(282 days)
Not Found
No
The summary describes a standard video endoscope system for visualization. There is no mention of AI, ML, image processing for analysis, or any data sets for training or testing such algorithms.
No.
The device is used for "endoscopic diagnosis" and visualization, which aligns with diagnostic purposes, not therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy".
No
The device description clearly outlines hardware components including a flexible and steerable endoscope, a camera control unit (CCU), an integrated LED light source, fiberoptic bundles, a CMOS imaging sensor, and a ventilation system. It is a physical medical device with integrated software for image capture and display.
Based on the provided information, the Schoelly CMOS Video Nasopharyngoscope System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor." This describes a device used for direct visualization of internal body structures, which is characteristic of an endoscope, not an IVD.
- Device Description: The description details a flexible endoscope with a camera and light source for internal examination. It does not mention any components or processes related to testing samples taken from the body (like blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct visualization within the body.
N/A
Intended Use / Indications for Use
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic 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
EOB
Device Description
The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.
The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.
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
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)
Performance data demonstrated that the Schoelly CMOS Video Nasopharyngoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate devices. The device is as safe, as effective, and performs as well as or better than the predicate devices. The risks associated with use of the new device were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits of predicate devices are the same as compared to the proposed one.
Testing has been conducted as per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 8600, and ISO 10993 to address the safety and performance aspects of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Schoelly Fiberontic GmbH 510(k) Premarket Notification (Traditional)
06/21/2013 CMOS Video Nusopharyngoscope System
Section 5-510(k) Summary
| General Information | |
|---|---|
| Preparation date: | 06/21/2013 |
| Owner's Name: | Schoelly Fiberoptic GmbH (Registration: 8043903) |
| Address: | Robert-Bosch-Str. 1-3 |
| 79211 Denzlingen | |
| Germany | |
| Telephone Number: | +49-7666-980-0 |
| Fax Number: | +49-7666-908-380 |
| Contact Person: | Dr. Sandra Baumann |
| Subject Device Name: | |
| Trade Name: | Schoelly CMOS Video Nasopharyngoscope System |
| Trade Name: | Schoelly CMOS Video Nasopharyngoscope System |
| Common/Usual Name: | Video Nasopharyngoscope System |
| Classification Name: | EOB - Nasopharyngoscope (flexible or rigid) |
| 21 CFR 874.4760; Class II | |
| Predicate Device Name: | |
| Trade Name: | Karl Storz CMOS Video Rhino-Laryngoscope System Model 11101CM |
| Trade Name: | Karl Storz CMOS Video Rhino-Laryngoscope System Model 11101CM |
| Common/Usual Name: | Video Rhino-Laryngoscope System |
| Classification Name: | EOB - Nasopharyngoscope (flexible or rigid) |
| 21 CFR 874.4760; Class II | |
| Premarket Notification: | K103467 (Karl Storz Endoscopy-America, Inc.), SE date June 28, 2012 |
| Predicate Device Name: | |
| Trade Name: | Schoelly Naso-Laryngo-Pharyngoscope |
| Trade Name: | Schoelly Naso-Laryngo-Pharyngoscope |
| Common/Usual Name: | Nasopharyngoscope |
| Classification Name: | EOB - Nasopharyngoscope (flexible or rigid) |
| 21 CFR 874.4760; Class II | |
| Premarket Notification: | K083553 (Schoelly Imaging, Inc.), SE date January 16, 2009 |
Device Description
The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.
The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.
The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.
The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.
1
06/21/2013 CMOS Video Nasopharyngoscope System
Predicate Devices
The Karl Storz predicate device is based on the same technology has the same essential design and dimension characteristics, the same essential optical parameters and the same principle of operations. It is made out of the same primary materials and the same standards were applied and met for design verification and validation as compared to the proposed Schoelly CMOS Video Nasopharyngoscope System.
The Schoelly predicate device differs with respect to the image transfer technology; however this device is built out of identical components/systems for light transmission, angulation of the endoscope's distal tip or ventilation. Further, the manufacturing process for major parts of the endoscope is identical as compared to the endoscope of the proposed Schoelly CMOS Video Nasopharyngoscope System.
Indications for Use
The Schoelly CMOS Video Nasopharyngoscope 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.
The indications for use of the proposed devices are identical to the indications for use of the Karl Storz predicate device.
Non-clinical Performance Testing
Performance data demonstrated that the Schoelly CMOS Video Nasopharyngoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate devices. The device is as safe, as effective, and performs as well as or better than the predicate devices. The risks associated with use of the new device were found acceptable when evaluated in accordance with ISO 14971. Risks and benefits of predicate devices are the same as compared to the proposed one.
Testing has been conducted as per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 8600, and ISO 10993 to address the safety and performance aspects of the device.
Reprocessing
The endoscope of the proposed Schoelly CMOS Video Nasopharyngoscope System is the subject of completed reprocessing validations including manual cleaning, high-level disinfection and STERRAD® 100S sterilization.
Cleaning studies have been performed in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilties: A Guide for Device Manufacturers) and AAMI TIR30:2003 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices). Devices that have been used for testing had been exposed to extensive clinical use including tip angulation, soiling, and reprocessing to address the FDA Draft Guidance Processing Medical Devices in Healthcare Settings (dated: May 2, 2011).
Sterilization studies have been performed in accordance with ISO 14937.
Conclusion
The Schoelly CMOS Video Nasopharyngoscope System meets all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2014
Schoelly Fiberoptic GmbH c/o Ms. Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K132009
Trade/Device Name: Schoelly CMOS Video Nasopharyngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 3, 2014 Received: March 5, 2014
Dear Ms. Papineau:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 may be subject to 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.
3
Page 2 - Ms. Pamela Papineau
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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
4
Indications for Use
510(k) Number (if known): K132009
Device Name: Schoelly CMOS Video Nasopharyngoscope System
Indications for Use:
The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
.
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park 2014.04.08 14:30:52 -04'00'
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