(24 days)
Not Found
No
The document describes a standard electrosurgical instrument for vessel fusion using RF energy. There is no mention of AI, ML, or any computational analysis of data for decision-making or control. The device relies on the physician's judgment and the electrosurgical generator's pre-set parameters.
Yes
The device is intended for the "fusion of vessels or tissues" using electrosurgical RF energy in various medical procedures, which aligns with the definition of a therapeutic device designed to treat a medical condition or perform a surgical procedure.
No
The device is an electrosurgical instrument designed for the fusion of vessels and tissues during various surgical procedures. Its function is to apply energy to achieve tissue effects, not to diagnose conditions.
No
The device description clearly states that the ERBE BiClamp™ Open and Laparoscopic Instruments are physical instruments made of stainless steel, plastic, and ceramic, designed to deliver high-frequency energy. This indicates a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The ERBE BiClamp™ Open and Laparoscopic Instruments are used during surgical procedures to fuse vessels and tissues within the body using electrosurgical energy. They are directly applied to the patient's tissues.
- Intended Use: The intended use clearly describes surgical procedures where the device is used in vivo (within the living body).
Therefore, the function and intended use of the ERBE BiClamp™ align with a surgical device used for tissue manipulation and sealing, not an in vitro diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 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 ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.
The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc .; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
Product codes
GEI
Device Description
The ERBE BiClamp™ Open and Laparoscopic Instruments are used with and The ENDL brolann - Open and estem having the Optional Bipolar Mode, BiClamp - High Electrosuly(HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp™ Frequency (HP) energy Trom the LOO is deliverou inveagn the juro of instruments are made mistrainless steel with plastic and ceramic insulation except at the jaw surfaces (which isolates of stamess steel with plastic and ocranion onesperation onesperation of the from the energy to only the jaw sandoo): The inches) in length with bent jaws that have a smooth 200 Thin (7.9 Inches) to 210 thin (10.0 Inches) in tong-in to made of metals and plastics with Surface: The ENDE Drolainp of Lapiaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter the Industry. The ERDE Groump - aspirity length. The Instruments are provided non-sterile (O.D.) and a o to him (The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510K SUMMARY
Page 1 of ②
Submitted By:
ERBE USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577
Contact Person:
Julie Stephens, President/Consultant Regulatory Resources Group, Inc.
510(k) Number:
Date Prepared:
January 20, 2006
510(k) Number: K033421
510(k) Number: K981916
Common Name:
Bipolar Electrosurgical Open and Laparoscopic Instruments
Electrosurgical cutting and coagulation device and accessories
Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments,
(21 CFR 878.4400) and Gynecologic electrocautery and
ERBE BiClamp™ Open and Laparoscopic Instruments,
ERBE BiClamp™ Open and Laparoscopic Instruments Trade/Proprietary Name:
Classification Name:
accessories (21 CFR Part 884.4120)
GEI and HGI Product Code:
Legally Marketed Predicate Devices:
Device Description:
The ERBE BiClamp™ Open and Laparoscopic Instruments are used with and The ENDL brolann - Open and estem having the Optional Bipolar Mode, BiClamp - High Electrosuly(HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp™ Frequency (HP) energy Trom the LOO is deliverou inveagn the juro of instruments are made mistrainless steel with plastic and ceramic insulation except at the jaw surfaces (which isolates of stamess steel with plastic and ocranion onesperation onesperation of the from the energy to only the jaw sandoo): The inches) in length with bent jaws that have a smooth 200 Thin (7.9 Inches) to 210 thin (10.0 Inches) in tong-in to made of metals and plastics with Surface: The ENDE Drolainp of Lapiaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter the Industry. The ERDE Groump - aspirity length. The Instruments are provided non-sterile (O.D.) and a o to him (The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).
Intended Use:
The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general The CNDE Drolanip - Open and Limblogical, and thoracic procedures where fusion of vessels surgery, laparoooople, gynoevices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar will in the jawe of the in the vessels placed between the jaws of the instrument.
The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE The ERDE Siolamp - Open one Espail System having an Optional Bipolar Mode/ BiClamp™
1
Page 2 of 2
510K SUMMARY
upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.
The indications for use with Open Instruments include: general surgery, gynecologic, urological, The Indications for use with Open mother including the more is performed including such and thoracic procedures where rasion of research and abdominal), Nissen procedures - ac - besiolysis (lysis of adhesions), oophorectomy, etc.
The indications for use with Laparoscopic Instruments include: all laparoscopic procedures The Midtations Tor use with Euparooosplo mot threacic surgery) where fusion of vessels or (including gynecologic, general, arongisures as bowel resections, hysterectornies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen (both vaginal and esiolysis (lysis of adhesions), oophorectomy, etc.
CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, CAO HON. Vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterlization/tubal coagulation for sterilization purposes.
Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):
Similarities
The ERBE BiClamp™ Open Instruments have similar physical and dimensional characteristics as the predicate devices. They have the same basic technological onaracteristics and the intended use is the same. There are no changes to the ERBE BiClamp™ Laparoscopic Instruments.
Differences within this 510(k)
The ERBE BiClamp™ Open Instruments are different in that the jaws have a sealed ceramic coating around the outside jaw area. This new coating around the outside of the jaws gives the instrument a greater resistance to hospital cleaning and sterilization techniques. The jaw area has the greatest susceptibility to wear due to the removal of blood and tissue. There are no changes to the ERBE BiClamp™ Laparoscopic Instruments.
All the instrument design changes have been verified or validated in design control by ERBE Elektromedizin GmbH.
Conclusion:
The ERBE BiClamp™ Open and Laparoscopic Instruments have the same intended use, prio into of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k).
The ERBE BiClamp™ Open Instruments differ only in that they have a sealed ceramic coating around the outside of the jaw area that has a greater durability with regards to cleaning and sterilization.
In conclusion, there are no issues with the ERBE BiClamp™ Open and Laparoscopic Instruments that would raise additional safety or efficacy issues when compared to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the United States Department of Health and Human Services. The seal features an abstract design of an eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2006
ERBE USA, Inc. c/o Ms. Julie Stephens Consultant Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K060170
K000170
Trade/Device Name: ERBE BiClamp™ Open and Laproscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 20, 2006 Received: January 25, 2006
Dear Ms. Stephens:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) premeined is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosule) to regally manatise promotive provide Americal posice American Carlos Free de Frys commence prof to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the devices, belyer to the general controls provisions of tactice, 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 such additional controls. Existing major regulations affecting your device It may be subject to such additional control - Lines 800 to 898. In addition, FDA can be found in the Court of Features concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT 3 issuality to rour device complies with other requirements of the Act that I DA has made a acternmadations administered by other Federal agencies. You must of any I cueral statutes and regulations as annuding, but not limited to: registration and listing (21 Comply with an the Act 31equirements) neart 801 ); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200) 1050 fornit in the quality bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Stephens
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hankemig your artial equivalence of your device to a 'cegally premarket notification. "The I DA Intuing of bassification 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 80) ), please If you desire specific advice for your de rice on on one see note the regulation entitled, Contact the Office of Comphance at (21 CFR Part 807.97). You may able in the of Small "Misoranding by Teleficate to premaince notifications of the Act from the Division of Small other general information on your responsentation at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Prosideri/industry/support/industry/support/index.html.
Sincerely yours,
Sincerely yours,
C. Huck N. Mcllwee, III
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K Obol 70
Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments
Indications For Use:
The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 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 ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.
The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.
CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc .; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number.