(347 days)
K#905315, K#962952, K#925699, K#944201
Not Found
No
The summary describes a standard ultrasonic surgical system that uses electrical energy converted to mechanical vibration for tissue incision and coagulation. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures, which aligns with the definition of a therapeutic device as it directly treats or modifies a physiological function.
No
This device is described as a surgical tool used for incising and coagulating soft tissue, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components like a Generator and Handpiece, which are essential for its function of incising and coagulating tissue.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details how the device uses ultrasonic vibration to cut and coagulate tissue. This is a physical interaction with the tissue, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
The Olympus SonoSurg System has been for use in medical facilities under supervision of a trained physician. This system designed to incise and coagulate body tissues for general, laparoscopic, and interaabdominal surgery. The operation of SonoSurg System is that the electrical energy employed in the main unit is exchanged mechanical energy by ultrasonic vibration in the handpiece.
Therefore, This system can incise, and coagulate body tissue by ultrasonic vibration.
This system is designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The major components of this system are Generator, Handpiece, and accessories. This SonoSurg generator is supplied the electrical energy to transducer built-in handpiece. The electrical energy is exchanged mechanical energy by ultrasonic vibration at the transducer. The ultrasonic vibration is transferred to the tip of probe. In conjunction with the Generator, the body tissue is incised and coagulated with handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical facilities under supervision of a trained physician
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.
K#905315, K#962952, K#925699, K#944201
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
N/A
0
MAY 1 8 1998
OLYMPUS
510(k) Summary Olympus SonoSurg System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 21 CFR Subsectic 1 807.92.
510(k) number : Not assigned yet
| Device Name: | Olympus SonoSurg System | ||
|---|---|---|---|
| Common/Usual Name: | Ultrasonic surgical system | ||
| Classification Name: | No classification | ||
| Predicate Devices: | Harmonic Scalpel Generator | Utracision | K#905315 |
| Ultrasonic Surgical System USU | Olympus | K#962952 | |
| Harmonic Scalpel Laparosonic | Ultracision | K#925699 | |
| Clamp Coagulator | |||
| HIQ Hand Instruments | Olympus | K#944201 |
Prepared by: Mr. Yoshihito Shimizu Manager, Product Development Department, Endoscope Division Olympus Optical Co., Ltd. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
Summary Preparation Date: May 7, 1997
Statement of intended use:
The Olympus SonoSurg System has been for use in medical facilities under supervision of a trained physician. This system designed to incise and coagulate body tissues for general, laparoscopic, and interaabdominal surgery. The operation of SonoSurg System is that the electrical energy employed in the main unit is exchanged mechanical energy by ultrasonic vibration in the handpiece.
Therefore, This system can incise, and coagulate body tissue by ultrasonic vibration.
1
Device description:
The major components of this system are Generator, Handpiece, and accessories. This SonoSurg generator is supplied the electrical energy to transducer built-in handpiece. The electrical energy is exchanged mechanical energy by ultrasonic vibration at the transducer. The ultrasonic vibration is transferred to the tip of probe. In conjunction with the Generator, the body tissue is incised and coagulated with handpiece.
Predicate devices for this system are following:
| Harmonic Scalpel Generator | Utracision | K#905315 |
|---|---|---|
| Ultrasonic Surgical System USU | Olympus | K#962952 |
| Harmonic Scalpel Laparosonic | Utracision | K#925699 |
| Clamp Coagulator | ||
| HIQ Hand Instruments | Olympus | K#944201 |
Actuation mechanism of the USU and the LCS is the same as the SonoSurg System based as the following:
The ultrasonic vibrating which is generated in this system is transferred to the probe, is mounted on the edge of a handpiece.
Both the SonoSurg System and the USU use the ultrascaic and operate with the almost same frequency. However, the USU incises the soft tissue by use of the shock force of ultrasound. The SonoSurg System is safer than the USU.
General safety and conclusions:
The Olympus SonoSurg System is designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 601-1 and IEC 601-1-2, as well as CISPR 11.
When compared to the predicate devices, the Olympus SonoSurg System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines forming the body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18 1998
Ms. Susan D. Goldstein-Falk Official Correspondent for Olympus Optical Company, Limited c/o MDI Consultants, Incorporated 55 Northern Boulevard Great Neck, New York 11021
Re: K972114 Olympus SonoSurq System Trade Name: Regulatory Class: II Product Code: LFL Dated: February 13, 1998 Received: February 17, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice reguirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Goldstein-Falk
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number # _972114 ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Device Name: Olympus SonoSurg System Indication for use:
This system is designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | (Division Sign-Off)
Division of General Restorative Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | K972114 |
| Prescription Use | or | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |