(65 days)
Not Found
No
The description focuses on the physical components and function of a bipolar electrosurgical probe for hemostasis, with no mention of AI or ML.
Yes
The device is used to "provide hemostasis throughout the gastrointestinal tract", which is a therapeutic function.
No
The device is described as being used for providing hemostasis, which is a therapeutic function (stopping bleeding), not a diagnostic one (identifying a condition). It connects to electrosurgical generators, further indicating a therapeutic purpose.
No
The device description clearly outlines physical components like a catheter shaft, probe, and plugs, indicating it is a hardware device, 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 is to "endoscopically provide hemostasis throughout the gastrointestinal tract." This describes a therapeutic procedure performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The description details a probe used for direct application of energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition (hemostasis) within the body.
N/A
Intended Use / Indications for Use
Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.
Product codes
78 KNS
Device Description
The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal 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
Testing: Biocompatibility has been established for the patient contacting materials through a history of use in the Biosearch Bipolar Probe. This product line has been subjected to Design Verification. During Design Verification, visual, dimensional and functional testing to ensure the performance, design integrity for this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
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
3/25/99
PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS I.
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.
| Trade Name: | Wilson-Cook Bipolar Probe |
|---|---|
| Common/Usual Name: | Bipolar Probe |
| Classification Name/Code: | Unit, Electrosurgical, Endoscopic (with or without accessories)/78 KNS |
| Classification: | FDA has classified similar devices as Class II, as per 21 CFR § 876.4300. This device falls within the purview of the Gastroenterology and Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. |
| Intended Use: | Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL
NUMBER |
|--------------------------------------|-------------------------------------|----------------------------|
| Dobbhoff Bipolar
Hemostatic Probe | Biosearch Medical
Products, Inc. | K912129 |
Substantial Equivalence:
The Wilson-Cook Bipolar Probe is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.
1
PREMARKET NOTIFICATION FOR THE WILSON-COOK BIPOLAR RE: PROBE
| DEVICE
CHARACTERISTIC | Wilson-Cook Bipolar
Probe
[Subject of 510(K)] | Biosearch Hydromer
grafted Bipolar
Hemostatic Probe
(K912129) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used in conjunction with
single or dual plug bipolar
electrosurgical generators
to endoscopically provide
hemostasis throughout the
gastrointestinal tract. | The probe is designed to
function as a conventional
electro-coagulation device
when supplied with current
from a standard bipolar
electro-surgical generator.
The device is intended to
be passed through an
endoscope's working
channel to provide
hemostasis throughout the
GI tract. |
| Sterility | Sterile Disposable | Non-Sterile Disposable |
I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Testing: Biocompatibility has been established for the patient contacting materials through a history of use in the Biosearch Bipolar Probe. This product line has been subjected to Design Verification. During Design Verification, visual, dimensional and functional testing to ensure the performance, design integrity for this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
2
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAR 2 5 1999
Ms. Paula Joyce QA/RA Manager Wilson-Cook® Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K990145
Wilson-Cook® Bipolar Probe Dated: January 15, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS
Dear Ms. Joyce:
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 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 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 vitro diagnostic devices), please contact the Office of Compliance 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,
Dan Petit
APT 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
3
Page __ 13_ of __ 13
510(k) Number (if known): _K99 Ol 45
Wilson-Cook Bipolar Probe Device Name:
Indications for Use:
Used in conjunction with a single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.
t
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter (Optional Format 1-2-96)
Elarid le. Heyman
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .