(44 days)
No
The device description and performance studies focus on the electrical and mechanical properties of cables for electrosurgery, with no mention of AI or ML technologies.
No
The device is a cable that conducts electrical power to an electrosurgical instrument, which then performs the therapeutic action. The cable itself is not performing a therapeutic function on the patient.
No
The device, a monopolar cable for electrosurgery, is designed to conduct electrical power for surgical procedures (cutting, coagulation), not to diagnose medical conditions.
No
The device description clearly states it is a physical cable designed to conduct electrical power, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct electrical power from an electrosurgical generator to an instrument for surgical procedures. This is a therapeutic/surgical function, not a diagnostic one performed on in vitro samples.
- Device Description: The description reinforces its role in electrosurgery, a surgical technique.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived 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
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.
Product codes
GEI
Device Description
Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie 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 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 IEC 60601 and IEC 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 sterility 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)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the first profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Güenter Bissinger Medizintechnik GmbH Matthias Bissinger Managing Director Hans-Theisen-Straße 1 79331 Teningen Baden-Wuerttemberg Germany
Re: K150024
Trade/Device Name: Monopolar Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 1, 2014 Received: January 7, 2015
Dear Mr. Bissinger:
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
1
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.
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/Resourcesfor You/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
2
Indications for Use
510(k) Number (if known) K150024 I
Device Name Monopolar Cables
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Bissinger. The logo features a stylized letter 'b' in red, with the center of the 'b' forming the pupil of an eye. Below the eye is the word 'bissinger' in lowercase, with a line underneath the 'er' at the end of the word.
K
VOLUME 006
510(k) Summary
DATE OF APPLICATION: 2014-12-01
| APPLICANT: | Guenter Bissinger Medizintechnik GmbH
Hans-Theisen-Str. 1,
D-79331 Teningen ,
Germany
Tel.: +1.603.570.2039
Fax: +1.603.570.2055
E-Mail: info@bissinger.com
Internet: www.bissinger.com |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Matthias Bissinger
Tel.: +49.7461 914330
E-Mail: bissinger@bissinger.com |
4
Image /page/4/Picture/0 description: The image shows a logo for "bissinger". The logo features a stylized letter "b" in red, with a white outline resembling an eye around it. Below the "b", the word "bissinger" is written in a smaller, black, sans-serif font.
1. Device Name
| Product code: | GEI |
|---|---|
| Trade Names: | Bissinger Monopolar Cables |
| Common Name: | electrosurgical, cutting & coagulation & accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
Classification Product Code / Subsequent Code 2.
2.1. Product Code
| Device | Medical
Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|-------------------------------------------------------------------------|----------------------|--------------------------------|--------------|--------------|-------------------|
| Electrosurgical cutting
and coagulation de-
vice and accessories. | Part 878 | General & Plastic Sur-
gery | GEI | 2 | 878.4400 |
Predicate Device 3.
Bissinger's Monopolar Cables are substantially equivalent to the following predicate devices, already cleared by the FDA:
| Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|
| Hans Hermann Laparoscopes and | ||
| Accessories | K051610 | HANS HERMANN GMBH |
| Suffer Electrosurgical Cables | K073450 | Suffer Medizintechnik GmbH |
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Image /page/5/Picture/0 description: The image shows a logo for Bissinger. The logo features a stylized letter 'b' that is shaped like an eye, with a dark red iris and a black pupil. The word 'bissinger' is written in lowercase letters below the eye-shaped 'b'. The font is simple and modern, and the overall design is clean and eye-catching.
Description of the Device 4.
Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
Indications for Use 5.
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 6.
| | NEW DEVICE | Predicate Device 1 | Predicate Device 2 | Reference DEVICE | RE-
SULT |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 510(k)
Submitter/
Holder | Bissinger Medizintechnik
GmbH | HANS HERMANN
GMBH | Sutter Medizintechnik
GmbH | Jarit Surgical Instru-
ments Inc. | NA |
| Trade
Name | Bissinger Monopolar
Cables | Hans Hermann Lapa-
roscopes and acces-
sories | Sutter Electrosurgical
Cables | Unipolar Endoscopic
Coagulator-cutter and
Accessories | NA |
| Device | Bissinger Monopolar
Cables | Laparoscopes | Sutter Electrosurgical
Cables | JARIT SURGICAL
INSTRUMENTS | NA |
| 510(k)
Number | | K051610 | K073450 | K932456 | NA |
| Intended
use | Cables for electrosur-
gery are designed to
conduct electrical power
from the output of a
high-frequency electro-
surgical generator to the
electrosurgical
instru-
ment.
Do not exceed a maxi-
mum output of 6250 Vp
of your generator. | The Laparosopes and
accessories are
intended for use in
providing access to
and visualization of
body cavities, organs,
and canals to perform
various diagnostic
and therapeutic
surgical procedures.
