(83 days)
Not Found
No
The device description focuses on the physical components and basic image processing for display, with no mention of AI or ML for analysis or interpretation.
No.
The device described is an endoscope used for visualization and to facilitate endoscopic procedures, not to directly treat a condition. It is used with "Endotherapy Devices such as a Biopsy Forceps," which implies the endotherapy device itself would be the therapeutic device, not the scope.
Yes
Explanation: The device is used to display images from inside the body cavity on a monitor, which is a common function for diagnostic purposes (e.g., identifying abnormalities, lesions, etc.). The mention of intended use for "endoscopy" and the display of "the image inside the body cavity" supports its diagnostic capability.
No
The device description clearly outlines physical hardware components such as the Insertion Portion, Control Body, PVE Connector, Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, Water Jet Nozzle, Angulation Control lever, Suction Cylinder, Suction Nipple, Remote Button, Instrument Channel Inlet, Magnification Control Lever, Light Guide Plug, Light Carrying Bundle, and CCD. These are all tangible hardware elements, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instrument is for endoscopy and endoscopic surgery within the upper and lower digestive tracts. This involves direct visualization and intervention within the body, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a device designed for insertion into the body, with components like an insertion portion, control body, and connector to a video processor for displaying images of the internal anatomy. This is consistent with an endoscopic device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or performing tests on them in vitro.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is designed for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
EG Family: This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum. EC Family: This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
Product codes (comma separated list FDA assigned to the subject device)
FDS, FDF
Device Description
The subject devices are identical to the predicate devices. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes and PENTAX Medical Video Colonoscopes as described in K131902 and K131855 respectively. The PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family) are used with Video Processors. They are composed of three main components: Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion. The Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens. The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity. The Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function is performed electrically, focus and depth of field are not changed. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that is connected to the Light Source. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor. The PENTAX Medical Video Upper G.I. scopes and Colonoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper digestive tract including the esophagus, stomach, and duodenum. Lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
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)
PENTAX Medical conducted a Summative Human Factors Study to validate the effectiveness and the risk management measures that are in place for the reprocessing of the EG29-i10 Video Gastroscope with a water jet channel. An ancillary study of the EC-3890TLK limited to its second therapeutic channel was carried out with the same group of stakeholders. The combination of these 2 scopes provides adequate Human Factors evaluation of all design features of EG/EC families related to reprocessing. As a result of testing, use errors, close calls and difficulties were observed to have occurred in some critical tasks. However, it is estimated that the risks identified, and the root causes assigned to those risks can be reduced and/or mitigated via additional modifications of the rIFU design and the further refinement of the training materials.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
May 13, 2021
PENTAX of America, Inc. William Goeller VP Quality Assurance and Regulatory Affairs 3 Paragon Drive Montvale, NJ 07645-1782
Re: K210485
Trade/Device Name: PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDS, FDF Dated: February 17, 2021 Received: February 19, 2021
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.
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
1
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 (QS) 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,
Shanil P. Haugen, Ph.D. 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) K210485
Device Name
PENTAX Medical Video Upper GI Scopes (EG Family) PENTAX Medical Video Colonoscopes (EC Family)
Indications for Use (Describe)
EG Family:
This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
EC Family:
This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
| 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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PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rIFUs Traditional 510(k) Submission
510(k) Summary
SUBMITTER l.
PENTAX of America, Inc., HOYA Corporation PENTAX Division 3 Paragon Drive Montvale, New Jersey 07645-1782 Phone: 201-571-2318 Ext 2318 Fax: 201-571-2340
Contact: William Goeller Date Prepared: February 17, 2021
II. DEVICE
The purpose of this 510(k) is to obtain clearance for the simplified reprocessing instructions which are separated into (5) rIFU's to eliminate the need for reprocessing personnel to identify what configuration endoscope they are working with.
There are no other changes to the reprocessing instructions for use, nor are there any changes to the design, intended use, or indications for use of the EG Family and EC Family of endoscopes.
| Table 5.1: Regulatory Classification of PENTAX Medical Video Upper GI Scopes. | |
|---|---|
| ------------------------------------------------------------------------------- | -- |
| Device Name | PENTAX Video Upper GI Scopes (EG Family) |
|---|---|
| 510(k) Number | K131902 |
| Common Name | Gastroscope And Accessories, Flexible/Rigid |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
| Device Class | 2 |
| Product Code | FDS |
| Classification Panel | Gastroenterology/ Urology |
Table 5.2: Regulatory Classification of PENTAX Medical Video Colonoscopes
| Device Name | PENTAX Video Colonoscopes (EC Family) |
|---|---|
| 510(k) Number | K131855 |
| Common Name | Colonoscopes And Accessories |
| Classification Name | Endoscope and accessories |
| Regulation No. | 876.1500 |
4
PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rIFUs Traditional 510(k) Submission
| Device Class | 2 |
|---|---|
| Product Code | FDF |
| Classification Panel | Gastroenterology/ Urology |
III. PREDICATE DEVICES
The predicate devices for this submission are also the subject of this submission, the PENTAX Medical Video Upper G.I. scopes (EG Family) (K131902) and PENTAX Medical Video Colonoscopes (EC Family) (K131855). The predicate devices are identical to the devices subject to this 510(k); the only change relates to the reprocessing instructions that are now broken down into 5 separate manuals for each endoscope type.
