← Product Code [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE) · K121091 # CATALYS PRECISION LASER SYSTEM (K121091) _Optimedica Corporation · OOE · Aug 28, 2012 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K121091 ## Device Facts - **Applicant:** Optimedica Corporation - **Product Code:** [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE.md) - **Decision Date:** Aug 28, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4390 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The OptiMedica® Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. ## Device Story Catalys™ Precision Laser System is an ophthalmic surgical laser for cataract surgery. It uses femtosecond (FS) laser technology integrated with Optical Coherence Tomography (OCT) to perform anterior capsulotomy, phacofragmentation, and corneal incisions. The system utilizes a common optical path for OCT and treatment lasers, featuring a three-dimensional scanner and Liquid Optics™ patient interface for co-registered imaging and treatment. Operated by a physician in a clinical setting, the system uses computerized scanning to direct laser pulses, creating localized plasma and cavitation events to cut tissue. The healthcare provider uses the system to facilitate efficient lens removal and precise corneal incisions. Benefits include increased precision and accuracy in surgical patterns compared to manual techniques. ## Clinical Evidence No clinical data. Evidence consists of bench testing and animal/cadaver studies. Bench testing used NIST-traceable reticules and magnified digital image analysis to validate corneal incision patterns, meeting acceptance criteria of ±75um. Animal testing compared laser-created corneal incisions to manual surgical incisions via histology, confirming safety. Cadaver eye testing qualitatively validated the system's ability to cut various tissue types across a range of laser parameters. ## Technological Characteristics Femtosecond laser system; integrated OCT; 3D scanner; Liquid Optics™ patient interface. Complies with Class I laser requirements per ANSI Z136.1-2007. Controlled by dedicated electronics. Software-driven computerized scanning system for 3D pattern delivery. ## Regulatory 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. ## Predicate Devices - OptiMedica Catalys™ Precision Laser System ([K113479](/device/K113479.md)) - LenSx Laser System (Alcon Corporation) ([K101626](/device/K101626.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ · AUG 2.8 2012 #### 510(k) Summary The following 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92: #### 5.1.1. Applicant OptiMedica® Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.850.8600 Fax: 408.583.4380 #### 5.1.2. Contact Person Alan Marquardt Vice President of Regulatory, Clinical and Quality OptiMedica® Corporation l 310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.792.8173 Fax: 408.583.4380 Email: amarquardt(@optimedica.com #### 5.1.3. Date Prepared March 23, 2012 #### 5.1.4. Classification Class II Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Classification Product Code: OOE Classification Product Code Name: Ophthalmic Femtosecond Laser #### 5.1.5. Trade Name OptiMedica® Catalys™ Precision Laser System #### 5.1.6. Predicate Devices - OptiMedica Catalys™ Precision Laser System; K113479 . - LenSx Laser System (Alcon Corporation); K101626 . #### 5.1.7. Intended Use The OptiMedica® Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. {1}------------------------------------------------ ## 5.1.8. Device Description The Catalys™ Precision Laser System ("Catalys™ System" or "System") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect phacofragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007. ## 5.1.9. Substantial Equivalence The OptiMedica Catalys™ Precision Laser System is substantially equivalent to both predicate devices in terms of indications for use, technological characteristics and performance specifications. The mechanism of laser cutting is the same for all three systems in that the ultra-short laser pulses create a highly localized plasma and subsequent cavitation event that when controlled by a computerized scanning system direct the laser beam through a three-dimensional pattern to produce a precise capsulotomy, fragment the crystalline lens and create arc cuts/incisions in the cornea. ## 5.1.10. Summary of Bench and Animal Performance Testing Bench testing of the Catalys™ System was conducted to demonstrate the System's ability to deliver a variety of laser patterns intended for corneal incisions with corresponding accuracy and precision. In this test, the System's entire suite of corneal incision patterns was bracketed to test the full spectrum of physicianselectable pattern variations. Multiple samples for a given test pattern were created in a test substrate that was subsequently cross-sectioned and measured using a NIST-traceable reticule, under magnified digital image analysis. All massurad values met the test protocol acceptance criteria of ±75um relative to the intended cut dimensions. The spectrum of pattern testing validated the system capability to cut a variety of single plane and multi-plane arc cuts/incisions patterns within specified limits for accuracy and precision. Animal testing was performed to demonstrate corneal safety. In this test, lascr created corneal incisions and standard manual surgical incisions histology was compared. The laser parameters selected for this performance testing represent a worst case type evaluation using the minimum horizontal and vertical spot spacing coupled with maximum pulse energy. Each and all laser created corneal incisions met the histological acceptance criteria when compared to manual surgical incisions histology. {2}------------------------------------------------ Cadaver eye testing was also conducted to demonstrate qualitatively the intended laser incisions can effectively cut a verity of tissue types. In this test, laser parameters, such as horizontal and vertical spot spacing, and laser pulse energy were bracketed to assess the full capability of the system. Each and all laser created corneal incisions met the qualitative acceptance criteria. な! {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OptiMedica Corporation c/o Mr. Alan Marquardt Vice President of Regulatory, Clinical and Quality 1310 Moffett Park Drive Sunnyvale, CA 94089 AUG 28 2012 Re: K121091 Trade/Device Name: OptiMedica Catalys™ Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: July 31, 2102 Received: August 1, 2012 Dear Mr. Marquardt: 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. {4}------------------------------------------------ #### Page 2 - Mr. Alan Marquardt 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. n Sincerely vours. Kesia Alexander Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use ## 510(k) Number (if known): TBD Device Name: Indications For Use: OptiMedica® Catalys™ Precision Laser System The OptiMedica® Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daryl Kausm (Division Sign-Off) . Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K121091 Page 1 of --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K121091](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K121091) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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