(79 days)
Not Found
No
The device description and performance studies focus on the electrical and mechanical properties of monopolar forceps and cables, with no mention of AI or ML.
Yes
The device is used to coagulate tissue, which is a therapeutic intervention aimed at treating medical conditions or alleviating symptoms.
No
The device is described as monopolar forceps and cables used for grasping, dissecting, and coagulating tissue in surgical applications, connected to an electrosurgical generator. Its function is to perform therapeutic actions (cutting, coagulation) rather than to acquire or analyze information for diagnosis.
No
The device description clearly states that the device is comprised of physical components (monopolar forceps and cables) used to conduct electrical power for surgical procedures. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "grasp, dissect and coagulate tissue" using electrical energy from an electrosurgical generator. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces the surgical application, mentioning grasping, dressing, and coagulating of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue samples) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation.
Do not exceed a maximum output of 2000 Vp of your generator.
Product codes
GEI
Device Description
Bissinger's Monopolar Forceps are used in various surgical applications. Therefore they are varying in size and build-up, though the general principle remains unchanged.
By using the firmly attached connecting cable, the monopolar forceps can be connected to high-frequency electrosurgical generators.
Monopolar Forceps are used for grasping, dressing and coagulating of tissue. They must be connected to a monopolar output of a high frequency generator by using the attached monopolar cable. The application of monopolar current and connection with a neutral electrode is mandatory.
Bissinger's monopolar forceps either have a straight or bayonet-shaped handle. They are equipped with a firmly attached connecting cable with dual spring connector.
Bissinger Cables are a line of non-sterile, reusable Monopolar Cables fitting Erbe, Martin, Berchtold, Bovie, Valleylab, Codmann Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
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)
Testing in order to proof safety and effectiveness of Bissinger's Monopolar Forceps and Cables has been performed according to recognized consensus Standards and results are conforming to the respective requirements.
Electrical Safety: The devices subject to this submission have been tested according to the requirements of EN 6061-1:2006 and EN 60601-2-2:2009.
Sterilization: The sterilization process has been validated under consideration of recognized standards. Testing shows that the Products can be steam sterilized with a sufficient sterlity assurance level by use of standard sterilization parameters.
Reprocessing: Reprocessability was tested and validated under consideration of recognized standards.
Manual cleaning: Manual cleaning validation was performed under consideration of recognized standards.
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.
K101080, K072124, K111262, K073450
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. Above the profiles is a curved line that resembles a wing or a stylized wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2015
Medagent Incorporated Mr. Frank Menean Managing Director 112 Corporate Drive, Unit 1 Portsmouth, New Hampshire 03801
Re: K143662
Trade/Device Name: Bissinger Monopolar Forceps and Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 25, 2014 Received: December 23, 2014
Dear Mr. Menean:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the word "MEDAGENT" in a stylized font, with the letters "ME" in black and the letters "AGENT" in gray. The word is enclosed in parentheses, with the left parenthesis in gray and the right parenthesis in gray. Below the word "MEDAGENT" are the words "Individual · Cooperative · Efficient" in a smaller font.
Indications for Use Statement
510(k) Number: K143622
Device Name: Monopolar Forceps
Indications for Use:
The monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation.
Do not exceed a maximum output of 2000 Vp of your generator.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use _____________ (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the logo for MEDAGENT. The word "MEDAGENT" is written in a combination of black and gray letters, with the "MED" in black and the "AGENT" in gray. Below the logo, the words "Individual · Cooperative · Efficient" are written in a smaller font.
... Kok ' ** &
VOLUME 006
510(k) Summary
DATE OF APPLICATION: 2014-01-07
Type of 510(K) submission: Traditional 510(K) submission
APPLICANT: MEDAGENT Inc. 112 Corporate Drive, Unit 1 Portsmouth, NH 03801 USA Tel.: +1.603.570.2039 Fax: +1.603.570.2055 E-Mail: mail@medagent-usa.com Internet: www.medagent-usa.com Establishment Registration Number: 3007219401
- CONTACT PERSON: Franz Menean Tel.: +49.7463.9954.0 E-Mail: franz.menean@medagent.de
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Image /page/4/Picture/1 description: The image shows the logo for MEDAGENT. The word "MEDAGENT" is written in bold, gray letters, and it is surrounded by parentheses. Below the word, the words "Individual," "Cooperative," and "Efficient" are written in a smaller font, separated by dots.
Device Name 1.
| Trade Names: | Bissinger Monopolar Forceps and Cables |
|---|---|
| Common Name: | Monopolar Instruments and Accessoires |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories. |
Classification Product Code / Subsequent Code 2.
