(17 days)
Not Found
No
The provided text describes a standard electrosurgical unit and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for electrosurgery, including cutting and coagulation in medical procedures, indicating a therapeutic function.
No
The device is described as an electrosurgical instrument for cutting and coagulation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is an "instrument" designed for electrosurgery and is used "in conjunction with Olympus designated electrosurgical accessories, endoscopes... light source, and ancillary equipment." This indicates a hardware component is central to its function, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for "general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation)". This involves surgical procedures performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Device Description: The description reinforces its use in surgical procedures, not laboratory testing.
The device is an electrosurgical instrument used for cutting and coagulation during surgical interventions.
N/A
Intended Use / Indications for Use
”This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, and rigid scopes) applicable to electrosurgery, light source and ancillary equipment.”
Product codes
GEI
Device Description
”This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.”
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
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)
UES-20 (#K970184)
Reference Device(s)
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
NOV 2 9 2002
SMDA 510(k) SUMMARY
KO23767 UES-30 Electrosurgical Unit and its associated accessories
A. Submitter's Name, Address, Phone and Fax Numbers
| Name & Address of manufacturer: | Olympus Optical Co., Ltd.
34-3 Hirai Hinide-Machi, Nishitama-Gun ,
Tokyo 190-00182, Japan |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Registration No.: | 3003637092 |
| Address, Phone and Fax Numbers
Of R&D Endoscope Division: | 2951 Ishikawa-Cho, Hachioji-shi,
Tokyo 192-8507,Japan
TEL 81-426-42-2891
FAX 81-426-46-5613 |
B. Name of Contact Person
| Name: | Laura Storms-Tyler |
|---|---|
| Address, Phone and Fax Numbers: | Olympus America Inc. |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| TEL: (631) 844-5688 | |
| FAX: (631) 844-5416 |
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name: | UES-30 Electrosurgical Unit and its associated accessories |
|---|---|
| Common Name: | Electrosurgical Unit |
| Classification: | 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, |
| Class II | |
| 21 CFR 878.4400 Electrosurgical cutting and coagulation device and | |
| accessories, Class II | |
| Predicate Device: | UES-20 (#K970184) |
1
D. Description of the Device(s)
This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.
E. Intended Use of the Device(s)
This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, videoscopes, and rigid scopes) applicable to electrosurgery, light source, and ancillary equipment.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 wavy lines representing the body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
NOV 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Olympus Optical Company Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Two Corporate Center Drive Melville, New York 11747-3157
Re: K023767
Trade/Device Name: UES-30 Electrosurgical Unit and its associated accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 11, 2002 Received: November 12, 2002
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
3
Page 2 -- Ms. Storms-Tyler
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. This letter will allow you to begin marketing your device as described in your Section 5100k) 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. 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" (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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
KO23767
Not assigned yet. 510(k) Number(if known):
Name: UES-30 Electrosurgical Unit and its associated Device accessories
Indications for Use: ·
This instrument has been designed for general and endoscopic electrosurgery including polypectomy, TUR, and laparoscopy (cutting and coagulation) in conjunction with Olympus designated electrosurgical accessories, endoscopes (fiberscopes, and rigid scopes) applicable to electrosurgery, light source and ancillary equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ાર
Over-The-Counter Use
(Prescription 21 CFR 801.109)
(Optional Format 1-2-96)
Misiam C. Provost
Avision Sign-Uit Division of General, Restorative nd Neurological Devices