(266 days)
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.
The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.
This device 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.
PENTAX Medical Video Processor EPK-i5500c
The PENTAX Medical Video Processor EPK-i5500c consists of a video system, monitor and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. The PENTAX Medical Video Processor EPK-i5500c contains a contrast enhancement feature: PENTAX i-scan technology. All visualization is done with the white light mode first. White light (RGB) illuminates the tissue and transfers the captured light through the Complementary MOS (CMOS) of the video scope. 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 Video Processor EPK-i5500c. The resulting i-scan image is then displayed on the observation monitor. The EPK-i5500c is compatible with PENTAX Medical endoscopes EG29-i10c, EC34-i10cL and EC38-i10cL.
PENTAX Medical Video Upper GI Scope EG29-i10c
The PENTAX Medical Video Upper GI Scope EG29-i10c is used with PENTAX Medical Video Processor EPK-i5500c.The PENTAX Medical Video Upper GI Scope EG29-i10c is composed of the following main parts: an Insertion Portion, Control Body and Scope 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, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Control Button, Magnification Control Lever, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS 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.
PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL
The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL are used with PENTAX Medical Video Processor EPK-i5500c. The endoscopes are composed of the following main parts: an Insertion Portion, Control Body and Scope 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, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Scope Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The endoscopes have two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity with LEDs. The CMOS 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 provided document is a 510(k) Pre-market Notification from the FDA regarding several PENTAX Medical devices. It outlines the substantial equivalence to predicate devices based on intended use, technological characteristics, and performance testing. However, the document does not contain information about a study that describes acceptance criteria for an AI device, the device's performance against those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for an AI component.
The only mention of "AI" or "imaging enhancement technology" related to AI is:
"This device 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."
This statement describes a feature of the PENTAX Medical Video Processor EPK-i5500c, but the document does not provide any specific study details, acceptance criteria, or performance metrics for this "i-scan" technology as if it were a separate AI device requiring standalone validation. The 510(k) summary focuses on the substantial equivalence of the entire endoscopy system (processor and scopes) to previous PENTAX models, citing general performance testing like "Optical Characterization," "Backflow Prevention," "Compatibility," and "Product Life," along with standard regulatory considerations such as reprocessing, biocompatibility, software, EMC, and electrical safety.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text for an AI component. The document is primarily a regulatory filing asserting substantial equivalence of hardware devices, not a detailed performance study of a specific AI feature.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
PENTAX of America, Inc. % Beryl Jeanne Regulatory Specialist NAMSA Inc. 400 Highway 169. Suite 500 Minneapolis, MN 55426
Re: K190805
Trade/Device Name: PENTAX Medical Video Processor EPK-i5500c PENTAX Medical Video Upper GI Scope EG29-i10c PENTAX Medical Video Colonoscope EC34-i10cL PENTAX Medical Video Colonoscope EC38-i10cL Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: PEA, FDS, FDF Dated: November 20, 2019 Received: November 21, 2019
Dear Beryl Jeanne:
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 (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. 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) K190805
Device Name
PENTAX Medical Video Colonoscope EC34-i10cL; PENTAX Medical Video Colonoscope EC38-i10cL; PENTAX Medical Video Upper GI Scope EG29-i10c; PENTAX Medical Video Processor EPK-i5500c
Indications for Use (Describe)
The PENTAX Medical Video Colonoscope EC34-i10cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for
the procedure are observed in patient populations with greater than 5kg of body weight.
The PENTAX Medical Video Colonoscope EC38-110cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes, but is not restricted to, the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel. This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Upper GI Scope EG29-i10c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.
This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.
The PENTAX Medical Video Processor EPK-i5500c is intended to be used with the PENTAX Medical camera heads, endoscopes, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation. It processes signals transmitted from a video endoscope into images that are displayed on an inspection monitor. This processor has air/water pump function.
This device 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.
