← Product Code [GCJ](/productcode/GCJ) · K972927 # ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR (K972927) _Richard Wolf Medical Instruments Corp. · GCJ · Nov 6, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K972927 ## Device Facts - **Applicant:** Richard Wolf Medical Instruments Corp. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Nov 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use Richard Wolf endoscopes for use in plastic surgery are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscopes may be used to visualize subcutaneous tissue when the indicated application is endoscopic cosmetic surgery of the facial and forethead / breast aughertation, and endospopic absominal plasity procedures. ## Device Story Panoview Telescopes are rigid endoscopes used for visualization of anatomy and subcutaneous tissue during plastic and reconstructive surgery. Devices feature 4mm, 7mm, or 10mm diameters; working lengths of 190mm to 300mm; and viewing angles of 0°, 25°, or 50°. Eyepieces are either fixed or detachable. Operated by surgeons in clinical settings, these devices provide direct optical visualization of body cavities and subcutaneous spaces to assist in surgical navigation and procedure performance. They function as passive optical instruments to facilitate minimally invasive surgical access. ## Clinical Evidence No clinical data provided. Bench testing only. ## Technological Characteristics Rigid endoscopes with 4mm, 7mm, 10mm diameters; 190mm-300mm lengths; 0°, 25°, 50° viewing directions. Features removable or permanent eyepieces. Passive optical visualization device. ## 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 - WECO Endoscopic System w/ Fiber Optic Light ([K951519](/device/K951519.md)) - Diamond-View™ Non-Autoclavable Endoscopes, 10mm ([K960400](/device/K960400.md)) ## Reference Devices - Storz Endoscope - Snowden-Pencer EndoPlastic™ Scope, 10mm ## 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}------------------------------------------------ son capitar in la sankar Vernon Hills, Illinois 60064 Phone: 847.943.1113 Fax: 847,913,1488 ## NOV - 6 1997 | | | | RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION | |--------------------------------|---------------------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------| | | 510(k) Summary of Safety and Effectiveness | | | | Submitter: | | | Date of Preparation:
August 5, 1997 | | Company / Institution Name: | Richard Wolf Medical Instruments Corp. | | FDA establishment registration number:
14 184 79 | | Division name (if applicable): | N.A. | | Phone number (include area code):
(847) 913-1113 | | Street address: | 353 Corporate Woods Parkway | | FAX number (include area code):
(847) 913-0924 | | City: | Vernon Hills | State / Province: | Illinois | | Country: | USA | ZIP / Postal Code: | 60061 | | Contact Name: | Mr. Robert L. Casarsa | | | | Contact Title: | Quality Assurance Manager | | | | Trade name: | Panoview Telescopes | Model number: | 8880.401, 8880.431, 8880.402,
8880.403, 8933.441, 8933.401,
8933.442, 8933.402, 8933.441,
8933.421, 8934.442, 8934.422 | | Common name: | Endoscopes | Classification name: | Laparoscope, Plastic and
General Surgery | | | Information on devices to which substantial equivalence is claimed: | | | | | 510(k) Number | Trade or proprietary or model name | Manufacturer | |---|---------------|----------------------------------------------------|-----------------------------| | 1 | K951519 | WECO Endoscopic System w/ Fiber Optic
Light | Wells Endoscopic
Company | | 2 | | Endoscope | Storz | | 3 | | EndoPlastic™ Scope, 10mm | Snowden-Pencer | | 4 | K960400 | Diamond-View™ Non-Autoclavable
Endoscopes, 10mm | Snowden-Pencer | | 5 | | | | #### 1.0 Description 파 The Richard Wolf Endoscopes have 4mm, 7mm, and 10mm diameters with working lengths ranging from 190mm to 300 mm. They have a viewing direction of 0°, 25°, and 50°. The eyepieces are fixed or detachable, depending upon the specific model. {1}------------------------------------------------ ResseS 10/97 #### 2.0 Intended Use Richard Wolf endoscopes for use in plastic surgery are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscopes may be used to visualize subcutaneous tissue when the indicated application is endoscopic cosmetic surgery of the facial and forethead / breast aughertation, and endospopic absominal plasity procedures. #### 3.0 Technological Characteristics · Removable and permanent eyepiece #### Substantial Equivalence 4.0 The Richard Wolf Endoscopes for plastic surgery are substantially equivalent to: - Snowden-Pencer . - · Wells Endoscopy - Karl Storz - Storz (USA) . All devices have the same intended use. #### 5.0 Performance Data - 6.0 Clinical Tests None #### 7.0 Conclusions Drawn These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual. By: Robert Casaran Robert L. Casarsa Quality Assurance Manager Date: Aug 5, 92 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The overall design is simple and clean, with a focus on the text and the symbolic image of the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 NOV - 6 1997 Re: K972927 Trade Name: Panoview Telescopes Regulatory Class: II Product Code: GCJ Dated: August 5, 1997 Received: August 8, 1997 Dear Mr. Casarsa: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) for Medical Devices: General regulation (21 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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. {3}------------------------------------------------ ### Page 2 - Mr. Robert L. Casarsa This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ≤ 10(k) **Number (if known):** # 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Endoscopes for Plastic Surgery Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: ## Indications for Use: Richard Wolf endoscopes for use in plastic surgery, are designed to visualize anatomy through natural and recenture well and socked for ass ar processors) may be used to visualize subcuraneous tissue when the indicated application is endoscopic plastic/reconstructive surgery. Revised 10/31/97 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices K972927 510(k) Number Prescription Use Per CFR 21 CFR 801.109 OR 1 - 3 Over-The-Counter Use_ --- **Source:** [https://fda-staging.innolitics.com/device/K972927](https://fda-staging.innolitics.com/device/K972927) **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