(70 days)
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.
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.
This document is a 510(k) summary for a Special 510(k) submission, meaning the changes described are limited to a modification of an already cleared device. In this specific case, the only change is an update to the Instructions for Use to add a validated method for high-level disinfection.
Therefore, the "device performance" described is specifically the performance of the High-Level Disinfection (HLD) process, not the overall performance of the nasopharyngoscope system for its intended diagnostic use. The study proves the HLD process meets the acceptance criteria for disinfection efficacy.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (HLD Efficacy) |
|---|---|
| Minimum 6-log reduction of an appropriate indicator organism (Mycobacterium terrae) | Successfully achieved a 7.5-log reduction. |
| No significant adverse effects on the endoscope from HLD process | No damage or material degradation observed after multiple, extended HLD cycles. |
| No residual disinfectant material that could adversely affect test results by obscuring residual indicator organisms. | Cytotoxicity testing confirmed no such residual material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for HLD Efficacy Test: "In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study." This refers to the number of test devices and control devices used in the disinfection validation.
- Data Provenance: The devices used for validation had "previously been in clinical use to ensure 'real life' conditions." This suggests the data provenance is retrospective clinical use, but the validation itself was a prospective laboratory study performed on these used devices. The country of origin for the data is not explicitly stated, but the manufacturer is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this specific study. The "ground truth" for the HLD efficacy study was established through laboratory methods (culturing viable indicator organisms to determine log reduction), not through expert clinical consensus or interpretation of images.
4. Adjudication Method for the Test Set
This is not applicable. The HLD efficacy test involved quantitative microbiological culturing and functional/material testing, not human interpretation that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases with and without AI assistance and is relevant for evaluating diagnostic accuracy, which is not the focus of this specific 510(k) submission (which only concerns HLD validation).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable. There is no "algorithm" or AI in the context of high-level disinfection validation. The study evaluated the mechanical and chemical process of disinfection.
7. The type of ground truth used
The ground truth used for the HLD efficacy study was laboratory-derived quantitative microbiological counts. Specifically, the number of viable indicator organisms (Mycobacterium terrae) remaining after disinfection, determined by culturing.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of validating a high-level disinfection process. This is a laboratory validation, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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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.
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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)
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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 - 379211 DenzlingenGermany |
| Telephone Number:Fax Number:Contact Person: | +49-7666-980-0+49-7666-908-380Dr. Sandra Baumann |
| Subject Device Name:Trade Name:Common/Usual Name:Classification Name: | Schoelly CMOS Video Nasopharyngoscope SystemSchoelly CMOS Video Nasopharyngoscope SystemVideo Nasopharyngoscope SystemEOB - Nasopharyngoscope (flexible or rigid)21 CFR 874.4760; Class II |
| Predicate Device Name:Trade Name:Common/Usual Name:Classification Name: | Schoelly CMOS Video Nasopharyngoscope SystemSchoelly CMOS Video Nasopharyngoscope SystemVideo Nasopharyngoscope SystemEOB - 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
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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.
§ 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.