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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510(k) Summary
| 510(k) Number | K190805 |
|---|---|
| Preparation Date: | November 20, 2019 |
| Submitter: | PENTAX of America, Inc. |
| Contact Person: | US Agent:William GoellerVice President, Quality Assurance and Regulatory AffairsPENTAX of America, Inc.3 Paragon DriveMontvale, New Jersey 07645-1782Official Correspondent:Beryl St. JeanneRegulatory ConsultantNAMSA400 Highway 169 South, Suite 500Minneapolis, MN 55426 |
| Device Name: | PENTAX Medical Video Processor EPK-i5500cPENTAX Medical Video Upper GI Scope EG29-i10cPENTAX Medical Video Colonoscope EC34-i10cLPENTAX Medical Video Colonoscope EC38-i10cL |
| Device Classification: | Regulation: 21 CFR 876.1500Regulation Description: Endoscope and accessoriesRegulatory Class: Class IIProduct Code: PEA, FDS, FDFClassification Panel: Gastroenterology/UrologyDevices: Endoscope, Accessories, Image Post-Processing For Color Enhancement; Gastroscopic and Accessories,Flexible/Rigid; Colonoscope andAccessories, Flexible/Rigid |
| PENTAX Medical Video Processor EPK-i5500cThis device is intended to be used with the PENTAX Medical cameraheads, endoscopes, monitors, and other ancillary equipment forendoscopic diagnosis, treatment, and video observation.It processes signals transmitted from a video endoscope into imagesthat are displayed on an inspection monitor. This processor hasair/water pump function.This device includes PENTAX i-scan™, a digital, post-processingimaging enhancement technology. i-scan is intended to be used as anoptional adjunct following traditional white light endoscopy and is notintended to replace histopathological sampling. | |
| Indications for Use | PENTAX Medical Video Upper GI Scope EG29-i10cThe PENTAX Medical Video Upper GI Scope EG29-i10c is intendedto provide optical visualization of (via a video monitor), andtherapeutic access to, the upper gastrointestinal tract. This anatomyincludes, but is not restricted to, the organs; tissues; and subsystems:esophagus, stomach, and duodenum.This endoscope is introduced via the mouth when indicationsconsistent with the need for the procedure are observed in patientpopulations with greater than 20kg of body weight. |
| PENTAX Medical Video Colonoscope EC34-i10cLThe PENTAX Medical Video Colonoscope EC34-i10cL is intendedto provide optical visualization of (via a video monitor), andtherapeutic access to, the lower gastrointestinal tract. This anatomyincludes, but is not restricted to, the organs, tissues, and subsystems:Large Bowel to the cecum, terminal ileum of the small bowel.This endoscope is introduced via the rectum, as decided by thephysician, when indications consistent with the need for the procedureare observed in patient populations with greater than 5kg of bodyweight. | |
| PENTAX Medical Video Colonoscope EC38-i10cLThe PENTAX Medical Video Colonoscope EC38-i10cL is intendedto provide optical visualization of (via a video monitor), andtherapeutic access to, the lower gastrointestinal tract. This anatomyincludes, but is not restricted to, the organs, tissues, and subsystems:Large Bowel to the cecum, terminal ileum of the small bowel.This endoscope is introduced via the rectum, as decided by thephysician, when indications consistent with the need for the procedureare observed in patient populations with greater than 20kg of bodyweight. | |
| Device Description | PENTAX Medical Video Processor EPK-i5500cThe PENTAX Medical Video Processor EPK-i5500c consists of avideo system, monitor and ancillary equipment. This processor isintended for endoscopic diagnostic, treatment and video observation.The PENTAX Medical Video Processor EPK-i5500c contains acontrast enhancement feature: PENTAX i-scan technology.All visualization is done with the white light mode first. White light(RGB) illuminates the tissue and transfers the captured light throughthe Complementary MOS (CMOS) of the video scope. Note that thewhite light visualization mode is always used first by the physician.For i-scan image enhancement, the modification of the combination ofRGB components for each pixel occurs when the i-scan function isturned on in the PENTAX Medical Video Processor EPK-i5500c. Theresulting i-scan image is then displayed on the observation monitor.The EPK-i5500c is compatible with PENTAX Medical endoscopesEG29-i10c, EC34-i10cL and EC38-i10cL.PENTAX Medical Video Upper GI Scope EG29-i10c |
| The PENTAX Medical Video Upper GI Scope EG29-i10c is usedwith PENTAX Medical Video Processor EPK-i5500c.The PENTAXMedical Video Upper GI Scope EG29-i10c is composed of thefollowing main parts: an Insertion Portion, Control Body and ScopeConnector. The Insertion Portion is inserted into the body cavity ofpatient. The Insertion Portion includes the Distal End and BendingSection. The Objective Lens, Light Guide, Instrument Channel,Air/Water Nozzle, and Water Jet Nozzle are located on the Distal Endof the Insertion Portion. The Control Body is held by the user's hand.The Control Body includes the Angulation Control Knob, AngulationLock Knob/Lever, Air/Water Cylinder, Suction Cylinder, RemoteControl Button, Magnification Control Lever, and Instrument ChannelInlet. The Air/Water Feeding Valve is attached to the Air/WaterCylinder, and the Suction Control Valve is attached to the SuctionCylinder. The Inlet Seal is attached to the Instrument Channel Inlet.The Scope Connector is connected to the Video Processor via anElectrical Contacts. The Bending Section is bent by the AngulationControl Knob to operate the endoscope angulation. The AngulationLock Knob/Lever is used to adjust the rotation torque of theAngulation Control Knob.The Air/Water Feeding System is used to deliver the air and water tothe Objective Lens from the Air/Water Nozzle. When the hole at the | |
