(20 days)
The Karl Storz Video Rhino-Laryngoscope System is indicated for use by physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.
The KARL STORZ Video Rhino-Laryngoscope System includes flexible endoscopes, CCU and lights source unit. The Rhino-Laryngoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures. The Karl Storz Video Rhino-Laryngoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
This document is a 510(k) summary for the Karl Storz Video Rhino-Laryngoscope System. It is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. As such, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not explicitly available in the provided text.
Based on the information provided:
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A table of acceptance criteria and the reported device performance:
Not provided in the document. The submission focuses on substantial equivalence rather than explicit performance acceptance criteria. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a performance study with a test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for a test set is not mentioned as a performance study was not conducted or reported. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an endoscope system, not an AI or diagnostic algorithm, so an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant and was not conducted or reported. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an endoscopic visualization system, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth is described as a performance study was not conducted or reported. -
The sample size for the training set:
Not applicable. The device is a hardware system, not a machine learning algorithm, so a training set is not applicable. -
How the ground truth for the training set was established:
Not applicable. A training set and ground truth establishment are not relevant for this device.
Summary of the study that proves the device meets the acceptance criteria (based on the provided text):
The provided document describes a 510(k) Pre-market Notification for the Karl Storz Video Rhino-Laryngoscope System. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific, quantitative performance acceptance criteria through a clinical study.
The core argument for the device meeting regulatory requirements (and implicitly, its intended performance) is stated as: "The Karl Storz Video RhinoLaryngoscope System is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz Video Rhino-Laryngoscope System and 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."
Therefore, the "study" proving the device meets acceptance criteria, in this context, is the comparison to an existing legally marketed predicate device, establishing that despite minor differences, the new device functions similarly and poses no new safety or effectiveness concerns. No specific performance metrics or clinical study results with acceptance criteria are presented.
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2072387 SEP 1 3 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) 558-1500 |
|---|---|
| Contact: | Monika CampbellSenior Regulatory Affairs SpecialistTelephone +1-310-348-4293Fax +1-310-410-5519E-mail: mcampbell@ksea.com |
| Device Identification: | Common Name:Video Rhino-Laryngoscope System |
Trade Name: Karl Storz Video Rhino-Laryngoscope System
The Karl Storz Video Rhino-Laryngoscope System is indicated for use by Indication: physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.
Device Description: The KARL STORZ Video Rhino-Laryngoscope System includes flexible endoscopes, CCU and lights source unit. The Rhino-Laryngoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures. The Karl Storz Video Rhino-Laryngoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
Substantial Equivalence: The Karl Storz Video Rhino-Laryngoscope System is substantially equivalent to the predicate device since the basic features and intended uses
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are the same. The minor differences between the Karl Storz Video Rhino-Laryngoscope System and 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.
Signature: Hawke Campbell
Monika Campbell Senior Regulatory Affairs Specialist
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SEP 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy - America, Inc. c/o Monika Campbell Senior Regulatory Affairs Specialist 600 Corporate Pointe Culver City, CA 90230
Re: K072387
Trade/Device Name: Karl Storz Video Rhino-Laryngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: August 23, 2007 Received: August 24, 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 yours,
M. B. Egelston, m.d.
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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Indication for Use
510(k) Number (if known): Not assigned yet
Device Name: Karl Storz Video Rhino-Laryngoscope System
Indications for Use: The Karl Storz Video Rhino-Laryngoscope System is indicated for use by physicians for endoscopic diagnosis within the nasal lumens and airway anatomy. The endoscope is intended to provide visualization via a video monitor.
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)
Thiollet
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Numb
(Posted November 13, 2003)
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.