(243 days)
Not Found
No
The summary describes a standard ultrasonic surgical system for cutting and coagulating tissue, with no mention of AI or ML capabilities in its intended use, device description, or any other section.
Yes
The device is designed to cut and coagulate soft tissue for various surgical procedures, which is a direct therapeutic intervention.
No
The device is an ultrasonic surgical system designed to cut and coagulate soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (scissors, transducer, generator set) that constitute the system, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "cut and coagulate soft tissue for open and endoscopic procedures in general surgery," "obstetric/gynecologic surgery," and "open and laparoscopic surgery." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details components like "Scissors," "Hook," "Transducer," and "Generator Set," which are consistent with surgical instruments and their power sources.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.
Product codes
LFL
Device Description
The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).
- (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
- (2) Olympus SonoSurg Transducer SonoSurg-T2H.
- (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
#K002981, #K972114, #K990430, #K972114, #K000095
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) SUMMARY Olympus Ultrasonic Surgical System
KO21962
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.
A. Submitter's Name, Address, Phone and Fax Number
1. Manufacturer of the subject device
| Name & Address of Manufacturer ; | Olympus Optical Co,. Ltd.
2-3-1 Shinjuku Monolis Nishi-shinjuku,
Shinjuku-ku, Tokyo, 163-0914
Japan |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Registration No : | 8010047 |
| Address, Phone and Fax Number
of R&D Department
Endoscope Division | 12951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
TEL 81-426-42-5101
FAX 81-426-46-2786 |
| 2 Name of Contact Person
Name : | Ms. Laura Storms-Tyler
Director, Regulatory Affairs
Olympus America Inc. |
| Address, Phone and Fax | Two Corporate Center Drive
Melville, NY 11747-3157
Japan
TEL (631)844-5688
FAX (631)844-5416 |
| B. Device Name, Common Name | |
| 1. Device Name : | Olympus Ultrasonic Surgical System |
| 2. Common/Usual Name : | Ultrasonic Surgical System |
| 3. Classification Name : | Class II Instrument, Ultrasonic Surgical LFL |
C. Predicate Devices :
| #K002981 | Harmonic Scalpel |
|---|---|
| #K972114 | Olympus SonoSurg Scissors Set T3000 |
| #K990430 | Hand piece |
| #K972114 | Olympus Transducer MAJ-336 |
| #K000095 | SonoSurg Generator Set SonoSurg-G2 Set |
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D. Summary Description of the Device
1. Summary
The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).
- (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
- (2) Olympus SonoSurg Transducer SonoSurg-T2H.
- (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
This device is intended to cut and coagulate soft tissue for obstetric/ gynecologic surgery, and for open and laparoscopic surgery.
2. Design
"Olympus Ultrasonic Surgical System" has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1, IEC60601-1-1,IEC60601-1-2.
3. Materials
There are no new patient-contacting materials.
E. Intended Use of the device
Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.
F. Technological Characteristics
Theory of the operation of "Olympus Ultrasonic Surgical System" is that the electrical energy employed in the "Olympus SonoSurg-G2" is changed to mechanical energy by ultrasonic vibration in the "Olympus SonoSurg Transducer SonoSurg-T2H". Therefore, this system can cut and coagulate body tissue by ultrasonic vibration. This system is the same as the Predicate Devices which include, "Olympus SonoSurg Scissors Set T3000(#K972114)", "Olympus Transducer MAJ-336 (#K972114)" and "Olympus SonSurg-G2 (#K000095)".
G. Reason for not requiring clinical data
When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
FEB 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Olympus Optical Company Tina Steffanie-Oak Senior Regulatory Affairs Specialist 2 Corporate Center Drive Melville, New York 11747
Re: K021962
Trade/Device Name: Olympus Ultrasonic Surgical System Regulation Name: Ultrasonic surgical system Regulatory Class: Unclassified Product Code: LFL Dated: November 8, 2002 Received: November 18, 2002
Dear Ms. Steffanie-Oak:
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. 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). Other general information on your responsibilities under the Act may be obtained 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,
Miriam C. Provost
for 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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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. There is a thin, blurry line underneath the word, possibly indicating the edge of a document or a shadow.
Indications for Use Statement
KO 21962 510(k) Number(if known): Not-assigned-yet. Device Name: Olympus Ultrasonic Surgical System
Indications for Use :
OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for open and endoscopic procedures in general surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for obstetric/gynecologic surgery, and for open and laparoscopic surgery.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ OR (Prescription 21 CFR 801.109)
Over - The - Counter Use