← Product Code [GCJ](/productcode/GCJ) · K021456 # ER150/M2 (K021456) _World of Medicine Lemke GmbH · GCJ · Aug 1, 2002 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K021456 ## Device Facts - **Applicant:** World of Medicine Lemke GmbH - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Aug 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy. ## Device Story ER150/M2 is a 20-inch color video monitor for endoscopic surgery and diagnostic procedures; accepts composite (FBAS), Y-UV, analog RGB, digital RGB, Y/C, NTSC, PAL, and SECAM video signals. Device utilizes a digital microprocessor for automatic input selection; allows user adjustment of color, contrast, hue, brightness, sharpness, and color temperature (6500K/9300K). Output sockets enable connection to secondary monitors or recording devices. Used in clinical settings by medical professionals to visualize endoscopic procedures; facilitates real-time surgical decision-making by providing high-quality visual feedback. ## Clinical Evidence No clinical data. Substantial equivalence is based on design, intended use, and technological characteristics compared to the predicate device. Compliance with IEC 60601-1, IEC 60601-1-2, UL2601-1, and 21 C.F.R. 1020.10 performance standards is documented. ## Technological Characteristics 20-inch color video monitor; digital microprocessor-based; supports multiple analog/digital video inputs (FBAS, Y-UV, RGB, Y/C, NTSC, PAL, SECAM). Complies with IEC 60601-1, IEC 60601-1-2, and UL2601-1 safety standards. Features user-adjustable image parameters (color, contrast, hue, brightness, sharpness, color temperature). ## 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 - Sony Trinitron Color Video Monitor PVM-1343 MD ([K885042](/device/K885042.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 ER150/M2 ## I. Submitter: WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany ## II. Device Names: - Classification Name: し. - 2. Common or Usual Name: - Proprietary Name: 3. Accessory to an Endoscope Medical Monitor ER 150/M2 KO21456 ### III. Classification: The proposed device is classified as class II according to 21 C.F.R. § 876.1500. The product code for the device is GCJ. ### IV. Predicate Devices: - Sony Trinitron Color Video Monitor PVM-1343 MD (K885042) ● manufactured by Sony Medical Electronics, Co. ### V. Intended Use: The ER150/M2 is a video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy. ### VI. Device Description: The ER150/M2 is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery. The monitor accepts and processes composite=FBAS, Y-UV, analog RGB, digital RGB, Y/C signals and NTSC, PAL and SECAM standard video signals. The ER150/M2 is designed with a digital microprocessor and offers an automatic input selection. The received signal is displayed on a 20" screen. The images can be adjusted by the user for color, contrast, hue, brightness, enhanced sharpness and color temperature (6500K or 9300K). Additional output sockets of the ER150/M2 allow the connection to further equipment including a second monitor or recording device. {1}------------------------------------------------ 510(K) SUMMARY Page -2- / -2- KU2/456 page 2 of 2 #### VII. Performance Standards: The ER150/M2 meets the requirements of the performance standard 21 C.F.R. 81020.10. #### Voluntary Standards: VIII. The medical monitor ER150/M2 complies with the International Standard IEC 60601-1, IEC 60601-1-2 and conforms to the Medical Device Directive 93/42/EEC. In addition, the ER150/M2 meets the requirements of the Underwriters Laboratories standard UL2601-1. #### Substantial Equivalence: VIII. The medical monitor ER150/M2 described in this notification is similar in intended use, design and technological characteristics to the Sony Trinitron Color Video Monitor PVM-1343 MD (K885042) manufactured by Sony Medical Electronics, Co. Both the ER150/M2 and the predicate device are intended to display viewable medical images containing information on surgical or diagnostic procedures including video signals gernerated by endoscopic video equipment. The differences between the ER150/M2 and the predicate device are limited to picture quality and handling convenience and do not raise new questions of safety and effectiveness. Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the medical monitor ER150/M2 is substantially equivalent to the predicate device which received clearance from FDA on December 22, 1988 (K885042). Signed: S. Rojas Susanne Raab Official Correspondent {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/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 stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## AUG 0 1 2002 World of Medicine Lemke GmbH c/o Mrs. Susanne Raab 91 Trowbridge Street, #21 Cambridge, MA 02138 Re: K021456 Trade/Device Name: ER 159/M2 Medical Video Monitor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 23, 2002 Received: May 6, 2002 Dear Mrs. Raab: 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. {3}------------------------------------------------ Page 2 – Mrs. Susanne Raab 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Sincerely yours, Mark A. Milkerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE | APPLICANT: | WORLD OF MEDICINE Lemke GmbH | |---------------------------|------------------------------| | 510(K) NUMBER (if known): | K021456 | | DEVICE NAME: | ER150/M2 | INDICATIONS FOR USE: The ER150/M2 is a color video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 C.F.R. § 801.109) (Optional Format 1-2-96) Mark N. Millhiser (Division Sign Off) (Division Sign-Off) Division of General and Neurological D. tive 510(k) Number ***_*** 021456 --- **Source:** [https://fda.innolitics.com/device/K021456](https://fda.innolitics.com/device/K021456) **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