The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

Device Description

The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the of the upper airways and tracheobronchial tree and surrounding organs.

Ultrasonic Probes UM-S20-17S and UM-S20-20R are designed to be used in conjunction with bronchoscopes. The Probes are inserted into the patient through a channel of the endoscope.

The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.

The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.

The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.

The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.

UM-S20-17S and UM-S20-20R use direct contact method only.

The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).

AI/ML Overview

The provided FDA 510(k) clearance letter for the Olympus Ultrasonic Probes (UM-S20-17S and UM-S20-20R) details the acceptance criteria and the study that proves the device meets those criteria. However, it's crucial to note that this document pertains to ultrasonic probes (hardware) and does not involve Artificial Intelligence (AI). Therefore, many of the typical elements related to AI/ML device testing (e.g., training set, ground truth experts, MRMC studies, standalone algorithm performance) are not applicable or described in this type of submission.

The "studies" described here are non-clinical performance tests (bench testing), demonstrating the safety and effectiveness of the physical medical device by comparing its characteristics and performance to a legally marketed predicate device.

Acceptance Criteria and Device Performance for Olympus Ultrasonic Probes

The acceptance criteria for these ultrasonic probes are predominantly based on meeting the performance specifications of the predicate and reference devices, and complying with established medical device standards for safety and functionality. The "reported device performance" indicates that the subject devices met all the acceptance criteria through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Based on Predicate/Reference & Standards)	Reported Device Performance
Acoustic Output	Compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 21, 2023). This includes parameters like: - Frequency: 20 MHz (matching Reference Device UM-3R) - Axial Resolution: 2mm or less (matching Reference Device UM-3R) - Lateral Resolution: 2mm or less (matching Reference Device UM-3R) - Frame Rate: 6.67rps (matching Reference Device UM-3R) - Scanning Field of View: 360° (matching Reference Device UM-3R) - Display Mode: B-mode (matching Predicate and Reference Devices)	All acoustic output parameters passed/met the specified criteria and standards.
Durability	Demonstrated adequate operational lifespan and resistance to wear and tear. Specific quantitative thresholds are not detailed but are implied by "Durability" testing.	Testing passed/met acceptance criteria.
Measurement Accuracy	Verified the accuracy of measurements obtained using the ultrasonic probes. Specific accuracy metrics are not detailed but are implied by "Measurement Accuracy" testing.	Testing passed/met acceptance criteria.
Human Use Factors	Compliance with FDA Guidance Documents: Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016). Ensures safe and effective use by healthcare professionals.	Testing passed/met acceptance criteria.
Biocompatibility	Compliance with ISO 10993 series (ISO 10993-1, -5, -10, -12, -17, -18, -23). Ensures materials are safe for patient contact.	Testing passed/met acceptance criteria.
Reprocessing Validation	Compliance with ISO 17664-1, AAMI TIR12, ANSI AAMI ST98, ANSI AAMI ST58, ISO 11135, ISO 11138-2. Ensures safe and effective cleaning and sterilization through methods like ETO.	Testing passed/met acceptance criteria.
Electrical Safety/EMC	Compliance with IEC 60601-1, IEC ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, IEC TR 60601-4-2. Ensures electrical safety and electromagnetic compatibility.	Testing passed/met acceptance criteria.

Study Details (Applicable to Non-AI Hardware Verification)

As this is a hardware device 510(k) submission, the study methodology focuses on non-clinical performance data and bench testing rather than clinical trials with human subjects or AI-specific assessment methods.

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

Sample Size: The document does not specify a "sample size" in terms of cases or patients, as the testing was non-clinical (bench testing). The "test set" in this context refers to the manufactured probes themselves and the conditions under which they were tested (e.g., phantom models for acoustic output, simulated use for durability, material samples for biocompatibility).
Data Provenance: The tests were conducted internally by Olympus Medical Systems Corporation and its manufacturing site, SHIRAKAWA OLYMPUS CO., LTD. in Japan. The data is from bench testing and in-house validation, not from real-world patient data (retrospective or prospective). The manufacturing site is in Japan.