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|------------------------------------------|----------------------|------------------------------|--------------|--------------|-------------------|
| Monopolar Instruments
and Accessoires | Part 878 | General & Plastic
Surgery | GEI | 2 | 878.4400 |
3. Prior Submissions
There have been no prior submissions of the subject devices so far.
Predicate Device 4.
Bissinger's Monopolar Forceps and Cables are substantially equivalent to the following predicate devices, already cleared by the FDA:
| Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|
| EGON FAULHABER Bipolar Forceps, Non | ||
| Stick Bipolar Forceps and Monopolar For- | ||
| ceps | K101080 | EGON FAULHABER Surgical Instruments Pinzetten |
| Black and Black Electrosurgical Cutting and | ||
| Coagulation Forceps and Electrodes | K072124 | Black & Black surgical Inc. |
| Olsen Medical Electrosurqical Ca- | ||
| ble/Adapters | K111262 | Olsen Medical |
| Suffer Electrosurqical Cables | K073450 | Suffer Medizintechnik GmbH |
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Image /page/5/Picture/1 description: The image shows the word "MEDAGENT" in a stylized font, enclosed in parentheses. The first three letters, "MED", are in black, while the last four letters, "AGENT", are in gray. Below the word, there are three words separated by dots: "Individual", "Cooperative", and "Efficient". The words are in a smaller font size than "MEDAGENT". The overall design appears to be a logo or branding element.
Description of the Device 5.
Bissinger's Monopolar Forceps are used in various surgical applications. Therefore they are varying in size and build-up, though the general principle remains unchanged.
By using the firmly attached connecting cable, the monopolar forceps can be connected to high-frequency electrosurgical generators.
Monopolar Forceps 5.1.
Monopolar Forceps are used for grasping, dressing and coagulating of tissue. They must be connected to a monopolar output of a high frequency generator by using the attached monopolar cable. The application of monopolar current and connection with a neutral electrode is mandatory.
Bissinger's monopolar forceps either have a straight or bayonet-shaped handle. They are equipped with a firmly attached connecting cable with dual spring connector.
Monopolar Cables 5.2.
Bissinger Cables are a line of non-sterile, reusable Monopolar Cables fitting Erbe, Martin, Berchtold, Bovie, Valleylab, Codmann Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
Indications for Use 6.
6.1. Monopolar Forceps
The monopolar forceps and clamps are designed to grasp, dissect and coagulate tissue. They must be connected to the monopolar output of an electrosurgical generator and must only be used with parameters for monopolar coagulation.
Do not exceed a maximum output of 2000 Vp of your generator
6.2. .Monopolar Cables
Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument.
Do not exceed a maximum output of 6250 Vp of your generator.
Technological Characteristics 7.
The technological characteristics of Bissinger's Forceps and Cables are identical or substantial equivalent as the previously cleared predicate devices stated in section 4 in terms of design, dimensions, intended use and materials.
8. Testing
Testing in order to proof safety and effectiveness of Bissinger's Monopolar Forceps and Cables has been performed according to recognized consensus Standards and results are conforming to the respective requirements.
8.1. Electrical Safety
The devices subject to this submission have been tested according to the requirements of EN 6061-1:2006 and EN 60601-2-2:2009.
001 510K Summary v.4
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Image /page/6/Picture/1 description: The image shows the logo for MEDAGENT. The word "MEDAGENT" is written in a sans-serif font, with the "MED" portion in black and the "AGENT" portion in gray. The word is enclosed in parentheses. Below the word, the words "Individual · Cooperative · Efficient" are written in a smaller font.
8.2. Sterilization
The sterilization process has been validated under consideration of recognized standards. Testing shows that the Products can be steam sterilized with a sufficient sterlity assurance level by use of standard sterilization parameters.
8.3. Reprocessing
Reprocessability was tested and validated under consideration of recognized standards.
Manual cleaning 8.4.
Manual cleaning validation was performed under consideration of recognized standards.
Biocompatibility 9.
All requirements of biocompatibility are met through the composition of the used materials which demonstrate the appropriate levels of biocompatibility for its clinical use. The used materials are also used in many other medical devices and have an established history of safe use and biocompatibility outlined in ISO 10993-1.
10. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, Bissinger's Monopolar Forceps and Cables are considered substantial equivalent to the predicate devices in terms of indications for use, material, technoloqy, design and performance specifications.
There are no differences between the devices which would raise new issues of safety or effectiveness.