The EB-1970UK, Ultrasound Video Bronchoscope, 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 Description

The EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination and video signals. The ultrasound umbilical connector will be attached to the ultrasound scanner unit.

The control body includes controls for up/down anqulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. A sterile, single use disposable latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. It is designed to be inflated with a specific volume of water during the procedure so that the effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer can take place.

The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) 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).

AI/ML Overview

The provided text describes the PENTAX Ultrasound Video Bronchoscope EB-1970UK and its regulatory submission. However, it does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set, expert readers, or ground truth data.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

Here's an analysis based on the information provided and what is missing:

Acceptance Criteria and Study Details

The document details the device's conformance to various non-clinical standards and protocols, which serve as the "acceptance criteria" for safety and fundamental performance. However, there is no mention of a clinical or performance study with a test set of data, human readers, or a specific ground truth for diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Metric/Standard	Reported Device Performance	Comments
Electrical Safety	IEC 60601-1	Satisfied	General requirements for basic safety and essential performance.
	IEC 60601-1-1	Satisfied	Safety requirements for medical electrical systems.
	IEC 60601-2-18	Satisfied	Particular requirements for endoscopic equipment.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Satisfied	Requirements and tests.
Biocompatibility	ISO 10993-1, 5, 10	Confirmed	Cytotoxicity, Sensitization, Intracutaneous Reactivity testing.
Reprocessing Validation	FDA Draft Guidance (2011), AAMI TIR 12, 30, 79	Satisfied	Cleaning validation and High-Level Disinfection validation.
Endoscopic Equipment Performance	ISO 8600-1	Satisfied	General requirements for endoscopes.
	ISO 8600-3	Satisfied	Determination of field of view and direction of view.
	ISO 8600-4	Satisfied	Determination of maximum width of insertion portion.
Software Life Cycle	IEC 62304	Satisfied	Medical device software life cycle processes.
Usability	IEC 60601-1-6, IEC 62366	Satisfied	Usability engineering application.
Risk Management	ISO 14971	Satisfied	Application of risk management to medical devices.
Quality Management Systems	ISO 13485	Satisfied	Requirements for regulatory purposes.
Symbols for Equipment	IEC 60417, ISO 15223-1, IEC 60878	Satisfied	Graphical symbols and labeling requirements.
Substantial Equivalence	Comparison to Predicate Device (K081518)	Established	Minor dimensional differences do not impact intended use or raise new safety/effectiveness questions.

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

Not applicable for a clinical performance test. The testing focused on compliance with engineering, safety, and sterilization standards through in-house and external lab protocols. There isn't a defined "test set" of patient data in the context of diagnostic accuracy.

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

Not applicable. No clinical performance study involving expert assessment of diagnostic accuracy is described.

4. Adjudication method for the test set:

Not applicable. No clinical performance study involving expert adjudication is described.

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. This device is an Ultrasound Video Bronchoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

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

No. This device is an instrument used by a clinician, not a standalone algorithm.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" was typically defined by the specified requirements and methodologies of the referenced standards (e.g., specific chemical levels for biocompatibility, sterility for reprocessing, electrical thresholds for safety).

8. The sample size for the training set:

Not applicable. No training set for a diagnostic algorithm is mentioned.

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

Not applicable. No training set for a diagnostic algorithm is mentioned.

Summary of what the document does provide regarding acceptance criteria and performance:

The document primarily focuses on demonstrating that the PENTAX Ultrasound Video Bronchoscope EB-1970UK meets the acceptance criteria for safety and basic functional performance by complying with a comprehensive list of FDA-recognized consensus standards and in-house test protocols for:

Electrical safety
Electromagnetic compatibility
Biocompatibility of materials
Reprocessing and sterilization effectiveness
Usability
Software life cycle processes
Risk management
Quality management systems
Specific optical and mechanical characteristics relevant to endoscopes.

The "study" in this context refers to the comprehensive series of non-clinical design verification and validation tests performed according to these standards, with the reported device performance being that "All the study results satisfy the acceptance criteria specified by the above applicable standards." The ultimate conclusion is that the device is "as safe and effective and substantially equivalent" to its predicate device based on these non-clinical evaluations.

