← Product Code [OCW](/productcode/OCW) · K980815 # ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER (K980815) _Ethicon Endo-Surgery, Inc. · OCW · May 1, 1998 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K980815 ## Device Facts - **Applicant:** Ethicon Endo-Surgery, Inc. - **Product Code:** [OCW](/productcode/OCW.md) - **Decision Date:** May 1, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and / or the creation of anastomoses. ## Device Story ENDOPATH® EZ45 Endoscopic Linear Cutter is a surgical instrument used for tissue transection, resection, and anastomosis creation. It is designed for use in both open and minimally invasive surgical procedures, such as radical prostatectomy. The device functions by delivering staples to tissue and may be used in conjunction with buttressing materials like bovine pericardium to reinforce the staple line. It is operated by surgeons in clinical settings (OR). The device is a mechanical surgical cutter/stapler; it does not involve electronic processing, software, or AI/ML algorithms. ## Clinical Evidence No clinical data provided; substantial equivalence is based on identical design and performance characteristics to the predicate device. ## Technological Characteristics Mechanical endoscopic linear cutter. Materials, design, and physical properties are identical to 510(k) #970720. No electronic, software, or energy-based components. ## 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 - 510(k) #970720 ## 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 of Safety and Effectiveness | MAY | 1 1998
Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule "...510(k) Summaries
and 510(k) Statements..." (21 CFR §807) and can be used to provide a
substantial equivalence summary to anyone requesting it from the Agency. | |-----|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Device
description | All device functions, scientific concepts, significant physical and performance
characteristics (i.e. device design, materials, physical properties, etc.) are
identical to the design and manufacture described in 510(k) #970720. | | | Intended use | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for
transection, resection, and / or the creation of anastomoses. | | | Indications
statement | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for
transection, resection, and / or creation of anastomoses, has application in
multiple open or minimally invasive surgical procedures, including radical
prostatectomy, and can be used with staple line or tissue buttressing materials,
such as bovine pericardium. | | | Technological
characteristics | The technological characteristics of the ENDOPATH® EZ45 Endoscopic
Linear Cutter are identical to those described in 510(k) #970720. | | | Performance
data | The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identical
to that described in 510(k) #970720. | | | | Continued on next page | ETHICON ENDO-SURGERY, INC. ENDOPATH® EZ45 Endoscopic Linear Cutter : · · {1}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness, continued ส : | Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the
information provided herein, we conclude that the ENDOPATH® EZ45
Endoscopic Linear Cutter is substantially equivalent to the Predicate Device
under the Federal Food, Drug and Cosmetic Act. | |------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Edwin O. Billips, RAC
Senior Associate
Regulatory Affairs Department
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 | | Date | April 29, 1998 | ENDOPATH®EZ45 Endoscopic Linear Cutter {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized representation of three human figures, one behind the other, with their heads tilted slightly upwards. The figures are depicted in a simple, abstract manner, with flowing lines suggesting movement or progress. The text "DEPARTMENT OF" is vertically oriented and placed to the left of the figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1 1000 MAY Ms. Lorri Chavez Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242-2839 Re: K980815 Endopath® EZ45 Endoscopic Linear Cutter Dated: March 2, 1998 Received: March 3, 1998 Regulatory Class: II 21 SCFR 876.1500/Procode: 78 KOG Dear Ms. Chavez: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510ks) 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 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html". Sincerely yours. Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement K9808/5 Following is the Indications for Use Statement: Statement > 510(k) Number: K980815 Device Name: ENDOPATH® EZ45 Endoscopic Linear Cutter ## Indications for Use: The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium. Continued on next page Roder P. Satling/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K 98081 510(k) Number. ﺳ Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use_ ETHICON ENDO-SURGERY, INC. ENDOPATH® EZ45 Endoscopic Linear Cutter --- **Source:** [https://fda.innolitics.com/device/K980815](https://fda.innolitics.com/device/K980815) **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