(582 days)
Not Found
No
The description focuses on the hardware components (CMOS sensor, fiber optics, monitor) and standard performance testing, with no mention of AI/ML, image processing beyond display, or data sets for training/testing.
No.
The device is used for endoscopic diagnosis and visualization, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy..." which indicates its purpose is for diagnosis.
No
The device description explicitly states that the system includes a flexible endoscope with integrated hardware components (light, fiber optic bundles, CMOS imaging sensor) and a monitor, indicating it is a hardware-based medical device with potential software components for image processing and display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis within the nasal lumens and airway anatomy" and to "provide visualization via a video monitor." This describes a device used for direct visualization of internal body structures, not for examining specimens (like blood, urine, or tissue) outside the body to diagnose disease.
- Device Description: The description details a flexible endoscope with a camera and monitor for visualizing anatomy. This aligns with a device used for direct examination, not for in vitro testing.
- Anatomical Site: The device is used within the "nasal lumens and airway anatomy," which are internal body sites. IVDs typically analyze samples taken from the body.
- Regulatory Classification: The device is classified under 21 CFR 874.4760, which is for "Rhino-Laryngoscope and accessories." This is a classification for devices used for direct examination of the nasal and laryngeal areas, not for IVDs.
IVD devices are specifically designed to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. This device is used in vivo (within the body) for direct visualization.
N/A
Intended Use / Indications for Use
The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The Karl Storz CMOS Video Rhino-Laryngoscope System includes a flexible endoscope and a monitor. The rhino-laryngoscope consists of an integrated light located in the handle. The light is transmitted thought the fiber optic bundles and illuminates the anatomy under visualization. A new Storz specific CMOS imaging sensor located at the distal tip of the endoscope shaft which is inserted into the body cavities. The captured video signal is then transferred to the C-MAC monitor for display purposes. The Karl Storz CMOS Video Rhino-laryngoscope is a Class II device under 21 CFR874.4760, Rhino-Laryngoscope and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and airway anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Karl Storz Flexible Video Rhino-Laryngoscope system has been successfully tested for its functions, performance and safety as per FDA recognized standards. Testing has been conducted as per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and ISO 10993 to address the safety aspect of the device. The performance of the device is tested by complying with ISO 8600.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUN 2 8 2012
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.
Karl Storz Endoscopy-America, Inc. Applicant: 2151 E. Grand Avenue El Segundo. CA 90245
Contact: Shiven Gandhi Regulatory Affairs Associate Telephone: (424) 218-8322 FAX: (424) 218-8519 E-mail:shiven.gandhi@karlstorz.com
Date Prepared: 14th June 2012
Device Identification:
Common Name: Video Rhino-Laryngoscope System
Trade Name: CMOS Video Rhino-Laryngoscope System
Predicate Device: KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM. MODEL11101SERIES (K072387)
Indication: The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
Device Description:
The Karl Storz CMOS Video Rhino-Laryngoscope System includes a flexible endoscope and a monitor. The rhino-laryngoscope consists of an integrated light located in the handle. The light is transmitted thought the fiber optic bundles and illuminates the anatomy under visualization. A new Storz specific CMOS imaging sensor located at the distal tip of the endoscope shaft which is inserted into the body cavities. The captured video signal is then transferred to the C-MAC monitor for display purposes. The Karl Storz CMOS Video Rhino-laryngoscope is a Class II device under 21 CFR874.4760, Rhino-Laryngoscope and accessories.
Substantial Equivalence:
The Karl Storz CMOS Video Rhino-Laryngoscope System is substantially equivalent to the predicate device (K072387) since the intended uses and the technological characteristics are the same. The minor differences between the Karl Storz CMOS Video Rhino-Laryngoscope System and predicate device raise no issue of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.
1
| Subject Device | Predicate Device (K072387) | |
|---|---|---|
| Applicant | Karl Storz Endoscopy America, | |
| Inc. | Karl Storz Endoscopy America, | |
| Inc. | ||
| Device Name | Karl Storz CMOS Video Rhino- | |
| Laryngoscope | Karl Storz Video Rhino- | |
| Laryngoscope | ||
| Type of Device | Videoscope System | Videoscope System |
| Indication for use | For endoscopic diagnosis | |
| within the nasal lumens and | ||
| airway anatomy. | For endoscopic diagnosis | |
| within the nasal lumens and | ||
| airway anatomy. | ||
| Imaging Sensor | CMOS | CCD |
| Illumination source | LED | Xenon |
| Working Length | Same | Same |
| Shaft Diameter | Same | Same |
| Data Storage | Yes | Yes |
Technological Characteristics Comparison Table
Non-Clinical Performance Data:
The Karl Storz Flexible Video Rhino-Laryngoscope system has been successfully tested for its functions, performance and safety as per FDA recognized standards. Testing has been conducted as per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and ISO 10993 to address the safety aspect of the device. The performance of the device is tested by complying with ISO 8600.
Reprocessing:
The CMOS Video Rhino-Laryngoscope is cleaned using manual cleaning with enzymatic detergent and is subjected to high level disinfection using CIDEX OPA. No methods of sterilization are validated for the CMOS Video Rhino-Laryngoscope. The cleaning and highlevel disinfection studies were perform in accordance with AAMI TIR 12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR 30:2003 (A compendium of processes, materials. test methods, and acceptance criteria for cleaning reusable medical devices), AAMI 7: 1999 (Chemical Sterilants and High-Level Sterilants: A Guide to Selection and Use), AAMI E 1837 (Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices) and FDA draft guidance for Processing Medical devices in Healthcare settings (dated: May 2,2011)
Conclusion :
Hence the CMOS Video Rhino-Laryngoscope system is as safe and as effective to the predicate device in terms of its intended use and technological characteristics.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the emblem in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 8 2012
Karl Storz Endoscopy America Inc. c/o Mr. Shiven Gandhi, Regulatory Affairs Associate 2151 E. Grand Avenue El Segundo, CA 90245
Re: K103467
Trade/Device Name: Karl Storz CMOS Video Rhino Laryngoscope System Regulation Number: 21 CFR 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: June 14, 2012 Received: June 15, 2012
Dear Mr. Gandhi:
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 r ou may, attresses, and include requirements for annual registration, listing of general volurely provincitice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Teasoneter ODTE assess that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be may be subject to additional vehicles, 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 I lease of advised that I Dr over and that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any I carated and the regirements, including, but not limited to: registration and listing (21 comply with an the rece brequirements on 301); medical device reporting of medical CI'N I all 807), labeling (21 OFF 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Gandhi
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. A. Khan, M.D., f
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name: Karl Storz CMOS Video Rhino-Laryngoscope System
Indication for use: The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C Cluff
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K103467