(214 days)
No
The description mentions "digital filter-based image enhancement technique" and "optical imaging enhancement technology," which are traditional image processing methods, not AI/ML. There is no mention of AI, ML, or related concepts like training data or algorithms.
No.
The device is a video processor intended for diagnosis, treatment, and video observation, primarily focusing on enhancing imaging for better visualization, not directly delivering therapy. While it supports "treatment," the device itself is a video processor and not the therapeutic instrument.
Yes
The device is explicitly stated to be used for "bronchoscopic diagnosis" and its imaging enhancement technologies are intended to give the user "an enhanced view of the texture of the mucosal surface and blood vessels" and "emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface," all of which contribute to diagnostic purposes.
No
The device is described as a "Video Processor" and includes accessories like a keyboard, foot switch, and cables, indicating it is a hardware device with integrated software for image processing.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The PENTAX Medical EPK-i7010 Video Processor is used with endoscopes to visualize internal body structures (specifically the bronchial surface) for diagnosis and treatment. It processes video images obtained directly from within the body.
- Lack of Sample Testing: The device does not perform any tests on samples taken from the body. It processes real-time video data.
Therefore, the device falls under the category of an imaging or visualization device used for in-vivo procedures, 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 bronchoscopic 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 bronchoscopes.
Product codes
EOO
Device Description
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 bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.
In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.
The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:
- . Keyboard - input device for the video processor.
- . Foot Switch - used to remotely control processor functions.
- . White Balance Adjuster - used as the object of white balance feature.
- Condenser Earth Cable - used to reduce high-frequency noise generated during highfrequency electro cautery device use with Pentax endoscopes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical imaging
Anatomical Site
mucosal structures on the bronchial surface
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)
a. Electrical Safety and Electromagnetic Compatibility (EMC): The PENTAX Medical EPK-i7010 Video Processor and PENTAX Medical EB Family of Scopes were tested and comply with the following standards for electrical safety and EMC: CISPR 11:2009, A1:2010 Group 1 Class B; IEC 61000-4-2:2008; IEC 61000-4-3:2006; A1:2007, A2:2010, IEC 61000-4-4:2012; IEC 61000-4-5:2005; IEC 61000-4-6:2013; IEC 61000-4-8:2009; IEC 61000-4-11:2004; IEC 61000-3-2:2014; IEC 61000-3-3:2013; IEC 60601-1-2:2007; IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012; IEC 60601-2-18:2009; ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012; IEC 62304:2006; CAN/CSA-C22.2 NO. 60601-2-18:11.
b. Software Verification and Validation: Software verification and validation testing was 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 for this device is considered a "moderate" level of concern based on the FDA guidance.
c. Performance Testing:
Bench Testing: Optical testing was performed with the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes, as well as PENTAX Medical EKP-i5010 with EB Family. Testing consisted of Signal to Noise, Color (IEE), Resolution, Modulation Transfer Function, Distortion, Light Distribution, Spectral Distribution, Total Luminous Flux, and Photobiological Safety testing. It was concluded that the performance of the subject and predicate devices are equivalent.
Animal Testing: PENTAX Medical performed a porcine animal study to show the similarity of visual experience of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (subject) in comparison to PENTAX Medical EKP-i5010 Video Processor with EB Family (predicate). A library of images was captured to show visual experience for both processors for white light images (WLE) and i-Scan images. Images of the pig larynx demonstrate similar visual experience between scopes.
Key results: The optical data analysis demonstrates the equivalence of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes to the predicate device. Furthermore, a porcine animal study shows the similarity of visual experience with PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes in comparison with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
July 3, 2018
PENTAX of America, Inc. William Goeller Vice President. Ouality/Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K173679
Trade/Device Name: PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: June 1. 2018 Received: June 4, 2018
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Michael J. Ryan -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173679
Device Name
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
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 bronchoscopic 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 bronchoscopes.
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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510(k) Summary
I. SUBMITTER
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Fax: 201-2340
Contact: William Goeller Date Prepared: November 8, 2017
II. DEVICE
| Device Name | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes |
|---|---|
| Common Name | Endoscopic Video Processor and Light Source |
| Classification Name | Endoscopic video imaging system/component |
| Regulation No. | 21 CFR Part 874.4680 |
| Regulation Name | Bronchoscopes (Flexible or Rigid) and accessories |
| Device Class | 2 |
III. PREDICATE DEVICES
The PENTAX Medical EPK-i5010 Video Processor with EB Family (K143727) is the predicate device for this 510(k) Premarket Notification as the processors have the same intended use and the minor technology differences do not raise new issues of safety and effectiveness.
The PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) is utilized as a Reference Device for this 510(k) Premarket Notification as the processor is identical to the subject device.
