The subject device consists of the papillotomy knife for endoscopic sphincterotomy. The subject device consists of a partially open guidewire lumen. The partially open guidewire lumen is called the C-Channel design. The subject device is a variation of the predicate device.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215". This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory approval.

However, the provided text does not contain the acceptance criteria or a study that proves a device meets specific performance criteria related to an AI/ML algorithm or diagnostic accuracy testing as requested in the prompt. The document is a regulatory submission for a physical medical instrument (a sphincterotome) used in endoscopic procedures, not a software-as-a-medical-device (SaMD) or a device that directly generates or interprets data for diagnostic purposes requiring performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving device performance in the context of AI/ML or diagnostic accuracy.

The document mentions "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," but it does not provide the specific acceptance criteria or the results of these design verification tests. It also mentions a "Shelf-life of three years have been confirmed by accelerated aging test in accordance with ASTM F-1980-07," but no specific acceptance criteria for shelf-life performance are detailed, nor are the full results of this test provided.

In summary, the document discusses the regulatory approval process for a physical medical device and its non-clinical testing for safety and shelf-life, but not for diagnostic or AI/ML performance.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.

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

March 1, 2016

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

Re: K160241

Trade/Device Name: Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical unit and accessories Regulatory Class: Class II Product Code: KNS Dated: January 29, 2016 Received: February 1, 2016

Dear Daphney 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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

for 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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Indications for Use

510(k) Number (if known)

K160241

Device Name

Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215

Indications for Use (Describe)

This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

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

2 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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Image /page/3/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, lighter font.

510(k) SUMMARY

Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215

January 29, 2016

5.1 General Information

■	Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,JapanEstablishment Registration No: 8010047
■	Official Correspondent:	Daphney Germain-KolawoleProject Manager, Regulatory AffairsOlympus Corporation of the Americas3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5691FAX: 484-896-7128Email: daphney.germain-kolawole@olympus.com
■	Manufacturer:	Aomori Olympus Co., Ltd.2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357,JapanEstablishment Registration No.: 9614641

5.2 Device Identification

	Device Trade Name:	Single Use Sphincterotome V(Distal Wireguided)KD-VC412Q-0215
	Common Name:	Sphincterotome
	Regulation Number:	876.4300
	Regulation Name:	Endoscopic electrosurgical unit and accessories
	Regulatory Class:	II
	Classification Panel:	Gastroenterology and urology
	Product Code:	KNS
		Section 5 510(k) SummaryPage2 of 4

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Image /page/4/Picture/0 description: The image contains the logo for Olympus. The word "OLYMPUS" is written in large, bold, dark blue letters. Below the word is a thin, yellow line. Underneath the line is the text "Your Vision, Our Future".

5.3 Predicate Device Information

Single Use Sphincterotome V(Distal Wireguided)
Model name	Applicant	510(k) No.
Single Use Sphincterotome V	OLYMPUS MEDICALSYSTEMS CORP.	K141991

5.4 Device Description

5.5 Indications for Use

This instrument has been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.

Comparison of Technological Characteristics 5.6

Compared to the predicate device, the subject sphincterotome is different from the predicate device in the following five points on the distal end, on the shelf-life, and tube fixation to the guidewire port mold. This change of the distal end is to meet user's preference. The other features are identical to the predicate device.

O Difference on the distal end
- Tip length
- Knife length
- Addition of notches
- Removal of 8 mm marker
- Removal of radiopaque marker
O Shelf-life is extended to three years
0 Tube fixation to the guidewire port mold

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Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the text "Your Vision, Our Future" is written in a smaller font.

5.7 Summary of non-clinical testing

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.

Shelf-life of three years have been confirmed by accelerated aging test in accordance with ASTM F-1980-07.

Conclusion 5.8

When compared to the predicate device, the Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215 does 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).