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.

Device Description

FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.

Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.

AI/ML Overview

This document describes the Fujifilm Endoscopic Ultrasonic Probe (P2612S-L/P2620S-L), which is a medical ultrasonic probe intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs in adults.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria for performance metrics (like accuracy or sensitivity) for the ultrasound imaging itself. The performance data presented are related to safety and compatibility with regulatory standards.

Acceptance Criteria (related to safety/technical performance)	Reported Device Performance
Reprocessing efficacy (cleaning, disinfection, sterilization)	Validated on P2612S-L/P2620S-L
Biocompatibility (cytotoxicity, sensitization, irritation)	Evaluated in accordance with FDA guidance (ISO 10993-1, -5, -10, -23)
Electrical Safety	Tested according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007 (for P2612S-L/P2620S-L)
Electromagnetic Compatibility (EMC)	Evaluated according to IEC 60601-1-2:2014 (for P2612S-L/P2620S-L with SP-900)
Ultrasonic Probe Specifications (e.g., insertion diameter, working length, scanning method)	Differences from predicate/reference devices were evaluated and determined not to raise new concerns for safety or efficacy. Specific technical specifications like axial and lateral resolution, sound operating frequency, and penetration were also compared and tested according to 60601-2-37.

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

The document does not describe a test set in the context of clinical performance or image analysis. The "testing" mentioned refers to engineering and safety performance evaluations. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided here for clinical performance.

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

As no clinical performance test set involving image interpretation or diagnosis is described, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set:

Since a clinical test set requiring expert adjudication is not present, this information is not applicable and not provided.

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

The document states, "Clinical testing is not applicable to this submission." Therefore, an MRMC comparative effectiveness study was not done, and there is no reported effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasonic probe, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This device is an ultrasonic probe, a hardware component for ultrasound imaging. It does not contain an algorithm for standalone performance evaluation in the context of AI or diagnostic software. Therefore, a standalone performance study was not done.

7. Type of Ground Truth Used:

For the technical and safety evaluations, the "ground truth" was established by adherence to recognized international standards and guidance documents (e.g., ISO 10993, ANSI/AAMI ES60601-1, IEC 60601-2-37, IEC 60601-1-2) confirmed through specific tests. For example, biocompatibility tests themselves generate the "ground truth" (e.g., cytotoxicity results, sensitization/irritation responses).

8. Sample Size for the Training Set:

This device is a hardware component and is not an AI/ML-driven device that requires a training set in the typical sense. Therefore, information regarding a training set sample size is not applicable and not provided.

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

As there is no training set for an AI/ML algorithm described, this information is not applicable and not provided.

Summary

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December 13, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fujifilm Healthcare Americas Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN

Re: K231666

Trade/Device Name: Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: November 7, 2023 Received: November 7, 2023

Dear Chaitrali Kulkarni:

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.

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).

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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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, Yanna S. Kang -S

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

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Indications for Use

Submission Number (if known)

K231666

Device Name

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

Indications for Use (Describe)

Modes of Operation: B-mode

Never use this product for any other purposes,

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)

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510(k) Summary

K231666

FUJIFILM Corporation

FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L

Date: December 13, 2023

Submitter's Information:

FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN

Contact Person:

Chaitrali Kulkarni Senior Regulatory Affairs Specialist E-Mail: chaitrali.kulkarni@fujifilm.com Telephone: (704) 517 4886

Identification of the Subject Device:

Device Name	Endoscopic UltrasonicProbe (P2612S-L);Endoscopic UltrasonicProbe (P2620S-L)
Common Name	Ultrasonic Probe
Product Code	• ITX
Device Class	Class 2
Regulation Number	• 892.1570
Regulation Description	• Diagnostic ultrasonictransducer
Review Panel	• Radiology

Predicate Device:

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

Reference Device:

Modifications to EUB-525 Diagnostic Ultrasound Scanner; EUB-2000 Diagnostic Ultrasound ● Scanner; Sp-711 Sonoprobe System (K012239)

Intended Use / Indications for Use:

Modes of Operation: B-mode

Never use this product for any other purposes.

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Device Description:

Comparison of Technological Characteristics:

Comparisons of technological characteristics between the subject devices are provided in the tables below:

Table 1

Device name	Predicate Device	Reference Device:	Proposed Device
	Olympus Ultrasonic Probe		Endoscopic Ultrasonic
			Probe
	UM-S30-25R	PL2226-12	P2612S-L/P2620S-L
		P2226-20
510(k) number	K994103	K012239	K231666

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Indications for use (IFU)	The Olympus UM-S30-25RUltrasonic Probe has beendesigned to be used with anOlympus Endoscopic Ultrasoundcenter, Probe Driving Unit and anendoscope forintraluminal ultrasonic imaging ofthe gastrointestinal tract andsurrounding organs. Modes ofOperation: B-mode	The intended use of thesubject device is forendoscopic observationof the gastrointestinaltract (esophagus,stomach, duodenum,large intestine) andbiliary system (pancreato-biliary ducts). TheUltrasound DeviceIndications Statementsfor each application andmode of thesystem/transducers areincluded with thisdocument.	This product is a medicalultrasonic probe. It isintended for theobservation and diagnosisof the gastrointestinaltract and surroundingorgans under themanagement ofphysicians at medicalfacilities. This product isintended for adults.Modes of Operation: B-modeNever use this product forany other purposes.	Same
Probe specification
Diameter of insertion portion	2.4mm	2.6mm	2.5mm	The proposed deviceand the predicatedevice have differentinsertion portiondiameters, however theproposed device has asmaller insertionportion diameter thanthe reference device,therefore there is nonew concern for safetyand efficacy.
Maximum diameter of insertionportion		2.7mm	2.6mm	The proposed deviceand the referencedevice have differentmaximum diameter of

