(272 days)
Not Found
No
The document describes digital post-processing imaging enhancement technology (i-Scan), but does not mention AI or ML. The performance study focuses on image quality and visualization compared to a predicate device, not on AI/ML-driven analysis or diagnosis.
No.
The intended use of the device is for observation and diagnosis, including image enhancement for visualization, rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the PENTAX Medical EPK-3000 Video Processor is intended for "ENT endoscopic observation and ENT diagnosis".
No
The device description clearly outlines multiple hardware components including video processors, camera heads, endoscopes, light guides, and monitors. While it includes software for image processing (i-Scan), it is an integral part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PENTAX Medical EPK-3000 and EPK-i5010 Video Processors, along with their associated components (camera heads, endoscopes, etc.), are used for direct visualization of internal body cavities (specifically ENT areas) through endoscopy. They process and display video images captured by the endoscope.
- Intended Use: The intended use clearly states "ENT endoscopic observation and ENT diagnosis, treatment and video observation." This involves looking inside the body, not analyzing samples taken from the body.
- No mention of biological samples: The description of the device and its function does not involve the collection or analysis of any biological samples.
The device is a medical imaging system used for direct visualization and diagnosis within the body, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11-110, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scan™, digital, post-processing imaging enhancement technology.
Product codes (comma separated list FDA assigned to the subject device)
EOB, PEA, EOL, OUG
Device Description
PENTAX Medical EPK-3000 and ENT Video Imaging Systems are used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation. The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.
The new component to be added to the subject system is the PENTAX Medical Camera Head, model PVK-J10. The PVK-J10 is used in conjunction with a non-video endoscope, video processor, and light guide. The non-video endoscope is connected to the video processor via the camera head and the light guide. The light supplied from the video processor is transmitted to the distal end of the endoscope via the light guide and connector in order to illuminate the patient's body cavity. Light captured by the endoscope are converted into the video signals by the camera head, and the signals are transferred to the video processor to display the video images on the monitor.
The PVK-J10 camera head connects to rigid, non-video sinuscopes (K142249). It takes images formed on the ocular lens by CCD sensor inside the control head, and transmits the image signal to the video processor. Image signal from CCD sensor is adjusted in terms of color, contrast, etc., inside the video processor, and displayed on video equipment such as a monitor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light captured by endoscope converted into video signals.
Anatomical Site
ENT (Ear, Nose & Throat), including nasopharyngo-laryngoscopic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 provided in support of substantial equivalence:
- Reprocessing Validation: Simulated use testing, cleaning, high level disinfecting and rinsing validation studies of PVK-J10 were conducted and confirmed effectiveness of reprocessing procedures. All acceptance criteria were satisfied.
- Sterilization and Shelf Life: System 1E liquid chemical sterilization for PVK-J10 was validated. Device not provided sterile, so shelf-life not applicable.
- Biocompatibility: PVK-J10 is non-contact with patients, so biocompatibility evaluation is not applicable.
- Software and Cybersecurity: Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 and FDA Guidances.
- Electrical Safety and EMC: Acceptable level of ES and EMC confirmed by IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.
- System Performance: Demonstrated equivalence to predicate devices. Test results demonstrated six years of service life for PVK-J10 and AP-RV3.
- Optical Performance: Optical properties of imaging and illumination performances were measured for PVK-J10 with representative Sinuscopes and light guides in conjunction with EPK-3000 and EPK-i5010 Video Processors. Results show optical characteristics are equivalent to predicate device.
- Photobiological Safety of lamps and lamp systems: Photobiological safety of lamps and lamp systems for PVK-J10 with representative Sinuscope and light guide in conjunction with EPK-3000 and EPK-i5010 Video Processors was evaluated. Results show all hazards acceptable.
- Animal Image Capture Study: N/A
- Clinical Image Capture Study: Performed as part of optical and color performance testing. Imaging systems with PVK-J10 and Sinuscope 8893 and PVK-J10 with Sinuscope 8891 were used as representative models. Results indicate that the subject device is able to visualize structure, vascularity and mucosal surface as well or better than the predicate device.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2022
PENTAX of America, Inc. William Goeller Vice President, Ouality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, New Jersey 07645-1782
Re: K220465
Trade/Device Name: PENTAX Medical EPK-3000 Video Imaging System PENTAX Medical ENT Video Imaging System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB. PEA. EOL. OUG Dated: October 14, 2022 Received: October 17, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220465
Device Name PENTAX Medical EPK-3000 Video Imaging System
Indications for Use (Describe)
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8892, 8893), PENTAX Medical VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
**Type of Use (Select one or both, as applicable)**X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K220465
Device Name PENTAX Medical ENT Video Imaging System
Indications for Use (Describe)
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11-110, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scan™, a digital, post-processing imaging enhancement technology.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below that is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif letters. The logo is simple and modern.
5. 510(k) Summary
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.
1 SUBMITTER
- 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: 02/08/2022
SUBJECT DEVICE 2
PENTAX Medical is seeking clearance of two Imaging Systems that include a new camera head product, the PENTAX Medical Camera Head PVK-J10.