The arthroscope is
indicated for illumina-
tion during joint ex-
aminations, arthros-
copies, biopsies an (
diagnosis of joint
disease in minimally
invasive procedures
of the knee, shoulder,
wrist (carpal tunnel
syndrome), temporal
mandibular joint,
ankle and elbow. The
bipolar electrodes are
use to coagulate and
to remove or destroy
tissue by the use of
bipolar HF current. | To electrically con-
nect monopolar
/bipolar electrosurgi-
cal instruments to an
electrosurgical gen-
erator. | For use by, or as di-
rected by, a surgeon in
endoscopic surgery.For
use in
endoscopic
surgery. For use when a
rigid endoscopic instru-
ment for grasping
and/or dissecting if soft
tissue is determined to
be appropriate by the
surgeon.
Monopolar
electrosurgical current
can be used for coagu-
lation and/or cutting as
determined necessary
and appropriate by the
surgeon. | Sub-
stan-
tial
Equiv-
alent |
| Type | Monopolar Cable | Monopolar silicone
Cables | Monopolar silicone
Cables | Jarit 600-290 | Sub-
stan-
tialEqu
ivalent |
6
Image /page/6/Picture/0 description: The image shows a logo with the word "bissinger" in lowercase letters. Above the word is a stylized graphic that combines the letter "b" with an eye. The "b" is colored in a dark red, and the eye is outlined in black with a black pupil. The word "bissinger" is in a simple, sans-serif font.
Monoplar Cables
Page 4 of 5
| | NEW DEVICE | Predicate Device 1 | Predicate Device 2 | Reference DEVICE | RE-
SULT |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Design | Length: 3,080 m.
Socket: Ø 4 mm
Plug Ø 8 mm
Connection: Bovie | Length: 3 m,
Connector: 4 mm
Connection: Erbe,
Martin, Berchtold, | Length: 3.5 mtr, 4,5
mtr. Connector: 4 mm
Connection:
Val-
leylab,
Conmed,
Bovie, Bowa, Erbe, K.
Storz, R. Wolf, Martin,
Berchtold, Aesculap | Length: 3,080 m.
Socket: Ø 4 mm
Plug Ø 8 mm
Connection: Bovie | Sub-
stan-
tialEqu
ivalent |
| Materials /
Biocom-
patibility | Material: Silicon
Cables do not have
direct contact with the
human body or only with
uninjured skin, so that
biocompatibility must not
be evaluated. | Silicon | Silicon | Silicon | Sub-
stan-
tialequ
iva-
lenrt |
| Sterility | Reusable
Instruments.
Delivery non sterile.
The instruments must be
sterilized in moist heat
(Autoclave).
Pre-vacuum Cycle
- Temperature: 132°C
- Exposure time: 4 min.
- Drying time: at least 20
min. | Reusable
Instru-
ments. Delivery non
sterile.
The instruments must
be sterilized in moist
heat
(Autoclave).
Pre-vacuum Cycle - Temperature:
132°C, max 137°C - Exposure time: 3
min. - Drying time: at least
10 min. | Sutter Electrosurgical
Cables are supplied
non-sterile and can
be reused after clean-
ing and steam sterili-
zation.
Steam-sterilize in the
autoclave in accord-
ance with DIN EN
13060 / DIN EN 285.
Fractioned
pre-
vacuum sterilization:
Temperature 134 °C
(273 °F), 3 minutes;
max.
Temperature
138 °C (280 °F),
max. duration
20
minutes. | Similar: Reusable In-
struments | Sub-
stan-
tialEqu
ivalent |
| Compati-
bility with
environ-
ment and
other
devices | Generators: Bovie | Generators: Erbe,
Martin, Berchtold, | Generators: Erbe,
Martin, Valleylab,
Conmed, Berchtold,
Bowie, Bowa, Aescu-
lap | Generators: Bovie | Sub-
stan-
tialEqu
ivalent |
| Standards
met | IEC 60601-2-2: 2009 | IEC 60601-2-2:2009 | IEC 60601-2-2:2007 | IEC 60601-2-2:2009 | Sub-
stan-
tialEqu
ivalent |
| Energy
applied | Power maxima 6.250 Vp | Power maxima 6.250
Vp | Maximum Monopolar
cablesVoltage 10000
Vpp | Power maxima 6.250
Vp | Sub-
stan-
tialEqu
ivalent |
7. Testing
Testing in order to proof safety and effectiveness of Bissinger's Monopolar Cables has been performed according to recognized consensus Standards and results are conforming to the respective requirements.
Electrical Safety 7.1.
The devices subject to this submission have been tested according to the requirements of IEC 60601 and IEC 60601-2-2:2009.
7
7.2. Sterilization
The sterilization process has been validated under consideration of recognized standards. Testing shows that the Products can be steam sterilized with a sufficient sterility assurance level by use of standard sterilization parameters.
7.3. Reprocessing
Reprocessability was tested and validated under consideration of recognized standards.
7.4. Manual cleaning
Manual cleaning validation was performed under consideration of recognized standards.
8. Biocompatibility
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.
Substantial Equivalence Summary / Conclusion 9.
Based on available 510(k) information provided herein, Bissinger Monopolar Cables are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.
There are no differences between the devices which would raise new issues of safety or effectiveness.