The SonoSurg Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.

Device Description

The subject SonoSurg is an ultrasonic surgical device designed to be used with Generator Irrigation Unit and Transducer and ultrasonic surgical instruments to dissect, fragment, enulsify and aspirate tissue in the neurosurgical field. This system consists of the SonoSurg Senerator (SonoSurg-G2 set), SonoSurg Imigation Unit (SonoSurg-IU), SonoSurg-Transducer(SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.

AI/ML Overview

This submission is for a 510(k) premarket notification for the SonoSurg Ultrasonic Surgical System. The document does not describe a study to establish acceptance criteria or demonstrate device performance through clinical trials or specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

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

The provided documentation does not include a table of acceptance criteria or specific performance metrics with reported results for the SonoSurg Ultrasonic Surgical System. The demonstration of safety and effectiveness is primarily through substantial equivalence to predicate devices, supported by non-clinical tests for design and materials.

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

Not applicable. The submission relies on non-clinical tests and a comparison with predicate devices, rather than a test set with patient data.

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)

Not applicable. There is no test set in the conventional sense that would require expert-established ground truth.

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

Not applicable.

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 device is an ultrasonic surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is an ultrasonic surgical system, not an algorithm, and is intended for use with a human medical professional.

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

Not applicable. The evaluation is based on non-clinical tests and comparison to predicate devices, not on a ground truth derived from clinical data.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

Summary

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K041566

SEP - 8 2004

SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant

Name & Address:

Registration Number:

2. Initial Importer

Name & Address:

Registration Number:

3. Submission Correspondent

Name, Address, Tel & Fax:

Aomori Olympus Co., Ltd. 2-248-1 Okkonoki Kuroishi-shi, Aomori-ken, Japan 036-0357 9614641

OLYMPUS AMERICA Inc. Two Corporate Center Drive, Melville, NY 11747-3157 2429304

OLYMPUS AMERICA Inc. Two Corporate Center Drive, Melville, NY 11747-3157 Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor 631-844-5477 631-844-5416 2429304

Registration Number:

B. DEVICE IDENTIFICATION

1. Common/Usual Name Ultrasonic Surgical System
1. Device Name SonoSurg Ultrasonic Surgical System
1. Class, Classification Number and Classification Name No classification, Ultrasonic Surgical Instrument, 80LFL

C. IDENTIFICATION OF LEGALLY MARKETED DEVICES WHICH WE CLAIM SUBSTANTIAL EQUIVALENCE

The following list identifies the predicate devices:

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Model	510(k)#	Manufacturer	Class	ProductCode
SonoSurg System	#K032066	OlympusCorporation	No Classification	80-LFL
SonoSurg Trocar XT3900 System	#K000095	OlympusCorporation	II	80-LFL
Ultrasonic Surgical System	#K021962#K031710#K031523#K031305	OlympusCorporation	No Classification	80-LFL
CUSA Excel Ultrasonic SurgicalAspirator System	#K981262	Valleylab	No Classification	80-LFL84-LBK
SONOPET UST-2001 UltraSurgical Aspirator	#K010309	Miwatec	No Classification	80-LFL
Ultrasonic Surgical System USU	#K962952	OlympusCorporation	No Classification	84-LBK

D. DEVICE DESCRIPTION

1. Summary

2. Design

This System has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC 60601-1, IEC 60601-1-1 and IEC 60601-1-2.

3. Materials

Certificate of Identical Materials is included in Attachment 5. Concerning the patient contacting part, some materials are identical with the predicate device. While the others are not identical with the predicate device, biocompatibility testing was performed in accordance with ISO 1093. 1. The test data has shown in Attachment 5-A.

4. Intended Use of the device: Indications for Use of the SonoSurg Ultrasonic Surgical System

The SonoSurg Ultrasonic Surgical System is indicated for use in surgical System neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

5. Summary including conclusion drawn from Non-clinical Tests

When compared to the Olympus SonoSurg System (#K032066), CUSA EXcel Ultrasonic Surgical Aspirator System (#K681262), SONOPET UST-2001 Ultra Surgical Aspirator (#K010309) and Ultrasonic System (#K062952, #K000095, #K021962, #K031710,

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#K031523, #K031305), SonoSurg Ultrasonic Surgical System does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect safety or effectiveness. Therefore clinical data is not necessary for its evaluation of safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

Aomori Olympus Co., Ltd. c/o Ms. Tina Steffanie-Oak Associate Manager, Regulatory Affairs/Clinical Monitor Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K041566

Trade/Device Name: SonoSurg Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: June 8, 2004 Received: June 10, 2004

Dear Ms. Steffanie-Oak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined 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). and Cosmetic Free, increating subject to the general controls provisions of the Act. The r ou may, aterere, mains 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 or uny 1 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. Tina Steffanie-Oak

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K041566 Device Name: SonoSurg Ultrasonic Surgical System Indications for Use:

Indications for Use of SonoSurg Ultrasonic Surgical System

The SonoSurg Olympus Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ 1 (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)
Mark A Milkeusen

vision of General, Restorative, and Neurological Devices

510(k) Number K041566

Regulation Number and Section

N/A