Summary

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510(k) Summary

The following summary is provided in accordance with 21 CFR 807.92:

Date: 25 Jun 2013

Submitter:	PENTAX Medical Company,HOYA Corporation PENTAX Division3 Paragon DriveMontvale, New Jersey 07645-1782
Contact:	Krishna GovindarajanRegulatory ManagerPENTAX Medical Company,3 Paragon DriveMontvale, New Jersey 07645-1782Phone: 800-431-5880 x 2125, 201-251-2300 x 2125Fax: 201-799-4117Email: Krishna.govindarajan@pentaxmedical.com
Trade/Device Name:	PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISIONPreirus
Common/Usual Name:	Endoscopic Ultrasound / Ultrasound Bronchoscope
Requlation Number:Regulation Name:	21 CFR Part 874.4680Bronchoscopes (Flexible or rigid) and accessoriesDiagnostic Ultrasound Transducer
Requlatory Class:Product Code:	Class IIEOQ and ITX
Predicate Device:	PENTAX EB-1970UK Ultrasound Video Bronchoscope + EUB 5500(K081518; dated Sep 5 2008)
Regulation Number:Regulation Name:	21 CFR Part 874.4680Bronchoscopes (Flexible or rigid) and accessoriesDiagnostic Ultrasound Transducer
Regulatory Class:Product Code:	Class IIEOQ and ITX

PENTAX Ultrasound Video Bronchoscope EB-1970UK 510(k) Summary

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Image /page/1/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is directly underneath the word "PENTAX". The word "MEDICAL" is in a smaller, bold, sans-serif font on the bottom line.

Device Description:

Intended Use:

Summary of Technology Characteristics

The PENTAX Ultrasound Video Bronchoscope EB-1970UK has the same fundamental technology and operating principles in comparison to those of the predicate device, including same intended use, design technological characteristics, such as Insertion Portion, Control Body and fiber-optics illumination. The minor differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.

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Image /page/2/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is directly underneath the word "PENTAX". The word "MEDICAL" is in a similar font, but slightly smaller, on the bottom line.

Safety and Performance Data (Non-clinical tests)

Design Verification and Validation testing has been performed in accordance with Design control per 21 CFR Part 820.30. The performance of the PENTAX Ultrasound Video Bronchoscope EB-1970UK has been evaluated using the appropriate methodology as specified in the following FDA recognized consensus standards in conjunction with our inhouse test protocols and use of external testing laboratories:

1. IEC 60601-1:1988+A1:1991+A2:1995 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-1:2000 General requirements for safety- Collateral standard: Safety requirements for medical electrical systems
1. IEC 60601-1-2:2001+A1:2004 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
1. ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ട. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10:Tests for 6. irritation and skin sensitization
1. IEC 60601-2-18:1996+A1:2000 Medical electrical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
1. ISO 8600-1:2005 - Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements
റ്റ. ISO 8600-3:1997+A1:2003 - Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
1. ISO 8600-4:1997 Optics and optical instruments -Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
AAMITIR12:2010 Designing, testing, and labeling reusable medical devices for 11. reprocessing in health care facilities: A guide for device manufacturers
1. AAMITIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
1. ANSI/AAMI_TIR79:2010 Comprehensive quide to steam sterilization and sterility assurance in health care facilities
Medical devices Quality management systems Requirements for 14. IS013485:2003 regulatory purposes
1. ISO 14971:2007 (corrected version): Medical devices -Application of risk management to medical devices
1. IEC 60601-1-4:2000 Ed. 1.1 Medical electrical equipment- Part 1-4: General requirements for safety- Collateral Standard: Programmable electricalmedical systems
1. IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

PENTAX Ultrasound Video Bronchoscope EB-1970UK 510(k) Summary

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Image /page/3/Picture/0 description: The image shows the logo for Pentax Medical. The word "PENTAX" is in large, bold, sans-serif font on the top line. A horizontal line is directly underneath the word "PENTAX". The word "MEDICAL" is in large, bold, sans-serif font on the bottom line.

