(88 days)
Not Found
K#960476
No
The description focuses on the mechanical and electrical functions of standard surgical forceps and does not mention any AI/ML capabilities or data processing.
No
The device is described as surgical forceps used for tissue grasping, manipulation, and coagulation, which are procedural tools rather than a device that provides therapy for a condition.
No
Explanation: The device is intended for grasping/manipulation and coagulation of tissue during open surgical procedures, not for identifying the nature of a medical condition or disease.
No
The device description clearly states it is a physical, reusable device (forceps) intended for surgical procedures, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "facilitate tissue grasping/manipulation, bipolar point coagulation, and bipolar coagulation while grasping soft tissue... in open surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- 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 any such tests on samples.
- Device Description: The description details a surgical instrument that connects to an electrosurgical generator for coagulation. This aligns with a surgical device, not an IVD.
Therefore, the ETHICON Non-Stick Bipolar Forceps are a surgical device, not an In Vitro Diagnostic.
N/A
Device Name:
ETHICON Non-Stick Bipolar Forceps
Intended Use / Indications for Use
The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulation and bipolar coagulation.
The ETHICON Non-Stick Bipolar Forceps are non-sterile, reusable devices intended to facilitate tissue grasping/manipulating bipolar point coagulation and bipolar coagulation while grasping soft tissue, including vessels up to 3mm in diameter in open surgical procedures.
Product codes
GEI
Device Description
The ETHICON Non-Stick Bipolar forceps are available in various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, including vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures.
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)
Preclinical laboratory evaluations (complies with IEC-602-2.2) were performed to ensure that the device functions as intended. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been gathered from preclinical testing to assess the safety and effectiveness characteristics of the new device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kirwan Surgical Products Bipolar Forceps
Reference Device(s)
K#960476
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC - 5 1997
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
Information supporting claims of substantial equivalence, as 510(k) Summary of defined under the Federal Food, Drug and Cosmetic Act , Safety and Effectiveness respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: ETHICON Non-Stick Bipolar Forceps PREDICATE DEVICE NAME: Kirwan Surgical Products Bipolar Forceps 510(K) SUMMARY The ETHICON Non-Stick Bipolar forceps are available in Device Description various standard sizes and shapes similar to conventional forceps. These forceps can be connected to the bipolar output mode on electrosurgical generators to facilitate bipolar coagulation and bipolar point coagulation. The ETHICON Non-Stick Bipolar Forceps are designed for use with the ETHICON Bipolar Cable (K#960476). The ETHICON Bipolar Cable is used to connect the ETHICON Non-Stick Bipolar Forceps to the generator (ESU). The intended use of the ETHICON Non-Stick Bipolar Forceps is Intended Use to facilitate tissue grasping/manipulation and bipolar coagulation.
Continued on next page
ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
………
ﺴﺴ
| Indications
Statement | The ETHICON Non-Stick Bipolar Forceps are non-sterile,
reusable devices intended to facilitate tissue grasping/
manipulating bipolar point coagulation and bipolar coagulation
while grasping soft tissue, including vessels up to 3mm in
diameter in open surgical procedures. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The new device is technologically the same as the predicate. |
| Performance Data | Preclinical laboratory evaluations (complies with IEC-602-2.2)
were performed to ensure that the device functions as intended.
Clinical data was deemed unnecessary to support the Premarket
Notification. Sufficient data has been gathered from preclinical
testing to assess the safety and effectiveness characteristics of
the new device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug and Cosmetic Act. |
| Contact | Gregory Jones
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 |
| Date | September 5, 1997 |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 5 1997
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Incorporated P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K973384 Trade Name: Ethicon Non-Stick Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: September 5, 1997 Received: September 8, 1997
Dear Mr. Jones:
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 requirements , as set forth in the Quality 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
3
Page 2 - Mr. Jones
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) 594-4595. 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,
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
4
INDICATION FOR USE
| 510(k) Number (if known): | K973384 |
|---|---|
| Device Name: | ETHICON Non-Stick Bipolar Forceps |
| Indications for Use: | The ETHICON Non-Stick Bipolar Forceps are non-sterile, |
| reusable devices intended to facilitate tissue grasping/ | |
| manipulation, bipolar point coagulation, and bipolar coagulation | |
| while grasping soft tissue, including vessels up to 3mm in | |
| diameter in open surgical procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K973384 (Optional Format 1-2-9G) |
|---|---|
| --------------- | ---------------------------------- |
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ETHICON Non-Stick Bipolar Forceps ETHICON, Inc.