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

This concept is not applicable to this type of hardware 510(k) submission. "Ground truth" for these tests is established by adhering to widely accepted international standards (ISO, IEC, AAMI) and FDA guidance documents for medical device performance, safety, and manufacturing. These standards define the measurable physical and electrical properties that the device must meet. The experts involved would be engineers, quality control specialists, and regulatory affairs personnel responsible for designing, manufacturing, and testing the probes to these standards.

4. Adjudication Method for the Test Set:

This concept is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of medical images or data, which is relevant for AI image analysis or clinical trials. For hardware testing, "adjudication" is replaced by adherence to established test protocols, measurement equipment calibration, and standard-defined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant for this non-AI hardware device. The equivalence claim for this device is based on technical specifications and non-clinical performance data compared to a predicate device.

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

No, a standalone algorithm performance test was not done. This device is a physical diagnostic ultrasonic transducer, not a software algorithm. Its "performance" refers to its ability to generate images when connected to an ultrasound center, which is then interpreted by a human operator.

7. The Type of Ground Truth Used:

The "ground truth" for this hardware device is defined by engineering specifications, physical measurements, and compliance with national and international medical device standards. For example, acoustic output parameters are measured against specific limits defined in IEC standards, and biocompatibility is confirmed by testing against ISO 10993. There is no "expert consensus" on imaging findings, pathology, or outcomes data used as ground truth for this device's clearance.

8. The Sample Size for the Training Set:

This concept is not applicable. There is no "training set" as this is not an AI/ML device that requires machine learning.

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

This concept is not applicable as there is no training set.

In summary, the FDA 510(k) clearance for the Olympus Ultrasonic Probes is based on a comprehensive set of non-clinical, bench-level performance tests demonstrating technical equivalence to a predicate device and compliance with relevant safety and performance standards for diagnostic ultrasonic transducers. It does not involve AI/ML components or associated clinical study designs like MRMC or standalone algorithm performance assessment.

Summary

FDA 510(k) Clearance Letter - Olympus Ultrasonic Probes

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

Olympus Medical Systems Corporation
℅ Brenda Geary
Senior Manager Regulatory Affairs
Olympus Surgical Technologies of the Americas
800 West Park Drive
WESTBOROUGH MA 01581

Re: K250762
Trade/Device Name: Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic Ultrasonic Transducer
Regulatory Class: Class II
Product Code: ITX, EOQ
Dated: June 11, 2025
Received: June 11, 2025

Dear Brenda Geary:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

July 11, 2025

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July 11, 2025

Olympus Medical Systems Corporation
℅ Brenda Geary
Senior Manager Regulatory Affairs
Olympus Surgical Technologies of the Americas
800 West Park Drive
WESTBOROUGH MA 01581

Dear Brenda Geary:

K250762 - Brenda Geary Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

Page 3

K250762 - Brenda Geary Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

MARJAN NABILI -S for

Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250762

Device Name
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S)
ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Indications for Use (Describe)

Modes of operation:
The Mode of Operation is B mode.

Operator qualifications:
Appropriately trained healthcare professionals.

Device use settings:
Healthcare facility

Modes of operation:
The Mode of Operation is B mode.

Operator qualifications:
Appropriately trained healthcare professionals.

Device use settings:
Healthcare facility

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Page 5

TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 1 of 8

510(k) Summary: K250762

1. COMPANY INFORMATION

• Applicant

OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 Ishikawa-cho, Hachioji-shi
Tokyo 192-8507, Japan
FDA Establishment Registration #: 8010047

• Official Correspondent

Wendy Perreault
c/o Olympus Surgical Technologies of the Americas
800 West Park Drive
Westborough, MA 01581
Cell: 404-542-5854
Email: wendy.perreault@olympus.com

• Manufacturing Site

SHIRAKAWA OLYMPUS CO., LTD.
3-1 Okamiyama, Odakura
NISHIGO-MURA
NISHISHIRAKAWA-GUN Fukushima, JAPAN 961-8061

• Date Prepared: 9 July 2025

2. PRODUCT INFORMATION

Trade Name: ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Common Name: Diagnostic Ultrasound Transducer

Classification Number: 21 CFR 892.1570, 21 CFR 874.4680

Product Code Names: Transducer, Ultrasonic Diagnostics; Bronchoscope (Flexible or Rigid) and Accessories

Product Codes: ITX, EOQ

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 2 of 8

Regulatory Class: II

Classification Panel: Radiology

3. PREDICATE DEVICE

The Subject devices are equivalent to the Predicate device listed below in Table 1.