1. IEC 62366:2007 Medical devices -Application of usability engineering to medical devices
1. IEC 62304:2006 Medical device software- Software life cycle processes
1. IEC 604171SO 7000-DB-12M:2004 Graphical symbols for use on equipment 12month subscription to online database comprising all graphical symbols published in IEC 60417 and ISO 7000
Medical devices Symbols to be used with medical device 21. ISO 15223-1:2012 labels, labeling and information to be supplied - Part 1: General requirements'
1. IEC 60878:2003 Graphical symbols for electrical equipment in medical practice

The PENTAX Ultrasound Video Bronchoscope EB-1970UK test results satisfy the acceptance criteria specified by the above applicable standards.

Biocompatibility Test

Biocompatibility of direct and indirect contact materials were confirmed by testing the Cytotoxicity, Sensitization and Intracutaneous Reactivity for the surface device, mucosal membrane contact less than 24 hours duration device category in accordance with the ISO 10993-1, 5, and 10 Biological evaluation of medical devices standard and the FDA's quidance the Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.

Reprocessing Validation

Simulated use conditioned test samples were used in the Cleaning validation and High Level Disinfection validation studies for validating the effectiveness of the reusable Bronchoscope Reprocessing procedures/methodology in accordance with the FDA's Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011, AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities. A guide for device manufacturers, AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, and AAMI TIR79:2010 Comprehensive quide to steam sterility assurance in health care facilities. All the study results satisfy the acceptance criteria specified by the above applicable standards.

In addition, the Reprocessing Instructions (Manual) were validated based on the FDA's Draft Guidance for Industry and FDA Staff Processing Medical Devices in Health Care Settings: Validation Methods and Labeling distributed in May 2, 2011. The validation confirmed that the PENTAX Ultrasound Video Bronchoscope EB-1970UK. Reprocessing Instructions are complete, understandable, and can reasonably be executed by the user.

EMC and Electrical Safety

The acceptable level of Electromagnetic compatibility (EMC) and Electrical Safety (ES) for the PENTAX Ultrasound Video Bronchoscope EB-1970UK was confirmed by testing in accordance with the IEC 60601-1; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Safety

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Image /page/4/Picture/0 description: The image shows the words "PENTAX MEDICAL" in bold, black letters. The word "PENTAX" is on the top line, and the word "MEDICAL" is on the bottom line. There is a horizontal line separating the two words. The font is sans-serif and appears to be a blocky, bold typeface.

requirements for medical electrical systems, Electromagnetic compatibility - Requirements and tests; and IEC 60601-2-18:1996+A1:2000 Medical equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.

Substantial Equivalence discussion:

The PENTAX Ultrasound Video Bronchoscope EB-1970UK has the same intended use, fundamental technology and operating principles including design technological characteristics, such as Insertion Portion, Control Body and fiber-optics illumination in comparison to those of the predicate device. The minor dimensional differences in the Depth of Field, Distal end width, Insertion Tube width, instrument channel width, and Total Length between two devices do not impact the intended use, and do not raise different questions of safety and effectiveness and that the device is as safe and effective as a legally marketed device.

Conclusion:

The PENTAX Medical Company believes that the PENTAX Ultrasound Video Bronchoscope EB-1970UK as indicated in this 510(k) premarket notification submission is to be as safe, as effective and substantially equivalent in performance to the above identified cleared predicate device/system.

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Image /page/5/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the top half of the circle. In the center of the circle is a stylized image of an eagle. The eagle is facing to the right and has three lines representing its wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO60-G60 Silver Spring, MD 20993-0002

April 25, 2014

PENTAX Medical Company % Mr. Krishna Govindarajan Regulatory Manager 3 Paragon Drive Montvale, NJ 07645-1782

Re: K131946

Trade/Device Name: PENTAX Ultrasound Video Bronchoscope EB-1970UK+HI VISION Preirus

Regulation Number: 21 CFR 874.4680

Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ, ITX Dated: April 14, 2014 Received: April 15, 2014

Dear Mr. Govindarajan:

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. 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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Page 2 - Mr. Krishna Govindarajan

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director

Division of Ophthalmic and Ear,

Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: PENTAX Ultrasound Video Bronchoscope EB-1970UK + HI VISION Preirus

Indications for Use:

The EB-1970UK, Ultrasound Video Bronchoscope, 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, 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sageev George -S 2014.04.21 16:39:23 -04'00'

Page 1 of 1

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.