(259 days)
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 -7010 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 video gastrointestinal endoscopes.
The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for 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.
White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPKi7010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician.
For i-Scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the PENTAX Medical EPKi7010 video processor. The resulting i-Scan image is then displayed on the observation monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting OE image is then displayed on the observation monitor.
The provided document describes the Pentax Medical EPK-i7010 Video Processor with GI Family, which includes digital (PENTAX i-Scan™) and optical (OE) imaging enhancement technologies for use as an adjunct to traditional white light endoscopy in gastrointestinal endoscopic diagnosis, treatment, and video observation.
However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria in the typical sense of a diagnostic performance study with sensitivity, specificity, or similar metrics. Instead, the performance data focuses on establishing substantial equivalence to a predicate device (PENTAX Medical EPK-i5010 Video Processor) and a reference device (OLYMPUS EVIS EXERA III Video System) through compliance with standards and non-clinical testing.
Here's an attempt to answer your questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria with corresponding performance metrics like sensitivity or specificity for its imaging enhancement technologies. Instead, the performance is demonstrated through compliance with electrical safety, EMC, software standards, and non-clinical (optical bench and animal) testing to show comparability with predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety (ES) | Confirmed by testing in accordance with IEC 60601-1:2005+A1:2012, IEC 60601-1-6 Edition 3.0:2010, and IEC 60601-2-18 Edition 3.0:2009. |
| EMC | Confirmed by testing in accordance with IEC 60601-1-2:Edition 3:2007. |
| Software Verification & Validation | Conducted and documented as per FDA guidance. Classified as CLASS B software (IEC 62304:2006) with a "Moderate" level of concern. Compliance with ISO 14971:2007, IEC 62304:2006, and IEC 62471:2006. All testing demonstrated that the device performs as intended and did not raise safety or effectiveness questions despite additional functionalities compared to the predicate device. |
| Optical Performance (Bench & Animal Testing) | Animal Study: A library of images (white light, PENTAX OE, Olympus NBI) was obtained from porcine gastrointestinal mucosa for image evaluation and quantitative data analysis. Bench Testing: Optical Enhancement (OE) and Artifact Analysis were performed using images from porcine gastrointestinal locations with PENTAX and Olympus gastrointestinal endoscopes. Effects of processing features on Limited Resolution optical bench testing were also conducted. Conclusion: These tests established the equivalence of the subject device to the predicate device and that the EPK-i7010 performs comparably to the predicate for the same indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document refers to "a library of images" from porcine gastrointestinal mucosa for the animal study and "images from the porcine gastrointestinal location" for the bench testing. No specific numerical sample size (e.g., number of images, number of animals) is provided.
- Data Provenance: The animal study used porcine (pig) gastrointestinal mucosa. The country of origin for the data is not specified. The nature of the image acquisition for the animal and bench studies would be prospective as these were generated specifically for the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document mentions "image evaluation" for the animal study but does not specify the number of experts, their qualifications, or how they established ground truth for the test set. Given the context of a 510(k) summary focused on substantial equivalence and non-clinical data, it's likely that a formal expert review for diagnostic accuracy wasn't the primary endpoint.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth for a test set, as the performance evaluation in this 510(k) application focuses on technical and comparative performance, not a human reader diagnostic accuracy study.
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
A multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with or without AI (or in this case, imaging enhancement technologies) was not explicitly mentioned or described in the provided text. The document focuses on demonstrating substantial equivalence through technical performance and animal/bench testing, not direct clinical or reader performance improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as including "digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE)." These technologies process images to enhance visualization. The "performance data" section focuses on "Optical Performance Testing (Bench and Animal non-clinical testing)" and states "The optical data analysis demonstrate that the PENTAX Medical EPK-i7010 Video Processor performs comparably to the predicate device." This implies an assessment of the algorithm's output (images) in a standalone fashion, determining features like resolution, artifact analysis, and enhancement capabilities without direct human diagnostic decision-making as the primary endpoint for the 510(k). The "image evaluation and quantitative data analysis" of porcine images would fall under this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal study, the ground truth explicitly stated or implied is for "image evaluation and quantitative data analysis" comparing white light, PENTAX OE, and Olympus NBI images from "porcine gastrointestinal mucosa." This likely refers to inherent characteristics of the mucosa as visualized under different modalities or technical imaging quality parameters, rather than a diagnostic 'ground truth' in the clinical sense (e.g., presence/absence of disease confirmed by pathology). The focus is on the imaging enhancement capability, not the diagnostic accuracy of the enhancement itself.
