(470 days)
Not Found
No
The summary describes a standard video endoscopy system and does not mention any AI or ML capabilities. The focus is on image capture, processing for display/recording, and standard performance/safety testing.
No
The device is described as an endoscopic examination tool for diagnosis, not for providing therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used with a medical video monitor for endoscopic examination", which is a diagnostic procedure.
No
The device description explicitly states that the solution includes both a video processor (CP-1000) and a video nasopharyngo-laryngoscope (VNL9-CP), which is a physical hardware component with an insertion tube, LED, fiber optic cables, and a CMOS video sensor. While software is mentioned and validated, it is part of a larger hardware system.
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 examination between the upper respiratory tracts of the nasal passage and the vocal cords." This describes a procedure performed on the patient's body to visualize internal structures.
- Device Description: The device is a videoscope solution that includes a flexible insertion tube with a camera and light source. This is consistent with an endoscopic device used for direct visualization.
- Lack of mention of in vitro testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body. IVD devices are specifically designed for such testing.
The device is clearly intended for direct visualization within the patient's body, which falls under the category of an endoscopic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the video processor CP-1000 and the video nasopharyngo-laryngoscope VNL9-CP. The naso-pharyngoscope consists of a handheld device with a flexible thin insertion tube. The illuminating LED is integrated in the handle while light is transmitted to the distal end through a bundle of fiber optic cables within the insertion tube. A CMOS video sensor is located at the bendable distal tip. The video signal of the sensor is transferred to the CP-1000 Video Processor for video image together with other information on an attached monitor and for recording video sequences or still images to a USB storage device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic Video
Anatomical Site
upper respiratory tracts of the nasal passage and the vocal cords.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by persons with an appropriate medical qualification who have thoroughly studied all the characteristics of this device and who are acquainted with the endoscopic technique.
clinical or ambulatory medical environment.
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)
Non-Clinical Performance Data: The PENTAX Medical VIVIDEO ENT Videoscope Solution has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. Testing has been conducted as per IEC60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993.
Optical Testing: Optical properties including signal to noise ratio, spatial resolution (MTF), distortion, and spectral distribution were measured for the video naso-pharyngoscope VNL9-CP in conjunction with the CP-1000 video processor. All results show that there are no differences between the subject device, PENTAX Medical VIVIDEO ENT Videoscope Solution, and the predicate device, KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System.
Reprocessing Validation: Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the VIVIDEO ENT Videoscope Solution and its accessories were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance"). Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing.
Sterilization and Shelf Life: PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for sterilization of the VIVIDEO ENT Videoscope Solution. The device is not provided sterile, therefore, shelf-life is not applicable.
Biocompatibility: Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices. A biocompatibility assessment of the amount of carbon black and titanium oxide contained in the patient contact parts of the device as well as the tolerable exposure (TE) value was conducted. The risk level of colorant was determined as "Very Low" based on the low concern for toxicity of colorant. The risk level of local toxicity was determined as "Acceptable" as a result of the biocompatibility testing.
Software: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS A under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Cybersecurity risks have been assessed and mitigated according to the FDA Guidance for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
EMC and Electrical Safety: The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX VIVIDEO ENT Videoscope Solution were confirmed by the following standards: IEC 60601-1-2:2001, A1:2004; IEC 60601 1:2005+CORR 1:2007+AM 1:2012; and IEC 60601-2-18:2009.
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.
KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System (K103467, clearance received on June 28, 2012)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2018
Pentax Medical William Goeller Vice President. Ouality/Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K171011
Trade/Device Name: PENTAX Medical VIVIDEO ENT Videoscope Solution Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: June 15, 2018 Received: June 18, 2018
Dear William Goeller:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Srinivas Nandkumar -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
2
Indications for Use
510(k) Number (if known) K171011
Device Name PENTAX Medical VIVIDEO ENT Videoscope Solution
Indications for Use (Describe)
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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3
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 221 CFR 807.92. All data included in this document is accurate and complete to the best of PENTAX Medical's knowledge.
