These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit

Device Description

The major components of this system are the generator, handpiece, and accessories. The generator supplies electrical energy for ultrasonic vibration of the handpiece (transducer). The ultrasonic vibration is transferred to the tip of probe. Soft body tissue is incised and coagulated through the ultrasonic energy delivered by the handpiece.

AI/ML Overview

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System SonoSurg, which is a premarket notification to the FDA to market a medical device. This type of submission is for proving substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study for a novel device.

The relevant sections of the document explicitly state:

G. REASON FOR NOT REQUIRING CLINICAL DATA: "When compared to the predicate device, the Ultrasonic Surgical System SonoSurg does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device."

Instead of a study proving performance against acceptance criteria, the submission focuses on demonstrating:

Substantial Equivalence: The primary "study" here is a comparison to predicate devices, showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
Compliance with Voluntary Safety Standards: The document states, "The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000." These standards serve as the "acceptance criteria" for electrical safety and EMC, and the "study" is the testing performed to demonstrate compliance.

Given this, I cannot fill out the requested table and answer the study-related questions as if a clinical or performance study was conducted to prove specific accuracy or effectiveness metrics. The information is simply not present in a 510(k) summary for a substantially equivalent device that does not require clinical data.

I can, however, extract the information about the predicate devices for context:

Predicate Devices:

Device Name	510(k) #	Manufacturer	Class	Product Code
Olympus Ultrasonic Surgical System	#K021962#K031523#K031710	Olympus Corporation.	II	LFL
Olympus SonoSurg System	#K972114	Olympus Corporation.	II	LFL

Summary of Device and Claim for Equivalence:

Intended Use: These instruments (ultrasonic surgical instruments, ultrasonic generator, and transducers) have been designed to be used together to cut and coagulate soft tissue in bariatric procedures which include: laparoscopic and general (open) surgery in intraabdominal, obstetric/gynecologic, thoracic and urologic procedures. The ultrasonic surgical instruments are also compatible for use with an electrosurgical unit.
Technological Characteristics: The mechanism of this system is that the electrical energy employed in the main unit is changed to mechanical energy by ultrasonic vibration. This is the same as the referenced Olympus predicate devices.
Materials: All of the patient contacting materials used in the components of the "Olympus Ultrasonic Surgical System SonoSurg" are identical materials used in legally marketed Olympus devices.

The "study" proving acceptance criteria here is the demonstration of substantial equivalence to already cleared devices and compliance with relevant safety standards, not a new clinical performance study.

Summary

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K050885

SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with this caminary of 510 (1) Jan 990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant:	OLYMPUS MEDICAL SYSTEMS Corp.
Address:	2951 Ishikawa-cho, Hachioji-shi, Tokyo
	192-8507, Japan
	1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 0 - 1 - 0 - 1 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - 0 - - 0 - - 0 - - 0 - - 0 - - - - - - - -

Establishment Registration No .: 8010047

Aomori Olympus Co., Ltd. 2. Manufacturer: 248-1 Okkonoki 2-chome Kuroishi-shi Address: Aomori, Japan, 036-0367

Establishment Registration No.:9614641

3. Submission Correspondent: OLYMPUS AMERICA Inc.

Address:	Two Corporate Center Drive, Melville, NY 11747-3157
Contact:	Laura Storms-Tyler
Title:	Director, Regulatory Affairs and Quality Assurance
Telephone:	631-844-5688
Facsimile:	631-844-5554
E-mail address:	Laura.Storms-Tyler@olympus.com
Establishment Registration No.:	2429304

OLYMPUS AMERICA Inc. 4. Initial Importer: Two Corporate Center Drive, Melville, NY 11747-3157 Address: Establishment Registration No. 2429304

B. DEVICE IDENTIFICATION

1. Common/Usual Name

Ultrasonic Surgical Instrument

1. Device Name
  Olympus Ultrasonic Surgical System SonoSurg

3. Classification Name

Class II , LFL - Instrument, Ultrasonic Surgical

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C. PREDICATE DEVICES

Device Name	510(k) #	Manufacturer	Class	ProductCode
Olympus Ultrasonic SurgicalSystem	#K021962#K031523#K031710	Olympus Corporation.	II	LFL
Olympus SonoSurg System	#K972114	Olympus Corporation.	II	LFL

D. SUMMARY DESCRIPTION OF THE DEVICE

1. Summary

2. Design

The Olympus SonoSurg Generator SonoSurg-G2 has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1: 1995, IEC 60601-1-1:2000 and IEC 60601-2-18:1996, Amendment:2000.

3. Materials

All of the patient contacting materials used in the components of the "Olympus Ultrasonic Surgical System SonoSurg" are identical materials used in legally marketed Olympus devices.

E. INTENDED USE

F. TECHNOLOGICAL CHARACTERISTICS

The mechanism of this system is that the electrical energy employed in the main unit is changed to mechanical energy by ultrasonic vibration. This is the same as the referenced Olympus predicate devices.

G. REASON FOR NOT REQUIRING CLINICAL DATA

When compared to the predicate device, the Ultrasonic Surgical System SonoSurg does not incorporate any significant change that impacts safety and efficacy in comparison to the predicate device. Therefore, clinical data is not necessary to establish the subject device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Olympus Medical Systems Corporation C/o Ms. Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America Incorporated Two Corporate Center Drive Melville, New York 11747-3157

Re: K050885

Trade/Device Name: Olympus Ultrasonic Surgical System SonoSurg Regulatory Class: Unclassified Product Code: LFL Dated: March 17, 2005 Received: April 7, 2005

Dear Ms. Storms-Tyler:

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 such 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); 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.

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Page 2 - Ms. Laura Storms-Tyler

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow your to ough finding of substantial equivalence of your device to a legally premiured predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific at notialiance at (240) 276-0115 . Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 050885 510(k) Number(if known): Alet assigned yet_

Device Name: Olympus Ultrasonic Surgical System SonoSurg

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	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K050885

Regulation Number and Section

N/A