8. The sample size for the training set
The document does not provide any information about a training set size. The device uses "digital post-processing imaging enhancement technology" and "optical imaging enhancement technology." These might be based on pre-defined algorithms rather than machine learning models that require explicit training sets in the sense of supervised learning.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth might have been established. The technologies are described as "imaging enhancement," likely relying on fixed algorithms or optical filtering techniques rather than a trained AI model in the typical sense that would necessitate a labeled training set for diagnostic classification.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Pentax of America, Inc. Krishna Govindarajan Senior Manager, Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645
Re: K150618
Trade/Device Name: Pentax Medical EPK-i7010 Video Processor with GI Family Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: PEA Dated: October 19, 2015 Received: October 20, 2015
Dear Krishna Govindarajan,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150618
Device Name
Pentax Medical EPK-i7010 Video Processor with GI Family
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 -7010 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 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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Image /page/3/Picture/0 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.
510(k) Summary
The following summary is provided in accordance with 21 CFR 807.92:
I. SUBMITTER
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782
Phone: 201-251-2300 x 2125 Fax: 201-799-4117
Contact Person: Krishna Govindarajan Date Prepared: October 16, 2015
II. DEVICE
| Name of Device: | PENTAX Medical EPK-i7010 Video Processor with GI Family |
|---|---|
| Common or Usual Name: | Endoscopic Video Processor and Light Source |
| Classification Name: | Endoscopic video imaging system/component, |
| Classification Name: | Gastroscopes (Flexible or rigid) and accessories (21 CFR Part876.1500) |
| Regulatory Class: | Class II |
| Product Code: | PEA |
III. PREDICATE DEVICE
The PENTAX Medical EPK-i5010 Video Processor (K122470; dated April 22, 2013) is the primary predicate for this submission. This predicate device has not been subject to a design-related recall.
The OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV -190, Xenon Light Source (K112680) is the reference device for this submission.
IV. DEVICE DESCRIPTION
The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for 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.
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Image /page/4/Picture/0 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in large, red, bold letters. Below the word "PENTAX" is a gray line, and below the line is the word "MEDICAL" written in gray, bold letters.
White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPKi7010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician.
For i-Scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the PENTAX Medical EPKi7010 video processor. The resulting i-Scan image is then displayed on the observation monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting OE image is then displayed on the observation monitor.
The table below are the list of accessories and compatible devices that are used with the EPK-i7010 Video Processor.
| Accessories Name | Intended Use | Model Number |
|---|---|---|
| PENTAX CondenserEarth Cable | Condenser earth cable OL-Z4 is intendedto reduce high- frequency noise which isgenerated during high- frequency electrocautery device use together with Pentaxendoscopes. | OL-Z4 |
| PENTAX Foot Switch | Foot Switch OS-A61 is used to remotelycontrol processor functions. | OS-A61 |
| PENTAX Keyboard | PENTAX medical keyboard OS-A83 isintended to be used with compatiblePENTAX video processor EPK-i7010.OS-A83 keyboard for input data entry andoperate the video processor by assignedfunction keys. | OS-A83 |
| PENTAX White BalanceAdjuster | White Balance Adjuster OS- A43H is awhite tube used as the object of whitebalance feature. | OS-A43H |
| PENTAX MedicalDispoCap Air(MEDIVATORS EndoSmartCap Tubing -K093665) | PENTAX Medical DispoCap tubing isintended to be used with an air or CO2source along with a sterile water source tosupply air or CO2 and sterile water to angastrointestinal endoscope duringendoscopic procedures. | 100160P(DispoCap AirTubing) |
Table 1: List of Accessories
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| Compatible Devices | Manufacturer | Model Name |
|---|---|---|
| Printer | Sony Business Solutions Corporation | UP-55MD |
| Sony Business Solutions Corporation | UP-25MD | |
| External Hard Drive | Western Digital Corporation | WDBAAU0020HBK |
| HD Video Recorder | Sony Business Solutions Corporation | HVO-1000MD |
| USB Flash Memory | Transcend Information Inc. | TS32GJF600 |
| LCD Monitor | NDS Surgical Imaging | 26"Radiance G2 HB |
Table 2: List of Compatible Devices
The EPK-i7010 is compatible with PENTAX video gastrointestinal endoscopes.
