PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

K183516 · Pentax of America, Inc. · EOQ · Sep 6, 2019 · Ear, Nose, Throat

Device Facts

• Record ID: K183516
• Device Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
• Applicant: Pentax of America, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Sep 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Device Story

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is a flexible endoscope used for diagnostic and therapeutic procedures in the pulmonary tract. It features a CCD for optical imaging and a convex array ultrasound transducer for ultrasonic imaging. The device connects to a video processor and an ultrasound scanner (e.g., Arietta 70, Noblus, or Preirus). During procedures, the physician inserts the scope per-orally; the device provides real-time endoscopic and ultrasound images to the connected systems. The control body allows for angulation, suction, and the introduction of biopsy or other therapeutic instruments through a working channel. The device aids in visualizing internal structures and guiding interventions, potentially improving diagnostic accuracy and therapeutic outcomes. It is intended for use by trained clinicians in clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including system compatibility, optical characteristics, electrical safety, EMC, biocompatibility (ISO 10993), and validation of reprocessing and sterilization processes.

Technological Characteristics

Flexible bronchoscope with CCD optical sensor and convex array ultrasound transducer. Features include angulation control, suction, and working channel. Connects to external video processors and ultrasound scanners. Biocompatible materials per ISO 10993. Sterilization via ethylene oxide for accessories. Software-controlled operation.

Indications for Use

Indicated for optical and ultrasonic visualization and therapeutic access to the pulmonary tract (nasal passage, pharynx, larynx, trachea, bronchial tree) in adult and pediatric patients.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS (K131946)

Reference Devices

• PENTAX Medical EPK-3000 Video Imaging System (K172156)
• PENTAX Medical EPK-i5010 Video Processor with EB Family of Scopes (K143727)
• PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679)
• Hitachi Arietta70 Diagnostic Ultrasound System (K134016)
• Hitachi Noblus™ Diagnostic Ultrasound Scanner (K142368)
• Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner (K093466)

Submission Summary (Full Text)

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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.

September 6, 2019

PENTAX of America, Inc. % Beryl Jeanne Associate Regulatory Specialist NAMSA Inc. 400 Highway 169. Suite 500 Minneapolis, Minnesota 55426

Re: K183516

Trade/Device Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO, ITX Dated: August 1, 2019 Received: August 5, 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K183516

Device Name

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Indications for Use (Describe)

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

| 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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## Indications for Use 510(k) Number: K183516 Device Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

| System: | ARIETTA 70 | | | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|----------------------|
| Probe: | EB19-J10U | | | | | | |
| | Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows. | | | | | | |
| | Clinical Application | | Mode of Operation | | | | |
| General<br>(TrackI only) | Specific<br>(TrackI & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | |
| | Fetal | | | | | | |
| | Abdominal | | | | | | |
| | Intra-operative (Spec.) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| | Fetal Imaging Laparoscopic | | | | | | |
| & Other | Pediatric | | | | | | |
| | Small Organ (Spec.) | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Endoscopy | P | P | P | | P | P |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (Spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | |
| | Other (Spec.) | | | | | | |

N=new indication: P=previously cleared by FDA, K131946 E=added under Appendix E

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## Indications for Use 510(k) Number: K183516 Device Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

| System: | Noblus | | | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|
| Probe: | EB19-J10U | | | | | | |
| | Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows. | | | | | | |
| | Clinical Application | Mode of Operation | | | | | |
| General<br>(TrackI only) | Specific<br>(TrackI & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | |
| | Fetal | | | | | | |
| | Abdominal | | | | | | |
| | Intra-operative (Spec.) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | |
| | Pediatric | | | | | | |
| | Small Organ (Spec.) | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Endoscopy | P | P | P | | P | P |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (Spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | |
| | Other (Spec.) | | | | | | |

