The Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in combination with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the urinary tract.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for urinary tract. Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.

Device Description

In routine examination of the urinary tract, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the urinary tract. The ponventional type therapeutic urethro-cystoscope limits the physician's ability to access certain areas of interest. The UM-2R / UM-3R Ultrasonic Probes, when used with an endoscope offer transendoscopic access to the urinary tract. The 2.4 mm insertion tube of these probes can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with therapeutic urethro-cystoscope with a minimum capacity size of 9Fr.. A probe-driving unit controls the rotation of the transducer.

AI/ML Overview

The provided text describes a 510(k) submission for the Olympus UM-2R and UM-3R Ultrasonic Probes, seeking clearance for use within the urinary tract. The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific study with acceptance criteria and performance data for the new intended use.

Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics for acceptance criteria is not present in the provided text. The document states that the devices meet existing safety and performance requirements for ultrasound products and are substantially equivalent to previous models for their general operating principles.

However, I can extract information related to the devices and their intended use.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) summary primarily relates to demonstrating substantial equivalence to predicate devices and adherence to established regulatory standards for diagnostic ultrasound transducers. Specific quantitative performance metrics for the new intended use (urinary tract imaging) are not detailed as they would be in a clinical trial report.

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (Inferred from submission)
Compliance with International Standard IEC 60601-1 (Safety)	Device is designed, manufactured, and tested in compliance with IEC 60601-1.
Compliance with FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985 (Acoustic Output, Safety)	Ultrasound characteristics of the probes meet the requirements of the FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985.
Substantial Equivalence to Predicate Devices (Olympus EU-M30, K951994; Olympus UM-2R/UM-3R, K944610; Olympus EU-M20, K926514; Olympus EU-M3, K882061) regarding method of operation, material, and design.	The devices incorporate no significant change in method of operation, material, or design that could affect safety or effectiveness, except for the intended use.
Ability to provide intraluminal sonographic imaging of the urinary tract.	The devices are designed for this purpose, leveraging their existing technology for gastrointestinal imaging. The FDA clearance letter acknowledges this new indication.

Study Information (Based on provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The submission is focused on demonstrating substantial equivalence to predicate devices and compliance with existing standards, rather than reporting on a specific test set from a clinical study for the urinary tract indication.
- Data Provenance: Not specified. There is no mention of specific clinical data (country of origin, retrospective/prospective) for the urinary tract indication. The clearance is based on the devices' existing design and safety profile.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document does not describe a process for establishing ground truth via expert consensus for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. There is no mention of a formal adjudication process for a test set in relation to the new urinary tract indication.
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:
- MRMC Study: No. This document is from 1998, well before the common use of AI in medical imaging interpretation, and it describes a hardware device (ultrasonic probe), not an AI algorithm.
- Effect Size: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This document describes a physical medical device (ultrasound probe), not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified in the context of a study for the urinary tract indication. The basis for clearance relies on established safety and performance of the device type and its substantial equivalence to previously cleared devices. For the new indication, it is likely that the FDA evaluated the technical specifications and existing safety profile to determine that it could be safely and effectively used in the urinary tract, without requiring a specific "ground truth" study for this 510(k) process.
The sample size for the training set:
- Sample Size: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.

Summary

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NOV 16 1998

K982610

510(k) SUMMARY OLYMPUS UM-2R/UM-3R ULTRASONIC PROBE

Device Name:	Olympus UM-2R / UM-3R Ultrasonic Probesand its ancillary equipment for urinary tract
Common / Usual Name:	Olympus Ultrasonic Probes
Classification Number& Classification Name:	Class II , 21CFR 892.1570Diagnostic ultrasound transducerClass II, 21CFR876.1500Endoscope and accessories
Predicate Devices:	Olympus EU-M30 (K951994)Olympus UM-2R / UM-3R (K944610)Olympus EU-M20 (K926514)Olympus EU-M3 (K882061)
Submitted By:(Contact Person)	Laura Storms-TylerOlympus America Inc.Regulatory AffairsTwo Corporate Center DriveMelville, NY 11747(516) 844-5688
Summary Preparation Date:	July 23, 1998

Statement of Intended Use

The Olympus UM-2R and UM-3R Ultrasonic Probes have been cleared for use within the gastrointestinal tract in 510(k) #K944610.

The Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in combination with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the urinary tract.

Device Description

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can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with therapeutic urethro-cystoscope with a minimum capacity size of 9Fr.. A probe-driving unit controls the rotation of the transducer.

The UM-2R and UM-3R probes produce a B-mode scans using the de-aerated water immersion method and offer 360 degree mechanical/radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4 mm and the length is 2050 mm. Both probes incorporate similar design, construction, intended use, and method of operation. The only difference between these two probes is that the UM-2R probe operates at 12 MHz and is compatible with both Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, while the UM-3R probe operates at 20 MHz and is compatible with the EU-M30 and the EU-M20 Endoscopic Ultrasound System. The Olympus EU-M30 Endoscopic Ultrasound Center was cleared for marketing in 510(k) # K951994. The Olympus EU-M20 Endoscopic Ultrasound System was cleared for marketing in 510(k) # K926514 and EU-M3 Endoscopic Ultrasound System was cleared for marketing in the 510(k) # K882061.

All components and associated equipment of the UM-2R / UM-3R Ultrasonic Probes will be marketed non-sterile and can be reprocessed as described in the Instruction Manual.