This product is used in conjunction with 3rd party non-video endoscopes (such as a rigid scope) and converts light captured by the non-video scope into video images through a processor, to be displayed on a monitor. Addition of the camera head expands utility of the video imaging systems by providing compatibility with additional ENT scopes.
PENTAX Medical Camera Head PVK-J10 is compatible with following two systems:
- PENTAX Medical EPK-3000 Video Imaging System ●
- PENTAX Medical ENT Video Imaging System ●
Compatible Endoscopes for above systems are as follows;
- Video Endoscopes : VNL-1570STK, VNL15-J10, VNL11-J10, VNL8-J10 ●
- Add-on Camera Head: PENTAX Medical camera head PVK-J10 with previously cleared Sinuscope models 8890, 8891,8892, 8893.
The regulatory classification of PENTAX Medical Camera Head PVK-J10 is identified in Table 5.1.
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| Table 5.1: Regulatory Classification of PENTAX Medical Imaging Systems with PVK-J10 |
|---|
| Camera Head |
| Device Names | PENTAX Medical EPK-3000 Video Imaging System |
|---|---|
| Common Name | Naso-Pharyngo-Laryngoscope |
| Classification Name | Nasopharyngoscope (Flexible or Rigid) and Accessories |
| Regulation No. | 874.4760 |
| Device Class | II |
| Product Code | EOB, PEA, EQL, OUG |
| Classification Panel | Ear Nose & Throat |
| Device Names | PENTAX Medical ENT Video Imaging System |
|---|---|
| Common Name | Naso-Pharyngo-Laryngoscope |
| Classification Name | Nasopharyngoscope (Flexible or Rigid) and Accessories |
| Regulation No. | 874.4760 |
| Device Class | II |
| Product Code | EOB, PEA, EQL, OUG |
| Classification Panel | Ear Nose & Throat |
3 PREDICATE DEVICE
The Predicate Devices for each Subject Devices are identified in Table 5.2. And Figure 5.1 shows system difference between Predicate Devices and Subject Devices Table 5.2: Subject Device and Predicate Device relation
| Subject Device | Predicate Device | Predicate Device 510(k)
Clearance Number |
|----------------------------------------------------|----------------------------------------------------|---------------------------------------------|
| PENTAX Medical
EPK-3000 Video Imaging
System | PENTAX Medical
EPK-3000 Video Imaging
System | K172156, K182846 |
| PENTAX Medical
ENT Video Imaging System | PENTAX Medical
ENT Video Imaging System | K183691 |
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Image /page/6/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below it is a gray line, and below that is the word "MEDICAL" in gray, bold, sans-serif letters. The logo is simple and modern.
Image /page/6/Figure/3 description: The image shows a comparison between a subject device and a predicate device. The subject device includes a PENTAX rigid scope with the label (Schoelly: K142249), an adaptor AP-RV3, a PVK-J10, a PENTAX light guide cable labeled (510(k) exempt), a connector 8879 (K944656), an EPK-3000/EPK-i5010 video processor light source, a monitor, and a 9310HD/9372HD video capture module. The predicate device includes a VNL11-J10, an EPK-3000/EPK-i5010 video processor light source, a monitor, and a 9310HD/9372HD video capture module.
Figure 5.1. System configuration difference Predicate Devices and Subject Devices
DEVICE DESCRIPTION 4
PENTAX Medical EPK-3000 and ENT Video Imaging Systems are used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation. The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.
The new component to be added to the subject system is the PENTAX Medical Camera Head, model PVK-J10. The PVK-J10 is used in conjunction with a non-video endoscope, video processor, and light guide. The non-video endoscope is connected to the video processor via the camera head and the light guide. The light supplied from the video processor is transmitted to the distal end of the endoscope via the light guide and connector in order to illuminate the patient's body cavity. Light captured by the endoscope are converted into the video signals by the camera head, and the signals are transferred to the video processor to display the video images on the monitor.
The PVK-J10 camera head connects to rigid, non-video sinuscopes (K142249). It takes images formed on the ocular lens by CCD sensor inside the control head, and transmits the image signal to the video processor. Image signal from CCD sensor is adjusted in terms of color, contrast, etc.,
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Image /page/7/Picture/2 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif letters. Below the word "PENTAX" is a gray line. Below the gray line is the word "MEDICAL" in gray, bold, sans-serif letters.
inside the video processor, and displayed on video equipment such as a monitor.
The camera head has a zoom function with focal lengths of 6.5 mm for the wide end and 13mm for the telephoto end.
The video processors to be connected to the PVK-J10 camera head and light guides are PENTAX Medical Video Processors EPK-i5010 and EPK-3000, both of which have been cleared.