Table 1: Predicate device for ULTRASONIC PROBE UM-S20-17S and UM-S20-20R

Device name	510(k) Submitter	510(k) No.
FUJIFILM Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	Fujifilm Healthcare Americas Corporation	K231666

The Predicate device has not been subject to a design-related recall.

The Reference device supporting the performance of the Subject devices is listed below in Table 2.

Table 2: Reference device for ULTRASONIC PROBE UM-S20-17S and UM-S20-20R

Device name	510(k) Submitter	510(k) No.
UM-3R Ultrasonic Probe	OLYMPUS MEDICAL SYSTEMS CORPORATION	K063683

4. DEVICE DESCRIPTION

Ultrasonic Probes UM-S20-17S and UM-S20-20R are designed to be used in conjunction with bronchoscopes. The Probes are inserted into the patient through a channel of the endoscope.

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 3 of 8

The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.

UM-S20-17S and UM-S20-20R use direct contact method only.

The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).

The target population for this device is Adults.

5. INDICATIONS FOR USE

• The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

[Modes of operation]
The Mode of Operation is B mode.

[Operator qualifications]
Appropriately trained healthcare professionals.

[Device use settings]
Healthcare facility

• The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.

[Modes of operation]
The Mode of Operation is B mode.

[Operator qualifications]

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 4 of 8

Appropriately trained healthcare professionals.

[Device use settings]
Healthcare facility

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Compared to the Predicate and Reference devices, the Subject devices offer similar functions. A detailed comparison of the technological characteristics of the devices is provided in Table 3 below. These differences in technological characteristics do not raise new questions of safety or effectiveness.

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 5 of 8

Table 3: Subject, Predicate and Reference Device Comparison of Technological Characteristics

Item	Subject Devices (SD)		Predicate Device (PD)	Reference Device (RD)
	UM-S20-17S	UM-S20-20R	FUJIFILM Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	UM-3R
Manufacturer	OLYMPUS MEDICAL SYSTEMS CORPORATION	OLYMPUS MEDICAL SYSTEMS CORPORATION	Fujifilm Healthcare Americas Corporation	OLYMPUS MEDICAL SYSTEMS CORPORATION
510(k) #	N/A	N/A	K231666	K063683
Classification Product Code	ITX	ITX	ITX	IYN
Subsequent Product Code(s)	EOQ	EOQ	N/A	ITX, IYO, ODG
Indications for Use	The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. [Modes of operation] The Mode of Operation is B mode. [Operator qualifications] Appropriately trained healthcare professionals. [Device use settings] Healthcare facility	The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. [Modes of operation] The Mode of Operation is B mode. [Operator qualifications] Appropriately trained healthcare professionals. [Device use settings] Healthcare facility	This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults. Modes of Operation: B-mode Never use this product for any other purposes.	These instruments have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Water Supply Unit (For Ultrasonic Endoscope), a Probe Driving Unit, a Probe/Irrigation Plug and an endoscope for intralumenal ultrasonic imaging of the gastrointestinal tract and surrounding organs, the upper airways and tracheobronchial tree and the urinary organs.
Frequency	20 MHz	20 MHz	P2612S-L: 10MHz±15% P2620S-L: 17MHz±15%	20 MHz

