(80 days)
The Karl Storz Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
The Karl Storz Video Bronchoscope System includes a flexible endoscope, a CCU and a lightsource unit. The Bronchoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a Bronchoscope system, focusing on its substantial equivalence to predicate devices rather than specific performance metrics or clinical study results.
Therefore, I cannot extract the requested information such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document states that the "minor differences between the Karl Storz Video Bronchoscope System and the predicate devices 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," implying that extensive performance testing may not have been deemed necessary beyond demonstrating equivalence.
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AUG 2 4 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 DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | Monika CampbellSenior Regulatory Affairs Specialist |
| Date of Submission: | June 4th, 2007 |
| Device Identification: | Common Name:Video Bronchoscope System |
Trade Name: (optional)
Karl Storz Video Bronchoscope System
Indication: The Karl Storz Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
Device Description: The Karl Storz Video Bronchoscope System includes a flexible endoscope, a CCU and a lightsource unit. The Bronchoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures.
Substantial Equivalence: The Karl Storz Video Bronchoscope System is substantially equivalent to the predicate devices since the basic features and intended uses are the same. The minor differences between the Karl Storz Video Bronchoscope System and the predicate devices 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:
James A. Lee, Ph.D. Manager, Regulatory Affairs
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2007
Karl Storz Endoscopy- America, Inc. c/o Ms. Monika Campbell Senior Regulatory Affairs Specialist 600 Corporate Pointe Drive Culver City, CA 90230
Re: K071530
Trade/Device Name: Karl Storz Video Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: August 7, 2007 Received: August 9, 2007
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.
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.
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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 at (240) 276-0115. 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,
M.B. Eglehus, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071530
Device Name: Karl Storz Video Bronchoscope System
Indications for Use: The Karl Storz Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
OR Over-The-Counter Use: Prescription Use: __ (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Pinalut
510(k) Number -
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.