This instrument has been designed to be used with the OLYMPUS EVIS Video System Center, EVIS Universal Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the small intestine.

Device Description

The subject device, the XSIF-1TQ140 is basically identical to the preamendment device, the SIF-B except that the mechanical structure of variable stiffness has been added and the imaging system has been changed from fiber to CCD.

AI/ML Overview

This document is a 510(k) premarket notification for an Olympus XSIF-1TQ140A Small Intestinal Videoscope and its accessories (XB01-681-26 Stylet and ST-S1 Splinting Tube). It is a traditional submission, not one related to AI/ML.

Therefore, the requested information about acceptance criteria, study details, ground truth, and training set for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of the new device to previously marketed predicate devices based on design, materials, and intended use, rather than a performance study against specific acceptance criteria in the context of AI/ML.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird figure.

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

OLYMPUS OPT-ELECTRONICS CO., LTD. % Ms. Tina Steffanie-Oak Senior R.A. Analyst Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

JUL 2 7 2015

Re: K031256

Trade/Device Name: XSIF-1TQ140A Small Intestinal Videoscope XB01-681-26 Stylet ST-S1 Splinting Tube

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDA Dated (Date on orig SE ltr): April 18, 2003 Received (Date on orig SE Itr): April 24, 2003

Dear Ms. Steffanie-Oak,

This letter corrects our substantially equivalent letter of July 23, 2003.

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

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Page 2 -

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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510(k) Number(if known): XSIE-1TQ140A SMALL INTESTINAL VIDEOSCOPE Device Name: XBO1-681-26 STYLET ST-S1 SPLINTING TUBE

Indications for Use:

XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

XBO1-681-26 STYLET

This product has been designed to increase stiffness of insertion part of Olympus small intestinal videoscope XSIF-1TQ140A by inserting to the endoscope biopsy channel.

ST-S1 SPLINTING TUBE

This product has been designed to be used with the XSIF-1TQ140A for endoscopy within the small intestinal tract. This product is intended to facilitate insertion of the scope by straightening from the esophagus through stomach to descending part of duodenum.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K031256

Over-The-Counter Use
(Optional Format 1-2-86)

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SMDA 510(k) SUMMARY

K03/256
pg/183

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-machiAizuwakamatsu-shi Fukushima, Japan, 965-8520
Establishment Registration No.:	9610595

2. Submission Correspondent:	Tina Steffanie-Oak
Title:	Senior R.A. 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 SMALL INTESTINAL VIDEOSCOPE
1. Device Name SIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

3. Classification Name

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K 031,256
pg 2 of 3

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
SIF-BSmall Intestinal Fiberscope	PreamendmentDevice	Olympus Optical Co., Ltd.	II	78-KOG
SIF-SW Sonde-type SmallIntestinal Fiberscope	#K904800	Olympus Optical Co., Ltd.	II	78-KOG
EVIS EXERAColonovideoendoscopes	#K001241	Olympus Optical Co., Ltd.	II	78-KOG
PR-2B(Cannula with Stylet)for EVIS-200 System	#K931154	Olympus Optical Co., Ltd.	II	77-EOQ
ST-C6/C8 Splinting Tubefor EVIS-140 SeriesScopes	#K954451	Olympus Optical Co., Ltd.	II	78-FDS

D. DEVICE DESCRIPTION

1. Summarv

While the mechanical structure of variable stiffness (Refer to Attachment 2, "Flexibility Adjustment Function") and the CCD imaging system for use in the small intestine are considered new technologies, these features are identical to those of another predicate device, the EVIS EXERA Colonovideoendoscopes (#K001241). Any new insertion method and techniques in consequence of the added mechanical structure of variable stiffness are not considered. A variable stiffness enteroscope enhances insertion depth compared to the conventional enteroscope with or without overtube. The mechanical structure of variable stiffness facilitates insertion of this scope into the small intestine (Refer to Appendix-3, "Clinical Literature").

By changing the imaging systems from fiber to CCD, this scope shows more excellent images than the SIF-B. Since the optical system of the subject device is equivalent to that of the predicate device, the CF-Q160AL (#K001241), it does not affect the safety and efficacy for diagnoses and treatments.

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.

2. Design

XSIF-1TQ140A 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.

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Ko 3 1256 pg 3 of 3

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

5. Summary including conclusion drawn form Non-clinical Tests

When compared to the preamendment/predicate device, XSIF-1TQ140A does not incorporate any significant changes in the intended use, method of operation, material, or designed that could affect the safety effectiveness. Therefore the clinical data is not necessary for its evaluation of safety and efficacy.

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.