GASTROINTESTINAL VIDEOSCOPE XGIF-Q140M, XGIE-2T140M
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

COLONOVIDEOSCOPE XCF-Q140ML/L XPCF-160AML/I
This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Eguipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).

Device Description

The subject devices. XGIF-Q140M. XGIF-2T140M. XCF-Q140ML/I. XPCF-160AML/I are basically identical to the predicate devices, GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I except that the mechanical structure of variable stiffness* and Multi-bending function has been added.
*This feature has been added to XPCF-160AML/I only.
While XPCF-160AML/I has the mechanical structure of variable stiffness (Refer to Attachment 2. "Flexibility Adiustment Function") this feature is identical to those of another predicate device, the EVIS EXERA Colonovideoendoscopes (#K001241). The addition of the variable stiffness function does not require any new insertion method or technique.
The Multi-bending function has two independent bending sections in the insertion portion of the scope. This new function provides an easier approach in reaching the lesion and also a better view of the lesion from the front. Some lesions in the upper digestive tract were difficult to perform a perfect biopsy and endoscopy with the conventional forward-viewing gastroscope. (Refer to Appendix-3, "Clinical Literature"). The subject devices improve the approach to the lesion in the lower digestive tract compared with the predicate devices. We have evaluated the approach performance of the XPCF-160AMI compared to the predicate device using a colon model. (Refer to Attachment 1, "Comparison between approach performance of Predicate and Subject Device using a colon model").

AI/ML Overview

This document is a 510(k) summary for OLYMPUS OPT-ELECTRONICS CO., LTD.'s Gastrointestinal Videoscopes and Colonovideoscopes. It describes the device, its intended use, and claims substantial equivalence to predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific performance acceptance criteria in terms of numerical thresholds for clinical metrics (e.g., sensitivity, specificity, accuracy, or other quantifiable performance measures). Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices.

The "reported device performance" in this context is the assertion that the new devices XGIF-Q140M, XGIF-2T140M, XCF-Q140ML/I, XPCF-160AML/I perform equivalently to their predicate devices GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I, and EVIS EXERA Colonovideoendoscopes.

The document states:

"The subject devices... are basically identical to the predicate devices... except that the mechanical structure of variable stiffness* and Multi-bending function has been added."
"The addition of the variable stiffness function does not require any new insertion method or technique."
"The subject devices improve the approach to the lesion in the lower digestive tract compared with the predicate devices."

The study mentioned directly related to performance is:

"We have evaluated the approach performance of the XPCF-160AMI compared to the predicate device using a colon model. (Refer to Attachment 1, 'Comparison between approach performance of Predicate and Subject Device using a colon model')."

Specifically, for acceptance criteria and performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (GIF-Q140, GIF-2T140, CF-Q140L/I, PCF-140L/I for GI/Colonoscopes; EVIS EXERA Colonovideoendoscopes for variable stiffness) for safety and effectiveness in intended use.	The subject devices are "basically identical" to predicates, with added mechanical features (variable stiffness, multi-bending) that do not alter safety or fundamental efficacy.
Compliance with voluntary safety standards IEC60601-1, IEC60601-1-1, IEC60601-2-18.	Devices "designed, manufactured and tested in compliance" with these standards.
Biocompatibility of patient-contacting materials.	All patient contacting materials are "identical materials that have been cleared in the past 510(k) submissions" and "confirmed with ISO 10993-1."
Improved lesion approach performance (for XPCF-160AML/I Multi-bending function).	"Evaluated the approach performance... using a colon model." (Specific quantitative results are not provided in this summary but referenced in Attachment 1).

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

Test Set Sample Size: The document mentions a study evaluating "approach performance... using a colon model." However, it does not specify the sample size (e.g., number of attempts, number of users, number of colon models) for this test set within the provided text.
Data Provenance: The study was conducted "using a colon model," suggesting it was a simulated, non-clinical study rather than using human data. The country of origin for this specific "colon model" test is not stated, but the applicant is based in Japan.

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

The document does not describe the use of human experts to establish "ground truth" for the colon model test. The test described appears to be a performance assessment on a physical model, likely measuring physical parameters of scope maneuverability or reach.
The concept of "ground truth" as typically applied in AI/image analysis (e.g., expert consensus on diagnoses) is not relevant to this type of mechanical device performance study.

4. Adjudication method for the test set:

The document does not mention any adjudication method as it relates to expert review. This is consistent with the type of non-clinical, mechanical performance testing described.

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:

No MRMC study was done. The device described is a gastrointestinal videoscope/colonovideoscope, which is an imaging and intervention tool, not an AI-assisted diagnostic software. Therefore, human reader improvement with or without AI assistance is not applicable to this device submission.

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

No standalone algorithm performance study was done. As noted above, this is a hardware medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the only specific study mentioned (approach performance on a colon model), the "ground truth" would likely be objective, measurable physical characteristics or outcomes on the model itself (e.g., successful navigation, time to reach a target, visualization of simulated lesions). It would not involve expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

No training set is applicable or mentioned. This is not an AI/machine learning device. The design, manufacturing, and testing refer to engineering and safety standards, not a data-driven training process.

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

Not applicable. There is no training set mentioned for this device.

