Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in conjunction with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

Device Description

In routine examination of the upper airways and tracheobronchial tree, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the upper airways and tracheobronchial tree. The conventional type bronchoscopes limit 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 upper airways and tracheobronchial tree. 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 bronchoscopes with a minimum channel size of 2.8 mm. The rotation of the transducer is controlled by a probe driving unit.

AI/ML Overview

The provided text describes a 510(k) summary for the Olympus UM-2R/3R Ultrasonic Probes. It primarily focuses on the device's description, intended use, and safety compliance, particularly regarding its extension to bronchial use. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with detailed performance metrics.

The document states that the probes "meet the requirements of the FDA's 510(k) Diagnostic Ultrasound Guidance for 1993 and 1985," and that "neither ultrasound probe incorporates any significant change in method of operation, material, or design that could affect safety or effectiveness" when compared to predicate devices, except for the expanded intended use. This implies that the device is deemed to meet safety and effectiveness standards, likely by demonstrating substantial equivalence to previously cleared devices. However, explicit performance metrics, such as sensitivity, specificity, accuracy, or any quantitative results from a specific clinical study for the new bronchial indication, are not presented.

Therefore, many of the requested sections regarding a specific study design and results cannot be filled from the provided text.

Here's a breakdown of what can be inferred or directly stated from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantitative metrics. The implicit acceptance criteria are that the device meets existing FDA guidance for diagnostic ultrasound and is substantially equivalent in safety and effectiveness to predicate devices for its new intended use (bronchial imaging).
Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, effect size) are reported for the device in the provided document.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1 (Electrical Safety)	Device is designed, manufactured, and tested in compliance.
Compliance with FDA 510(k) Diagnostic Ultrasound Guidance (1993, 1985)	Device meets these requirements for ultrasound characteristics.
Substantial Equivalence to Predicate Devices (Safety & Effectiveness)	No significant change in method, material, or design affecting safety or effectiveness compared to predicates (except for intended use).
Ability to visualize upper airways and tracheobronchial tree via intraluminal sonographic imaging	Device is designed for this purpose, but no performance data is given.

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

Sample Size for Test Set: Not mentioned. No specific test set or clinical study supporting the new bronchial indication is described.
Data Provenance: Not mentioned.

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

Not mentioned. No specific ground truth establishment is described for a test set.

4. Adjudication method for the test set:

Not mentioned.

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 MRMC study is mentioned. This device is an ultrasonic probe, not an AI-assisted diagnostic tool as described in this document.

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

Not applicable. This is a hardware device (ultrasonic probe), not an algorithm.

7. The type of ground truth used:

Not mentioned. The document relies on demonstrating substantial equivalence to predicate devices and compliance with existing standards rather than presenting a novel clinical study with a defined ground truth.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards for an ultrasonic probe. It does not describe a clinical study with new performance data beyond these regulatory requirements.

Summary

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play 982323

DEC 1 1 1998

510(k) Summary Olympus UM-2R/3R Ultrasonic Probe

Device Name:	Olympus UM-2R/3R Ultrasonic Probe and ancillaryequipment for bronchial use
Common/Usual Name:	Olympus Ultrasonic Probes
Classification Numberand Name:	Class II, 21 CFR 892.1570Diagnostic Ultrasound TransducerClass II 21 CFR 874.4680Bronchoscope and accessories
Predicate Devices:	Olympus EU-M30 (K951994)Olympus UM-2R/3R (K944610)Olympus EU-M20 (K926514)Olympus EU-M3 (K882061)
Submitted by:	Laura Storms-TylerOlympus America Inc.Two Corporate Center DriveMelville, NY 11042-1179(516) 844-5688
Summary PreparationDate:	June 26, 1998

Statement of Intended Use:

The Olympus UM-2R/3R Ultrasonic Probes have been cleared for use within the gastrointestional 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 upper airways and tracheobronchial tree.

Device Description

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-K982323 p. 242

to the upper airways and tracheobronchial tree. 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 bronchoscopes with a minimum channel size of 2.8 mm. The rotation of the transducer is controlled by a probe driving unit.

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 a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. 2 Corporate Center Melville, NY 11747-5416

K982323 Re: Trade Name: Olympus UM-3R Ultrasonic Probes and associated ancillary equipment, for bronchial use Requlatory Class: II/21 CFR 892.1570 Product Code: 90 ITX Dated: June 30, 1998 Received: July 2, 1998

Dear Ms. 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, Druq, 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 aqainst misbranding and adulteration.

This determination of substantial equivalence applies to the following Ultrasound Systems intended for use with the Olympus UM-2R and UM-3R Ultrasonic Probes, as described in your premarket notification:

System Model Number

EU-M30
EU-M20
EU-M3

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 Requlation (QS) for Medical Devices: General (GMP) requlation (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 regulations.

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Page 2 - Laura Storms-Tyler

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. position on this use.

This letter will allow you to begin marketing your device as described in your The FDA finding of substantial equivalence of your premarket notification. 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 "Misbranding by reference to premarket notification" (21 CFR entitled, Other general information on your responsibilities under the Act may 807.971. 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 Paul Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Voril A. Klymm
Lillian Yin, Ph.D.

irector, 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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KVDLJLJ

Appendix F

ﺮ

Diagnostic Ultrasound Indications for Use Form

Diagnostic Ultrasound system and each transducer.

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

Fill out one form for each ultrasounce of every of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Intended Use: Diagnostic ultrasound imaging of fluid

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	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-skeletal
Conventional
Musculo-skeletal Superficial			N/P
Other (specify)

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

Additional Comments:

New indications = Intraluminal ultrasound for upper airways and tracheobronchial tree.

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)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

Prescription Use (Per 21 CFR 801.109)

F-3

510(k) Number: K982323

જ્યન

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K982323

510(k) Number (if known):

Device Name:

Olympus UM-2R / UM-3R Ultrasonic Probes and associated Ancillary Equipment (for bronchial use)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number	K982323
	(Optional Format 1-2-96)

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.