← Product Code [MPA](/productcode/MPA) · K970878 # ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (K970878) _American Medical Devices, Inc. · MPA · May 6, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K970878 ## Device Facts - **Applicant:** American Medical Devices, Inc. - **Product Code:** [MPA](/productcode/MPA.md) - **Decision Date:** May 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use For illumination during surgery. Regular Monofilament – Inserts into any standard Fiberoptic Pic Set. Fine Monofilament – Inserts into any standard Fiberoptic Forceps. ## Device Story Fiberoptic bare end fibers (19 Ga. Regular and 20 Ga. Fine monofilaments) used for surgical illumination. Regular monofilament inserts into standard fiberoptic pic sets; fine monofilament inserts into standard fiberoptic forceps. Enables bimanual surgical technique. Used in ophthalmic surgery by surgeons. Device transmits light to surgical site; provides illumination to assist visualization during procedures. ## Clinical Evidence Bench testing only. Sterilization validated via AAMI Overkill Method; SAL 10^-6. Non-pyrogenic status verified via LAL method. Residue limits for ethylene oxide (25 ppm), ethylene chlorohydrin (25 ppm), and ethylene glycol (250 ppm) established. ## Technological Characteristics Materials: PMMA fiber, PMMA cladding, aluminum connector. Form factor: 19 Ga. (Regular) and 20 Ga. (Fine) monofilaments. Sterilization: ETO (AAMI Overkill Method). Packaging: Tyvek pouch with polymylar sheath. ## 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 - Gamp & Assoc. (not specified) - Grieshaber (not specified) ## 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} K 970878 AMERICAN MEDICAL DEVICES, Inc. MAY - 6 1997 1100 Northside Drive Atlanta, Georgia 30318 February 27, 1997 # Premarket Notification [510(k)] Summary Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 30318 Phone: (404) 815-5233 Fax: (404) 815-5235 Official Correspondent: Frank J. Tighe Trade Name: The American Medical Devices, Inc., 19 and 20 Ga. Endolight™ Regular and Fine Monofilaments. Common Name: Fiberoptic Bare End Fiber. Registration Number: We have registered but have not received our application back as of this date. Class: Class II Class Name: We were unable to find the device listed in the classification regulations, 21 CFR Parts 862-892 [807.87 (c)]. Panel: Ophthalmic Product Code: MPA Device Description: The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber. Please see Device Replica Diagram in Appendix C. | Toll-Free | Direct | Facsimile | Page 1 Summary Internet | | --- | --- | --- | --- | | 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com | {1} K970878 Statement of indications for use. - For illumination during surgery. Regular Monofilament – Inserts into any standard Fiberoptic Pic Set. Fine Monofilament – Inserts into any standard Fiberoptic Forceps. | Substantial Equivalence Comparison | American Medical Devices, Inc. | Gamp & Assoc. | Grieshaber | | --- | --- | --- | --- | | PMMA Fiber | X | X | X | | PMMA Cladding | X | X | X | | Aluminum Connector | X | X | X | | For Illumination During Surgery | X | X | X | | ETO Sterilized | X | X | X | The American Medical Devices, Inc Regular and Fine Monofilaments are produced and sterilize same locations as the Grieshaber products. ## Sterility The Device will be ETO Sterilized. The method used to validate the sterilization cycle is AAMI Overkill Method Packaging Material: Tyvek Pouch with a Ploymylar Sheath. The SAL is 10 to the –6. The maximum levels of residues of ethylene oxide: 25 parts per million; ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million. This device is non-pyrogenic and the LAL Method is used to make that determination. Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic. Page 2 Summary --- **Source:** [https://fda-staging.innolitics.com/device/K970878](https://fda-staging.innolitics.com/device/K970878) **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