(261 days)
No
The description focuses on the mechanical and electrical function of a bipolar hemostasis forceps and its interaction with an electrosurgical generator. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device itself.
Yes
The device is used in endoscopic procedures for fusion of vessels or tissue bundles by applying bipolar electrosurgical RF energy, which is a therapeutic intervention.
No
The device is described as flexible bipolar hemostasis forceps used for the fusion of vessels or tissue bundles by applying electrosurgical RF energy, which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a sterile, single-use physical instrument (forceps) used in endoscopic procedures, which is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are used during a surgical procedure (endoscopic procedures) to physically fuse vessels or tissue bundles using electrosurgical energy. It is a surgical instrument used directly on the patient's tissue.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples taken from the patient. Its function is to apply energy to tissue in situ.
Therefore, this device falls under the category of a surgical instrument or electrosurgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument.
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.
Product codes
GEI
Device Description
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.
The Ethicon Endo-Surgery® Flexible Bipolar Technological Hemostasis Forceps is designed for use with currently marketed therapeutic gastroscopes and colonoscopes. It requires a 3.7-mm working channel or port for deployment. The device has a flexible shaft with a distal tip consisting of a set of jaws housing the electrodes. The Flexible Bipolar Hemostasis Forceps' is used to create a vessel fusion by applying bipolar electrosurgical RF energy (coagulation) to the vessel placed between the iaws of the instrument. The jaws contain atraumatic "grooves" which enable the device to grasp and manipulate tissue during endoscopic procedures. At the proximal end is a handle assembly. The rotation knob on the handle assembly can be used to rotate the end effector/jaws to facilitate positioning on the vessel. The Ethicon Endo-Surgery Flexible Bioolar Hemostasis Forceps is provided with an insulated cable assembly with a plug for use with the bipolar receptacle of the ERBE VIO Electrosurgical Generator.
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)
Bench, animal, biocompatibility, and electrical testing was performed to demonstrate that the EES device performs as intended and is mentioned in later sections of the application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051950, K033421, K062517, K973384
Reference Device(s)
Not Found
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
K0912859
JAN 1 5 2010
510(k) Summary
Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
Contact Renee Rowe Staff QS/RA Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-8243 (513) 337-2243 Fax: Email: rrowe ! @its.jnj.com
Date Prepared April 27, 2009
New Device Name
Trade Name: Ethicon Endo Surgery® Flexible Bipolar Hemostasis Forceps Common or Usual Name: Electrosurgical Forceps Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI)
Predicate Devices
Ethicon Endo-Surgery Multiple Clip Applier (K051950) Erbe BiClamp Open and Laparoscopic Instruments (K033421) Olympus Medical Electrosurgical Hemostatic Forceps Series (K062517) Ethicon Non-Stick Bipolar Forceps (K973384)
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of The device can be used on vessels up to 3 mm vessels or tissue bundles is performed. and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.
Indications for Use The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument.
1
The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.
Characteristics: The Ethicon Endo-Surgery® Flexible Bipolar Technological Hemostasis Forceps is designed for use with currently marketed therapeutic gastroscopes and colonoscopes. It requires a 3.7-mm working channel or port for deployment. The device has a flexible shaft with a distal tip consisting of a set of jaws housing the electrodes. The Flexible Bipolar Hemostasis Forceps' is used to create a vessel fusion by applying bipolar electrosurgical RF energy (coagulation) to the vessel placed between the iaws of the instrument. The jaws contain atraumatic "grooves" which enable the device to grasp and manipulate tissue during endoscopic procedures. At the proximal end is a handle assembly. The rotation knob on the handle assembly can be used to rotate the end effector/jaws to facilitate positioning on the vessel. The Ethicon Endo-Surgery Flexible Bioolar Hemostasis Forceps is provided with an insulated cable assembly with a plug for use with the bipolar receptacle of the ERBE VIO Electrosurgical Generator.
Bench, animal, biocompatibility, and electrical testing was Performance Data. performed to demonstrate that the EES device performs as intended and is mentioned in later sections of the application.
2
Image /page/2/Picture/1 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 a human figure with outstretched arms, representing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery Inc. % Ms. Renee Rowe 4545 Creek Drive Cincinnati, Ohio 45242
JAN 1, 5 2010
Re: K091259
Trade/Device Name: Ethicon Endo Surgery Flexible Bipolar Hemostasis Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 9, 2009 Received: December 10, 2009
Dear Ms. Rowe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Renee Rowe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Deothin Deror
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known);
Device Name: Ethicon Endo Surgery® Flexible Bipolar Hemostasis Forceps
Indications for Use:
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument.
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (
Page 1 of 1 (Posted November 13, 2003)
f Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091259 15
::