IV. DEVICE DESCRIPTION
The subject devices are identical to the predicate devices. There are no changes to the design, specifications, or technological characteristics of the PENTAX Medical Video Upper GI Scopes and PENTAX Medical Video Colonoscopes as described in K131902 and K131855 respectively. The associated model numbers for the PENTAX Medical Video Upper GI Scopes are provided in Table 5.2.
| PENTAX Video Upper G.I. scopes (EG Family) | |||||
|---|---|---|---|---|---|
| EG-2990i | EG-1690K | EG-2790K | EG-3490K | EG27-i10 | |
| EG-2790i | EG-2490K | EG-2990K | EG-3890TK | EG29-i10 |
Table 5.2: Model Numbers Associated with the PENTAX Medical Video Upper GJ Scopes
The associated model numbers for the PENTAX Medical Video Colonoscopes are provided in Table 5.3.
| Table 5.3: Model Numbers Associated with the PENTAX Medical Video Colonoscopes | |||
|---|---|---|---|
| PENTAX Video Colonoscopes (EC Family) | ||||
|---|---|---|---|---|
| EC-3890TLK | EC-3490Li | EC-3490TLi | EC-3890LK | EC34-i10L |
| EC-2990Li | EC-3890Li | EC-3490LK | EC-3890LZi | EC38-i10L |
The PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family) are used with Video Processors. They are composed of three main components: Insertion Portion, Control Body and PVE Connector.
The Insertion Portion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel are located on the Distal End of the Insertion. The Distal End also contains an Air/Water
5
PENTAX Medical Video Upper G.I. scopes (EG Family) and Colonoscopes (EC Family)- 5 rlFUs Traditional 510(k) Submission
Nozzle and Water Jet Nozzle. This Air/Water Feeding System is used to deliver the air and water to the Objective Lens.
The Control Body is held by the user's hand. The Control Body includes the Angulation Control lever used to operate the endoscope angulation; Suction Cylinder and Suction Nipple for suctioning fluid and air in the body cavity; Remote Button used to operate the function of video processor; and Instrument Channel Inlet used to insert endotherapy devices, such as biopsy forceps, into the body cavity.
The Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function is performed electrically, focus and depth of field are not changed.
The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. The Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that is connected to the Light Source. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.
The PENTAX Medical Video Upper G.I. scopes and Colonoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.
V. INDICATIONS FOR USE
There are no changes to the Indications for Use for the subject devices. The sole purpose of this 510(k) is to simplify the reprocessing instructions by breaking two rIFU's into (5) to eliminate the need for reprocessing personnel to identify what configuration endoscope they are working with.
The PENTAX Medical Video Upper Gl Scopes (EG Family) are intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.
The PENTAX Medical Video Colonoscopes (EC Family) are intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
6
VI. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE
The subject devices are identical to the predicate devices. The subject devices have the same fundamental technology and operating principles of the predicate devices, including the same intended use and design technological characteristics, such as Insertion Portion, Control Body and fiberoptic illumination. There are no differences in specifications, including, but not limited to, the depth of field, distal end width, insertion tube width, instrument channel width, and total length. The sole difference between the subject and predicate device is that the reprocessing instructions have been simplified by breaking down rIFUs into (5) separate groups. This modification does not impact the intended use and does not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
The optimization of the reprocessing instructions for the PENTAX Medical Video Upper GI scopes and Colonoscopes do not affect the biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, or performance testing for the scopes.
VIII. HUMAN FACTORS
PENTAX Medical conducted a Summative Human Factors Study to validate the effectiveness and the risk management measures that are in place for the reprocessing of the EG29-i10 Video Gastroscope with a water jet channel. An ancillary study of the EC-3890TLK limited to its second therapeutic channel was carried out with the same group of stakeholders.
The combination of these 2 scopes provides adequate Human Factors evaluation of all design features of EG/EC families related to reprocessing.
As a result of testing, use errors, close calls and difficulties were observed to have occurred in some critical tasks. However, it is estimated that the risks identified, and the root causes assigned to those risks can be reduced and/or mitigated via additional modifications of the rIFU design and the further refinement of the training materials.
VIII. CONCLUSION
The subject devices are identical to the predicate devices. The subject devices have the same intended use and technological characteristics as the predicate devices. There are no changes to the design of the subject devices.
The data submitted support the separation of reprocessing instructions into 5 groups for the PENTAX Medical Video Upper G.I. scopes and Colonoscopes demonstrate that the scopes 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.