(225 days)
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.
I am sorry, but the provided text is a 510(k) summary for a medical device (VISULAS yag), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria and device performance results as requested.
The document does not contain:
- A table of acceptance criteria and reported device performance for a specific study.
- Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study.
- Details regarding training set size or how ground truth was established for a training set.
Instead, the document primarily compares the subject device's indications for use and technical characteristics to two predicate devices (Ellex YAG Laser K212630 and VISULAS YAG III K042139) to establish substantial equivalence. It mentions "Non-Clinical Performance Testing" and "functional and system level testing showed that the system met the defined specifications," and "Software verification and validation testing were conducted... All testing passed," but these are general statements and do not provide the detailed study information you've asked for.
Therefore, I cannot fulfill your request based on the provided text.
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September 22, 2023
Carl Zeiss Meditec Inc Tanesha Bland Sr. Regulatory Affairs Specialist 5300 Central Parkway Dublin, California 94568
Re: K230350
Trade/Device Name: VISULAS yag Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 16, 2023 Received: August 16, 2023
Dear Tanesha Bland:
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 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
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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 mediation-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,
Bennett Digitally signed by Bennett N. ﮯ Walker -S Date: 2023.09.22 Walker -S 10:23:07 -04'00'L
for Claudine Krawczyk Acting 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
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Indications for Use
510(k) Number (if known) K230350
Device Name VISULAS yag
Indications for Use (Describe)
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "ZEISS" in white letters against a blue background. The letters are bold and sans-serif. The background is a solid blue color, and the word "ZEISS" is centered in the image.
In accordance with 21 CFR 807.92 the 510(k) Summary for the VISULAS yag is provided below.
1. SUBMITTER
| Applicant: | Carl Zeiss Meditec Inc5300 Central ParkwayDublin, CAUSA |
|---|---|
| Primary Correspondent | Tanesha BlandSr. Regulatory Affairs SpecialistCarl Zeiss Meditec, Inc.5300 Central Parkway Dublin, CA 94568(925) 216-7963 PhoneE-mail: tanesha.bland@zeiss.com (preferred) |
| Secondary Correspondent | Ling RenRegulatory Affairs ManagerCarl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 Jena, Germany |
Date Prepared: September 22, 2023
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2. SUBJECT DEVICE
| Device Trade Name: | VISULAS yag |
|---|---|
| Classification: | 21CFR886.4390 laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |
3. PREDICATE DEVICE
| Predicate Device: | Ellex YAG Laser (Ultra Q, Ultra O Reflex) (K212630) |
|---|---|
| Classification: | 21CFR886.4390 Ophthalmic Laser |
| Regulatory Class: | ﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ |
| Product Code: | HOF |
4. DEVICE DESCRIPTION
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of \ = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.
INDICATIONS FOR USE .
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
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SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.
Table 1. Subject to Predicate Device Comparison Table – Indications for Use
| Device | Subject Device | Primary Predicate Device(K212630) | EquivalencyAnalysis |
|---|---|---|---|
| Indicationsfor Use | VISULAS yag is intended for use inphotodisrupting ocular tissues in thetreatment of diseases of the eye,including:• Posterior capsulotomy• Iridotomy• Posterior Membranectomy | In the YAG mode (Ultra Q, Ultra QReflex):• Iridotomy and iridectomy• Posterior capsulotomy• Posterior membranectomy | The indication ofVISULAS yag isequivalent to thatof the referencedevice. |
Table 2. Subject to Primary Reference Device Comparison Table – Indications for Use
| Device | Subject Device | Primary Reference Device(K042139) | EquivalencyAnalysis |
|---|---|---|---|
