The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs.

Device Description

The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract and surrounding organs. The probe is connected to the endoscopic ultrasound center through the probe driving unit. The probe is attached to the endoscope which allows the user to use probe. The probe is inserted into the patient through a channel of the endoscope. A probe driving unit controls the rotation of the transducer.

UM-S30-25R Ultrasound Probe produces a B-mode scans using the de-aerated water immersion method and balloon method. The probe offers 360 degree mechanical /radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4mm and the length is 2050mm.

AI/ML Overview

The provide information does not describe specific acceptance criteria a study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Olympus UM-S30-25R Ultrasonic Probe) seeking substantial equivalence to predicate devices. The document focuses on demonstrating that the new device does not introduce significant changes that would affect its safety or effectiveness compared to already cleared devices.

Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and separate performance metrics cannot be directly extracted from this document.

However, I can extract information related to the non-clinical tests conducted to support substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which assesses whether a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a clinical study.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable as no clinical test set is described in the provided document. The non-clinical tests mentioned are related to design and material comparisons and compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as no clinical test set or ground truth establishment by experts is described for performance evaluation.

4. Adjudication Method for the Test Set:

This information is not applicable as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The document does not describe a MRMC study or any study involving human readers with or without AI assistance. The device in question is an ultrasonic probe, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable. The device is an ultrasonic probe, not an algorithm, and the document describes non-clinical tests for the device itself, not for an algorithm's standalone performance.

7. Type of Ground Truth Used:

This information is not applicable. The document focuses on comparing the new device to predicate devices and compliance with safety standards, not on establishing ground truth for diagnostic accuracy.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as the device is not an AI algorithm that requires a training set.

Summary of what is provided regarding testing for substantial equivalence:

The document describes non-clinical tests conducted to support a determination of substantial equivalence for the Olympus UM-S30-25R Ultrasonic Probe and its associated ancillary equipment.

Type of Study: Non-clinical tests focusing on design, materials, and compliance with recognized standards. This is to demonstrate that the new device is as safe and effective as the predicate devices.
Acceptance Criteria (Implied):
- Design: Compliance with IEC 60601-1 (medical electrical equipment safety) and Revised 510(k) Diagnostic Ultrasound Guidance for 1993, 1995.
- EMC: Compliance with IEC 60601-1-2 (electromagnetic compatibility) for the Ultrasonic Probe UM-S30-25R.
- Materials: Patient-contacting materials are identical to the predicate device.
Reported Device Performance / Results of Non-clinical Tests:
- Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240: "have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995."
- Ultrasonic Probe UM-S30-25R: "has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2."
Conclusion: "When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness."

Summary

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K994103
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ATTACHMENT 11.

510(k) Summary

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K994103
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510(k) SUMMARY OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT

A. Submitter's Name, Address, Phone and Fax Numbers

1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division

Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786

B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5474 FAX: (516) 844-5416

C. Device Name, Common Name, Classification Name and Predicate Devices

Device Name:

Ultrasonic Probe UM-S30-25R Endoscopic Ultrasound Center EU-M30 Probe Driving Unit MH-240

Common Name:

Ultrasonic Probe

Classification Name:

21 CFR892.1570 Diagnostic Ultrasonic transducer

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K994103
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Predicate Device:

MODEL	NAME	510(k)#
UM-2R	Ultrasonic Probe	K944610
UM-3R	Ultrasonic Probe	K944610
EU-M30	Endoscopic Ultrasound Center	K982610(for urinary),K951994(for gastrointestinal tract),K982323(for bronchial use)4
MH-240	Probe Driving Unit	K982610(for urinary),K951994(for gastrointestinal tract),K982323(for bronchial use)
MH-240	Balloon Sheath	K944610 (for UM-2R/3R)

D. Description of the Device(s)

Flexible endoscope: inner channel is φ2.8mm, φ3.2mm,φ6mm and φ5.5mm. Rigid endoscopes : minimum capacity is 9Fr.

E. Intended Use of the Device(s)

F. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)

Ultrasonic Frequency

The ultrasonic frequency is changed to 30MHz.

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G. Summary including a Brief Discussion of Non-clinical Tests and How their Results support Determination of Substantial Equivalence

1. Design

Endoscopic Ultrasound Center EU-M30 and Probe Driving Unit MH-240 have been designed, manufactured and tested in compliance with IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995. It meets the requirements of IEC 60601-1 and Revised 510(k) Diagnostics ultrasound Guidance for 1993,1995.

Ultrasonic Probe UM-S30-25R has been tested to verify electromagnetic compatibility (EMC) with IEC 60601-1-2. It meets the requirements of IEC 6060-1-1-2.

2. Materials

The patient contacting materials are identical to predicate device.

H. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the Olympus UM-S30-25R Ultrasonic probe and associated ancillary equipment do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2000

Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

Re: K994103

UM-S30-25R Ultrasonic Probe (Gastrointestinal Tract Use) Regulatory Class: II Product Code: 90 ITX/21 CFR 892.1570 Dated: March 30, 2000 Received: July 20, 2000

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, 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 UM-S30-25R Ultrasonic Probe intended for use with the Olympus EU-M30 Endoscopic Ultrasound Center as described in your premarket notification.

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 regulations.

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.

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Page -2- Ms. Laura Storms-Tyler

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 ( If you desire specific advice for your device on on Arceling (ogmiiance at (301) 594-4591. Additionally, for in for in vitro diagnostic devices), prease contact une Office of Coffice of Compliance at (31) 594-1
questions on the promotion and advertising of your device, please contact t questions on the promotion and advertising of your develop by reference to premarket notification" (21 CFR
4639). Also, please note the regulation entitled, "Misbranding by r 4639. Associetal information on your responsibilities of er the Act may be obtained from the Division of
807.97). Other general information on your responsibilities under in 807.97). Other general information on your responsibilities and in the many of (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 M. Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K994103

Device Name:

Olympus UM-S30-25R Ultrasonic Probe and associated ancillary equipment for gastrointestinal tract

Indications for Use:

The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be The OEFAIT OD ONPUS Endoscopic Ultrasound System for intraluminal ason with an OD ing of the gastrointestinal tract and surrounding organs.

(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)

David A. Bryson

(Optional Format 1-2-96)

Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1794103 510(k) Number .

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Diagnostic Ultrasound Indications for Use Form OLYMPUS UM-S30-25R ULTRASONIC PROBE (Subject Device) OLYMPUS UM-S30-25R ULTAASONIO PRODE (Subject Solary of Start)

Intended Use: Diagnostic uttrasound imaging or fluid flow analysis or the human body as follows:

Appendix F

Intended Use: Diagnostic ultrasound imaging

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		N
Transrectal		N
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Specify)		N

Note: N = new indication; P = previously cleared by FDA; F = added under Appendix EOther (open))
N = new indication; P = previously cleared by FDA; E = added under Appendix i Additional Comments:

the gastrointestinal tract and the surrounding organs (GI use)

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON AVOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)

F-3

Prescription Use (Per 21 CFR 801.109)

Omid A. Moghadam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.

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K994103

Appendix F

Diagnostic Ultrasound Indications for Use Form OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER (ancillary system) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis or the human body as follows:

Clinical 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		P
Transrectal		P
Transvaginal
Transurethral		P
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (Specify)		P

Other (open))
N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

Additional Oonlinens.
Previously cleared indication : Intraluminal ultrasound for gastrointestinal tract and surround organs, upper air and tracheobronchial tree and urinary tract.

(PLEASE DO NOT WRITE BELOW THE UNE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evalution (ODE)

Prescription Use (Per 21 CFR 801.109)

David b. Syzmm

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

F-3

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.