Summary

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K 032177

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SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant:	OLYMPUS OPT-ELECTRONICS CO., LTD. (New Company Name: AIZU OLYMPUS CO., LTD)
Address:	500 Aza Muranishi Ooaza Niidera, Monden-machi Aizuwakamatsu-shi Fukushima, Japan, 965-8520
Establishment Registration No.:	9610595
2. Submission Correspondent:	Tina Steffanie-Oak
Title:	Senior Regulatory Affairs Analyst OLYMPUS AMERICA INC.
Address:	Two Corporate Center Drive, Melville, NY 11747-3157
Telephone:	631-844-5477
Facsimile:	631-844-5416
E-mail address:	Tina.Steffanie-Oak@olympus.com
Establishment Registration No.:	2429304

3. Initial Impoter: Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-3157 Address: Establishment Registration No .: 2429304

B. DEVICE IDENTIFICATION

1. Common/Usual Name

GASTROINTESTINALVIDEOSCOPE / COLONOVIDEOSCOPE

2. Device Name

GASTROINTESTINALVIDEOSCOPE XGIF-Q140M, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q140ML/I, XPCF-160AML/I

3. Classification Name

	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company of the program of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A Clair		.
CARLING COMMENT CARA 2 4 4 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8programs and only of the consisted on the program and any and any and------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	· GAMUSCANDOAND STORESCOLIBE------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Complete of the can and management comments on any a more and considered to the control of the first and the may be	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	i1ALL BRANDER AT MALLER A LE BREAK E & REPORTER FREE S

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Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K032177", which appears to be a reference or identification number. Below this, the text "Pg 2 of 3" indicates that this is page 2 of a 3-page document. The handwriting is cursive and slightly stylized.

C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

The following listed devices are considered as predicate devices in consideration of their characteristics, and the following table shows their regulatory histories.

Model	510(k)#	Manufacturer	Class	ProductCode
GIF-Q140EVIS-140 Series Scopes	#K954451	Olympus Optical Co., Ltd.	II	78-FDS
GIF-2T140EVIS-140 Series Scopes	#K954451	Olympus Optical Co., Ltd.	II	78-FDS
CF-Q140L/IEVIS-140 Series Scopes	#K954451	Olympus Optical Co., Ltd.	II	78-FDS
PCF-140L/IEVIS-140 Series Scopes	#K954451	Olympus Optical Co., Ltd.	II	78-FDS
EVIS EXERAColonovideoendoscopes	#K001241	Olympus Optical Co., Ltd.	II	78FDF

D. DEVICE DESCRIPTION

1. Summary

*This feature has been added to XPCF-160AML/I only.

While XPCF-160AML/I has the mechanical structure of variable stiffness (Refer to Attachment 2. "Flexibility Adiustment Function") this feature is identical to those of another predicate device, the EVIS EXERA Colonovideoendoscopes (#K001241). The addition of the variable stiffness function does not require any new insertion method or technique.

The Multi-bending function has two independent bending sections in the insertion portion of the scope. This new function provides an easier approach in reaching the lesion and also a better view of the lesion from the front. Some lesions in the upper digestive tract were difficult to perform a perfect biopsy and endoscopy with the conventional forward-viewing gastroscope. (Refer to Appendix-3, "Clinical Literature"). The subject devices improve the approach to the lesion in the lower digestive tract compared with the predicate devices. We have evaluated the approach performance of the XPCF-160AMI compared to the predicate device using a colon model. (Refer to Attachment 1, "Comparison between approach performance of Predicate and Subject Device using a colon model").

In conclusion, the subject device is substantially equivalent to the predicate devices. A comparison table of the subject device and predicate devices is found in Attachment 1.

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K032177

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2. Design

XGIF-Q140M, XGIF-2T140M, XCF-Q140MLII, XPCF-160AMLII has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1, IEC60601-1-1and IEC60601-2-18.

3. Materials

All the patient contacting materials used in this endoscope and ancillary equipment are identical materials that have been cleared in the past 510(k) submissions. And all materials have been confirmed with ISO 10993-1.

4. Intended Use of the device

GASTROINTESTINALVIDEOSCOPE XGIF-Q140M, XGIF-2T140M

This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

COLONOVIDEOSCOPE XCF-Q140ML/I, XPCF-160AML/I

This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).

5. Summary including conclusion drawn form Non-clinical Tests

When compared to the preamendment/predicate devices, XGIF-Q140M. XGIF-2T140M. XCF-Q140ML/I, XPCF-160AML/I does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety and effectiveness. Therefore clinical data is not necessary for its evaluation of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure with three curved lines representing its wings or body.

OCT - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OL YMPUS OPT-ELECTRONICS CO., LTD./AIZU OLYMPUS CO., LTD. c/o Ms. Tina Steffanie-Oak Senior Regulatory Affairs Analyst Olympus America Inc. Two Corporate Center Drive MELVILLE NY 11747-3157

Re: K032177

Trade/Device Name: Gastrointestinal Videoscope, XGIF-Q140M, XGIF-2T140M and Colonovideoscope, XCF-Q140ML/I, XPCF-160AML/I Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDS and FDF Dated: July 11, 2003 Received: July 16, 2003

Dear Ms. Steffanie-Oak:

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 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); good manufacturing practice requirements as 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 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

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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K 032/77

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510(k) Number(if known): GASTROINTESTINALVIDEOSCOPE XGIF-Q140M, XGIE-2T140M Device Name: COLONOVIDEOSCORE XCF-Q140ML/L XPCF-160AML/I

Indications for Use:

GASTROINTESTINAL VIDEOSCOPE XGIF-Q140M, XGIE-2T140M

COLONOVIDEOSCOPE XCF-Q140ML/L XPCF-160AML/I

This instrument has been designed to be used with the OLYMPUS Video System Center, Light Source, Documentation Eguipment, Video Monitor, Electrosurgical unit, Endo-Therapy Accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Gabriel A. Segarra

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

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.