PENTAX Medical sinuscopes 8890, 8891,8892, 8893, manufactured by Schoelly Fiberoptic GmbH and cleared under K142249. The light guides 8899HT used to connect PVK-J10 with these endoscopes are also manufactured by Schoelly Fiberoptic GmbH. PENTAX Medical sell Schoelly Sinuscopes and light guide as private brand, Model Name combination are shown in Table 5.3
| Sinuscopes | | Light Guides | | K#
Schoelly |
|--------------------------------|-------------------------|--------------------------------|-------------------------|----------------|
| PENTAX Medical
Model Number | Schoelly
Item number | PENTAX Medical
Model Number | Schoelly
Item number | |
| 8893 | 31.0801a | 8899HT | 05.0090I.ht | K142249 |
| 8890 | 31.0804a | | | |
| 8892 | 31.0810a | 8898HT | 05.0088I.ht | |
| 8891 | 31.0811a | | | |
Table 5.3:PENTAX Private Brand Name and Schoelly Item Number Combination
5 INTENDED USE AND INDICATIONS FOR USE
PENTAX Medical EPK-3000 Video Imaging System
PENTAX Medical EPK-3000 Video Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-Scan™, a
digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.
PENTAX Medical ENT Video Imaging System
The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893),
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PENTAX Medical VNL-1570STK, VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy.
The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scan™, digital, post-processing imaging enhancement technology.
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE 6 PREDICATE
The subject Imaging systems that include the PENTAX Medical PVK-J10 Camera Head are functionally equivalent to the predicate devices, PENTAX Medical EPK-3000 Video Imaging (K172156, K182846) and PENTAX Medical ENT Video Imaging System (K183691) . The main difference between the subject and the predicate are minor technological changes that add a compatible Camera Head with sinuscope to the predicate systems.
The changes in the subject device 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 devices.
The optical components of the PENTAX Medical Camera Head have the same fundamental technology ( Software, Type of Image Sensor, CCD Pixel ) as the optical components of the predicate device. Both the PENTAX Medical Camera Head and the predicate device are intended for illuminating and viewing the inside of the human body. Subject devices that add PVK-J10 with sinuscope to the predicate system configurations have the same visual capabilities as the predicate systems. This has been successfully substantiated by a series of bench tests and the clinical image capture study.
Both subject and the predicate scopes are reprocessed by the user.
7 NON-CLINICAL PERFORMANCE DATA
The PENTAX Medical Imaging Systems with PVK-J10 Camera Head have been successfully tested for their function, performance and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.
Operational and Reprocessing Instructions for Use are provided for the PVK-J10.
i. Reprocessing Validation
As result of the assessment, simulated use testing, cleaning, high level disinfecting and rinsing (after cleaning and after HLD) validation studies of PVK-J10 was conducted and
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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.
All acceptance criteria were satisfied.
-
ii. Sterilization and Shelf Life
PENTAX Medical coordinated with STERIS Corporation to validate the use of System 1E liquid chemical sterilization for the sterilization of the PVK-J10. The device is not provided sterile, therefore, shelf-life is not applicable. -
iii. Biocompatibility
PVK-J10 is the camera head used in combination with scope and non-contact with patients, therefore biocompatibility evaluation is not applicable. -
iv. Software and Cybersecurity
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 and FDA Guidances for Industory and Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.", "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices."
Electrical Safety and EMC V.
The acceptable level of electrical safety (ES) and electromagnetic compatibility (EMC) for the PENTAX Medical Camera Head PVK-J10 was confirmed by the following standards: IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.
-
vi. System Performance
The system performance of the subject devices demonstrated the equivalence to the predicate devices. Test results also demonstrated six years of the service life for the PVK-J10 and AP-RV3 (PENTAX Medical Endoscope Mount Adapter for Rigid Ocular Endoscopes) -
vii. Optical Performance
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the PVK-J10 with representative Sinuscopes and light guides in conjunction with the EPK-3000 and EPK-i5010 Video Processors. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device.
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Image /page/10/Picture/2 description: The image contains the logo for Pentax Medical. The word "PENTAX" is in red, bold, sans-serif font. Below the word "PENTAX" is a gray line. Below the gray line is the word "MEDICAL" in gray, bold, sans-serif font.
viii. Photobiological Safety of lamps and lamp systems
PENTAX Medical evaluated the photobiological safety of lamps and lamp systems for the PVK-J10 with the representative Sinuscope and light guide in conjunction with the EPK-3000 and EPK-i5010 Video Processors. The results show that all hazards related to the photobiological safety are acceptable for the subject device.
- ix. Animal Image Capture Study N/A
- x. Clinical Image Capture Study
Clinical image capture study was performed as a part of optical and color performance testing. In this study, the Imaging systems with PVK-J10 and Sinuscope 8893 and PVK-J10 with Sinuscope 8891 were used as the representative model. The results indicate that the subject device is able to visualize structure, vascularity and mucosal surface as well or better than the predicate device.
8 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, PENTAX Medical concludes that the subject Imaging Systems with PVK-J10 camera head are as safe and effective as the predicate devices. There are no differences in indications for use and intended use between the subject and predicate devices The technological differences in terms of design features, performance characteristics and constituent materials are not substantive. Thus, the subject and predicate devices are substantially equivalent.
9 CONCLUSION
Accordingly, PENTAX Medical believes the PENTAX Medical Imaging systems with PVK-110 Camera Head are substantially equivalent to the identified predicates. PENTAX Medical EPK-3000 video imaging system (K172156 and K182846) and PENTAX Medical ENT Video Imaging System ( K183691).