(57 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of ultrasonic surgical instruments and does not mention any AI or ML components or functionalities.
No.
The device is used to cut and coagulate soft tissue, which is a surgical function rather than a therapeutic one (treatment or prevention of disease).
No
The device is described as an ultrasonic surgical instrument used to cut and coagulate soft tissue. It is not mentioned anywhere that it is used for diagnostic purposes.
No
The device description clearly outlines hardware components like a generator, handpiece, and accessories that deliver ultrasonic energy for surgical procedures. This is not a software-only device.
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 instruments are designed to "cut and coagulate soft tissue" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description explains how the device uses ultrasonic energy to incise and coagulate tissue. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical instrument used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LFL
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraabdominal, obstetric/gynecologic, thoracic, urologic
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)
#K021962, #K031523, #K031710, #K972114
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
-
- Device Name
Olympus Ultrasonic Surgical System SonoSurg
- Device Name
3. Classification Name
Class II , LFL - Instrument, Ultrasonic Surgical
1
C. 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 |
D. SUMMARY DESCRIPTION OF THE DEVICE
1. Summary
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.
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
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.
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.
2
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.
3
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
4
K 050885 510(k) Number(if known): Alet assigned yet_
Device Name: Olympus Ultrasonic Surgical System SonoSurg
indications for 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ā | 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