| top of Air/Water Feeding Valve is covered, air is delivered. When theAir/Water Feeding Valve is pushed, the water is delivered. TheSuction Control System is used to suction the fluid and air in bodycavity from the Instrument Channel. When the Suction Control Valveis pushed, the fluid and air are suctioned. The Remote Button is usedto operate the function of video processor and external device fromthe control body, as necessary. | |
| Endotherapy Device such as Biopsy Forceps is inserted from theInstrument Channel Inlet into the body cavity through the instrumentchannel. The Water Jet System is used to stream forward the sterilewater from Water Jet Nozzle. | |
| The Light Guide of the Distal End is used to illuminate the bodycavity with LEDs. The CMOS built into the Distal End receivesreflected light (image data) from the body cavity, and sends the imagedata to the Video Processor through the video cable. The image dataare converted into the image signal by the Video Processor, and theimage inside the body cavity is displayed on the Monitor. | |
| PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL | |
| The PENTAX Medical Video Colonoscopes EC34-i10cL and EC38-i10cL are used with PENTAX Medical Video Processor EPK-i5500c. | |
| The endoscopes are composed of the following main parts: anInsertion Portion, Control Body and Scope Connector. | |
| The Insertion Portion is inserted into the body cavity of patient. TheInsertion Portion includes the Distal End and Bending Section. TheObjective Lens, Light Guide, Instrument Channel, Air/Water Nozzle,and Water Jet Nozzle are located on the Distal End of the InsertionPortion. The Control Body is held by the user's hand. The ControlBody includes the Angulation Control Knob, Angulation LockKnob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button,Suction Selector Cylinder, and Instrument Channel Inlet. TheAir/Water Feeding Valve is attached to the Air/Water Cylinder, andthe Suction Control Valve is attached to the Suction Cylinder. TheSuction Channel Selector is attached to the Suction Selector Cylinder.The Inlet Seal is attached to the Instrument Channel Inlet. The ScopeConnector is connected to the Video Processor via an ElectricalContacts. | |
| The Bending Section is bent by the Angulation Control Knob tooperate the endoscope angulation. The Angulation Lock Knob/Lever | |
| is used to adjust the rotation torque of the Angulation Control Knob.The Air/Water Feeding System is used to deliver the air and water tothe Objective Lens from the Air/Water Nozzle. When the hole at thetop of Air/Water Feeding Valve is covered, the air is delivered. Whenthe Air/Water Feeding Valve is pushed, the water is delivered. TheSuction Control System is used to suction the fluid and air in bodycavity from the Instrument Channel. When the Suction Control Valveis pushed, the fluid and air are suctioned. The endoscopes have twochannels; the primary channel and secondary one. Suction ChannelSelector is used to switch between the primary and secondarychannels as necessary. The Remote Button is used to operate thefunction of video processor and external device from the control body,as necessary. | |
| Endotherapy Device such as Biopsy Forceps is inserted from theInstrument Channel Inlet into the body cavity through the instrumentchannel. The Water Jet System is used to stream forward the sterilewater from Water Jet Nozzle. | |
| The Light Guide of the Distal End is used to illuminate the bodycavity with LEDs. The CMOS built into the Distal End receivesreflected light (image data) from the body cavity, and sends the imagedata to the Video Processor through the video cable. The image dataare converted into the image signal by the Video Processor, and theimage inside the body cavity is, displayed on the Monitor. | |
| K122470PENTAX EPK-i5010 VIDEO PROCESSORPENTAX Medical Company | |
| Predicate Devices: | K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)PENTAX Medical Company |
| K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)PENTAX Medical Company | |
| Performance Testing: | Optical CharacterizationBackflow PreventionCompatibilityProduct Life |
| Substantial Equivalence: | The PENTAX Medical system, which includes subject devicesPENTAX Medical Video Processor EPK-i5500c, PENTAX MedicalVideo Upper GI Scope EG29-i10c, PENTAX Medical VideoColonoscope EC34-i10cL, and PENTAX Medical Video ColonoscopeEC38-i10cL, is substantially equivalent to predicate devices K122470PENTAX EPK-i5010 VIDEO PROCESSOR, K131902 PENTAXVIDEO UPPER G.I. SCOPES (EG FAMILY), and K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY) whenevaluating intended use and technological characteristics.• The system's subject devices have similar indications/intended usesas the predicate devices. There are minor differences between thesubject devices and predicate devices with respect toindications/intended use.• The system's subject devices designs and the predicate devicesdesigns are substantially equivalent with only minor differencesrelating to the light source and mode through which image iscaptured. Reprocessing, biocompatibility, software, EMC andelectrical safety, and bench testing demonstrate there are no additionalrisks.• The system's subject devices do not raise new questions of safety oreffectiveness. |
| Conclusion: | The system's subject devices have similar indications/intended usesand substantially equivalent technological characteristics as thepredicate devices. The differences do not raise new issues of safety oreffectiveness. Reprocessing, biocompatibility, software, EMC andelectrical safety, and bench testing are provided in support of thissubmission. |
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§ 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.