(125 days)
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
The provided text describes the 510(k) submission for the PENTAX Medical Video Processor EPK-i8020c. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document, as the submission relies on non-clinical performance data and a comparison to an already cleared predicate device.
However, I can extract information related to the device's performance testing and the nature of the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional and Safety Standards Compliance | The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for its functions, performance, and safety as per FDA recognized consensus standards. This includes: |
| - Reprocessing Validation (for non-reprocessed devices) | Not required, as the subject device is not reprocessed and provided non-sterile. Reprocessing procedures for reference devices (video bronchoscopes) remain unchanged. |
| - Sterilization and Shelf Life (for non-sterile devices) | Not required, as the subject device is not reprocessed and is not provided sterile. |
| - Biocompatibility (for devices without direct/indirect patient contact) | Not required, as the subject device does not contain any direct or indirect patient contact components. Materials of reference devices (video bronchoscopes) remain unchanged. |
| - Software and Cybersecurity Compliance | Software verification and validation, including cybersecurity assessments, were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry and Staff documents on software and cybersecurity in medical devices. |
| - Electrical Safety (ES) and Electromagnetic Compatibility (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 Equivalence to Predicate | The system performance of the subject device demonstrated equivalence to the predicate device. |
| - Optical Performance Equivalence to Predicate and Reference | Optical properties of imaging and illumination performances were measured. All results show that the optical characteristics of the subject device are equivalent to those of the predicate device and the reference device. |
| - Ability to visualize vascularity and mucosal surface | An animal image capture study indicated that the subject device is able to visualize vascularity and mucosal surface for targeted anatomical areas as well as the predicate device and the reference device. This was performed as part of optical and color performance testing. "This study raised no issues of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device." (From section 7) |
| - Substantial Equivalence to Predicate | The subject device is deemed "as safe and effective as the predicate device" with "no differences in indications for use and intended use" and "technological differences... are not substantive." |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "performance testing" and an "animal image capture study" but does not quantify the number of cases or animals involved.
- Data provenance: For the "animal image capture study," the data provenance is from an animal study. The country of origin is not specified but implicitly assumed to be from within PENTAX Medical's research and development. This was a non-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The animal study evaluated the device's ability to "visualize vascularity and mucosal surface," implying an objective assessment rather than a diagnostic interpretation requiring expert ground truth establishment for a specific medical condition. The study aimed to assess optical and color performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the "animal image capture study" for optical and color performance, an adjudication method for diagnostic agreement with a ground truth is not described as the primary objective was visualization capability comparison.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The device (PENTAX Medical Video Processor EPK-i8020c) includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)." However, the submission does not describe a human-in-the-loop study to evaluate the effectiveness of these enhancements or how human readers' performance improves with or without these features. The statement is that these technologies are "intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- A standalone performance assessment was done for various system components, including software and optical performance. The "animal image capture study" can be considered a standalone assessment of the device's imaging capabilities (optical and color performance) in a biological setting, comparing it to predicate/reference devices. This was an evaluation of device capability itself, not an algorithm's diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "animal image capture study," the "ground truth" was the objective presence of vascularity and mucosal surface in the animal model. The assessment was likely based on the visual quality and clarity of these features as captured by the device, compared to the predicate and reference devices. It was not a ground truth for a diagnostic condition established by pathology or expert consensus.
8. The sample size for the training set:
- Not applicable/Not specified. This submission does not describe a machine learning algorithm that would require a distinct training set. The device contains "digital post-processing imaging enhancement technology (PENTAX i-Scan™)," which might involve algorithms, but the development and training of these are not detailed as part of this 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set is discussed in this context.
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January 18, 2024
PENTAX of America, Inc. Gurvinder Singh Nanda Senior Director Regulatory and Quality 3 Paragon Drive Montvale. New Jersey 07645-1782
Re: K232860
Trade/Device Name: PENTAX Medical Video Processor EPK-i8020c Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 20, 2023 Received: December 20, 2023
Dear Gurvinder Singh Nanda:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Shuchen Peng -S
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 Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232860
Device Name
PENTAX Medical EPK-i8020c Video Imaging System
Indications for Use (Describe)
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes.
| 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)
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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
Gurvinder Singh Nanda Contact: Senior Director, Regulatory Affairs and Quality PENTAX Medical 3 Paragon Drive Montvale, New Jersey 07645-1782 Telephone: 650-722-4189 FAX: (201)391-4189 Email: gurvinder.nanda@pentaxmedical.com
Date Prepared: 1/17/2024
2. SUBJECT DEVICE
| PENTAX Medical EPK-i8020c Video Imaging System | ||
|---|---|---|
| Device Name | PENTAX Medical Video Processor EPK-i8020c | |
| Common Name | Endoscopic Video Processor and Light Source | |
| Classification Name | Bronchoscope (flexible or rigid) and accessories | |
| Regulation No. | 874.4680 | |
| Device Class | II | |
| Product Code | EOQ * | |
| Classification Panel | Ear Nose & Throat |
- The gastrointestinal use (product code: PEA) of the subject device has been cleared in K231249, and pulmonary use (product code: EOQ) is added through this submission.
