Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

Device Description

Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847. The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and supporting studies, as per your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not contain a specific table or detailed discussion of acceptance criteria for the performance of the Fujinon/Fujifilm Ultrasonic Endoscope (EG-530UR2 and EG-530UT2) in terms of image quality metrics (e.g., resolution, contrast, penetration depth) or diagnostic accuracy. Instead, the focus of this submission is on demonstrating substantial equivalence to previously cleared devices.

The "acceptance criteria" can be implicitly understood as compliance with relevant safety and performance standards, and the ability to reproduce the performance of the predicate devices. The device "performance" is implicitly deemed acceptable if it meets these standards and is substantially equivalent.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance
Safety	Compliance with IEC 60601-1 (General safety)	Evaluated in accordance with IEC 60601-1
	Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems)	Evaluated in accordance with IEC 60601-1-1
	Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Evaluated in accordance with IEC 60601-1-2
	Compliance with IEC 60601-2-18 (Safety of endoscopic equipment)	Evaluated in accordance with IEC 60601-2-18
	Compliance with IEC 60601-2-37 (Safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)	Evaluated in accordance with IEC 60601-2-37
	Compliance with ISO 10993 (Biological evaluation of medical devices)	Evaluated in accordance with ISO 10993
	Reprocessing instructions validated	Reprocessing instructions updated and validated by a third-party lab
Performance (Substantial Equivalence)	Ability to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment.	Deemed "substantially equivalent" to predicate devices (K063847 and K111243) and conforms to applicable medical device safety and performance standards.
	Functional equivalence to predicate devices (EG-530UR and EG-530UT; SU-7000, SU-8000).	Modified versions of previously-cleared devices, used with the same ultrasonic processor. Detailed modifications provided in the submission (but not in this summary).

Study Details:

It's crucial to understand that this is a 510(k) submission focused on demonstrating substantial equivalence for modified versions of existing devices. Therefore, the types of studies typically associated with novel AI devices (like detailed performance studies, MRMC studies, training set details) are not present here. The document explicitly states: "No clinical test was conducted."

Here's a breakdown based on your requested information:

A table of acceptance criteria and the reported device performance: See table above. The performance evaluation primarily relied on compliance with standards and a detailed comparison matrix (not provided in this summary) to demonstrate equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. No clinical tests or performance validation studies using patient data (test sets) are mentioned.
- Data Provenance: Not applicable, as there's no patient data involved in the studies described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts/Qualifications: Not applicable. No ground truth establishment for a test set is discussed, as no clinical performance study was conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. No test set requiring ground truth adjudication was used.
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 device is an ultrasonic endoscope, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical test was conducted." Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This device is an imaging instrument, not an algorithm. Its operation inherently involves a human operator (the endoscopist) interpreting the images.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. No clinical performance study requiring ground truth was conducted. For the reprocessing validation, the ground truth would be chemical/microbiological testing results confirming effectiveness. For the safety standards, the "ground truth" is adherence to the specified requirements of each standard.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is hardware (an endoscope) and not an AI/machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. No training set was used.

Summary of the Study:

The primary "studies" conducted for this 510(k) submission were engineering verification and validation studies to ensure compliance with international safety and performance standards (IEC, ISO) and reprocessing validation by a third party. The core argument for clearance is substantial equivalence to existing, legally marketed predicate devices, meaning the new device is as safe and effective as the older ones, with documented modifications. There is no evidence of clinical studies involving patient data or evaluation of diagnostic accuracy.

Summary

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510(k) Summary

AUG 1 3 2012

Date: December 16, 2011

Submitter's Information:

Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Person:

Name:	Gina Walljasper
Title:	Director, Quality and Regulatory Compliance
Telephone:	(973) 633-5600 Ext. 484
Facsimile:	(973) 633-8818
E-Mail:	gwalljasper@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	Fujinon/Fujifilm Ultrasonic endoscopeEG-530UR2 and EG-530UT2
Common Name:	Ultrasonic Endoscope
Device Class:	Class 2
Review Panel:	Gastroenterology/Urology
Classification Information:

Classification Name	CFR Section	Product Codes
Gastroscope and accessories, flexible/rigid	21 CFR 876.1500	FDS
Diagnostic Ultrasonic Transducer	21 CFR 892.1570	ITX

INDICATIONS FOR USE l.

