|
| Title: | Manager, Regulatory and Clinical Affairs |
| Phone: | 925.245.7721 |
- Date Prepared
November 27, 2017
3. Device Identification
| Trade/Proprietary Name: | PSLT for PASCAL Streamline |
|---|---|
| Common/Usual Name: | Laser surgical instrument |
| Classification Name: | Ophthalmic laser/ Powered laser surgical instrument |
| Regulation Number: | 886.4390 |
| Product Code: | HQF, Ophthalmic laser |
Device Class: Class II
Classification Panel: Ophthalmic and General & Plastic Surgery
4. Legally Marketed Predicate Device(s)
Predicate Device: K100019, PASCAL® Streamline Classification Name: Ophthalmic laser
4
Regulation Number: 886.4390 Product Code: HQF Classification: Class II
Predicate Device: K111108, PASCAL Streamline 577 (with accessories) Classification Name: Ophthalmic laser Regulation Number: 886.4390 Product Code: HQF Classification: Class II
Reference Device #1: K081704, Selecta Family of Laser Systems Classification Name: Powered Laser Surgical Instrument Regulation Number: 886.4810 Product Code: GEX, HQF Classification: Class II
Reference Device #2: K071687, IRIDEX IQ Laser Systems Classification Name: Powered Laser Surgical Instrument Regulation Number: 886.4810 Product Code: GEX Classification: Class II
5. Indication for Use Statement
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Streamline for procedures in trabeculoplasty in open angle glaucoma.
6. Device Description
Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K100019 and K111108). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.
7. Substantial Equivalence Discussion
The PASCAL Streamline with PSLT option has similar performance characteristics, the same environment of use and patient populations as currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices. The
5
addition of this new feature does not raise new questions of safety and effectiveness for the PASCAL Streamline.
| Manufacturer | TopCon Medical Laser
Systems, Inc. | TopCon Medical Laser
Systems, Inc. | Device Comparison |
|---------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | PASCAL Streamline PSLT | PASCAL Streamline | |
| 510(k) Number | K171488 | K100019 | -- |
| Product Code | HQF | HQF | -- |
| Regulation
Number | 886.4390 | 886.4390 | -- |
| Regulation Name | Ophthalmic laser | Ophthalmic laser | -- |
| Indications for Use | Intended for use with
PASCAL Streamline for
procedures in
trabeculoplasty in open
angle glaucoma. | Intended for use in the
treatment of ocular
pathology in the posterior
segment. Retinal
photocoagulation,
panretinal
photocoagulation, focal
photocoagulation and grid
photocoagulation for
vascular and structural
abnormalities of the
retina and choroid
including:
Proliferative and
nonproliferative
diabetic
retinopathy Macular edema Choroidal | Different; the subject
device has different
indications for use, same
intended use. The
expanded indications for
use was tested in a clinical
study. |
| Manufacturer | TopCon Medical Laser
Systems, Inc. | TopCon Medical Laser
Systems, Inc. | Device Comparison |
| Trade Name | PASCAL Streamline PSLT | PASCAL Streamline | |
| | | neovascularization Branch and central retinal vein occulusion Age-related macular degeneration Lattice degeneration Retinal tears and detachments Intended for use in the treatment of ocular pathology in the anterior segment including: Iridotomy trabeculoplasty | |
| Output
Wavelength (nm) | 532 (green) | 532 (green) | Same |
| Treatment Laser
Sources | Frequency doubled solid-state | Frequency doubled solid-state | Same |
| Treatment Laser
Power | Up to 2W | Up to 2W | Same |
| Aiming Beam λ
(power output) | 635 nm; Direct diode
(adjustable to 2.5 dB; no or stable anti-glaucomatous drug therapy since at least 3 months. Exclusion – refractory glaucoma, patients having undergone ocular laser procedures (SLT, LPI) or intraocular surgery for the treatment of glaucoma; corneal or conjunctival abnormality precluding contact lens adaptation; or severe dry eve syndrome.
- Study Monitoring - primary endpoints were evaluated at the 1, 3, 6, and 12-month endpoint
- Data Analysis – the modified intent to treat was used in the analysis to the data. Data were analyzed statistically using a 2-tailed unpaired t test, chi-square test, Mann-Whitney U test, repeated-measures analysis of variance. Kaplan-Meier survival analysis with Mantel-Cox logrank test was used to compare outcomes between groups. The sample size of 58 eyes was calculated to have sufficient power (at least 80% and two-sided alpha of 0.05) to detect to reject the null hypothesis of an inter-group IOP difference of 3 mmHg with a standard deviation of 3.5 mmHg at 1 month. The chief outcome measure was absolute change in IOP from baseline.
Results of the clinical investigation support the indications for use of the PSLT for PASCAL Streamline to for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Both laser modalities had similar safety and efficacy profiles. Clinical study conclusion confirms that the device is safe and effective as used according to the instructions for use.
10. Conclusion
The PSLT for PASCAL Streamline has similar intended use and technological characteristics as the predicate device, and therefore, is substantially equivalent to the predicate device. Preclinical and clinical study results demonstrate the substantial equivalence as well as the safety and effectiveness of the PSLT for PASCAL Streamline laser for use in trabeculoplasty. Additionally, the new device does not raise additional questions regarding its safety and effectiveness when compared to the predicate device(s).
The PSLT for PASCAL Streamline, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).