(55 days)
The SCB/ConMed ESU Interface Module is an accessory to a Karl Storz-SCB control devices (SCB Interface Control, SCB Media Control or ACC Control) which allows for use of the third party device, ConMed ESU models 2450/5000. The ESU's are remote controlled surgical generators operated by a Karl Storz-SCB control device via the Karl Storz interface module.
The Karl Storz SCB/ConMed ESU Interface Module is an accessory to integrate the third party devices ConMed ESU models 2450/5000 units to a Karl Storz-SCB control device and permits remote control via the Storz SCB-RUI System.
I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) premarket notification for an "SCB/ConMed ESU Interface Module," which is an accessory to integrate third-party devices. This is a medical device, but it is not an AI/ML powered device.
The information you are asking for, such as acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, are typical requirements for evaluating the performance of AI/ML-powered medical devices. Since this device is an interface module and not an AI/ML algorithm, these types of performance evaluation metrics are not present in the provided documentation.
The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for non-AI/ML devices. Therefore, I cannot extract the AI/ML-specific information you've requested from this text.
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Kosotto
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APR - 9 2008 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. |
|---|---|
| 600 Corporate Pointe Drive | |
| Culver City, CA 90230 | |
| (310) 338-8100 | |
| Contact: | Monika Campbell |
| Senior Regulatory Affairs Specialist | |
| Device Identification: | Remote Control |
| Karl Storz SCB/ConMed ESU Interface Module |
The SCB/ConMed ESU Interface Module is an accessory to a Karl Storz-Indication: control devices (SCB Interface Control, SCB Media Control or ACC Control) SCB which allows for use of the third party device, ConMed ESU models 2450/5000. The ESU's are remote controlled surgical generators operated by a Karl Storz-SCB control device via the Karl Storz interface module.
Device Description: The Karl Storz SCB/ConMed ESU Interface Module is an accessory to integrate the third party devices ConMed ESU models 2450/5000 units to a Karl Storz-SCB control device and permits remote control via the Storz SCB-RUI System.
Substantial Equivalence: The Karl Storz SCB/ConMed ESU Interface Module is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/ConMed ESU Interface Module and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.
Signed: Melisa Campbell
Monika Campbell Senior Regulatory Affairs Specialist
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Susie Chen Director, Regulatory and Legal Affairs Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor CULVER CITY CA 90230-7600
Re: K080410
Trade/Device Name: Karl Storz SCB/ConMed ESU Interface Module Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated: February 12, 2008 Received: February 15, 2008
Dear Ms. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the deyice 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, listing 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/9 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars at the bottom of the logo.
Protecting and Promoting Public Health
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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 et 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.
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 prome of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Karl Storz SCB/ConMed ESU Interface Module Device Name: ____
Indications for Use:
The SCB/ConMed ESU Interface Module is an accessory to a Karl Storz-SCB control devices (SCB Interface Control, SCB Media Control or ACC Control) which allows for use of the third party device, ConMed ESU models 2450/5000. The ESU's are remote controlled surgical generators operated by a Karl Storz-SCB control device via the Karl Storz interface module.
Prescription Use (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 Evaluation (ODE)
Page of
(Posted November 13, 2003)
Nona M. White
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
6009
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.