II. DEVICE DESCRIPTION

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FUJIFILM

The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.

Detailed information on the modifications for the proposed endoscopes EG-530UR2 and EG-530UT2 are provided in the submission.

III. SUMMARY OF STUDIES

Fujinon/Fujifilm Ultrasonic endoscope EG-530UR2 were evaluated in accordance with following safety and performance requirements in addition to the applicable quality system regulations:

IEC 60601-1	Medical electrical equipment - Part 1: General requirements forsafety
IEC60601-1-1	Medical electrical equipment - Part 1-1: General requirements forsafety - Collateral standard: Safety requirements for medicalelectrical systems
IEC60601-1-2	Medical electrical equipment - Part 1-2: General requirements for thebasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
IEC60601-2-18	Medical electrical equipment - Part 2-18: Particular requirements forthe safety of endoscopic equipment
IEC 60601-2-37	Medical electrical equipment - Part 2-37: Particular requirements forthe basic safety and essential performance of ultrasonic medicaldiagnostic and monitoring equipment
ISO10993	Biological evaluation of medical devices

The reprocessing instructions were updated and validated using a third party lab. No clinical test was conducted.

SUBSTANTIAL EQUIVALENCE IV.

Fujinon/Fujifilm Ultrasonic endoscope EG-530UR2 and EG-530UT2 are substantially equivalent to the following device(s):

Legally Marketed Device(s)	510(k) #
Fujinon Ultrasonic Endoscopes & Processor(EG-530UR, EG-530UT and SU-7000)	K063847
Fujinon Ultrasonic Processor SU-8000	K111243

See Section 12 Comparison Matrix for detailed comparison.

V. CONCLUSION

Fuiinon/Fuilfilm Ultrasonic endoscope EG-530UR2 and EG-530UT2 are substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 13 2012

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FUJIFILM Medical System U.S.A., Inc. % Mr. Mark Job Responsible=Third-Party Official= Regulatory Technology Services LLC . 1394 25th Street NW BUFFALO MN 55313

Re: K120446

Trade/Device Name: Fujinon/Fujifilm Ultrasonic endoscope (EG-530UR2 and EG-530UT2) {to be used with Fujinon/Fujifilm ultrasonic processor (SU-7000/SU-8000)]

Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, ITX Dated: August 2, 2012 Received: August 3, 2012

Dear Mr. Job:

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 (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. 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.

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

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device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Genters9ffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 'Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,

Benjamin K-tarko

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

570(k) Number (If Known): - K120446

Device Name:

Fujinon/Fujifilm Ultrasonic endoscope (EG-530UR2 and EG-530UT2) [to be used with Fujinon/Fujifilm ultrasonic processor (SU-7000/SU-8000)]

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Besicuer R. Devis 13 August 2012
(Division Sign-Off)

(División Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120446

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Diagnostic Ultrasound Indications For Use

K120446 510(k) Number (If Known): Fujinon Ultrasonic Processor (SU-7000/SU-8000) System Name: Transducer: Ultrasonic Endoscope (EG-530UR2)

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined¹	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast, Testes, etc.)
	Neonatal Cephalic
General	Adult Cephalic
Application	Trans-rectal
	Trans-vaginal
	Trans-urethral	P	P	P		P	P¹
	Tran-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	IntravascularOther (Specify)²	P	P	P		P	P¹
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Tran-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

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

1 Combined modes includes B+M, B+PWD, B+CD+PWD modes

2 Other includes gastro-intestinal 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)
	DRGUD 13 AUGUST 2012

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, andUrological Devices
510(k) Number	K120446

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Diagnostic Ultrasound Indications For Use

510(k) Number (If Known): K120441

Fujinon Ultrasonic Processor (SU-7000/ SU-8000) System Name: Transducer:

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

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	Combined1	Other
Ophthalmic	Ophthalmic
GeneralApplication	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast, Testes, etc.)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Tran-esoph. (non-Card.)	P	P	P		P	P1
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)2	P	P	P		P	P1
	Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Tran-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)

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

1 Combined modes includes B+M, B+PWD, B+CD+PWD modes

2 Other includes gastro-intestinal tract and surrounding organs

13 August 2012

3 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, Gastro-Renal, and
Urological Devices K120446
510(k) Number

Fujinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.