Predicate Devices

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)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and signal processing for ultrasound and optical imaging, but there is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function.

Therapeutic

No.
The device is intended for diagnostic imaging and visualization, and while it allows for therapeutic access, it does not provide therapy itself.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body". The device also provides "optical visualization" and "ultrasonic visualization" of the pulmonary tract for identifying conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components such as a flexible insertion tube, control body, connectors, light carrying bundles, a CCD, and an ultrasound transducer. While it connects to software-controlled devices (video processor and ultrasound scanner), the bronchoscope itself is a physical medical device with integrated hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
Device Function: The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is an endoscopic device used for direct visualization and ultrasound imaging inside the human body (in vivo). It is introduced into the pulmonary track to visualize organs and tissues and perform diagnostic ultrasound imaging.
Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis if the human body" and "Endoscopy." This describes procedures performed directly on the patient, not on samples taken from the patient.
Device Description: The description details the components and function of an endoscope used for internal examination and imaging. It does not mention any components or processes related to testing biological samples.

Therefore, the device's function and intended use fall under the category of in vivo diagnostic imaging and visualization, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

EOQ, ITX

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.

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.

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.

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.

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.

The instrument is immersible (with the use of supplied cleaning accessories).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

optical visualization, ultrasonic visualization

Anatomical Site

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.

Indicated Patient Age Range

adult and pediatric patient populations.

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)

Substantial equivalence was evaluated based on intended use, technological characteristics, and non-clinical testing.
• The subject and predicate devices have identical intended use.
• The subject and predicate devices have equivalent technological characteristics. The differences do not raise new issues of safety or effectiveness.
• Sterilization, reprocessing, biocompatibility, software, EMC and electrical safety and bench testing are provided in support of this submission. Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended. Therefore, it is determined the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is substantially equivalent to legally marketed predicate device, PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS (K131946).

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.

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

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.

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)

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

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.

Summary

0

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.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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
(TrackI only)	Specific
(TrackI & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
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
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
(TrackI only)	Specific
(TrackI & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging
& 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 vessel
	Other (Spec.)

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

5

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
(TrackI only)	Specific
(TrackI & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
Fetal Imaging
& 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 vessel
	Other (Spec.)

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

6

510(k) Summary

510(k) Number	K183516
Submitter	PENTAX of America, Inc.
Primary Contact	William Goeller
Vice President, Quality Assurance and Regulatory Affairs
PENTAX of America. Inc.
3 Paragon Drive
Montvale, New Jersey 07645-1782
Preparation Date	June 21, 2019
Trade Name	PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Classification
Names	Bronchoscope (flexible or rigid) and accessories;
Diagnostic ultrasonic transducer
Device
Classification	Class II
Regulations	21 CFR 874.4680;
21 CFR 892.1570
Product Codes	EOQ, ITX
Predicate Device	PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS
(K131946, decision date April 25, 2014)
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)

7

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.

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.

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.

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.

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.

The instrument is immersible (with the use of supplied cleaning accessories). |

8

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

9

	Clinical Application
	General
(TrackI only)	Specific
(TrackI & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra operative (Spec.)
	Intra operative (Neuro.)
Fetal Imaging
& 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
Vessel	Other (Spec.)

10

	Clinical Application				Mode of Operation
General
(TrackI only)	Specific
(TrackI & III)	B	M	PWD	CWD	Color
Doppler	Amplitude
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.)

11

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

12

| Testing

Summary	Sterilization (Accessories Provided Sterile)
	• Sterilization
	• Packaging
	• Shelf Life
	Reprocessing
	• Soil accumulation
	• Cleaning validation
	• Rinsing validation study after cleaning process
	• HLD validation
	• Rinsing validation study after HLD process
	• Ethylene oxide sterilization for 100% EO
	Biocompatibility
	• Cytotoxicity
	• Sensitization
• Irritation
Software
EMC + Electrical Safety
Performance Testing - Bench
• System compatibility
• Optical characteristics
	Sterilization
The subject and predicate device accessories provided sterile have validated sterilization processes.
Packaging	The subject and predicate device accessories provided sterile have packaging that maintains the sterility of the accessory.
Shelf Life	The subject and predicate devices are not provided sterile; therefore, a shelf life is not applicable.
	The subject and predicate device accessories provided sterile demonstrate a shelf life of 2 years.
Reprocessing	The subject and predicate devices have validated reprocessing instructions.
Biocompatibility	The subject and predicate devices demonstrate the patient-contacting materials are
biocompatible according to ISO 10993.
Software	The subject and predicate devices demonstrate their respective software functions as
intended.
Electrical Safety
and EMC	The subject and predicate devices demonstrate electrical safety and electromagnetic
compatibility for use with their specified respective video processors and ultrasound
scanners.
System
Compatibility	The subject and predicate devices demonstrate system compatibility for use with their
specified respective video processors and ultrasound scanners.
Optical
Characteristics	The subject device demonstrates equivalent or better optical characteristics than the
predicate device.
Substantial
Equivalence
Determination	Substantial equivalence was evaluated based on intended use, technological
characteristics, and non-clinical testing.
	• The subject and predicate devices have identical intended use.
	• The subject and predicate devices have equivalent technological characteristics. The
differences do not raise new issues of safety or effectiveness.
	• Sterilization, reprocessing, biocompatibility, software, EMC and electrical safety
and bench testing are provided in support of this submission. Testing results confirm
the subject device is safe and effective as the predicate device, and performs as
intended.
Therefore, it is determined the PENTAX Medical Ultrasound Video Bronchoscope EB19-
J10U is substantially equivalent to legally marketed predicate device, PENTAX
Ultrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS (K131946).

13