(61 days)
The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Karl Storz Video Lower G.I. Endoscope System is intended to provide optical visualization via a video monitor and therapeutic access to the lower digestive tract.
The Karl Storz Video Lower G.I. Endoscope System includes flexible endoscopes with distal-CCD chip technology which connects to the Karl Storz Camera Control Processor treatment of the lower digestive tract. The flexible video endoscopes contain an image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Lower G.I. Endoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
This appears to be a 510(k) summary for a medical device submitted to the FDA, specifically for the Karl Storz Video Lower G.I. Endoscope System.
Based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies.
The document primarily focuses on:
- Applicant and contact information.
- Device identification (common name, trade name, indication for use).
- Device description (flexible endoscopes with distal-CCD chip technology, image module, air/water insufflation, jet nozzle, suction, illumination light, and biopsy channels).
- Regulatory classification (Class II, 21CFR876.1500).
- FDA's substantial equivalence determination letter.
Therefore, I cannot provide the requested information as it is not present in the given text.
Medical devices like endoscopes typically have performance criteria related to optics (resolution, field of view, illumination), mechanical properties (insertion tube flexibility, angulation, working channel dimensions), and electrical safety. However, these specific details or any studies validating them are not described in this 510(k) summary. The FDA's substantial equivalence determination is based on the device being similar enough to a previously cleared predicate device, implying its safety and effectiveness are comparable without necessarily requiring new clinical performance studies for every aspect.
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JAN 3 1 2007
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) 558-1500
Contact:
Susie Chen Director, Regulatory and Legal Affairs Telephone: (310) 348- 4201 Fax: (310) 410-5519 Email: schen@ksea.com
Monika Campbell Senior Regulatory Submissions Specialist Telephone: (310) 348-4293 Fax: (310) 410-5519 Email: mcampbell @ksea.com
Device Identification:
Common Name: Video Lower G.I. Endoscope System
Trade Name: Karl Storz Video Lower G.I. Endoscope System
Indication: The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physican / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Video Lower G.I. Endoscope System is intended to provide optical visualization via a video woontoo and therapeutic access to the lower digestive tract.
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STORZ
KARL STORZ ENDOSCOPY
Device Description: The Karl Storz Video Lower G.I. Endoscope System includes flexible endoscopes with distal-CCD chip technology which connects to the Karl Storz Camera Control Processor treatment of the lower digestive tract. The flexible video endoscopes contain an image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Lower G.I. Endoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
JAN 3 1 2007
Re: K063585
Trade/Device Name: Karl Storz Video Lower G.I. Endoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FDF, FAM and KOG Dated: November 30, 2006 Received: December 1, 2006
Dear Ms. Chen:
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 max. 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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with additional text and stars.
Protesting 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 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.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
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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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ ENDOSCOPY" in smaller letters.
Indication for Use
K063585 510(k) Number (if known):
Device Name: Karl Storz Video Lower G.I. Endoscope System
Indications for Use: The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Karl Storz Video Lower G.I. Endoscope System is intended to provide optical visualization via a video monitor and therapeutic access to the lower digestive tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: _ AND/OR Over-The-Counter Use: (Per 21 CFR 801.Subpart D) (21 CFR 801 Subpart C)
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive A and Radiological Devic 510(k) Number
§ 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.