These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for billary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

Device Description

The subject devices consist of the papillotomy knife for endoscopic sphincterotomy. The predicate device consists of a closed quidewire lumen, and the subject devices consist of a partially open quidewire lumen. The partially open guidewire lumen is called the C-Channel design, and the exchange operation of the quidewire is added.

The subject Single Use Preloaded Sphincterotome V(Distal Wireguided) has a preloaded guidewire, and the subject Single Use Sphincterotome V(Distal Wireguided) does not have a preloaded guidewire. The preloaded guidewire of the subject device is a minor modification of the product from Terumo Corporation that has been cleared via premarket notification, K091417.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Single Use Preloaded Sphincterotome V and Single Use Sphincterotome V). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI or diagnostic performance. Therefore, many of the requested items related to AI device performance, sample sizes for training/test sets, expert ground truth, and MRMC studies cannot be extracted from this document.

However, I can extract information regarding non-clinical performance and the general approach to demonstrating safety and effectiveness.

Here's an attempt to answer based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Basic Performance	Confirmed that the subject device works as intended.
Risk Analysis (ISO 14971:2007)	Design verification tests and their acceptance criteria were identified and performed, demonstrating an acceptable risk profile.
Applicable Standards Compliance	The device was tested against and complies with the following standards: - IEC 60601-1 - IEC 60601-1-2 - IEC 60601-2-2 - IEC 60601-2-18 - ISO 10993-1 - ISO 10993-5 - ISO 10993-10 - ISO 10993-11 - ISO 11135-1 - ISO 14971 - ASTM F-1980-07
Comparison to Predicate Device	No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to the predicate device. Minor modification of the guidewire does not affect safety and effectiveness.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document refers to "Performance testing" but does not detail the number of devices tested or the specific test parameters.
Data Provenance: Not applicable in the context of diagnostic data. The testing mentioned is engineering/performance testing of the physical medical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: This document describes a physical medical device (sphincterotome) and its engineering performance and safety, not an AI or diagnostic device that requires expert-established ground truth for a test set.

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

Not Applicable: This pertains to clinical or diagnostic studies, not the engineering performance testing described here.

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

Not Applicable: This document is for a physical surgical accessory, not an AI-assisted diagnostic device.

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

Not Applicable: This document is for a physical surgical accessory, not an algorithm.

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

For the non-clinical performance testing, the "ground truth" would be established engineering specifications, performance standards as defined in ISO and IEC documents, and the functional characteristics of the predicate device. It's not a diagnostic "ground truth" like pathology or expert consensus.

8. The sample size for the training set

Not Applicable: This document does not describe a machine learning or AI device that requires a training set.

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

Not Applicable: This document does not describe a machine learning or AI device that requires a training set.

In summary: The provided 510(k) notification focuses on the manufacturing, design, and non-clinical performance (e.g., electrical safety, biocompatibility, sterilization, functional testing) of a physical medical device to demonstrate substantial equivalence to a legally marketed predicate. It does not contain information relevant to AI/ML device acceptance criteria or studies involving diagnostic performance, expert ground truth, or statistical measures like sample size for AI training/test sets.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

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

March 31, 2015

Olympus Medical Systems Corp. % Daphne Germain-Kolawole Olympus Corporation of the Americas Regulatory Affairs Project Manager 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K141991

Trade/Device Name: Single Use Preloaded Sphincterotome V (Distal Wireguided) Single Use Sphincterotome V (Distal Wireguided) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: March 24, 2015 Received: March 26, 2015

Dear Daphne Germain-Kolawole,

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 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

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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 devicerelated 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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,

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K141991

Device Name Single Use Preloaded Sphincterotome V(Distal Wireguided)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) SUMMARY

Single Use Preloaded Sphincterotome V(Distal Wireguided) Single Use Sphincterotome V(Distal Wireguided)

July 21, 2014

l. General Information

. Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
. Official Daphney Germain-Kolawole Correspondent: Regulatory Affairs Project Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germain-kolawole@olympus.com
Manufacturer: 1 Aomori Olympus Co., Ltd. 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0357 Establishment Registration No.: 9614641
. Device Identification Single Use Preloaded Sphincterotome V(Distal Wirequided)

Single Use Sphincterotome V(Distal Wireguided)

. Device Trade Name: Single Use Preloaded Sphincterotome V(Distal Wirequided)
Common Name: . Sphincterotome
. Requlation Number: 876.4300
. Requlation Name: Endoscopic electrosurgical unit and accessories
. Regulatory Class: =

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Single Use Preloaded Sphincterotome VSingle Use Sphincterotome VOlympus Medical Systems, Corp	Traditional 510(k) Notification
Classification Panel:	Gastroenterology and urology
Product Code:	KNS
II. Device Identification	Single Use Sphincterotome V(Distal Wireguided)

Single Use Sphincterotome V(Distal Wirequided) Device Trade Name:
. Common Name: Sphincterotome
I Requlation Number: 876.4300
I Requlation Name: Endoscopic electrosurgical unit and accessories
Regulatory Class: . ll

ll.

Classification Panel: Gastroenterology and urology
. Product Code: KNS

. Predicate Device Information

Single Use Preloaded Sphincterotome V(Distal Wireguided)Single Use Sphincterotome V(Distal Wireguided)
Model name	Applicant	510(k) No.
Single Use PreloadedSphincterotome V	OLYMPUS MEDICALSYSTEMS CORP.	K122505

IV. Device Description

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V. Indications for Use

These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

VI. Comparison of Technological Characteristics

· Compared to the predicate sphincterotomes, the subject sphincterotomes have two lumens and one C-channel.

· The minor modification of the guidewire does not affect the safety and effectiveness.

VII. Summary of non-clinical testing

· Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device works as intended.

• Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

The following standards have been applied to the Single Use Preloaded Sphincterotome V(Distal Wireguided) & Single Use Sphincterotome V(Distal Wireguided)

· IEC 60601-1
· IEC 60601-1-2
· IEC 60601-2-2
· IEC 60601-2-18
· ISO 10993-1
· ISO 10993-5
· ISO 10993-10
· ISO 10993-11
ISO 11135-1
· ISO 14971
· ASTM F-1980-07

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VIII. Conclusion

When compared to the predicate device, the Single Use Preloaded Sphincterotome V(Distal Wireguided) & Single Use Sphincterotome V(Distal Wireguided) do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).