This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.

Device Description

Olympus Medical Systems Corp., intends to introduce the Guide Sheath for use in the respiratory organs. This Guide Sheath,XBO1-836-13 has been designed to be used with Olympus bronchoscopes with 2.8 mm instrument channel, accessories and ultrasonic probe unit for performing diagnostic and therapeutic procedures. The Guide Sheath allows physicians to advance the endo-therapy accessories or guide the ultrasonic probe precisely to the targeted lesions repeatedly.
This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Olympus Guide Sheath, XBO1-836-13". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that the device meets specific acceptance criteria through a study in the way a new drug or novel medical device might.

Therefore, the document does not contain the detailed information typically associated with acceptance criteria, reported device performance figures, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or comparative effectiveness study details as requested. These elements are primarily relevant for AI/ML device evaluations or clinical trials for novel devices with specific measurable performance endpoints.

However, I can extract the information that is present regarding the clinical evaluation.

Summary of Device Evaluation Information from the Text:

Since the provided document is a 510(k) summary for a guide sheath, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against quantitative acceptance criteria for a new, complex device (like an AI algorithm).

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The 510(k) submission focuses on substantial equivalence based on performance, materials, and specifications being "basically identical" to a predicate device.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use." The number of participants or cases in this evaluation is not detailed.
- Data Provenance: Prospective (as stated: "prospective clinical evaluation"). Country of origin is not specified, but the applicant and manufacturer are Japanese companies, while the regulatory submission is to the US FDA.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable/not specified. The "ground truth" concept is more relevant for diagnostic devices or AI, not a guide sheath. The evaluation would likely have focused on clinical use parameters, safety, and functionality, observed by clinicians, rather than establishing a "ground truth" for a diagnostic outcome.
Adjudication Method for the Test Set: Not applicable/not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is specifically for evaluating the effectiveness of a diagnostic tool, often with and without AI assistance, comparing human readers' performance. This is not reported for a guide sheath.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No. This device is a physical instrument for aiding human procedures, not an algorithm.
Type of Ground Truth Used: Not applicable in the context of diagnostic "ground truth". The "ground truth" for this device would be its demonstrated functional safety and efficacy in guiding instruments during bronchoscopy, which would be assessed through clinical observation and outcomes.
Sample Size for the Training Set: Not applicable/not specified. The device is a physical instrument, not an AI algorithm requiring a training set.
How the Ground Truth for the Training Set Was Established: Not applicable.

Key takeaway from the document: The 510(k) submission for the Olympus Guide Sheath relies on demonstrating substantial equivalence to a legally marketed predicate device (Cytology Brush: BC-14/15/16C, K931154). While a "prospective clinical evaluation" was sponsored to support safe and effective use, the detailed methodology, sample sizes, and specific performance metrics typically associated with acceptance criteria for novel or AI-driven devices are not disclosed in this summary. The primary argument for approval is that the device is "basically identical to the predicate device in performance, materials and specifications," differing only in intended use.

Summary

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January 23 , 2006

SMDA 510(k) SUMMARY "Olympus Guide Sheath, XBO1-836-13 "

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 Medical Systems Corporation2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, JapanRegistration number :8010047
2. Official Correspondent :	Laura Storm-TylerExecutive Director, Regulatory Affairs and Quality AssuranceOlympus America Inc.Two Corporate Center Drive, Melville, NY 11747-9058, USATEL 631-844-5688FAX 631-844-5554Registration Number :2429304
3. Manufacturer :	Aomori Olympus Co., Ltd.2-248-1 Okkonoki Kuroishi-shi, Aomori-ken,036-0357, JapanRegistration Number : 9614641

B. DEVICE IDENTIFICATION

1. Common/Usual Name :	Bronchoscope accessory
2. Device Name :	Olympus Guide Sheath, XBO1-836-13
3. Classification Name :	874.4680, class II , EOQ

C. PREDICATE DEVICES

Device Name	510(k) #	Manufacturer	Class	ProductCode
Cytology Brush: BC-14/15/16C(EVIS 200 System)	#K931154	OlympusCorporation.	II	EOQ

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D. SUMMARY DESCRIPTION OF THE DEVICE

1. Summarv

2. Materials

The patient contacting materials used as components of the Guide Sheath are identical to legally Marketed Olympus products.

E. SUMMARY

In summary, the Guide Sheath, XBO1-836-13 is basically identical to the predicate device in performance, materials and specifications. The subject device differs from the predicate device relative to the intended use.

F. INTENDED USE OF THE DEVICE

G. TECHNOLOGICAL CHARACTERISTICS

This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored. The following is the specification of the Guide Sheath:

Specifications	Dimension (m)
Outer Diameter	2.7
Inner Diameter	2.1
Sheath Length	900
Channel Size (Minimum $\phi$ )	2.8
Fluoro Tip for X-ray monitor	Provided

H. CLINICAL DATA

Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use.

2 9, 2

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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 eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Olympus Medical Systems Corporation c/o Ms. Laura Storm-Tyler Two Corporate Center Dr. Melville, NY 11747-9058

Re: K060243

Trade/Device Name: Olympus Guide Sheath. XBO1-836-13 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories (flexible or rigid) Regulation Class: II Product Code: EOQ Dated: May 30, 2006 Received: May 31, 2006

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.

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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Page 2 - Ms. Laura Storm-Tyler

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 Iogally marketed predicate device results in a classification for your device and thus, perceits your evice 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 (240) 276-0115. Also, please note (21 cm regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychler-SiMD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known) :

Device Name: Olympus Guide Sheath, XBO1-836-13

Indications for Use :

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Karen t. Baker

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K060243

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.