(353 days)
Not Found
No
The description focuses on the electrosurgical mechanism and physical characteristics of the instruments, with no mention of AI or ML.
No
Explanation: This device is an instrument used to fuse vessels and tissues during surgical procedures, which is a therapeutic function, but it is not itself a therapeutic device that administers therapy. It is an instrument used in therapy.
No
The device is described as an electrosurgical instrument used for the "fusion of vessels or tissues" through the application of "bipolar electrosurgical RF energy (coagulation)." Its function is therapeutic (to perform a medical procedure), not diagnostic (to identify or characterize a disease or condition). The text consistently refers to its use in performing surgical procedures like "bowel resections, hysterectomies," and "cholecystectomies."
No
The device description clearly states that the ERBE BiClamp™ Open and Laparoscopic Instruments are physical instruments made of stainless steel, metals, and plastics, 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:
- Intended Use: The intended use clearly states the device is for "fusion of vessels or tissues" during surgical procedures. This is a therapeutic/surgical intervention performed directly on the patient's body.
- Device Description: The device description details surgical instruments (clamps) that deliver electrosurgical energy to tissue. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue through energy application.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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), faparoscopic 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 coaqulation for sterilization purposes.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HGI
Device Description
The ERBE BiClamp™ Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ESU) System having the Optional Bipolar Mode, BiClamp. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp" Instruments to coagulate/desiccate tissue. The ERBE BiClamp™ Open Instruments are made of stainless steel with plastic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp'™ Laparoscopic Instruments are made of metals and plastics with the electrical energy isolated to the jaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Open Instruments range in size from 200 mm (7.9 inches) to 270 mm (10.6 inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter (O.D.) and a 340 mm (13.4 inches) working length. The Instruments are provided non-sterile and are reusable (Note: 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
vessels, tissues, bowel, uterus/vagina, gall bladder, ovaries
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
KO33421
510K SUMMARY - Revised August 6, 2004
| Submitted By: | OCT 1 4 2004
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: | K033421 |
| Date Prepared: | August 6, 2004 |
| Common Name: | Bipolar Electrosurgical Open and Laparoscopic Instruments |
| Trade/Proprietary Name: | ERBE BiClamp™ Open and Laparoscopic Instruments |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories
(21CFR878.4400) and Gynecologic electrocautery and
accessories (21 CFR Part 884.4120) |
| Product Code: | GEI and HGI |
| Legally Marketed
Predicate Device: | Valleylab Inc. LigaSure™ Open and Laparoscopic
Instruments 510(k) Number: K981916 |
Device Description:
The ERBE BiClamp™ Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ESU) System having the Optional Bipolar Mode, BiClamp. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp" Instruments to coagulate/desiccate tissue. The ERBE BiClamp™ Open Instruments are made of stainless steel with plastic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp'™ Laparoscopic Instruments are made of metals and plastics with the electrical energy isolated to the jaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Open Instruments range in size from 200 mm (7.9 inches) to 270 mm (10.6 inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter (O.D.) and a 340 mm (13.4 inches) working length. The Instruments are provided non-sterile and are reusable (Note: 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 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.
1
K033421 (pg 2 of 2)
510K SUMMARY - Revised August 6, 2004
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), faparoscopic 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 coaqulation for sterilization purposes.
Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):
Similarities
The ERBE BiClamp™ Open and Laparoscopic Instruments have similar physical and dimensional characteristics as the predicate devices. They have the same basic technological characteristics and the intended use is the same.
Differences
The ERBE BiClamp™ Open and Laparoscopic Instruments are different in that all of the product line components or parts are provided non-sterile and reusable: where as. the electrodes of the predicate's Open Instruments and Laparoscopic Instruments are sterile, single use. The ERBE BiClamp Open and Laparoscopic Instruments do not have closure mechanisms to hold the instrument closed (or clamped), where as, the predicate devices have closure mechanisms.
All the instrument designs 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, principles of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k).
The ERBE BiClamp™ Open and Laparoscopic Instruments differ only in that all the instruments and their parts are reusable and they do not have a closure mechanism to hold the instruments closed.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
OCT 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ERBE USA, Inc. c/o Ms. Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K033421
Trade/Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2004 Received: September 24, 2004
Dear Ms. Stephens:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no ro ro ro row a your 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 for associated in the 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). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are every inions 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 such 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); 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. Julie Stephens
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use - REVISED August 6, 2004
510(k) Number (if known): K033421
Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments
Indications For Use:
The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general The ERDE Dronalip - Opecologic, urological, and thoracic procedures where fusion of vessels surgery, laparoscopies, griesers, and e used on vessels up to 7 mm and bundles as large as of this us is a donrod. The instrument. A vessel fusion is created by the application of bipolar will in in the juve of argy (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 (incrading gracess), bootegory book 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)
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)
uriam C. Phiorrst
Page 1 of 1
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K63342/