(179 days)
No
The description mentions "digital post-processing imaging enhancement technology" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a training or testing process indicative of AI/ML. The performance studies listed are related to reprocessing, biocompatibility, and basic performance, not algorithmic performance.
No.
The device descriptions state its intended use is for "gastrointestinal endoscopic diagnosis, treatment and video observation," and it includes imaging enhancement technologies, but it does not claim to directly treat or cure a disease. Treatment here refers to the act of performing endoscopic procedures, not as a therapeutic drug delivery or a therapeutic instrument itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "gastrointestinal endoscopic diagnosis."
No
The device description explicitly states that the device consists of a "video system, integrated light source, monitor, and ancillary equipment," which are hardware components. While it includes software for image enhancement, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The PENTAX Medical EPK-i7010 and EPK-i5010 Video Processors are used with endoscopes to visualize the gastrointestinal tract directly. They process video signals from the endoscope to enhance the image for observation and diagnosis in vivo (within the living body).
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device works by processing images obtained from within the body.
Therefore, the device falls under the category of an endoscopic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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.
The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX EPK-i5010 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. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.
Product codes
PEA
Device Description
The PENTAX Medical EPK-i7010 Video Processor and PENTAX EPK-i5010 Video Processor each consist of a video system, integrated light source, monitor, and ancillary equipment. These processors are intended for gastrointestinal endoscopic diagnostic, treatment and video observation.
The PENTAX Medical EPK-i7010 Video Processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. The PENTAX EPK-i5010 Video Processor contains only PENTAX i-Scan. The PENTAX i-Scan technology is a digital post-processing image enhancement technique with three modes, i-Scan 1, 2 and 3.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reprocessing Validation: The PENTAX Water Bottle Assembly OS-H5 is a reusable semi-critical device. It was subjected to cleaning and sterilization validation studies including Soil Accumulation Study, Cleaning Efficacy Study, Rinsing Validation, and Sterilization Validation. All acceptance criteria were satisfied.
Biocompatibility: The biocompatibility of the PENTAX Water Bottle Assembly (OS-H5) (indirect patient contact materials) was confirmed by testing for Cytotoxicity, Sensitization, and Intracutaneous Reactivity. The results satisfied the acceptance criteria specified in ISO 10993-1, 5, and 10 and FDA Guidance Document.
Performance Testing: The PENTAX Water Bottle Assembly OS-H5 has been tested for backflow prevention. The testing provided evidence that contaminants from the distal end of the endoscope do not backflow into Water Bottle Assembly OS-H5. The results concluded that acceptance criteria were met, and no backflow occurred under worst-case test conditions.
In addition, flow rate and air delivery testing has been conducted with a rigid-walled OS-H5 water bottle to demonstrate its substantial equivalence to the predicate Endo Smart Cap. The results of the testing confirmed that the performance of OS-H5 is equivalent to or greater than that of the predicate Endo Smart Cap.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
November 8, 2019
PENTAX of America, Inc. William Goeller Vice President, Quality/Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K191282
Trade/Device Name: PENTAX Medical EPK-i7010 Video Processor with GI family and PENTAX EPK-i5010 Video Processor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PEA Dated: October 8, 2019 Received: October 9, 2019
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.
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 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 (OS) 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.
Martha W. Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191282
Device Name
PENTAX Medical EPK-i7010 Video Processor with GI Family and PENTAX EPK-i5010 Video Processor
Indications for Use (Describe)
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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.
The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX EPK-i5010 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. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.
| 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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PENTAX Medical EPK-i7010 and EPK-i5010 with GI Family of Endoscopes 510(k) Summary
Image /page/3/Picture/1 description: The image shows the Pentax Medical logo. The logo is red and gray. Above the logo is the text "K191282" and "Page 1 of 5".
I. SUBMITTER
PENTAX of America, Inc., HOYA Corporation PENTAX Lifecare Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340
Contact: William Goeller Date Prepared: April 26, 2019
II. DEVICE
The purpose of this 510(k) is to obtain clearance of the PENTAX Medical EPK-i7010 Video Processor with GI family and PENTAX EPK-i5010 Video Processor for use with the PENTAX Water Bottle Assembly OS-H5.
This 510(k) captures some minor design changes that have occurred during the evolution of the product line that includes expansion of the product line to include the reusable water bottle accessory. Although the changes are believed to be minor, the 510(k) is being submitted to account for technological advances in associated the compatible devices and to ensure that FDA has the most current information concerning the PENTAX Medical video processors with GI family of scopes.
The subject devices have the same indications for use, composition of patient contact materials, viewing direction, image size, and reprocessing/sterilization method as the predicate.
| Device Names | PENTAX Medical EPK-i7010 Video Processor with
GI Family
PENTAX EPK-i5010 Video Processor |
|----------------------|------------------------------------------------------------------------------------------------|
| Common Name | Endoscope, Accessories, Video Post-processing for
Color Enhancement |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | 2 |
| Product Code | PEA |
| Classification Panel | Gastroenterology/ Urology |
Table 5.1: Regulatory Classification of PENTAX Medical Video Processors.
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Image /page/4/Picture/1 description: The image shows the Pentax Medical logo. The logo has the word "PENTAX" in red, with the word "MEDICAL" in gray underneath. The text "K191282 Page 2 of 5" is at the top of the image.
III. PREDICATE DEVICES
The predicate device for this submission, PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618), is virtually identical to the subject device. It's predicate, the PENTAX EPKi5010 Video Processor was the predicate for the EPK-i7010 submission, cleared through K122470, and it will be bundled in this subject devices differ from the predicate due to the replacement of accessory PENTAX Medical Dispo Cap Air Tubing (using a disposable water bottle) with the PENTAX Water Bottle Assembly OS-H5.
