(76 days)
Not Found
No
The summary describes a standard bipolar forceps for grasping and coagulation, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is described as being used for "grasping and coagulation of soft tissue and blood vessels during endoscopic treatment," which are therapeutic actions.
No
The device is described for grasping and coagulation, which are therapeutic actions, not for diagnosing conditions.
No
The device is described as "Bipolar Forceps" and is intended for "grasping and coagulation of soft tissue and blood vessels," which are physical actions performed by a hardware instrument. The predicate devices also appear to be physical forceps.
Based on the provided information, the Olympus Bipolar Forceps is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "grasping and coagulation of soft tissue and blood vessels during endoscopic treatment." This describes a surgical instrument used directly on the patient's body for therapeutic purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Olympus Bipolar Forceps does not involve any such activities.
Therefore, the Olympus Bipolar Forceps is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and blood vessels
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)
K945975, K955001, K971565, K955623, K944201
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
5/24/99
Image /page/0/Picture/2 description: The image shows the logo and contact information for Olympus Winter & IBE. The business address is Kuehnstr. 61, D-22045 Hamburg, and the mailing address is Postfach 70 17 09, D-22017 Hamburg. The telephone number is (040) 6 69 66-0, and the telefax number is (040) 6 68 15 91.
EU
984417
510(k) SUMMARY
OLYMPUS BIPOLAR FORCEPS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Device Name: | Bipolar Grasping Forceps BiQ+ |
|---|---|
| Common/Usual Name: | Bipolar Forceps |
| Classification Name: | DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & |
| ACCESSORIES. | |
| Classification: | CFR 878.4400 Class II |
Predicate Devices:
| Manufacturer | Description | 510(k) |
|---|---|---|
| Everest Medical Corp. | BiCOAG® Bipolar Dissecting Forceps | K945975 |
| K955001 | ||
| K971565 | ||
| Olympus | A5380, A5382 Bipolar forceps, Ø5 mm, micro tweezers | K955623 |
| Olympus | A5384, A5386 Bipolar forceps, Ø5 mm, tweezers, thin | K955623 |
| Olympus | A5388, A5390 Bipolar forceps, Ø5 mm, tweezers, thick | K955623 |
| Olympus | A5392, A5394 Bipolar forceps, Ø5 mm, Hirsch | K955623 |
| Olympus | A6124, A6322 HiQ Handinstruments | K944201 |
Prepared & Submitted By: (Contact Person)
Mrs. Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, NY 11747-3157 Phone: 516-844-5688 Fax: 516-844-5416
Summary Preparation Date: February 16, 1999
Statement of Intended Use:
The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.
1
Image /page/1/Picture/1 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 perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157
Re: K984417
Trade Name: OLYMPUS Bipolar Forceps BiQ* Regulatory Class: II Product Code: GEI Dated: November 26, 1998 Received: December 10, 1998
Dear Ms. Storms-Tyler:
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, Drug, 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 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 (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 requirement, 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 regulatory 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.
2
Page 2 - Ms. Laura Storms-Tyler
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,
Sincerely yours,
Sathish Kumar, Ph.D., P.E.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 984417 510(k) Number (if known):
Device Name:
OLYMPUS Bipolar Forceps BiQ*
Indications for Use:
The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presciption Use (per 21CFR 801.109)
OR
Over-the Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of General Restorative Device 510(k) Number _