(70 days)
Not Found
No
The summary describes a standard video endoscope system for visualization and documentation, with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions. The performance studies focus on disinfection efficacy and functional testing, not algorithmic performance.
No.
The intended use of the device is for visualization for diagnosis, not for treatment or therapy.
Yes
The device is explicitly stated to be for "The endoscopic diagnosis within the nasal lumens and airway". Diagnosis is a key function of diagnostic devices.
No
The device description explicitly details hardware components including a flexible and steerable endoscope, a camera control unit (CCU), an integrated LED light source, fiberoptic bundles, a CMOS imaging sensor, a ventilation system, a shaust valve, and a leakage tester. The performance studies also include testing on the physical device (disinfection and functional testing).
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 and is intended to provide visualization via a video monitor." This describes a device used for direct visualization of internal body structures, which is a characteristic of an endoscope, not an IVD.
- Device Description: The description details a flexible endoscope with a camera and light source for visualizing anatomy. This aligns with the function of an endoscope.
- Lack of IVD Characteristics: An IVD is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis. This device is used in vivo (inside the body) for direct visualization.
- Performance Studies: The performance studies described focus on disinfection efficacy, cytotoxicity, and functional testing, which are relevant for a reusable medical device like an endoscope, but not typical for evaluating the diagnostic performance of an IVD.
Therefore, the Schoelly CMOS Video Nasopharyngoscope System is a medical device used for visualization during endoscopic procedures, not an In Vitro Diagnostic device.
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 rhino/laryngoscopic technique. The endoscopic diagnosis within the nasal lumens and airway 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 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 shaust 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
nasal lumens and airway
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)
High Level Disinfection Efficacy Testing: `This 510(k) contains a summary of the high level disinfection (HLD) validation conducted in accordance with ASTM E 1837 and ANSI AAMI ST 58. This validated HLD process consists of a 12 minute immersion in 0.55% orthophthaldehyde (Cidex OPA) followed by three water rinses, then air drying. The validation was conducted on devices that had previously been in clinical use to ensure "real life" conditions. Test devices and controls were inoculated in several locations with a high-titer (> 10° CFU/mL) suspension of an indicator organism (Mycobacterium terrae). The test devices were disinfected and rinsed according to the device Instructions for Use; the control devices were not disinfected after inoculation. Both the test (inoculated and disinfected) and control (inoculated only) devices were rinsed with a saline buffer solution and the rinse fluid was cultured to determine the number of viable indicator organisms on each device. These data were used to derive the log-reduction in M. terrae achieved through the HLD process. In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study.
The final recovery portion of this validation demonstrated that the HLD process successfully achieved a 7.5-log reduction in the indicator organism; all of the control devices were found to have the indicator organism present at a minimum concentration of 106 CFU at recovery. Therefore, the HLD process was successfully validated to achieve a minimum 6-log reduction of an appropriate indicator organism.`
Cytotoxicity Testing: Cytotoxicity testing performed on the test devices immediately after HLD confirmed that there was no residual disinfectant material that could adversely affect the test results by obscuring residual indicator organisms remaining after HLD.
Functional Testing: To confirm that the HLD process caused no adverse effects on the endoscope, several devices were subjected to multiple, extended HLD cycles followed by visual inspection; no damage or material degradation was observed in any of these test samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HLD process successfully achieved a 7.5-log reduction in the indicator organism
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
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
Schoelly Fiberoptic Gmbh % Ms. Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432
Re: K143673
Trade/Device Name: 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: January 29, 2015 Received: February 5, 2015
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.
1
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 devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
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Indications for Use
510(k) Number (if known) K143673
Device Name
Schoelly CMOS Video Nasopharyngoscope System
Indications for Use (Describe)
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 endoscopic diagnosis within the nasal lumens and airway and is intended to provide visualization via a video monitor.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Special 510(k) Summary
| Preparation date: | 27 February 2015 |
|---|---|
| 510(k) Number: | K143673 |
| Owner's Name: | |
| Address: | Schoelly Fiberoptic GmbH (Registration: 8043903) |
| Robert-Bosch-Str. 1 - 3 | |
| 79211 Denzlingen | |
| Germany | |
| Telephone Number: | |
| Fax Number: | |
| Contact Person: | +49-7666-980-0 |
| +49-7666-908-380 | |
| Dr. Sandra Baumann | |
| Subject Device Name: | |
| Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | Schoelly CMOS Video Nasopharyngoscope System |
| Schoelly CMOS Video Nasopharyngoscope System | |
| Video Nasopharyngoscope System | |
| EOB - Nasopharyngoscope (flexible or rigid) | |
| 21 CFR 874.4760; Class II | |
| Predicate Device Name: | |
| Trade Name: | |
| Common/Usual Name: | |
| Classification Name: | Schoelly CMOS Video Nasopharyngoscope System |
| Schoelly CMOS Video Nasopharyngoscope System | |
| Video Nasopharyngoscope System | |
| EOB - Nasopharyngoscope (flexible or rigid) | |
| 21 CFR 874.4760; Class II | |
| Premarket Notification: | K132009 (Schoelly Fiberoptic GmbH), SE date April 09, 2014 |
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 shaust 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.
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.
Predicate Device
The predicate device is identical to the proposed device with the same device specifications and design, the same indications for use, and the same fundamental scientific technology. The changes described in this submission are limited to a change in the device Instructions for Use to add a validated method for high level
4
disinfection to the Schoelly CMOS Video Nasopharyngoscope System that was cleared for marketing by FDA in K132009. This labeling change is the only change to the device cleared in K132009.
Performance Testing
High Level Disinfection Efficacy Testing
This 510(k) contains a summary of the high level disinfection (HLD) validation conducted in accordance with ASTM E 1837 and ANSI AAMI ST 58. This validated HLD process consists of a 12 minute immersion in 0.55% orthophthaldehyde (Cidex OPA) followed by three water rinses, then air drying. The validation was conducted on devices that had previously been in clinical use to ensure "real life" conditions. Test devices and controls were inoculated in several locations with a high-titer (> 10° CFU/mL) suspension of an indicator organism (Mycobacterium terrae). The test devices were disinfected and rinsed according to the device Instructions for Use; the control devices were not disinfected after inoculation. Both the test (inoculated and disinfected) and control (inoculated only) devices were rinsed with a saline buffer solution and the rinse fluid was cultured to determine the number of viable indicator organisms on each device. These data were used to derive the log-reduction in M. terrae achieved through the HLD process. In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study.
The final recovery portion of this validation demonstrated that the HLD process successfully achieved a 7.5-log reduction in the indicator organism; all of the control devices were found to have the indicator organism present at a minimum concentration of 106 CFU at recovery. Therefore, the HLD process was successfully validated to achieve a minimum 6-log reduction of an appropriate indicator organism.
Cytotoxicity Testing
Cytotoxicity testing performed on the test devices immediately after HLD confirmed that there was no residual disinfectant material that could adversely affect the test results by obscuring residual indicator organisms remaining after HLD.
Functional Testing
To confirm that the HLD process caused no adverse effects on the endoscope, several devices were subjected to multiple, extended HLD cycles followed by visual inspection; no damage or material degradation was observed in any of these test samples.
Conclusion
The proposed modification to the Schoelly CMOS Video Nasopharyngoscope System labeling has met all predetermined acceptance criteria as specified by applicable standards, test protocols, and/or customer inputs and does not introduce new patient or user risks. The device with the modified labeling is substantially equivalent to the device cleared in K132009.