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 6 of 8

Item	Subject Devices (SD)		Predicate Device (PD)	Reference Device (RD)
	UM-S20-17S	UM-S20-20R	FUJIFILM Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	UM-3R
Display mode	B-mode	B-mode	B-mode	B-mode
Compatible Endoscopic Ultrasound System	OLYMPUS : EU-ME2 EU-ME2 Premier Plus EU-ME3	OLYMPUS : EU-ME2 EU-ME2 Premier Plus EU-ME3	FUJIFILM Ultrasonic Processor SP-900	OLYMPUS XEU-M60A
Number of Transducers	1	1	-	1
Shape of Transducer	Rectangle	Rectangle	-	Rectangle
Size of Transducer	0.75 × 2.3mm	1.0 × 2.3mm	-	1.6 × 2.4mm
Scanning direction	Perpendicular to the direction of insertion	Perpendicular to the direction of insertion	-	Perpendicular to the direction of insertion
Scanning field of view (Scanning area)	360°	360°	-	360°
Frame rate	6.67rps	6.67rps	-	6.67rps
Axial resolution	2mm or less	2mm or less	1mm or less	2mm or less
Lateral resolution	2mm or less	2mm or less	3mm or less	2mm or less
Scanning method	Mechanical, radial scanning	Mechanical, radial scanning	Mechanical, radial scanning	Mechanical, radial scanning
Contact method	Direct contact method	Direct contact method	-	Direct contact method
	N/A	N/A	-	Sterile De-aerated water immersion method
	N/A	N/A	-	Balloon method (Balloon sheath [MH-246R] is necessary).
Insertion tube maximum outer diameter (mm)	φ 1.45 (Distal end side 1085mm) φ 1.8 (Connector side)	φ 1.75 (Distal end side 850mm) φ 2.05 (Connector side)	2.6	φ 2.5
Insertion tube outer diameter (mm)	φ 1.4 (Distal end side 1085mm) φ 1.7 (Connector side)	φ 1.7 (Distal end side 850mm) φ 2.0 (Connector side)	2.5	φ 2.4

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 7 of 8

Item	Subject Devices (SD)		Predicate Device (PD)	Reference Device (RD)
	UM-S20-17S	UM-S20-20R	FUJIFILM Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	UM-3R
Ultrasonic medium	Liquid paraffin (High White 70)	Liquid paraffin (High White 70)	-	Liquid paraffin (High White 70)
Working length (mm)	2150	2050	2620	2050
Total length (mm)	2225	2140	-	2140
Sterilization method for reprocessing	ETO	ETO	ETO	N/A
Compatible Olympus Reprocessor for cleaning and disinfection	OER-Pro OER-Elite	OER-Pro OER-Elite	N/A	N/A
Electrical safety	Compliance to IEC 60601-1, IEC 60601-2-18, IEC 60601-2-37	Compliance to IEC 60601-1, IEC 60601-2-18, IEC 60601-2-37	Compliance to IEC 60601-1, IEC 60601-2-37	Compliance to IEC 60601-1, IEC 60601-2-18
EMC	Compliance to IEC 60601-1-2	Compliance to IEC 60601-1-2	Compliance to IEC 60601-1-2	Compliance to IEC 60601-1-2

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TRADITIONAL 510(k)

ULTRASONIC PROBES UM-S20-17S and UM-S20-20R

510(k) Summary

Page 8 of 8

7. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

Results of the following testing support the safety and performance of the Subject devices and demonstrate their equivalence to the Predicate device and Reference device; all testing passed/met the acceptance criteria, demonstrated compliance with the cited standards and FDA Guidance shown below, and supported equivalent safety and performance to the Predicate and Reference devices:

• Performance Testing – Bench (including Acoustic Output in compliance with IEC 60601-2-37, IEC 62359, IEC 62127-1, and FDA Guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff (February 21, 2023); Durability, Measurement Accuracy; and Human Use Factors following FDA Guidance Documents Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff (issued February 3, 2016) and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff (issued March 17, 2015).

• Biocompatibility Testing (ISO 10993-1; ISO 10993-5; ISO 10993-10; ISO 10993-12; ISO 10993-17; ISO 10993-18; ISO 10993-23)

• Reprocessing Validation (ISO 17664-1; AAMI TIR12; ANSI AAMI ST98; ANSI AAMI ST58; ISO 11135; ISO 11138-2)

• Electrical Safety/EMC Testing (IEC 60601-1; IEC ES60601-1; IEC 60601-1-2; IEC 60601-2-18; IEC 60601-2-37; IEC TR 60601-4-2)

8. SUMMARY OF CLINICAL PERFORMANCE DATA

No clinical data were collected to support the performance of the Subject devices.

9. CONCLUSION

The results of non-clinical performance testing demonstrate that the Subject devices are as safe and effective as the Predicate device to support a substantial equivalence determination.

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.