PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · Pentax of America, Inc. · PEA · Nov 8, 2019 · Gastroenterology, Urology
Device Facts
Record ID
K191282
Device Name
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Applicant
Pentax of America, Inc.
Product Code
PEA · Gastroenterology, Urology
Decision Date
Nov 8, 2019
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
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.
Device Story
Video processors (EPK-i7010, EPK-i5010) integrate with endoscopes, light sources, and monitors for GI endoscopy. EPK-i7010 features digital i-Scan and optical enhancement (OE); EPK-i5010 features digital i-Scan. Systems process video signals from endoscope camera heads to provide real-time visualization for clinicians. i-Scan provides digital post-processing enhancement (3 modes); OE provides optical enhancement. Used in clinical settings by physicians for diagnosis and treatment. Output displayed on monitors for clinical decision-making. Subject devices introduce reusable water bottle assembly (OS-H5) for irrigation, replacing disposable cap systems. Benefits include enhanced visualization of mucosal structures to assist clinical observation.
Clinical Evidence
No clinical data. Bench testing only. Reprocessing validation (soil accumulation, cleaning efficacy, rinsing, sterilization) for OS-H5 satisfied all criteria. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity) per ISO 10993-1, 5, and 10 confirmed negligible toxicity. Performance testing confirmed backflow prevention and equivalent/superior flow rate compared to predicate.
Technological Characteristics
Video processors with integrated light source and digital/optical image enhancement. Materials for OS-H5 water bottle assembly tested per ISO 10993. Connectivity via standard video outputs to monitors/recorders. Reprocessing via cleaning and sterilization. i-Scan is a digital post-processing algorithm; OE is an optical enhancement technology.
Indications for Use
Indicated for gastrointestinal endoscopic diagnosis, treatment, and video observation in patients requiring such procedures. Used as an adjunct to white light endoscopy for imaging enhancement; not a replacement for histopathological sampling.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618)
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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
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# 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<br>GI Family<br>PENTAX EPK-i5010 Video Processor |
|----------------------|------------------------------------------------------------------------------------------------|
| Common Name | Endoscope, Accessories, Video Post-processing for<br>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<br>Condenser Earth Cable | OL-Z4 |
| PENTAX Foot Switch | OS-A61 |
| PENTAX Medical Keyboard | OS-A83<br>OS-A79 |
| PENTAX White Balance<br>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
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# 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.
K191287
| PENTAX Medical Water<br>Bottle Assembly | OS-H5 |
|-------------------------------------------------------------------------------|-------------------------------------|
| PENTAX Medical DispoCap<br>Air (MEDIVATORS Endo<br>SmartCap Tubing - K093665) | 100160P<br>(DispoCap Air<br>Tubing) |
# Table 2: List of Compatible Devices
| Compatible<br>Devices | Manufacturer | Model name | Compatible with | |
|------------------------------------------|----------------------------------------------------------------------------------------|------------------------|----------------------------------------------------|-----------|
| | | | EPK-i7010 | EPK-i5010 |
| Printer | Sony Business Solutions<br>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<br>HD Video Recorder | Western Digital Corporation | WDBBGB0030HBK | Y | --- |
| | Sony Business Solutions<br>Corporation | HVO-1000MD | Y | Y |
| USB Flash Memory | Transcend Information, Inc.<br>SanDisk | TS32GJF600 | Y | --- |
| | | SDCZ6-1024-A10 | --- | Y |
| LCD Monitor | (Any display devices which<br>satisfy safety requirements<br>and other specifications) | Safety<br>Requirements | UL 60601-1<br>CAN/CSA C22.2 No.601.1<br>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
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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
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# 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 (< 24 hours), as depicted in ISO 10993-1, 5, and 10, "Biological evaluation of medical devices," and the FDA Guidance Document, "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The results of the Cytotoxicity, Sensitization, and Intracutaneous Reactivity tests conducted for PENTAX Water Bottle Assembly OS-H5, including its components/accessories, indicated that toxicity was either not detected or of negligible level. Thus, it is determined that the test results satisfy the acceptance criteria specified.
### Performance Testing
The PENTAX Water Bottle Assembly OS-H5 has been tested for backflow prevention. The testing provided evidence that the 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 in OS-H5 under the 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.
### VIII. CONCLUSION
The subject devices are virtually identical to the predicate device. The intended use of the subject and predicate devices is identical. Any differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
The data submitted to support the performance and reprocessing for the PENTAX Water Bottle Assembly OS-H5 demonstrate that the device performs as intended and can be reprocessed in a safe and effective manner. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.
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
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Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
