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.

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
Clinical Application: Endoscopy
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler

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).

AI/ML Overview

The provided text is a 510(k) Summary for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. It details the device's technical specifications, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about a study proving that the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on non-clinical testing to demonstrate that the device is equivalent to a legally marketed predicate device, especially regarding safety and effectiveness from a design and manufacturing perspective. It mentions "Performance Testing - Bench" for "System compatibility" and "Optical characteristics," but does not provide specific acceptance criteria or quantitative results for these tests.

Therefore, I cannot fully answer your request for acceptance criteria and a study that proves the device meets them, as the provided text does not include the necessary information regarding a clinical performance study involving AI, human readers, or specific diagnostic performance metrics.

Here's an breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The document lists various types of non-clinical testing (Sterilization, Reprocessing, Biocompatibility, Software, EMC + Electrical Safety, System Compatibility, Optical Characteristics), and states that "Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. For example, it says "The subject device demonstrates equivalent or better optical characteristics than the predicate device," but gives no numerical value for either.

2. Sample size used for the test set and the data provenance:

Cannot be provided definitively for a performance study. The document outlines non-clinical bench testing. These tests typically don't involve "samples" in the same way clinical studies do (e.g., patient data). The data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for the types of tests described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This information is relevant for studies establishing diagnostic ground truth, often used for AI/clinical performance evaluations. The document describes engineering and safety testing, not clinical diagnostic performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations for ground truth establishment. This document doesn't describe such a study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, such a study was not done according to this document. This device is a bronchoscope, which is a physical instrument for visualization and access, not an AI software intended to assist human readers in image interpretation. The document does not mention any AI component or any MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is not an AI algorithm. This is a hardware device (bronchoscope) with associated software for its operation. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of diagnostic performance. The "ground truth" for the tests described relates to engineering specifications and safety standards (e.g., whether the device sterilizes correctly, whether electrical current is within safe limits, whether optical clarity meets design specs).

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI device being trained.

9. How the ground truth for the training set was established:

Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (a bronchoscope) through non-clinical testing of its physical, electrical, and reprocessing characteristics. It does not involve AI or diagnostic performance studies that would require the types of acceptance criteria and study details you requested for AI-driven devices.

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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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	ColorDoppler	AmplitudeDoppler
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.)
PeripheralVessel	Peripheral vessel
	Other (Spec.)

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

{4}------------------------------------------------

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	ColorDoppler	AmplitudeDoppler
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.)
PeripheralVessel	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	ColorDoppler	AmplitudeDoppler
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.)
PeripheralVessel	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 GoellerVice President, Quality Assurance and Regulatory AffairsPENTAX of America. Inc.3 Paragon DriveMontvale, New Jersey 07645-1782
Preparation Date	June 21, 2019
Trade Name	PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
ClassificationNames	Bronchoscope (flexible or rigid) and accessories;Diagnostic ultrasonic transducer
DeviceClassification	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)
ReferenceDevices	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).

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}------------------------------------------------

	System:Probe:	The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended toprovide optical visualization of, ultrasonic visualization of, and therapeutic access to, thePulmonary Track including but not restricted to organs, tissues, and subsystem: NasalPassage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem),and underlying areas. The instrument is introduced per orally when indications consistentwith the requirement for procedure are observed in adult and pediatric patient populations.ARIETTA 70EB19-J10UIntended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
		Clinical Application	Mode of Operation
	General(Track I only)	Specific(Track I & III)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler
		Ophthalmic Ophthalmic
		Fetal
		Abdominal
	Fetal Imaging& Other	Intra-operative (Spec.)
		Intra-operative (Neuro.)
Intended Use /Indications forUse		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.)
	PeripheralVessel	Peripheral vessel
		Other (Spec.)
		N=new indication: P=previously cleared by FDA, K131946E=added under Appendix E

{9}------------------------------------------------

	Clinical Application					Mode of Operation
	General(TrackI only)	Specific(TrackI & III)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler
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
PeripheralVessel	Other (Spec.)

{10}------------------------------------------------

	Clinical Application				Mode of Operation
General(TrackI only)	Specific(TrackI & III)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler
	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}------------------------------------------------

TechnologicalCharacteristics	The subject and predicate devices have the following identical technologicalcharacteristics: 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 tubewidth, insertion tube working length, minimum visible distance of biopsy forceps, type ofCCD, both use software, scan direction, scan system, and scan angle.
	The subject and predicate devices have the following different but equivalenttechnological characteristics: suction control functions, distal end width, minimuminstrument channel width, and acoustic frequency. A summary of the differences betweenthe equivalent technological characteristics of the subject and predicate devices are asfollows:
	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 thepredicate device.
	Minimum instrument channel width: The predicate device minimum instrument channelwidth is 0.2mm larger than the predicate device.
	Acoustic frequency: The predicate device acoustic frequency is 3MHz greater than thepredicate device.
	These differences do not raise new questions of safety or effectiveness.

{12}------------------------------------------------

TestingSummary	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• IrritationSoftwareEMC + Electrical SafetyPerformance 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 arebiocompatible according to ISO 10993.
Software	The subject and predicate devices demonstrate their respective software functions asintended.
Electrical Safetyand EMC	The subject and predicate devices demonstrate electrical safety and electromagneticcompatibility for use with their specified respective video processors and ultrasoundscanners.
SystemCompatibility	The subject and predicate devices demonstrate system compatibility for use with theirspecified respective video processors and ultrasound scanners.
OpticalCharacteristics	The subject device demonstrates equivalent or better optical characteristics than thepredicate device.
SubstantialEquivalenceDetermination	Substantial equivalence was evaluated based on intended use, technologicalcharacteristics, and non-clinical testing.
	• The subject and predicate devices have identical intended use.
	• The subject and predicate devices have equivalent technological characteristics. Thedifferences do not raise new issues of safety or effectiveness.
	• Sterilization, reprocessing, biocompatibility, software, EMC and electrical safetyand bench testing are provided in support of this submission. Testing results confirmthe subject device is safe and effective as the predicate device, and performs asintended.Therefore, it is determined the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is substantially equivalent to legally marketed predicate device, PENTAXUltrasound Video Bronchoscope EB-1970UK + HI VISION PREIRUS (K131946).

{13}------------------------------------------------

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.