N=new indication; P=previously cleared by FDA, K160559 E=added under Appendix E

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## Indications for Use 510(k) Number: K183516 Device Name: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

| System: | HI VISION Preirus | | | | | | |
|--------------------------|--------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|----------------------|
| Probe: | EB19-J10U | | | | | | |
| | Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows. | | | | | | |
| | Clinical Application | | Mode of Operation | | | | |
| General<br>(TrackI only) | Specific<br>(TrackI & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| Ophthalmic | Ophthalmic | | | | | | |
| | Fetal | | | | | | |
| | Abdominal | | | | | | |
| | Intra-operative (Spec.) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | |
| | Pediatric | | | | | | |
| | Small Organ (Spec.) | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Endoscopy | P | P | P | | P | P |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (Spec.) | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | |
| | Other (Spec.) | | | | | | |

N=new indication; P=previously cleared by FDA, K162447 E=added under Appendix E

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# 510(k) Summary

| 510(k) Number | K183516 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | PENTAX of America, Inc. |
| Primary Contact | William Goeller<br>Vice President, Quality Assurance and Regulatory Affairs<br>PENTAX of America. Inc.<br>3 Paragon Drive<br>Montvale, New Jersey 07645-1782 |
| Preparation Date | June 21, 2019 |
| Trade Name | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
| Classification<br>Names | Bronchoscope (flexible or rigid) and accessories;<br>Diagnostic ultrasonic transducer |
| Device<br>Classification | Class II |
| Regulations | 21 CFR 874.4680;<br>21 CFR 892.1570 |
| Product Codes | EOQ, ITX |
| Predicate Device | PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS<br>(K131946, decision date April 25, 2014) |
| Reference<br>Devices | PENTAX Medical EPK-3000 Video Imaging System (K172156)<br>PENTAX Medical EPK-i5010 Video Processor with EB Family of Scopes (K143727)<br>PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679)<br>Hitachi Arietta70 Diagnostic Ultrasound System (K134016)<br>Hitachi Noblus™ Diagnostic Ultrasound Scanner (K142368)<br>Hitachi HI VISION Preirus Diagnostic Ultrasound Scanner (K093466) |

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| Device Description | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U connects with a video processor and an ultrasound scanner, both of which are software controlled devices.<br><br>The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.<br><br>The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position, suction control, and ports for manual balloon insufflation/evacuation and accessory inlet.<br><br>The endoscope contains light carrying bundles to illuminate the body cavity, a change couple device to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.<br><br>The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners Arietta 70 and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.<br><br>The instrument is immersible (with the use of supplied cleaning accessories). |

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| | System:<br>Probe: | The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to<br>provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the<br>Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal<br>Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem),<br>and underlying areas. The instrument is introduced per orally when indications consistent<br>with the requirement for procedure are observed in adult and pediatric patient populations.<br>ARIETTA 70<br>EB19-J10U<br>Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows. | | | | | | | |
|------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|--|
| | | Clinical Application | Mode of Operation | | | | | | |
| | General<br>(Track I only) | Specific<br>(Track I & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | |
| | | Ophthalmic Ophthalmic | | | | | | | |
| | | Fetal | | | | | | | |
| | | Abdominal | | | | | | | |
| | Fetal Imaging<br>& Other | Intra-operative (Spec.) | | | | | | | |
| | | Intra-operative (Neuro.) | | | | | | | |
| Intended Use /<br>Indications for<br>Use | | Laparoscopic | | | | | | | |
| | | Pediatric | | | | | | | |
| | | Small Organ (Spec.) | | | | | | | |
| | | Neonatal Cephalic | | | | | | | |
| | | Adult Cephalic | | | | | | | |
| | | Trans-rectal | | | | | | | |
| | | Trans-vaginal | | | | | | | |
| | | Trans-urethral | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | |
| | | Musculo-skel. (Convent.) | | | | | | | |
| | | Musculo-skel. (Superfic.) | | | | | | | |
| | | Intra-luminal | | | | | | | |
| | | Endoscopy | P | P | P | | P | P | |
| | | Cardiac Adult | | | | | | | |
| | Cardiac | Cardiac Pediatric | | | | | | | |
| | | Trans-esophageal (card.) | | | | | | | |
| | | Other (Spec.) | | | | | | | |
| | Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | | Other (Spec.) | | | | | | | |
| | | N=new indication: P=previously cleared by FDA, K131946<br>E=added under Appendix E | | | | | | | |