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Image /page/4/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in red, bold letters, and it is placed above a gray line. Below the gray line, the word "MEDICAL" is written in gray, bold letters.
IV. DEVICE DESCRIPTION
The purpose of this 510(k) is to expand the indications for the PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) to include the PENTAX Video Bronchoscopes, EB Family (K131028): EB-1970TK, EB-1170K, EB-1570K, EB-1970K, EB-1575K, EB-1975K, EB -1990i).
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 bronchoscopic diagnosis, treatment and video observation.
The PENTAX Medical EPK-i7010 Video Processor contains PENTAX i-Scan and Optical Enhancement (OE) technologies.
The PENTAX i-Scan technology is a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.
In addition to i-Scan, OE is intended to provide alternative methods to improve blood vessel visibility by using band limited light illumination source. The OE technology emphasizes mucosal microvasculature and fine mucosal structures on the bronchial surface.
The following accessories are provided for use with the PENTAX Medical EPK-i7010 Video Processor and EB Family of Scopes:
- . Keyboard - input device for the video processor.
- . Foot Switch - used to remotely control processor functions.
- . White Balance Adjuster - used as the object of white balance feature.
- Condenser Earth Cable - used to reduce high-frequency noise generated during highfrequency electro cautery device use with Pentax 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 bronchoscopic 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 video bronchoscopes.
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
There are no differences between the subject and predicate devices with regard to intended use. Both subject and predicate devices are intended for illuminating the inside of the human body.
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Image /page/5/Picture/0 description: The image contains the logo for Pentax Medical. The word "PENTAX" is written in red, bold letters on the top line. Below a gray line, the word "MEDICAL" is written in gray, bold letters.
The subject and predicate video processors have virtually identical indications for use and are substantially equivalent with regard to design, technological characteristics, energy used, performance, safety, and effectiveness.
The subject and reference processors are identical with regard to design, technological characteristics, energy used, performance, safety, and effectiveness. The sole difference is the addition of a bronchoscopic indication.
There are no significant differences in technical characteristics that raise new questions of safety and effectiveness. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.
VI. PERFORMANCE DATA
The following performance data are provided to support the equivalence of the subject and predicate devices.
a. Electrical Safety and Electromagnetic Compatibility (EMC)
The PENTAX Medical EPK-i7010 Video Processor and PENTAX Medical EB Family of Scopes were tested and comply with the following standards for electrical safety and EMC.
- . CISPR 11:2009, A1:2010 Group 1 Class B
- . IEC 61000-4-2:2008; IEC 61000-4-3:2006; A1:2007, A2:2010, IEC 61000-4-4:2012; IEC 61000-4-5:2005; IEC 61000-4-6:2013; IEC 61000-4-8:2009; IEC 61000-4-11:2004; IEC 61000-3-2:2014; IEC 61000-3-3:2013
- IEC 60601-1-2:2007; IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012; IEC 60601-2-18:2009
- ANSI/AAMI ES60601-1:2005 + A2:2010 + A1:2012 ●
- IEC 62304:2006 ●
- CAN/CSA-C22.2 NO. 60601-2-18:11
b. Software Verification and Validation
Software verification and validation testing was 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 for this device is considered a "moderate" level of concern based on the FDA guidance.
c. Performance Testing
Bench Testing
Optical testing was performed with the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes, as well as PENTAX Medical EKP-i5010 with EB Family. Testing consisted of Signal to Noise, Color (IEE), Resolution, Modulation Transfer Function, Distortion, Light Distribution, Spectral Distribution, Total Luminous Flux, and Photobiological Safety testing. It was concluded that the performance of the subject and predicate devices are equivalent.
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Image /page/6/Picture/1 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, red, bold letters. Below that is a gray line, and below that is the word "MEDICAL" in gray, bold letters.
Animal Testing
PENTAX Medical performed a porcine animal study to show the similarity of visual experience of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (subject) in comparison to PENTAX Medical EKP-i5010 Video Processor with EB Family (predicate).
A library of images was captured to show visual experience for both processors for white light images (WLE) and i-Scan images. Images of the pig larynx demonstrate similar visual experience between scopes.
VIII. CONCLUSION
The data submitted in support of the safety of the device and the hardware and software verification and validation demonstrate that the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes performs as intended in the specified use conditions. The optical data analysis demonstrates the equivalence of the PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes to the predicate device. Furthermore, a porcine animal study shows the similarity of visual experience with PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes in comparison with the predicate device.
The subject and predicate devices have the same intended use, and there are no significant differences in technical characteristics that raise different questions of safety and effectiveness. The data provided in this 510(k) Premarket Notification support the equivalence of the subject and predicate devices.