Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current.

Device Description

The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.

The KD-610L and KD-611L knives have isolation tips on the distal tip to prevent inadvertent deep cauterization. The KD-611L knive also has an electrode at the bottom of the isolation tip, which can also cut tissue.

The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.

The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.

The KD-640L knife has a triangle tip to the distal end of the knife, which hooks mucous membrane to cut. Both longitudinal and lateral dissection is possible without rotating the instrument due to the triangle tip design.

AI/ML Overview

This document is a 510(k) summary for a "Single Use Electrosurgical Knife Series." It describes the device, its intended use, and compares it to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot fulfill your request for the specific points listed (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) because this information is not present in the provided text.

The document states:

"The Single Use Electrosurgical knives are basically identical to the predicate device in intended use, and similar in specifications except for cutting knife shapes." (Section 6)
"When compared to the predicate device, the Single Use Electrosurgical Knives do not incorporate any significant changes that could affect the safety or effectiveness of the device." (Section 7)

These statements indicate that the submission relies on the established safety and effectiveness of the predicate device (KD-1L-1, Preamendment Device) to support substantial equivalence for the new devices. No new performance studies with defined acceptance criteria are described.

Summary

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K092309
pg 1 of 2

510(k) SUMMARY

Single Use Electrosurgical Knife Series

OCT 3 0 2009

General Information 1

Applicant:
Official Correspondent:

발 Manufacturer: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, M.S., RAC

Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-5405 FAX: 484-896-7128 Email: Stacy.Kluesner@olympus.com Establishment Registration No: 2429304

OLYMPUS MEDICAL SYSTEMS CORP.

Aomori Olympus 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan, 036-0367 Establishment Registration Number: 9614641

Device Identification 2

. Device Trade Name:
트 Common Name:
Regulation Number:

■ Regulation Name:

■ Regulatory Class:

동 Classification Panel:
Product Code: .

Single Use Electrosurgical Knife Series

Electrosurgical Knife

21 CFR 876.4300

Endoscopic electrosurgical unit and accessories

Gastroenterology and urology

KGE

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K0923a
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Predicate Device Information 3

Device Name	Common Name	510(k) No.	Manufacturer
KD-1L-1	ElectrosurgicalKnife	PreamendmentDevice	Olympus Medical Systems Corp.

Device Description 4

The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.

The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.

The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.

5 Indications for Use

Comparison of Technological Characteristics હે

The Single Use Electrosurgical knives are basically identical to the predicate device in intended use, and similar in specifications except for cutting knife shapes.

7 Conclusion

When compared to the predicate device, the Single Use Electrosurgical Knives do not incorporate any significant changes that could affect the safety or effectiveness of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610

OCT 3.0 2009

Re: K092309

Trade/Device Name: Single Use Electrosurgical Knife Series Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 30, 2009 Received: August 3, 2009

Dear Ms. Kluesner:

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 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); medical device reporting (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092309

Device Name: Single Use Electrosurgical Knife series

Indications For Use:

Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L

This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arzich Wh

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

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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).