IV. DEVICE DESCRIPTION
The PENTAX Medical EPK-i7010 Video Processor and PENTAX EPK-i5010 Video Processor each consist of a video system, integrated light source, monitor, and ancillary equipment. These processors are intended for gastrointestinal endoscopic diagnostic, treatment and video observation.
The PENTAX Medical EPK-i7010 Video Processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. The PENTAX EPK-i5010 Video Processor contains only PENTAX i-Scan. The PENTAX i-Scan technology is a digital post-processing image enhancement technique with three modes, i-Scan 1, 2 and 3.
The table below is a list of accessories and compatible devices that are used with the EPKi7010 and EPK-i5010 Video Processors.
| Accessories Name | Model Number |
|---|---|
| PENTAX Medical | |
| Condenser Earth Cable | OL-Z4 |
| PENTAX Foot Switch | OS-A61 |
| PENTAX Medical Keyboard | OS-A83 |
| OS-A79 | |
| PENTAX White Balance | |
| Adjuster | OS-A43H |
| Table 1: List of Accessories | |
|---|---|
| ------------------------------ | -- |
P E N T A X M e d i c a l C o n f i d e n t i d e n t i a l
5
PENTAX Medical EPK-i7010 and EPK-i5010 with GI Family of Endoscopes 510(k) Summary
Image /page/5/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold, uppercase letters. Below "PENTAX" is a horizontal gray line. Below the line, the word "MEDICAL" is in gray, bold, uppercase letters.
| PENTAX Medical Water
| Bottle Assembly | OS-H5 |
|---|---|
| PENTAX Medical DispoCap | |
| Air (MEDIVATORS Endo | |
| SmartCap Tubing - K093665) | 100160P |
| (DispoCap Air | |
| Tubing) |
Table 2: List of Compatible Devices
| Compatible
| Devices | Manufacturer | Model name | Compatible with | |
|---|---|---|---|---|
| EPK-i7010 | EPK-i5010 | |||
| Printer | Sony Business Solutions | |||
| Corporation | UP-55MD | Y | Y | |
| UP-25MD | Y | --- | ||
| UP-D25MD | Y | --- | ||
| UP-21MD | --- | Y | ||
| UP-21MDA | --- | Y | ||
| UP-D23MD | --- | Y | ||
| UP-D23MDA | --- | Y | ||
| External Hard Drive | ||||
| HD Video Recorder | Western Digital Corporation | WDBBGB0030HBK | Y | --- |
| Sony Business Solutions | ||||
| Corporation | HVO-1000MD | Y | Y | |
| USB Flash Memory | Transcend Information, Inc. | |||
| SanDisk | TS32GJF600 | Y | --- | |
| SDCZ6-1024-A10 | --- | Y | ||
| LCD Monitor | (Any display devices which | |||
| satisfy safety requirements | ||||
| and other specifications) | Safety | |||
| Requirements | UL 60601-1 | |||
| CAN/CSA C22.2 No.601.1 | ||||
| EN 60601-1 |
The EPK-i7010 and EPK-i5010 are currently compatible with ENT and GI families of endoscopes.
P E N T A X M e d i c a l C o n f i d e n t i d e n t i d e n t i a l
6
Image /page/6/Picture/1 description: The image shows the Pentax Medical logo. The word "PENTAX" is in large, red, bold letters. Below "PENTAX" is a horizontal gray line. Below the line, the word "MEDICAL" is in gray, bold letters. The text "K191282 Page 4 of 5" is in the upper left corner of the image.
INDICATIONS FOR USE
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an 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.
The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.
The PENTAX EPK-i5010 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. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject devices are virtually identical to the predicate device. The subject devices have the same fundamental technology and operating principles of the predicate device, including the same intended use and design technological characteristics, such as Insertion Portion, Control Body and optical characteristics. The only substantive difference between the subject and predicate devices is the use of reusable PENTAX Water Bottle Assembly OS-H5 instead of Endo Smart Cap System (K093665). Since the PENTAX Water Bottle Assembly OS-H5 is initially supplied as non-sterile, an IFU for the device is provided with the EPK-i7010 and EPK-i5010 Video Processors. The IFU clearly instructs the user to clean and sterilize the water bottle daily or more frequently, depending on the patient and/or type of endoscopic procedure. However, these additional features did not affect the final product performance and did not raise any questions of safety or effectiveness as demonstrated by the biocompatibility and sterilization validation studies.
PERFORMANCE DATA
Reprocessing Validation
The PENTAX Water Bottle Assembly OS-H5 is a reusable semi-critical device (Spaulding Classification System). Since it is packaged non-sterile, it must be properly cleaned and sterilized BEFORE initial use. The OS-H5 must be subjected to an appropriate cleaning and sterilization process daily or more frequently, depending on the patient and/or type of endoscopic procedure.
The following tests have been performed for the PENTAX Water Bottle Assembly OS-H5:
- . Soil Accumulation Study
- Cleaning Efficacy Study
PENTAX Medical Confidential
7
PENTAX Medical EPK-i7010 and EPK-i5010 with GI Family of Endoscopes 510(k) Summary
Image /page/7/Picture/1 description: The image shows the Pentax Medical logo. The word "PENTAX" is in large, red, bold letters, and the word "MEDICAL" is in smaller, gray, bold letters below it. Above the logo, the text "K191282 Page 5 of 5" is visible.
- Rinsing Validation
- Sterilization Validation
All acceptance criteria were satisfied.
Biocompatibility
The biocompatibility of the PENTAX Water Bottle Assembly (OS-H5) (indirect patient contact materials) was confirmed by testing for Cytotoxicity, Sensitization, and Intracutaneous Reactivity. The acceptance criteria for the studies conform to those dealing with surface contact devices that contact mucosal membranes for limited contact duration (