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| | Clinical Application | | | | | Mode of Operation | | | |
|--------------------------|---------------------------|----------------------------|---|---|-----|-------------------|------------------|----------------------|--|
| | General<br>(TrackI only) | Specific<br>(TrackI & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra operative (Spec.) | | | | | | | | |
| | Intra operative (Neuro.) | | | | | | | | |
| Fetal Imaging<br>& Other | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Spec.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans rectal | | | | | | | | |
| | Trans vaginal | | | | | | | | |
| | Trans urethral | | | | | | | | |
| | Trans esoph. (non Card.) | | | | | | | | |
| | Musculo skel. (Convent.) | | | | | | | | |
| | Musculo skel. (Superfic.) | | | | | | | | |
| | Intra luminal | | | | | | | | |
| | Endoscopy | | P | P | P | | P | P | |
| | Cardiac Adult | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | |
| | Trans esophageal (card.) | | | | | | | | |
| | Other (Spec.) | | | | | | | | |
| | Peripheral vessel | | | | | | | | |
| Peripheral<br>Vessel | Other (Spec.) | | | | | | | | |

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| | Clinical Application | | | | Mode of Operation | | |
|--------------------------|----------------------------|---|---|-----|-------------------|------------------|----------------------|
| General<br>(TrackI only) | Specific<br>(TrackI & III) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler |
| | Ophthalmic Ophthalmic | | | | | | |
| | Fetal | | | | | | |
| | Abdominal | | | | | | |
| | Intra-operative (Spec.) | | | | | | |
| | Intra-operative (Neuro.) | | | | | | |
| | Fetal Imaging Laparoscopic | | | | | | |
| & Other | Pediatric | | | | | | |
| | Small Organ (Spec.) | | | | | | |
| | Neonatal Cephalic | | | | | | |
| | Adult Cephalic | | | | | | |
| | Trans-rectal | | | | | | |
| | Trans-vaginal | | | | | | |
| | Trans-urethral | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | |
| | Musculo-skel. (Convent.) | | | | | | |
| | Musculo-skel. (Superfic.) | | | | | | |
| | Intra-luminal | | | | | | |
| | Endoscopy | P | P | P | | P | P |
| | Cardiac Adult | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | |
| | Trans-esophageal (card.) | | | | | | |
| | Other (Spec.) | | | | | | |
| Peripheral | Peripheral vessel | | | | | | |
| Vessel | Other (Spec.) | | | | | | |
| | | | | | | | |

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| Technological<br>Characteristics | The subject and predicate devices have the following identical technological<br>characteristics: image supply, angulation control function, angulation lock function,<br>elevator control function, instrument channel inlet, air/water feeding function,<br>illumination, direction of view, field of view, depth of field, tip angulation, insertion tube<br>width, insertion tube working length, minimum visible distance of biopsy forceps, type of<br>CCD, both use software, scan direction, scan system, and scan angle. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The subject and predicate devices have the following different but equivalent<br>technological characteristics: suction control functions, distal end width, minimum<br>instrument channel width, and acoustic frequency. A summary of the differences between<br>the equivalent technological characteristics of the subject and predicate devices are as<br>follows: |
| | Suction control function: The subject device accessory suction control valve is single-use.<br>The predicate device accessory suction control valve is reusable. |
| | Distal end width: The predicate device distal end width is 0.1mm smaller than the<br>predicate device. |
| | Minimum instrument channel width: The predicate device minimum instrument channel<br>width is 0.2mm larger than the predicate device. |
| | Acoustic frequency: The predicate device acoustic frequency is 3MHz greater than the<br>predicate device. |
| | These differences do not raise new questions of safety or effectiveness. |

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| Testing<br>Summary | Sterilization (Accessories Provided Sterile) |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Sterilization |
| | • Packaging |
| | • Shelf Life |
| | Reprocessing |
| | • Soil accumulation |
| | • Cleaning validation |
| | • Rinsing validation study after cleaning process…