This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Device Description

The XTJF-Q160VF1 duodenoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum. The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. The optical system of the XTJF-Q160VF1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus XTJF-Q160VF1 Duodenovideoscope. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI/software as a medical device (SaMD) would.

Therefore, many of the requested data points related to clinical study design, acceptance criteria, sample sizes for test/training sets, expert adjudication methods, and standalone performance for AI/SaMD are not applicable to this type of regulatory submission for a medical device that is a physical endoscope.

However, I can extract information regarding the device's characteristics and its comparison to a predicate device, which serves as the basis for its "acceptance" or clearance by the FDA in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or accuracy) in the way one would for an AI/SaMD device. Instead, the "acceptance" for this 510(k) submission is based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

The "reported device performance" is essentially a comparison of its specifications to the predicate device.

Characteristic (Acceptance Criteria for Equivalence)	Subject Device XTJF-Q160VF1 (Reported Performance)	Predicate Device XTJF-160AF (Comparison Standard)
Intended Use	Endoscopy and endoscopic surgery within the duodenum	Endoscopy and endoscopic surgery within the duodenum
Field of View	100°	100°
Direction of View	Backward, Sideviewing 5°	Backward, Sideviewing 5°
Depth of Field	5~60mm	5~60mm
Optical System	Color (CCD-based)	Color
Outer Diameter of Distal End	φ13.2mm	φ13.2mm
Outer Diameter of Insertion Tube	φ11.3mm	φ11.6mm
Angulation (UP)	120°	120°
Angulation (DOWN)	90°	90°
Angulation (RIGHT)	110°	110°
Angulation (LEFT)	90°	90°
Working Length	1240mm	1240mm
Inner Diameter of Instrument Channel	φ4.2mm	φ4.2mm
Material	(Implied similar, slight difference mentioned but not detailed)	(Implied similar, slight difference mentioned but not detailed)

The document explicitly states: "The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. ... The new endoscope is basically identical to each predicate device shown in Table 15-1 in intended use, and similar in specifications, performance and materials." This confirms that "acceptance" means matching or being substantially equivalent to the predicate device's established specifications and intended use.

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

Not Applicable. This is a 510(k) for a physical medical device (an endoscope), not a clinical study on a dataset. The "test set" in this context would be the device itself tested against its own engineering specifications, not a clinical data set. The FDA clearance is based on comparison to a predicate device and adherence to general controls, not a performance study on a specific patient population.

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

Not Applicable. Ground truth, in the sense of expert annotation for a dataset, is not relevant to this type of device submission.

4. Adjudication method for the test set:

Not Applicable. See point 3.

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:

Not Applicable. This device is a traditional endoscope; it does not involve AI or "human readers" in the context of an MRMC study.

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

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

Not Applicable. "Ground truth" in the AI/SaMD sense is irrelevant. The "truth" for this submission is that its specifications and intended use are similar to a previously cleared device.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. See point 8.

Study Proving Device Meets Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria (substantial equivalence) is the 510(k) Premarket Notification itself, specifically the comparison of technological characteristics outlined in Section 6 of the provided document (Table 15-2).

Methodology: The manufacturer (Olympus Medical Systems Corp.) compared the specifications of the subject device (XTJF-Q160VF1 Duodenovideoscope) with those of the predicate device (XTJF-160AF Duodenovideoscope, K024033).
Conclusion: The submission concludes that "When compared to the predicate device, the XTJF-160AF does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." The FDA's letter (K080403) concurs, stating that the device is "substantially equivalent" to legally marketed predicate devices.

In summary, for a traditional medical device like an endoscope subject to a 510(k) pathway, "acceptance criteria" and "study" refer to demonstrating substantial equivalence to a predicate device by comparing its design, materials, and technological characteristics against established, cleared devices, rather than a clinical performance study with statistical metrics typical for AI/SaMD.