Safety

The Olympus UM-2R and UM-3R Ultrasound Probes are designed, manufactured, and tested in compliance with International Standard IEC 60601-1. The ultrasound characteristics of Olympus UM-2R and UM-3R Ultrasound Probes meet the requirements of the FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985.

When compared to the predicate devices listed in the "Regulatory History" portion of this section, except for intended use, neither ultrasound probe incorporates any significant change in method of operation, material, or design that could affect safety or effectiveness.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures in profile facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

NOV 16 199

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laura Storms-Tyler Director, Regulatory Affairs Olympus Optical Co., Ltd. C/O Olympus America 2 Corporate Center Melville, New York 11747

K982610 Re: Olympus UM-2R/3R Ultrasonic Probes Dated: October 22, 1998 Received: October 27, 1998 Requlatory class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Storms-Tyler:

We have reviewed your Section 510(k) 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, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for urinary test use with the Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

UM-2R (12 MHz) UM-3R (20 MHz)

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page - 2 - Ms. Storms-Tyler

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. Tt 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rod Perez at (301) 594-1212.

Sincerely yours,

David A. Szymon
Lillian Yin, Ph.D.

rector, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982610

Appendix F

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Int inded Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Cli ical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)			N/P

Ultrasound System: EU-M3

ખ્ય

A-new.Indication: P-previously cleared by FDA; E-added under Appendix E

A Iditional Comments:

New indications=Intraluminal ultrasound for urinary tract.

Previously cleared indications=Intraluminal ultrasound for

gastrointestinal tract.

In LINE - OONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evals

David A. Segner
(Division Sign-Off)

તું નુ

510(k) Number

Division of Reproductive, Abdominal, ENT and Radiological Dev

Frescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

fill out one form for each ultrasound system and each transducer.

In anded Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	PWD
Ophthalmic
Fe
At: lominal
Int soperative (specify)
Ini soperative Neurologloul
Pelletric
Srell Organ (specify)
Ne natal Caphallo
Ac #Cephalic
Ca diac
Tr neesophageal
To norectal
Ti nsvaginal
Ti nourethml
In avesculer
P. spharal Vascular
Laparoscopic
V. aculo-skaletai
C. nventional
Musculo-skeletal Superficiel
Other (specify)	N	/	P

N = new Indication; P= previously cleared by FDA; E= added under Appendix E

A Iditional Comments:

New indications-Intraluminal ultrasound for urinary tract.

Previously cleared indications=Intraluminal ultrasound for

gastrointestinal tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

F-3

l rescription Use (Per 21 CFR 801.109)

Ultrasound System: EU-M30

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _ 4011

(Division Sign-Off) 1

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Appendix F

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Int inded Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	A	B
Clinical Application	Mode of Operation
Ophthalmic
Fe I
Abdominal
Int soperative (specify)
Int soperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)		N/P

\ = new .Indication; P= previously cleared by FDA; E= added under Appendix E

A Iditional Comments:

New indications=Intraluminal ultrasound for urinary tract.

Previously cleared indications=Intraluminal ultrasound for

gastrointestinal tract.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hoganson
(Division Sign-Off)

દુર

I rescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, ENT, E-3 and Radiological Devices 510(k) Number

Ultrasound System: EU-M20

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Diagnostic Ultrasound Indications for Use Form

Fill out blief of the form for and imaging or fluid flow analysis of the human body as follows:
Internetic use: Diagnostic ultrasound Imaging or fluid flow analysis of the hu

Cli ical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fe al
At: tominal
Int ioperative (specify)
Int-operative Neurological
Pe iatric
Small Organ (specify)
Ne natal Cephalic
Ac Cephalic
Or theo
Ti essophageal
Ti norectal
Ti asvaginal
Th nourethral
In avascular
P-Aphecal Vascular
Laparoscopic
M usculo-skeletal
C ventioned
Musculo-skeletal Superficial
Other (specify)		N/P
Mode of Operation
Cll ical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fe &
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pelvic
Small Organ (specify)
Neonatal Cephalic
Adult & Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)		N/P
N = new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
New indications-Intraluminal ultrasound for urinary tract.

It on another Page of needed. o of CDHH, Oillos of Device Evaluation (ODE)

l · rescription Use (Per 21 CFR 801.109)

David A. Tyson
F(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Transducer

12 MHz Catalog #27023 Model UM2R

ven

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Diagnostic Ultrasound Indications for Use Form

Diagnosus Claim for each ultrasound system and each transducer.

Fill out one form for each ultrasound system in the lower bedress

In anded Use: Diagnostic utrasound imaging or fluid flow analysis of the human boty as follows:
In inded Use: Diagnostic ultrasound imaging or fluid flow analysis of the huma

Transducer

20 MHz Catalog # 27024 Mode1 UM3R

જીન્દ્ર

DELOW THIS LINE - DON'THOUR ON AND THEIR PAGE IF NEEDED on of CDFH, Office of Device Evaluation (ODE)

l rescription Use (Per 21 CFR 801.109)

gastrointestinal tract.

F-3
(Division Sign-Off)
Division of Res

પ્રદૂધની વસ્તર પ્રદૂષ

(Division of Reproductive, Abdominal
Division of Reproductive, Abdominal, ENT.
Score, recoloron of Reproduction and Radiological Dep

510(k) Number K962610

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.