| Indicationsfor Use | VISULAS yag is intended for use inphotodisrupting ocular tissues in thetreatment of diseases of the eye,including:• Posterior capsulotomy• Iridotomy• Posterior Membranectomy | This device will be used inophthalmic applications, includingposterior capsulotomy and peripheraliridotomy. This device is intended forhealth care workers and may only beused under the supervision of aphysician. This device will not besold to the general public. | For posteriorcapsulotomy andiridotomy, theindications for useare equivalent. |
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Table 3. Subject to Predicate Device Comparison Table – Technical Characteristics
| Attribute | Subject Device | Primary Predicate Device(K212630) | Primary Reference Device(K042139) | Equivalency Analysis andDiscussion |
|---|---|---|---|---|
| Device name | VISULAS yag | Ellex YAG Laser | VISULAS YAG III | |
| (Ultra Q, Ultra Q Reflex) | ||||
| Manufacturer | Carl Zeiss Meditec AG | Ellex Medical Pty Ltd | Carl Zeiss Meditec AG | |
| 510(k) | K230350 | K212630 | K042139 | |
| Classification ProductCode | HQF | HQF | GEX | Substantially Equivalent.Though the referencedevice was cleared underproduct code 'GEX' inregulation 21 CFR878.4810, current deviceswith these indications foruse and technologicalcharacteristics are classifiedunder product code 'HQF'("Laser, Ophthalmic") inregulation 21 CFR 886.4390("Ophthalmic laser"). |
| Regulation # | 21CFR886.4390 | 21CFR886.4390 | 21CFR878.4810 | Substantially Equivalent. |
| Ophthalmic Laser | Ophthalmic Laser | Laser surgical instrument foruse in general and plasticsurgery and in dermatology | ||
| Application | Ophthalmic surgery | Ophthalmic surgery | Ophthalmic surgery | Substantially Equivalent. |
| Combination Device | No | No | No | Substantially Equivalent. |
| Patient Population | Adults | No restrictions given in theoperator manual | Adults | Substantially Equivalent. |
| Attribute | Subject Device | Primary Predicate Device(K212630) | Primary Reference Device(K042139) | Equivalency Analysis andDiscussion |
| User Interface | Graphical user interface,TouchControl panel, footswitch, laser slit lamp | Remote control, console,footswitch pedal, laser slitlamp | Graphical user interface,control, foot switch, laser slitlamp | Substantially Equivalent. |
| Optic Principle | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Substantially Equivalent. |
| Wavelength ofTreatment Beam | 1064 nm | 1064 nm | 1064 nm | Substantially Equivalent. |
| Laser Class inAccordance with IEC60825-1 | 4 | 3B | 4 | Substantially Equivalent.The subject device utilizesstandard IEC 60825-1which contains safetyrequirements that shall befollowed to allow equallysafe usage of the lasers inhumans. |
| Light HazardClassificationAccording to ISO15004-2 | Group 2 | Group 2 | Group 2 | Substantially Equivalent. |
| Mode of Laser Beam | Super Gaussian | Not specified in the operatormanual | Super Gaussian | Substantially Equivalent. |
| Pulse Length | < 4 ns | < 4 ns | < 4 ns (typically 2 ns to 3 ns) | Substantially Equivalent. |
| Pulse Mode 1 (SinglePulse) | 9.0 mJ to 13.0 mJ, at max.2.5 Hz | 0.3 mJ to 10.0 mJ single pulse.Max. 3.0 Hz | 9.0 mJ to 13.0 mJ, 2.5 Hz(5 shots/ 2s) | Substantially Equivalent. |
| Pulse Mode 2 (DoublePulse) | 18.0 mJ to 28.0 mJ, at max.1 Hz (burst frequency33 kHz) | Not specified. Max. 1.8 Hz | 18.0 mJ to 28.0 mJ, 1 Hz(1 shots/ 1s) (burst frequency33 kHz) | Substantially Equivalent. |
| Attribute | Subject Device | Primary Predicate Device(K212630) | Primary Reference Device(K042139) | Equivalency Analysis andDiscussion |
| Pulse Mode 3 (TriplePulse) | 29.0 mJ to 45.0 mJ, at max.1 Hz (2 shots/ 2s) (burstfrequency 33 kHz) | Not specified. Max. 1.6 Hz | 29.0 mJ to 45.0 mJ, 0.5 Hz(1 shots/ 2s) (burst frequency 33kHz) | Substantially Equivalent. |
| Energy Attenuation | 2/4/6/8/10/12/14/16/20/24/28/32/36/40/42/48/56/60/64/70/80/100 % | Not specified. | 2/4/6/8/10/12/14/16/20/24/28/32/36/40/42/48/56/60/64/70/80/100 % | Substantially Equivalent. |
| Applied Energy | Resulting from pulse modeand attenuation:0.18 mJ – 13.0 mJ singlepulse in 22 steps.Maximum energy that canbe delivered during clinicaluse is 45 mJ. | 0.3 mJ to 10.0 mJ single pulse.Continuously variable.Maximum energy that can beselected during clinical use is30 mJ. | Average from the last fiveshots, continuously updatedduring the session.Maximum energy output is10 mJ. | Substantially Equivalent. |
| Focus diameter | 6.5 µm ± 20% | 8 µm (Full Width HalfMaximum) | 10 µm in air | Substantially Equivalent.The subject device hasrefined the measuringmethod of the predicatedevice. The focus diameterfor both lasers are identical. |
