← Product Code [MPA](/productcode/MPA) · K080067 # ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067) _Iscience Interventional · MPA · Jul 18, 2008 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K080067 ## Device Facts - **Applicant:** Iscience Interventional - **Product Code:** [MPA](/productcode/MPA.md) - **Decision Date:** Jul 18, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. ## Device Story Flexible microcatheter for atraumatic catheterization of eye spaces; enables infusion/aspiration of fluids during surgery. Incorporates optical fiber for surgical illumination and guidance. Used in ophthalmic surgery by physicians to perform viscodilation of Schlemm's canal. Output is physical access to canal for pressure reduction in glaucoma patients. Single-use, sterile device. ## Clinical Evidence Multi-center prospective study evaluated safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. Ex-vivo studies also conducted. ## Technological Characteristics Flexible microcatheter with integrated optical fiber for illumination. Sterilized via radiation (ANSI/AAMI/ISO 11137-1995). Biocompatibility per ISO 10993-1, -5, -10, -12. Packaging per ANSI/AAMI/ISO 11607-2000. Risk management per ISO 14971:2000. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - iScience Surgical Ophthalmic Microcannula ([K041108](/device/K041108.md)) - Endolight End Irrigating Endoilluminator ([K970882](/device/K970882.md)) - True Light End Irrigating Endoilluminator ([K973293](/device/K973293.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}------------------------------------------------ #### 510(k) Summary 5.0 | | JUL 1 8 2008 | |----------------------------------------------------|-----------------------------------------------| | iScience Interventional Corporation | | | 4055 Campbell Avenue | | | Phone (650) 421-2700 | | | (650) 239-3697
Fax | | | Grace Bartoo | | | June 11, 2008 | | | iScience Interventional Canaloplasty Microcatheter | | | Ophthalmic Microcatheter | | | | | | HMX, 21 CFR 886.4350 Manual ophthalmic surgical | | | instrument | | | Device Name | 510(k) Number | | iScience Surgical Ophthalmic | K041108 | | Microcannula | | | Endolight End Irrigating | K970882 | | Endoilluminator | | | True Light End Irrigating | K973293 | | Endoilluminator | | | | MPA, 21 CFR 876.1500 Endoscope and accessones | # Description of the Device Subject to Premarket Notification: The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use. # Indications for Use The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. # Technical Characteristics The intended use and technological features of the iScience Interventional Canaloplasty Microcatheter do not substantially differ from the legally marketed predicate devices. The iScience Interventional Canaloplasty Microcatheter and the predicate device(s) have similar intended uses and methods of operation. {1}------------------------------------------------ ## Performance Data The iScience Interventional Canaloplasty Microcatheter has been shown to conform to the following standards, practices, and guidance: ### STERILIZATION - > ANSVAAMI/ISO 11137-1995, Sterilization of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilization. ### BIOCOMPATIBILITY - > ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing - > ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in Vitro Cvtotoxicity - > ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Test for Irritation and Delayed-Type Hypersensitivity - > ISO 10993-12, Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials ### SHELF-LIFE AND PACKAGING INTEGRITY - > ANSI/AAMI/ISO 11607-2000, Packaging for Terminally Sterilized Medical Devices. ### RISK MANAGEMENT - > ISO 14971:2000. Medical Device Application of Risk Management to Medical Devices. The device also underwent testing to ensure that performance requirements were met. #### DIMENSIONAL AND MECHANICAL TESTING - > Tensile Strength of Joints - > Static Burst - > Fluid Infusion Line Leakage - > Aspiration - > Light Transmission {2}------------------------------------------------ ## PRECLINICAL STUDIES - > Ex-vivo studies of accessing Schlemm's canal using Canaloplasty Microcatheter # Clinical Studies - > A multi-center prospective study to evaluate the safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm's canal with the Canaloplasty Microcatheter to reduce intraocular pressure in adult patients with open angle glaucoma. # Basis for Determination of Substantial Equivalence: The indications for use for the iScience Interventional Canaloplasty Microcatheter are similar to the predicate devices cited in this application. The safety of the materials used for the manufacture of the iScience Interventional Canaloplasty Microcatheter has been demonstrated with biocompatibility testing. Performance testing demonstrates that the iScience Interventional Canaloplasty Microcatheter is functionally equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context. Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. JUL 1 8 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 iScience Interventional Corporation % Grace Bartoo, Ph.D., RAC, CBA Regulatory Consultant 4055 Campbell Avenue Menlo Park, CA 94025 Re: K080067 Trade/Device Name: iScience Interventional Canaloplasty Microcather Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: MPA, HMX Dated: June 11, 2008 Received: June 13, 2008 Dear Dr. Bartoo: 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincercly vours. M. B. Egorluns, mD Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### 4.0 Indication for Use 510(k) Number (if known): K080067 Device Name: iScience Interventional Canaloplasty Microcatheter Indications for Use: The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. Prescription Use X (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 OF NEEDED) Concurrence of CDRH, Office of Device Fivaluation (ODE) Sac Cellaurn (Division Sign Off) (Lervisión Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises Page 1 of 1 510(k) Number K080067 ISCIENCE INTERVENTIONAL 510(x) SUBMISSION CANALOPLASTY MICROCATHETER 4- | --- **Source:** [https://fda.innolitics.com/device/K080067](https://fda.innolitics.com/device/K080067) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com