(57 days)
Not Found
No
The summary describes a mechanical biopsy and coagulation device and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is used for endoscopic biopsy and coagulation, which are medical procedures aimed at treating or diagnosing conditions within the urinary tract. Coagulation, in particular, is a therapeutic action to stop bleeding.
No
Explanation: The device is described as being for "biopsy and coagulation," which are therapeutic and interventional procedures, not diagnostic ones. While obtaining a biopsy sample is a step towards diagnosis, the device itself performs the collection, not the analysis or diagnosis.
No
The device description clearly identifies the product as "Olympus Unipolar Optical Biopsy Forceps," which are physical instruments used for biopsy and coagulation, not software.
Based on the provided information, the OLYMPUS Unipolar Optical Biopsy Forceps is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic biopsy and coagulation within the urinary tract." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description is of a physical instrument used for a medical procedure.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples after removal).
- Providing diagnostic information based on the analysis of these samples.
- Reagents, calibrators, or controls.
The device is a surgical instrument used for obtaining tissue samples and performing coagulation during an endoscopic procedure. While the tissue sample obtained may be used for subsequent in vitro diagnostic testing (like pathology), the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.
Product codes
78 KGE
Device Description
Olympus Unipolar Optical Biopsy Forceps
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
DEC 24 1998
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VC983811
510(k) Summary
Olympus Unipolar Optical Biopsy Forceps
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Olympus Unipolar Optical Biopsy Forceps Device Name:
Common/Usual Name:Unipolar Optical Biopsy Forceps
Endoscopic Electrosurgical Unit and Accessories Classification Name:
Classification: CFR 876.4300 Class II
Predicate Devices:
| Olympus | O5106 | Rigid biopsy forceps with spoon jaw | K790071 |
|---|---|---|---|
| Olympus | O5105 | Rigid biopsy forceps, insulated | K790071 |
| Olympus | O3109/A | Biopsy forceps with sharp cutting jaws | K790071 |
| Olympus | O0115 | Coagulation Electrode | K790071 |
| Karl Storz | Biopsy Forceps, through cutting, double action jaws, | ||
| for unipolar coagulation | unknown | ||
| Richard Wolf | Coagulating biopsy forceps by Tauber Type 8650.62 | unknown |
| Prepared & Submitted by: | Laura Storms-Tyler |
|---|---|
| Olympus America Inc. | |
| Two Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| Phone: (516) 844-5688 | |
| Fax: (516) 844-5416 |
Summary Preparation Date: December 8, 1998
Statement of Intended Use:
The Olympus Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.
1
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal 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, representing the department's focus on people and health.
DEC 2 4 1998
Ms. Laura Storms-Tyler Olympus Winter & Ibe GmbH c/o Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747
Re: K983811
Unipolar Optical Biopsy Forceps Dated: October 27, 1997 Received: October 28, 1998 Regulatory Class: II 21 CFR 876,4300/Procode: 78 KGE
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 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). 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 III (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 requirements, 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.
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 witted diagnostic devices), please contact the Office of Compilance at (301) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
**2**
# Indications for Use Statement
## 510(k) Number (if known):
Device Name:
OL YMPUS Unipolar Optical Biopsy Forceps
# Indication for Use:
The OL YMPUS Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-the Counter Use ______ |
|---------------------|---------------------------------------------------|----|-----------------------------|
| (per 21CFR 801.109) | | | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | [K983811](https://510k.innolitics.com/search/K983811) |
|---------------|---------|
|---------------|---------|