Summary

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510(k) SUMMARY

EVIS EXERA II 180 SYSTEM

MAY 20 2008

1. General Information

OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
Official Correspondent: Laura Storms-Tyler Vice President Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway, PO Box 610 Center Valley PA 18034-0610 Phone: (484) 896-5688 Facsimile: (484) 896-7128 Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304

E Manufacturer:

■

예

Light source/Video system center:

Duodenoscope:

SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148

Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

노 Date Prepared: February 8, 2008

2. Device Identification

Device Name:
Class:

Common Name:

XTJF-160AF Duodenoscope

Regulation Number/Name:

Product Code:
Duodenoscope II

876.1500 Endoscope and accessories NWB - Endoscope, accessories, narrow band spectrum FDT - Duodenoscope, Esophago Gastro KNT - Tubes, gastrointestinal (and accessories)

Classification Panel:

Gastroenterology/Urology

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174

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/K080403

3. Legally Marketed Device to which Substantial Equivalence is Claimed

The following table shows the primary components of the EVIS EXERA II 180 System and each device to which we claim substantial equivalence (predicate device).

Subject Device(part of this submission)	Predicate Device	PD's510(k) No.
DUODENOVIDEOSCOPEXTJF TYPE Q160VF1	DuodenovideoscopeXTJF-160AF	K024033

4. Device Description

The XTJF-Q160VF1 duodenoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the duodenum . The XTJF-Q160VF1 duodenoscope is basically identical to the predicate device, Olympus XTJF Type 160AF Duodenovideoscope, in intended use, specifications, performance. The optical system of the XTJF-Q160VF1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The new endoscope is basically identical to each predicate device shown in Table 15-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes.

5. Indications for Use

DUODENOVIDEOSCOPE XTJF-Q160VF1

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K 080403
pg 3 of 3

6. Comparison of Technological Characteristics

The XTJF-Q160VF1 is similar to the predicate device XTJF-160AF in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.

Table 15-2. Comparison of Specifications Subject Device: DUODENOVIDEOSCOPE XTJF TYPE Q160VF1 Predicate Device: Duodenovideoscope XTJF-160AF (K024033)

Specifications	Subject DeviceXTJF-Q160VF1	Predicate DeviceXTJF-160AF(K024033)
Field of View	100°	100°
Direction of View	BackwardSideviewing 5°	BackwardSideviewing 5°
Depth of Field	5~60mm	5~60mm
Optical System	color	color
Outer Diameter ofDistal End	φ13.2mm	φ13.2mm
Outer Diameter ofInsertion Tube	φ11.3mm	φ11.6mm
Angulation	UP : 120DOWN : 90RIGHT : 110°LEFT : 90°	UP : 120DOWN : 90RIGHT : 110°LEFT : 90°
Working Length	1240mm	1240mm
Inner Diameter ofInstrument Channel	φ4.2mm	φ4.2mm

6. Conclusion

When compared to the predicate device, the XTJF-160AF does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe. The figure is composed of three wavy lines that form the shape of a person with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2008

Olympus Medical Systems Corporation % Ms. Laura Storm-Tyler Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610

Re: K080403

Trade/Device Name: XTJF Q160VF1 DUODENOVIDEOSCOPE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: February 13, 2008 Received: February 14, 2008

Dear Ms. Storm-Tyler:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 nequirements 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); good manufacturing practice requirements is set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

and the contraction of the starter of the may be the state of the states of the states

ないとかなるとなってきたのですが、その時間になってきませんですけどうしてきました

This letter will allow you to begin marketing your device as described in your $ection 510(k) premarket notification. The FDA finding of substantial equivalence of your device to Igally, marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, rolease contact CDRF 8 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276 3474. For questions regarding the reporting of device adverse events (Medical Device Leporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may othin 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html U

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K080403 Device Name: XTJF-Q160VF1 DUODENOVIDEOSCOPE

Indications For Use:_

DUODENOVIDEOSCOPE XTJF-Q160VF1

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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 and Radiological Devices 510(k) Number

Page 1 of _ 1

1932 Specifical

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.