V. 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The PENTAX Medical EPK-i7010 Video Processor with GI Family (subject device) has the same intended use, design, fundamental operating principle, and scientific technology as the PENTAX Medical EPK-i5010 Video Processor (K122470; dated April 22, 2013) (primary predicate device). Both devices also have the same indications for use; namely, for use in gastrointestinal endoscopic diagnosis, treatment and video observation in the upper and lower gastrointestinal anatomy. The devices differ slightly with regard to design and technological characteristics. Performance data, specifically optical bench and animal testing, is provided to support substantial equivalence of the devices. The EPK-i7010 Video Processor includes additional functionalities that are not available in the EPK-i5010, such as Optical Enhancement (OE) technology, Digital output, Electrical Zoom, Front Operation Panel, Language, Input method, Freeze Scan, Contrast, Twin Mode, and several additional video image display options. However, these additional functionalities do not affect the final product performance and did not raise any questions of safety or effectiveness as demonstrated by the software verification and validation testing.
PENTAX Medical EPK-i7010 Video Processor with GI Family 510(k) Summary
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The PENTAX Medical EPK-i7010 Video Processor with GI Family (subject device) has the same intended use and fundamental operating principle including the Optical Enhancement (OE) technology, compared to the commercially available The OLYMPUS EVIS EXERA III Video System CV - 190 Video System Center and CLV - 190, Xenon Light Source (K112680) (reference device). The devices differ slightly with regard to design and technological characteristics. Performance data, specifically optical bench and animal testing, is provided to support substantial equivalence of the devices.
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Electrical Safety and electromagnetic compatibility (EMC)
The acceptable level of Electromagnetic Compatibility (EMC) and Electrical Safety (ES) for the PENTAX Medical EPK-i7010 Video Processor with GI Family was confirmed by testing in accordance with the following standards:
-
- IEC 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2:Edition 3:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- IEC 60601-1-6 Edition 3.0:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usabilitv
-
- IEC 60601-2-18 Edition 3.0:2009, Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software is classified as CLASS B under the Software Safety Classification per IEC 62304:2006, Medical device software life cycle processes) and the software level of concern is "Moderate" based on the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
All testing of the software was conducted in compliance with the following standards:
-
- ISO 14971 Second Edition:2007, Medical devices Application of risk management to medical devices
-
- IEC 62304 First Edition:2006, Medical device software Software life cycle processes
-
- IEC 62471 First Edition:2006, Photobiological safety of lamps and lamp systems
PENTAX Medical EPK-i7010 Video Processor with GI Family 510(k) Summary
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Optical Performance Testing (Bench and Animal non-clinical testing)
Animal Study
A library of images [white light endoscopic (WLE), PENTAX Optical Enhancement (OE), and Olympus Narrow Band Imaging (NBI)] were obtained from the porcine gastrointestinal mucosa. The images were used for image evaluation and quantitative data analysis.
Bench Testing
Optical Enhancement (OE) and Artifact Analysis were performed with the images from the porcine gastrointestinal location that were gathered using two PENTAX Medical gastrointestinal endoscopes, one high definition and one standard definition, along with an Olympus gastrointestinal endoscopes. In addition. PENTAX Medical and Olympus gastrointestinal endoscopes were compared and the effects of processing features on Limited Resolution optical bench testing were conducted.
The animal and optical bench test image data gathered with gastrointestinal endoscopes establish the equivalence of the subject and predicate device.
VIII. CONCLUSIONS
The data submitted support the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-i7010 Video Processor performs as intended in the specified use conditions. The optical data analysis demonstrate that the PENTAX Medical EPK-i7010 Video Processor performs comparably to the predicate device that is currently marketed for the same indication for use.
§ 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.