K Number

Device Name

SONOSURG ULTRASONIC SURGICAL SYSTEM

Manufacturer

AOMORI OLYMPUS CO., LTD.

Date Cleared

2004-09-08

(90 days)

Product Code

LFL

Regulation Number

N/A

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K032066, #K000095, #K021962, #K031710, #K031523, #K031305, #K981262, #K010309, #K962952

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasonic surgical system and does not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is used to dissect, fragment, emulsify, and aspirate soft tissue in neurosurgery, which constitutes a therapeutic intervention.

Diagnostic

The device is described as an "ultrasonic surgical device" intended for "dissection, fragmentation, emulsification and aspiration of soft tissue" in neurosurgery. Its function is to perform surgical actions, not to diagnose conditions.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components (Generator, Irrigation Unit, Transducer, surgical instruments) that are part of the system.

IVD (In Vitro Diagnostic)

Based on the provided text, the SonoSurg Ultrasonic Surgical System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's for use in surgical procedures to dissect, fragment, emulsify, and aspirate soft tissue within the body (specifically in neurosurgery).
Device Description: The description reinforces its function as a surgical tool used directly on tissue during surgery.
Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a person's health. The SonoSurg system does not perform this function.

The SonoSurg is a surgical instrument used in vivo (within a living organism), not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoSurg Ultrasonic Surgical System is indicated for use in surgical System 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.

Product codes (comma separated list FDA assigned to the subject device)

LFL

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neurosurgical field

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

#K032066, #K000095, #K021962, #K031710, #K031523, #K031305, #K981262, #K010309, #K962952

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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:

| Model | 510(k)# | Manufacturer | Class | Product
Code |
|----------------------------------------------------|----------------------------------------------|------------------------|-------------------|------------------|
| SonoSurg System | #K032066 | Olympus
Corporation | No Classification | 80-LFL |
| SonoSurg Trocar XT3900 System | #K000095 | Olympus
Corporation | II | 80-LFL |
| Ultrasonic Surgical System | #K021962
#K031710
#K031523
#K031305 | Olympus
Corporation | No Classification | 80-LFL |
| CUSA Excel Ultrasonic Surgical
Aspirator System | #K981262 | Valleylab | No Classification | 80-LFL
84-LBK |
| SONOPET UST-2001 Ultra
Surgical Aspirator | #K010309 | Miwatec | No Classification | 80-LFL |
| Ultrasonic Surgical System USU | #K962952 | Olympus
Corporation | 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,

#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.

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.

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

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