This instrument has been designed to be use with Olympus Endo-therapy Accessories. The instrument is used as guidwire of endoscopic accessories for billiary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts

Device Description

G-201-35-45, G-202-35-45 are resin-treated coated gidwire. Removal of the guidewire is not necessary during sphinctecterotomy . G-201-35-45 is straight distal portion type, G-202-35-45 is angle distal portion type. These instruments have been designed to be used with Olympus Endo-Therapy Accessories. which are applicable for φ0.89mm (0.035 inch) diameter guidewires. These instruments are equipped with Laser-markers at the distal portion to conform guidewire placement under fluoroscopy endoscopic maneuvering.

AI/ML Overview

This document is a 510(k) premarket notification for the Olympus Disposable Guidewire, models G-205-3545S and G-205-3545A. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for a new AI/software device. Therefore, much of the requested information regarding acceptance criteria, study methodologies, and AI-specific details is not present in this document.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific performance metrics for the device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document describes a comparison to a predicate device and notes "non-clinical tests" but does not detail the methodology or sample sizes of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device is a physical guidewire, not an AI/software device that requires expert-established ground truth for performance evaluation in the context of this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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

This information is not applicable and not provided. The device is a physical guidewire, not an AI product.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/machine learning product.

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

This information is not applicable and not provided.

Summary of what can be gleaned from the document regarding the device's assessment:

Device Name: Olympus Disposable Guidewire, Models G-205-3545S and G-205-3545A.
Purpose of filing: 510(k) premarket notification to demonstrate substantial equivalence.
Predicate Device(s):
- Guide Wire G35-2LB (Olympus Optical Co.,Ltd.) #K933110
- Climber (Terumo) #K971937
- Lagwire 5658-1/5659-1 (Boston Scientific) #K922302
Method of demonstrating equivalence: "Summary including Conclusions drawn from Non-clinical Tests" (Section F).
Conclusion of non-clinical tests: "When compared to the predicate device, Disposable Guidewire G-205-3545S, G-205-3545A does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness."
Intended Use: To be used with Olympus Endo-therapy Accessories as a guidewire for endoscopic accessories in the biliary duct, including common bile, cystic, pancreatic, right, and left hepatic ducts.

In essence, this document is a regulatory submission for a physical medical device. It does not contain the type of detailed information requested for a software or AI-driven diagnostic device. The "study" mentioned is likely a series of non-clinical bench tests and comparisons to predicate devices to confirm the new device's safety and effectiveness are equivalent, without providing specific acceptance criteria or performance numbers in this summary document.

Summary

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

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

JUL 2:2, 2015

Re: K021179

Trade/Device Name: Olympus Disposable Guidewire, Models G-205-3545S and G-205-3545A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated (Date on orig SE ltr): April 11, 2002 Received (Date on orig SE Itr): April 15, 2002

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of July 5, 2002.

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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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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K021179 510(k) Number (if known):

Device Name: Disposable Guidewire G-205-3545S. G-205-3545A

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 Counter Use (Per 21 CFR 801.109) OR

Qyer-The-

Nancy C. Hodsdon

(Optional Format 1-2-96)

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

1. Submitter's Name
Name & Address of manufacturer:	Olympus Optical Co., Ltd.2-3-1 Shinjyuku Monolis Nishi-Shinjuku,Shinjyuku-ku Tokyo, 163-0914 Japan
Registration No.:	8010047
Address, Phone and Fax Numbers:	2951 Ishikawa-Cho,
of R&D Department,	Hachioji-shi, Tokyo 192-8507
Endoscope Division	Japan
TEL	81- 426-42-5177
FAX	81-426-46-5613
2. Manufacturer site/Sterilization site
Name & Address of manufacturer:	Ashitaka Factory of Terumo Corporation150, Mainmaigi-cho, Fujinomiya-CityShizuoka, 418-0015, Japan
Registration No.	9681834
B. Name of Contact Person
Name:	Ms. Laura Storms-Tyler

Address, Phone and Fax Numbers:

Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: (631) 844-5688 FAX: (631) 844-5416

1621179

C. Device Name, Common Name, Classification Name and Predicate Devices

Trade Name:	Disposable Guidwire G-205-3545S, G205-3545A
Common Name:	Guidewire
Classification:	Endoscope and accessories 21 CFR 876.1500
Predicate Device:	Guide Wire G35-2LB (Olympus Optical Co.,Ltd.)#K933110
	Climber (Terumo)#K971937
	Lagwire 5658-1/5659-1 (Boston Scientific)#K922302

D. Description of the Device(s)

E. Intended Use of the Device(s)

This instrument has been designed to be use with Olympus Endo-therapy Accessories.

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The instrument is used as guidwire of endoscopic accessories for biliary duct, including not only common bile but cystic, pancreatic, right and left hepatic ducts

F. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, Disposable Guidewire G-205-3545S, G-205-3545A does not incorporate any significant changes in the intended use, method of operation, material, or design 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.