					insertion portion, however the proposed device has a smaller insertion portion diameter than the reference device, therefore there is no new concern for safety and efficacy.
Working length		2050mm	2180mm	2620mm	Although the length of the proposed device is longer, the working length of the proposed device is compatible with the working length of its compatible endoscope, therefore there are no new concerns for the safety and efficacy of the proposed device.
Applicable reprocess method	Manual cleaning		Applicable	Applicable	Same as reference device
	Manual disinfection		Applicable	Applicable	Same as reference device
	Endoscope automatic cleaning and disinfection		Not Applicable	Applicable	The proposed device does have automatic cleaning and disinfection although the reference device does not. The difference in applicable reprocess methods does not affect the safety and efficacy of the device and cleaning instructions have been provided in the operation manual.
	EOG		Not Applicable	Applicable	EOG sterilization is
	Sterilization				applicable to theproposed device butnot the referencedevice. The differencein applicable reprocessmethods does not affectthe safety and efficacyof the device andcleaning instructionshave been provided inthe operation manual.
	StelladSterilization		Not applicable	Not applicable	Same as referencedevice
Applicable system		Olympus Endoscopic Ultrasoundcenter, Probe Driving Unit and anendoscope forintraluminal ultrasonic imaging ofthe gastrointestinal tract andsurrounding organs.	SP-711	SP-900	The difference inapplicable systemsbetween the subjectdevice and predicatedevice do not affect thesafety or efficacy of thesubject device. Thesubject device has beentested with the SP-900processor and theapplicable system islisted in the operationmanual.
Applicable scope		Flexible endoscope: inner channelis 2.8mm, 3.2mm,4.2mm,6mm and5.Smm.Rigid endoscopes: minimumcapacity is 9Fr.	Direct-viewing typeendoscopes with aforceps channel diameterof 2.8 mm or more and aworkinglength of 1700 mm orless	FUJIFILM endoscope-Upper gastrointestinalendoscope-Lower gastrointestinalendoscope1 The instrumentchannel diameter of eachendoscope must be 2.8mm or more and itsworkinglength 2200 mm or less.2 This product is notapplied in combination	The differences in theapplicable scope do notaffect the safety orefficacy of the subjectdevice. The subjectdevice has been testedwith its applicablescope and no newconcerns for safety orefficacy was seen.
			with Duodenoscope andUltrasonic endoscope.
Ultrasound specification
Scanning method	Mechanical radial	Mechanical radial	Mechanical radial	same
Sound operating frequency	30MHz	PL2226-12 :12MHz±20%PL2226-20 :18MHz±20%	P2612S-L :10MHz±15%P2620S-L :17MHz±15%	The differences in theultrasoundspecification from thepredicate device andthe proposed devicehave been testedaccording to 60601-2-37
Resolution		Axial: 1.5mm or lessLateral: 3.0mm or less	Axial: 1.0mm or lessLateral: 3.0mm or less	The differences in theultrasoundspecification from thepredicate device andthe reference devicehave been testedaccording to 60601-2-37.
Penetration		PL2226-12 : 15mmPL2226-20 : 5mm	P2612S-L : 20mmP2620S-L: 5mm	The differences in theultrasoundspecification from thepredicate device andthe proposed devicehave been testedaccording to 60601-2-

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			37.
Patient contact materials
Insertion portion	Distal end cap :Polyethylene• Distal ring : Stainlesssteel rod• Bonded part : Epoxyresin• Sheath :Polytetrafluoroethylene	Distal end cap :Polyethylene• Distal ring : Stainlesssteel rod• Bonded part : Epoxyresin• Sheath :Polytetrafluoroethylene	Same as referencedevice

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Performance Data:

FUJIFILM Ultrasonic P2612S-L/P2620S-L is supplied non-sterile and must be properly reprocessed prior to each use in accordance with its reprocessing instructions. The cleaning, disinfection, and sterilization were validated on P2612S-L/P2620S-L.

The biocompatibility was evaluated in accordance with FDA's quidance. Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued 2018. The cytotoxicity was evaluated according to ISO 10993-5. The sensitization study was conducted according to 10993-10 and irritation testing was conducted according to ISO 10993-23.

The subject device P2612S-L/P2620S-L contains electronic components. The testing was conducted to ensure the electrical safety of the subject device P2612S-L/P2620S-L according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007. The subject device P2612S-L/P2620S-L along with the applicable system (SP-900) was evaluated for the electromagnetic compatibility according to IEC 60601-1-2:2014.

Clinical Testing:

Clinical testing is not applicable to this submission.

Conclusions:

The subject device FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L and predicate device, Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract, have slight differences in the technological characteristics. Although there are differences in technological characteristics those differences do not raise any new concerns for safety and efficacy.

The subject device FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L is substantially equivalent to the respective predicate device Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract (K994103)

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.