a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and
b) for use in keeping the suitable depth of endoscopic field of view.

Device Description

Olympus Distal Attachment has the shape of short transparent tube. Olympus Distal Attachment is to be attached to the distal end of the endoscope to facilitate endoscopic therapy.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus Distal Attachment. It details its purpose and comparison to a predicate device, but it does not contain details about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement with AI vs. without AI assistance
If a standalone performance (algorithm only) study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This document primarily focuses on demonstrating substantial equivalence to a previously marketed device (Olympus MH-189) based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Olympus America, Inc. Ms. Laura Storms-Tyler Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157

·JUL 2 7 2015

Re: K984358

Trade/Device Name: Olympus Distal Attachment (MH and MAJ Models) for Endoscopic Mucosal Resection Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS Dated (Date on orig SE Itr): August 31, 1999 Received (Date on orig SE ltr): September 2, 1999

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of September 17, 1999.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

K 984358

510(k) Number (if known):

Device Name:

Indications for Use:

Olympus Distal Attachment

The Olympus Distal Attachment is intended to be used for the following:

a) for use with electrosurgical snares for endoscopic mucosal resection within the gastrointestinal tract; and
b) for use in keeping the suitable depth of endoscopic field of view.

Concurrence of CDRH, Office of Device Evaluation ODE

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

Labels	Values
510(k) Number	K984358

(Optional Format 1-2-96)

{3}------------------------------------------------

K984358/Si

page 1 of 2

510(k) SUMMARY OLYMPUS DISTAL ATTACHMENT

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

1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers : 2951 Ishikawa-Cho, of R&D Department, Endoscope Division

Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome, Shinjuku-ku, Tokyo 163-8610 Japan 8010047 Hachioji-shi, Tokyo 192-8507 Japan TEL 0426-42-5101 FAX 0426-46-2786

B. Name of Contact Person

Name: Address, Phone and Fax Numbers :

Laura Storms-Tyler Olympus Amcrica Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516) 844-5688 FAX: (516) 844-5416

C. Trade Name, Common Name and Classification Name

Trade Name: Olympus Distal Attachment MH-462, -463, -464, -465, -466, -483, -587, -588, -589, -590, -591, -592, -593, -594, -594, -595, -596, -597, -598, MAJ-289, -290, -291, -292, -293, -294, -295, -296, -297 Common Name : Transparent Cap Classfication Name: 21CFR 876.1500, Class II, Endoscope and accessories

D. Legally Marketed Device(s) which we claim Substantial Equivalence

Manufacturer	Device Description	510(k)#
--------------	--------------------	---------

Olympus MH-189

K954451 (Firdoscope Accessory for Model CF-140S. CF-Q1401/1 and CF-140L/I }

{4}------------------------------------------------

K 484358 $,
page 2 of 2

E. Description of the Device(s)

Olympus Distal Attachment has the shape of short transparent tube. Olympus Distal Attachment is to be attached to the distal end of the endoscope to facilitate endoscopic therapy.

R. Intended Use of the Device(s)

Olympus Distal Attachment has been designed to the distal end of the distal end of the endoscope to facilitate endoscopic therapy. Olympus Distal Attachment is used for the followings.

1. Gastrointestinal mucosal resection (endoscopic mucosal resection)
1. Keeping the suitable depth of endoscope's view field
1. Helping the endoscope with being inserted into the gastrointestinal tract.

G. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)

1. Design

In order to maintain the electrical safety, the cap length of the subject devices is longer than the predicate MH-189.

1. Matcrials
  All the patient contacting materials have not been used in Olympus legally marketed Devices.

H. Summary including a Bricf Discussion of Determination of Substantial Equivalence

1. Design
  The cap length supplies distance enough for the endoscopic therapy using the electrosurgical snares.
1. Materials
  The biocompatibility test reports show that new materials does not cause a problem.

I. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the subject devices do not incorporate any significant change that could affect the safety or effectiveness.

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.