(84 days)
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
This looks like a 510(k) premarket notification for a medical device (Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories). However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on:
- Identification of the applicant and device.
- Device description and intended use.
- Claim of substantial equivalence to a predicate device.
- FDA's letter of clearance for marketing the device.
For medical devices that clear via substantial equivalence to a predicate, extensive primary studies demonstrating performance and adherence to acceptance criteria are often not required to be submitted in the 510(k) itself, particularly for devices with well-established technologies and similar specifications to existing devices. The FDA clearance letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the device's safety and effectiveness are inferred from its similarity to an already approved device, rather than requiring new, detailed performance studies to meet specific acceptance criteria.
Therefore, I cannot provide the requested information. The document as provided does not contain the data to fill out your table or answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies.
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Image /page/0/Picture/0 description: The image shows the text "OCT 1 2008" in a bold, sans-serif font. The text is likely a date, with "OCT" representing October, "1" representing the first day of the month, and "2008" representing the year. The text is slightly blurred, suggesting it may be a scan or a photograph of a document.
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 DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Monika CampbellSenior Regulatory Affairs SpecialistTelephone +1-310-348-4293Fax +1-310-410-5519E-mail: mcampbell@ksea.com |
| Device Identification: | Common Name:Karl Storz Pediatric Flex-X2™Trade Name:Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope |
Accessories
Indication: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of a variety of arological endoscopic procedures for pediatric patients.
Device Description: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
Substantial Equivalence: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope is substantially equivalent to the predicate device since the basic features and intended uses
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The minor differences between the Karl Storz Pediatric Flexible Cystoare the same. are the battler - The Marcelicate 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.
KO82046
Signature:
Monika Campbell Senior Regulatory Affairs Specialist
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
Ms. Monika Campbell Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe CULVER CITY CA 90230
Re: K082046
Trade/Device Name: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: September 30, 2008 Received: October 1, 2008
Dear Ms. Campbell:
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, 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 (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.
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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 (OS) 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 procced 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 yours,
loque M. Whang
Joyce M. Whang, Ph.D. Acting 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): IBD K 682046
Device Name: _ Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Indications for Use: accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Prescription Use _ X (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)
Aomi M. Whim
(Divisi Division of Reproductive, Abdomi and Radiological D 510(k) Number
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§ 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.