(90 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard bipolar forceps and makes no mention of AI or ML.
Yes
The device is described as a "coagulating forceps device" used during "laparoscopic bipolar coagulation" to achieve hemostasis, which is a therapeutic action.
No
The device description indicates its purpose is coagulation during laparoscopic procedures by applying electrosurgical energy, rather than identifying or characterizing a disease or condition.
No
The device description explicitly states it is comprised of physical components like a handle, shafts, forceps, and a connecting cable, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "laparoscopic bipolar coagulation," which is a surgical procedure performed on the patient's body.
- Device Description: The description details a surgical instrument used to apply electrosurgical energy for coagulation during surgery.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body to diagnose or monitor a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The BiSure™ Laparoscopic Bipolar Forceps is intended for use during laparoscopic bipolar coagulation.
Product codes
GEI
Device Description
The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators.
The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.
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)
Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN 2 1 1999
K983743
SUMMARY OF SAFETY AND EFFECTIVENESS
BiSure™ Laparoscopic Bipolar Forceps
Submitter Information I.
Valleylab, Inc. 5920 Longbow Drive Boulder, CO 80301
Contact: Jack Rogers
Telephone: (303) 530-6172 Fax: (303) 530-6313
II. Date Prepared
October 22, 1998
III. Name of Device
| Proprietary Name: | BiSure™ Laparoscopic Bipolar Forceps |
|---|---|
| Common Name: | Laparoscopic Bipolar Forceps |
| Classification Name: | Electrosurgical Cutting & Coagulation and Accessories |
IV. Predicate Device
Olympus Bipolar Forceps (K955623)
V. Device Description
The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators.
The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.
1
VI. Intended Use
The BiSure™ Laparoscopic Bipolar Forceps is intended for use during laparoscopic bipolar coagulation.
Summary of Technological Characteristics VII.
The device is identical to the Olympus Bipolar Forceps (K955623), a legally marketed device, in design, function, and component composition, except for the following changes made to non-patient contacting portions:
- · The release (used when connecting or changing the forceps) and rotation (used to rotate the forceps) mechanism has been changed to incorporate both functions into a one button (knob) design on the handle. The forceps may be rotated up to 120 degrees by pushing the release/rotation knob side-to-side as much as 60° either direction from its vertical position.
- · The grip portion of the handle has been re-shaped. The grip incorporates a U-shaped stainless steel spring-action mechanism similar to the predicate device.
All patient-contacting components (forceps and shafts) of the device are identical to the Olymous Bipolar Forceps in design, function, and composition. Lengths of shafts for both devices are the same (330 mm and 450 mm) and the O.D. of the outer shaft is the same (5 mm).
VIII. Performance Data
Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Mr. Jack Rogers Regulatory Affairs Associate Vallevlab 5920 Longbow Drive Boulder, Colorado 80301
Re: K983743
Trade Name: BiSure™ Laparoscopic Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: October 22, 1998 Received: October 23, 1998
Dear Mr. Rogers:
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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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Page 2 - Mr. Jack Rogers
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,
Celia M. Witten, Ph.D., M.D.
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
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INDICATIONS FOR USE
K983743 510(k) Number (if known):
Device Name: BiSure™ Laparoscopic Bipolar Forceps
Indications For Use:
The BiSure™ Laparoscopic Bipolar Forceps is indicated for use during laparoscopic bipolar coagulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 2.1 CFR 801.109)
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983743
Over-The-Counter Use