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 the organs, tissues, and subsystems: 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, video signals, and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down angulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a radial 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 endossope 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 immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

AI/ML Overview

The provided document, K081518, is a 510(k) summary for the Pentax EB-1970UK Ultrasound Video Bronchoscope.

The document explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." This means that traditional acceptance criteria based on clinical outcomes or diagnostic accuracy thresholds are not applicable or provided in this submission. The device's clearance is based on its substantial equivalence to predicate devices through technical specifications and performance testing (likely bench testing, and electrical/mechanical safety) rather than clinical performance studies.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of diagnostic accuracy or clinical effectiveness with human readers, cannot be fully provided from the given text.

Based on the available information:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Type	Acceptance Criteria (Threshold)	Reported Device Performance
Substantial Equivalence	To be substantially equivalent to predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, Hitachi EUB-5500) based on specifications and performance testing.	The FDA determined the device is substantially equivalent to legally marketed predicate devices.
Functionality	Perform optical visualization, ultrasonic visualization, and therapeutic access to the pulmonary tract.	The device's description indicates it is designed for these functions. Specific performance metrics (e.g., image resolution, channel diameter) are summarized as being compared to predicates.
Safety (Acoustic Output)	Not explicitly stated in the summary, but implicit for an ultrasound device.	A post-clearance special report for acoustic output measurements based on production line devices is required.

Sample size used for the test set and the data provenance: Not applicable. No clinical performance test set data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance test set data is provided.
Adjudication method for the test set: Not applicable. No clinical performance test set data is provided.
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: Not applicable. This document predates widespread AI in medical devices, and no clinical effectiveness study is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an instrument used by a human operator; it's not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for proving substantial equivalence was likely based on the technical specifications and safety standards met by the predicate devices.
The sample size for the training set: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

Conclusion from document:

The 510(k) clearance for the Pentax EB-1970UK Ultrasound Video Bronchoscope was based on its substantial equivalence to existing, legally marketed predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, and Hitachi EUB-5500). This determination was made primarily through a comparison of technical specifications and performance testing (likely bench testing, electrical, and mechanical safety, as is common for such devices) rather than clinical performance data or studies involving human readers or patient outcomes. The submission explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." A post-clearance requirement for acoustic output measurements on production units was noted, indicating ongoing safety monitoring for the ultrasound component.

Summary

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K081518

SEP - 5 2008

510(k) Summarv

Submitter Information:

Pentax Medical Company 102 Chestnut Ridge Road Montvale, New Jersey 07645-1856

Name of Device

Trade Name:	EB-1970UK, Ultrasound Video Bronchoscope
Classification Name:	Diagnostic Ultrasound Transducer (ITX) {892.1570}; track3, tier2Bronchoscope and Accessories (EOQ) {874.4680}; tier2

Predicated Device(s) Information

Model, Description	Manufacturer	PMN #
BF type UC-160F, Ultrasound Brochofiberscope	Olympus	K070983
EB-1830T3, Video Bronchoscope	Pentax	K023376
EUB-5500 Diagnostic Ultrasound Scanner	Hitachi	K063518

Device Description:

Intended Use:

Comparison to Predicated Device(s)

The submission for substantial equivalence included literature describing the system including; specifications, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing. The substantial equivalence is not based on an assessment of clinical performance data.

Prepared by: Paul Silva

Signature: Paul Silva Date: 8-5-2008

Control Number: EB-1970UK.EUB-5500

Page 1 of 1

Revision: d

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2008

Mr. Paul Silva Regulatory Affairs Director Pentax Medical Company 102 Chestnut Ridge Road MONTVALE NJ 07645

Re: K081518

Trade/Device Name: EB-1970 Ultrasound Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: EOQ and ITX Dated: May 29, 2008 Received: June 9, 2008

Dear Mr. Silva:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the EB-1970 Ultrasound Video Bronchoscope, as described in your premarket notification:

Transducer Model Number

EB-1970UK

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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);

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Page 2 - Mr. Silva

labeling (21 CFR Part 801); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices. requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.

Sincerely yours,

forpt Matheras

ancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications For Use Statement

System:	EUB-5500
Probe:	EB-1970UK
	Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of 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
Fetal Imagingand other	Fetal
	Abdominal
	Intra-operative (Spec.)
	Intra-operative (Neuro.)
	Laproscopic
	Pediatric
	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vagina
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convert.)
	Musculo-skel. (Superfic.)
	Intra-luminal
	Endoscopy	N	N	N		N	N
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (card.)
	Other (spec.)
PeripheralVessel	Peripheral vessel
	Other (Spec.)

P = previously cleared by FDA; E = added under Appendix E ew application;

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.