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 thoracic and abdominal cavities.

Device Description

This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source.

AI/ML Overview

The provided 510(k) summary does not include specific acceptance criteria or an explicit study detailing how the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and technological characteristics.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No new patient-contacting materials	All patient-contacting materials are cleared by previous 510(k) submissions.
Compliance with voluntary safety standards	Designed, manufactured, and tested in compliance with IEC 60601-1 and IEC 60601-2-18.
Equivalence in safety and efficacy for electrosurgical applications (compared to predicate devices)	Expected to present no differences in safety or efficacy for electrosurgical applications compared to predicate devices, despite being a flexible endoscope where rigid endoscopes were historically used.
Intended Use as a pleuravideoscope	Designed for endoscopic diagnosis and surgery within the thoracic and abdominal cavities, with an Olympus video system, light source, documentation equipment, video monitor, endo-therapy accessories, and other ancillary equipment.

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

Not applicable. The submission does not describe a test set or clinical study with a sample size for performance evaluation. The device gained clearance based on substantial equivalence to predicate devices and compliance with safety standards, not through a direct performance study with a test set.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as there was no test set or clinical study.

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

Not applicable. No MRMC study was conducted or mentioned in the summary. The clearance was based on substantial equivalence to existing devices, not on demonstrating an improvement in human reader performance with AI assistance (as this is not an AI device).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is not an algorithm or AI system, so a standalone performance study in that context is irrelevant. The LTF-240 Pleuravideoscope is a medical instrument.

7. Type of Ground Truth Used

Not applicable. The clearance was based on demonstrating substantial equivalence to predicate devices and compliance with recognized safety standards, not on a ground truth established through expert consensus, pathology, or outcomes data from a performance study.

8. Sample Size for the Training Set

Not applicable. This device is a medical instrument and not an AI/ML algorithm that requires a training set.

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

Not applicable. As this device is a medical instrument and not an AI/ML algorithm, it does not have a training set or associated ground truth.

Summary

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510(k) SUMMARY

JAN 3 0 2002

K013617 1/2

LTF-240 Pleuravideoscope, its accessories and ancillary equipment

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.

A. Submitter's Name, Address, Phone and Fax Number

1. Manufacturer of the subject device

Name & Address of Manufacturer;

Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division

2 Name of Contact Person Name :

Address, Phone and Fax

Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioii-shi. Tokyo 192-8507 Japan TEL 81-426-42-5177 FAX 81-426-46-5613

Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416

B. Device Name, Common Name

1. Device Name :
1. Common/Usual Name :
1. Classification Name :

LTF-240 Pleuravideoscope, its accessories and ancillary equipment

Video Scope for Pleuravideoscope

21CFR 884.1720 21CFR 876.1500

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C. Predicate Devices:

Model	Device Description &410(k)#/Date of Cleared	Manufacturer	Class
OES Laparo-ThoracoscopeLTF-V	#K955403	Olympus Optical Co.,	II
Laparoscope,Hand Instruments	#K950103	Olympus America, Inc.	II
Flexible Trocar Tubes	#K930215	Olympus Optical Co.,	II
Flexible TipThoracoscope/Laparoscope	#K915857	Olympus Optical Co.,	II

Summary Description of the Device D.

1. Summary

2. Design

"XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18.

3. Materials

There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions.

Intended Use of the device E.

This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment of endoscopic diagnosis with the nasal and nasopharyngeal lumen.

F. Technological Characteristics

This endoscope does not have special technological characteristics, when compared to the predicate device.

G. Reason for not requiring clinical data

The subject device, LTF-240, is basically identical to the LTF-V laparoscopic thoracoscope, which is a flexible endoscope indicated for use in the thoracic and abdominal cavities, with the exception being that the LTF-V is not indicated for electrosurgery applications.

Historically, electrosurgery within the thoracic and abdominal cavities has been performed using a rigid endoscope. The use of the subject device, which is a flexible endoscope, should present no differences in safety or efficacy when compared to the predicate devices for electrosurgical applications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Olympus Optical Company, Ltd. c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747

Re: K013617

Trade/Device Name: LTF-240 Pleuravideoscope, accessories and ancillary equipment Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 1, 2001 Received: November 5, 2001

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 2015, 10:10 accordance with the provisions of the Federal Food, Drug, de rices that have occh require approval of a premarket approval application (PMA). and Cosmetion (110. (110.) that the device, subject to the general controls provisions of the Act. The r ou may, dierelove, manier the act include requirements for annual registration, listing of general controls provisions of vactice, 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 If your device is etablined too as controls. Existing major regulations affecting your device can may oe subject to back additions, 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 r lease be deviced that I Dr mination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fart 6077, laboring (21 CFR Part 820); and if applicable, the electronic for the qualis) by becam (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premits that in the Pro Pro maining of casion 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 and If you desire specific advice for your witto diagnostic devices), please contact the Office of additionally 21 CHC Fur 80711 Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1037. Transe Compliance at (301) 594-4639. Also, please note the your dovice, prease occident by reference to premarket notification" (21CFR Part 807.97). Tegulation chitted, "Nisoranaing of esponsibilities under the Act may be obtained from the Oincl general information on your responsional 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,

Miriam C. Provost

Cor Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OLYMPUS!

Indication for Use Statement

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ Not assigned y LTF-240 Pleuravideoscope, its accessories and Device Name: ancillary equipment.

Indications for Use:

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K013617

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Prescription 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.