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PENTAX Medical EPK-i8020c Video Imaging System Traditional 510(k) Submission
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The PENTAX Medical Video Processor EPK-i8020c is compatible also with the following endoscopes that have been cleared in past Premarket Notifications:
| Device Name | Model name |
|---|---|
| PENTAX MedicalVideo Bronchoscope | EB19-J10 (K200678) |
| EB15-J10 (K200678) | |
| EB11-J10 (K210928) | |
| PENTAX MedicalUltrasound Video Bronchoscope | EB19-J10U (K183516 and K203166) |
3. PREDICATE DEVICE
Previously cleared PENTAX Medical Video Processor and Video Scopes have been chosen as a predicate device:
| Subject Device | Predicate Device |
|---|---|
| PENTAX Medical Video ProcessorEPK-i8020c | PENTAX Medical EPK-i7010 VideoProcessor with EB Family of Scopes(K173679) |
4. REFERENCE DEVICE
A previously cleared PENTAX Medical Video Scopes have been chosen as a reference device:
Reference device for video scopes
| Model Name | Model Number | CompatibleVideo processor | 510(k) ClearanceNumber |
|---|---|---|---|
| PENTAX MedicalVideo Bronchoscope | EB19-J10 | EPK-i7010 | K200678 |
| EB15-J10 | |||
| EB11-J10 | K210928 |
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PENTAX Medical EPK-i8020c Video Imaging System Traditional 510(k) Submission
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| Model Name | Model Number | CompatibleVideoprocessor | UltrasoundScanner | 510(k)ClearanceNumber |
|---|---|---|---|---|
| PENTAX MedicalUltrasoundVideo Bronchoscope | EB19-J10U | EPK-i7010 | ARIETTA 70 | K183516 |
| ARIETTA 850 | K203166 |
Reference device for ultrasound video scopes
5. DEVICE DESCRIPTION
PENTAX Medical Video Processor EPK-i8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.
The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.
The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.
6. INTENDED USE AND INDICATIONS FOR USE
Intended use and Indications for use for PENTAX Medical Video Processor EPKi8020c
The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
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7. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject device is functionally equivalent to the predicate device, and the difference between the two devices are minor technological changes such as the application of a CMOS image sensor for the new endoscopes and an LED light source for the new video processor.
The changes in the subject device have been evaluated through performance testing including an image quality animal study. This study raised no issues of safety and effectiveness of the device as these differences have no effect on the performance, function or general intended use of the device.
The components of the subject device have the same fundamental technology and principle of operation as the predicate device. Both the subject device and the predicate device are intended for illuminating and viewing the inside of the human body. The components of the subject device consist of the same components as the predicate device, including:
- . A video processor
- . Video Bronchoscope to provide optical visualization of (via a video monitor), and therapeutic access to the trachea and bronchial tube.
- Accessories, including but not limited to a keyboard, foot switch, White Balance Adjuster, and Condenser Earth Cable
8. NON-CLINICAL PERFORMANCE DATA
The PENTAX Medical EPK-i8020c Video Imaging System has been successfully tested for their functions, performance, and safety as per FDA recognized consensus standards. The following performance data are provided in support of the substantial equivalence determination.
-
i. Reprocessing Validation
Additional Reprocessing Validation is not required, because the subject device is not reprocessed and provided non-sterile. The reprocessing procedures of the reference devices (video bronchoscopes) have not changed since past Premarket Notifications. -
ii. Sterilization and Shelf Life Sterilization and shelf life is not required because the subject device is not
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reprocessed and is not provided sterile.
-
iii. Biocompatibility
Additional biocompatibility is not required, because the subject device does not contain any direct or indirect patient contact components. Also, the materials of the reference devices (video bronchoscopes) have not changed since past Premarket Notifications. -
iv. Software and Cybersecurity
Software verification and validation including cybersecurity assessments were conducted according to IEC 62304: 2006 + A1: 2015 and FDA Guidance for Industry 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) were 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 device demonstrated the equivalence to the predicate device. -
vii. Optical Performance
As a part of Design Verification and Validation, optical properties of imaging and illumination performances were measured for the PENTAX Medical EPK-i8020c Video Imaging System. All results show that the optical characteristics of the subject device is equivalent to those of the predicate device and the reference device. -
viii. Animal Image Capture Study
An animal image capture study was performed as a part of optical and color performance testing. The results indicate that the subject device is able to visualize vascularity and mucosal surface for targeted anatomical areas as well as the predicate device and the reference device.
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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, reprocessing and sterilization methods, PENTAX Medical concludes that the subject device is as safe and effective as the predicate device. There are no differences in indications for use and intended use between the subject and predicate device and are therefore substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive.
9. CONCLUSION
Accordingly, PENTAX Medical believes the PENTAX Medical EPK-i8020c Video Imaging System does not raise any different questions of safety and effectiveness, and that the subject device of the PENTAX Medical Video Processor EPK-i8020c is substantially equivalent to the identified predicate, the PENTAX Medical Video Processor EPK-i7010, cleared by FDA in K173679.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.