Applicant: PENTAX Medical HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Contact: William Goeller Vice President, Quality and Regulatory Affairs PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: (201)571-2300 ext. 2318 FAX: (201)391-4189 Email: william.goeller@pentaxmedical.com
Date Prepared: 6/8/2018
Common Name: Nasopharyngoscope (Flexible or Rigid) Trade Name: PENTAX Medical VIVIDEO ENT Videoscope Solution Regulation Number: 21 CFR Part 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Predicate Device: KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System (K103467, clearance received on June 28, 2012)
Device Description:
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the video processor CP-1000 and the video nasopharyngo-laryngoscope VNL9-CP. The naso-pharyngoscope consists of a handheld device with a flexible thin insertion tube. The illuminating LED is integrated in the handle while light is transmitted to the distal end through a bundle of fiber optic cables within the insertion tube. A CMOS video sensor is located at the bendable distal tip. The video signal of the sensor is transferred to the CP-1000 Video Processor for video image together with other information on an attached monitor and for recording video sequences or still images to a USB storage device.
Intended Use/Indications for Use:
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGOLARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in clinical or ambulatory medical environment.
The device may only be used by persons with an appropriate medical qualification who have thoroughly studied all the characteristics of this device and who are acquainted with the endoscopic technique.
4
Summary of Technology Characteristics:
The PENTAX Medical VIVIDEO ENT Videoscope Solution is functionally equivalent to its predicate device, the KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System. The only difference between the two devices is that the predicate contains a combined monitor and video processor, whereas the subject device contains a separate monitor and video processor.
While there are some differences in the dimensional specifications in the subject device, these differences have been evaluated through performance testing and raise no issue of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device.
| Subject Device | Predicate Device | |
|---|---|---|
| Applicant | PENTAX Medical | KARL STORZ |
| Device Name | VIVIDEO ENT Videoscope Solution | CMOS Flexible Video Rhino- |
| Laryngoscope System (K103467) | ||
| Type of Device | Videoscope System | Videoscope System |
| Indications for use | For endoscopic examination | |
| between upper respiratory tracts | ||
| of the nasal passage and the vocal | ||
| cords. | For endoscopic diagnosis within | |
| the nasal lumens and airway | ||
| anatomy | ||
| Working Length | Same | Same |
| Shaft Diameter | 3.6mm | 3.7mm |
| Integrated CMOS sensor | Same | Same |
| Scope-integrated LED | ||
| illumination | Same | Same |
| No internal channels | Same | Same |
| Data Storage Capability | Yes | Yes |
Non-Clinical Performance Data
The PENTAX Medical VIVIDEO ENT Videoscope Solution has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. Testing has been conducted as per IEC60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993. The following performance data are provided in support of the substantial equivalence determination.
Optical Testing
Optical properties including signal to noise ratio, spatial resolution (MTF), distortion, and spectral distribution were measured for the video naso-pharyngoscope VNL9-CP in conjunction with the CP-1000 video processor. All results show that there are no differences between the subject device, PENTAX Medical VIVIDEO ENT Videoscope Solution, and the predicate device, KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System.
Reprocessing Validation
Simulated use testing, cleaning, high level dising (after cleaning and after HLD) validation studies of the VIVIDEO ENT Videoscope Solution and its accessories were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance"). Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing.
5
Sterilization and Shelf Life
PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for sterilization of the VIVIDEO ENT Videoscope Solution. The device is not provided sterile, therefore, shelf-life is not applicable.
Biocompatibility
Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization, and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.
A biocompatibility assessment of the amount of carbon black and titanium oxide contained in the patient contact parts of the device as well as the tolerable exposure (TE) value was conducted. The risk level of colorant was determined as "Very Low" based on the low concern for toxicity of colorant. The risk level of local toxicity was determined as "Acceptable" as a result of the biocompatibility testing.
Software
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS A under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity risks have been assessed and mitigated according to the FDA Guidance for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the PENTAX VIVIDEO ENT Videoscope Solution were confirmed by the following standards:
IEC 60601-1-2:2001, A1:2004; IEC 60601 1:2005+CORR 1:2007+AM 1:2012; and IEC 60601-2-18:2009.
Substantial Equivalence Discussion:
After analyzing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labeling, and sterilization method, we conclude that the subject device PENTAX Medical VIVIDEO ENT Videoscope Solution is as safe and effective as the predicate device, KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System. The differences in indications for use and intended use between the subject and predicate device do not raise new concerns of safety and effectiveness and are therefore, substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive.
Conclusion:
Accordingly, PENTAX Medical believes the PENTAX Medical VIVIDEO ENT Videoscope Solution is substantially equivalent to the identified predicate, KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System, cleared by FDA in 2009.