| Angle of Exit Aperture(Convergence) | 14° (round angle) | 16° (full cone angle) | 16° (round angle) | Substantially Equivalent.The subject device hasrefined the measuringmethod of the predicate |
| Attribute | Subject Device | Primary Predicate Device(K212630) | Primary Reference Device(K042139) | Equivalency Analysis andDiscussion |
| Aiming Beam | DiodeWavelength: 660 nm to 680 nmPower: max. 150 µW at thecornea (Class I inaccordance with IEC60825-1)Four-point aiming beamwhich is switchable to 2-point aiming beam | Laser diode-pumpedWavelength:Ultra Q: 635 nmUltra Q Reflex: 635 nm or 515 nmClass II in accordance to IEC60825-12-point aiming beam | DiodeWavelength: 660 nm to 680 nmPower: max. 150 µW at thecornea (Class I in accordancewith IEC 60825-1)Four-point aiming beam | device. The convergenceangles are identical.Substantially Equivalent. |
| Nominal Ocular HazardDistance (NOHD) | 4 m | 6.1 m | 2 m | The NOHD differs due todifferences in the design.This difference does notimpact the safety orperformance of the subjectdevice. |
| Rated Voltage;Frequency | 100 V to 240 V (±10 %);50 /60 Hz | 100 V to 240 VAC; 50/60 Hz | 100 V to 240 V ±10 %;50 Hz/60 Hz | Substantially Equivalent. |
| Focus Shift betweenAiming Beam andTherapy Beam | 0/150/225/300 µm anteriorand posterior adjustableTolerance: ±25 µm | Ultra Q: Posterior only,continuously variable withdetents at 100, 250 and 350 µmUltra Q Reflex: Anterior (A) &posterior (P), continuouslyvariable with detents at 0, 100,200, 300, 400 and 500 µm | 0/150 µm anterior and posterioradjustableTolerance: ±25 µm | Substantially Equivalent. |
| Illumination | LED5.6 V, 2 W | 12 V pre-centered halogen | Halogen lamp12 V, 30 W | Different. |
| Attribute | Subject Device | Primary Predicate Device(K212630) | Primary Reference Device(K042139) | Equivalency Analysis andDiscussion |
| Brightness continuouslyadjustable | Brightness continuouslyadjustable | |||
| IlluminationOrientation | Non-coaxial | Ultra Q: non-coaxial UltraQ Reflex:coaxial | Non-coaxial | Substantially Equivalent. |
| Illumination Angle | 0°/±45°/90° | 180° at horizontal plane(90° for right / left) | 0°/±45°/90° | Substantially Equivalent. |
| Slit Width | 0 mm to 14 mm(continuously adjustable) | 0 - 12 mm | 0 mm to 14 mm(continuously adjustable) | Substantially Equivalent. |
| Slit Height | 1/3/5/9/14 mm | 0.5, 5.0, 8.0 & 12.0 or 0.5, 3.0,8.0 & 12.0 mm | 1/3/5/9/14 mm | Substantially Equivalent. |
| Magnification | 8x/12x/20x | Ultra Q:Standard: 10×, 16×, 28×Accessory: 6×, 10×, 16×, 28×,45×Ultra Q ReflexStandard: 10×, 16×, 25×Accessory: 6×, 10×, 16×, 28×,45× | 5x/8x/12x/20x/32x | Substantially Equivalent. |
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7. SUMMARY OF STUDIES
Non-Clinical Performance Testing
Non-clinical system testing provided an evaluation of the performance of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device, VISULAS yag, and the predicate device, VISULAS YAG III.
VISULAS yag is not intended for sterilization and no shelf life is specified for VISULAS yag. Therefore, no testing was conducted on VISULAS yag concerning sterilization and shelf life.
Biocompatibility testing was performed on the appropriate components of the subject device. The testing performed aligns with current recognized standards and meets or exceeds testing performed on VISULAS YAG III. Biocompatibility testing demonstrated equivalency between VISULAS yag III.
Software verification and validation testing were conducted, and documentation was provided as recommended in accordance with IEC 62304. There have been no changes in level of concern or software architecture. All testing passed.
EMC and electrical safety are used in comparable standards to the predicate device and the relevant product standards given by the product indication and performance. Electrical safety and EMC testing were performed based on the ILAC-Scheme to include all national deviations for VISULAS yag. All testing passed.
No additional safety or performance concerns have been raised during development or device testing.
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8. CONCLUSION
The indications for use are identical to the indications for use of the predicate device; and therefore, are deemed to be substantially equivalent.
The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are deemed to be substantially equivalent.
Testing methods are equivalent to those of the predicate device; and therefore, are deemed to be substantially equivalent.
Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.
§ 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.