(421 days)
Not Found
No
The summary describes a standard bipolar forceps for grasping, dissection, and coagulation, with no mention of AI or ML capabilities. The performance studies are based on electrical safety and compatibility standards, not AI/ML performance metrics.
No
The device is used for grasping, dissection, and coagulation of tissues, which are surgical procedures, not therapeutic treatments.
No.
The document states that the device is used for grasping, dissection, and coagulation of biological tissues, which are interventional procedures, not diagnostic ones. It does not mention any function for identifying or characterizing diseases or conditions.
No
The device description clearly states it is a physical instrument (forceps) used for grasping, dissection, and coagulation, and it connects to an HF generator. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "grasping, dissection and coagulation of biological tissues." This describes a surgical or therapeutic procedure performed directly on the patient's body.
- Mechanism of Action: The device is connected to an HF generator to apply energy for coagulation. This is a physical intervention on tissue.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This device does not perform such tests.
The description clearly indicates a surgical instrument used for direct manipulation and treatment of tissue within the body, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator.
Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.
Product codes
GEI
Device Description
SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biological tissues
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
11/17/2022
Guenter Bissinger Medizintechnik GmbH Matthias Bissinger Managaing Director Hans-Theisen-Str. 1 Teningen, Baden-Wurttemberg 79331 Germany
Re: K213042
Trade/Device Name: Supra Non-Stick Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 14, 2022 Received: October 20, 2022
Dear Matthias 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr-S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name SUPRA Non-Stick Bipolar Forceps
Indications for Use (Describe)
The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator.
Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.
Type of Use (Select one or both, as applicable)
| Remediation Use (21 CFR 201.561 Subject to) | Over-The-Counter Use (21 CFR 201.66 Subject to) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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Image /page/3/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized red letter 'b' with an eye incorporated into its design. The word 'bissinger' is written in black below the symbol.
DATE OF APPLICATION:
16.09.2021
APPLICANT:
Guenter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 D-79331 Teningen Germany Tel: + 49 7641 914330 Fax: +49 7641 9143333 E-Mail: info@bissinger.com
CONTACT PERSON:
Matthias Bissinger Managing Director Tel.: +49 7461 914330 E-Mail: bissinger@bissinger.com
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Image /page/4/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized letter 'b' in red, with the upper part of the 'b' forming the outline of an eye. The pupil of the eye is black. Below the eye is the word 'bissinger' in black, lowercase letters.
ਹ Device Name
| Trade Name: | SUPRA Non-Stick Bipolar Forceps |
|---|---|
| Common Name: | Bipolar Forceps |
| Device Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
2 Classification / Product Code
SUPRA Non-Stick Bipolar Forceps can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review Panel | Product Code | Regulation
Number | Device
Classification |
|---------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------|------------------------------|--------------|----------------------|--------------------------|
| Electrosurgical,
Cutting &
Coagulation &
Accessories | Electrosurgical
cutting and
coagulation
device and
accessories | General & Plastic
Surgery | General & Plastic
Surgery | GEI | 878.440 | 2 |
ఆ Predicate Device / Reference Device
| Device | Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|---|
| SUPRA Non-Stick Bipolar Forceps | Claris Non-Stick Bipolar Forceps | K051429 | Günter Bissinger |
| Medizintechnik GmbH |
4 Device Description
SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.
5 Intended Use
The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected – with the appropriate cable to the bipolar output of an HF generator.
Contraindication:
Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.
б Technological Characteristics
The technological characteristics of SUPRA Non-Stick Bipolar Forceps are the technological characteristics of the predicate device.
6.1 Device Characteristics Table
| Company | Günter Bissinger Medizintechnik
GmbH
(New Device) | Günter Bissinger Medizintechnik
GmbH
(Predicate Device) | Result |
|-------------------|---------------------------------------------------------|---------------------------------------------------------------|--------|
| Device Name | SUPRA Non-Stick Bipolar Forceps | Claris Non-Stick Bipolar Forceps | -- |
| Regulation Number | 878.440 | 878.440 | -- |
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Image /page/5/Picture/2 description: The image shows the logo for Bissinger. The logo features a stylized red letter "b" with an eye in the upper portion of the letter. Below the "b" is the word "bissinger" in a sans-serif font. The logo is simple and modern.
| Company | Günter Bissinger Medizintechnik
GmbH
(New Device) | Günter Bissinger Medizintechnik
GmbH
(Predicate Device) | Result |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Class | II | II | Substantially Equivalent |
| Code | GEI | GEI | Substantially Equivalent |
| 510(k) number | --- | K051429 | --- |
| Indication for Use | The Bissinger SUPRA Non-Stick
Bipolar Forceps are used for
grasping, dissection and
coagulation of biological tissues.
The fully assembled instrument (if
assembly is needed) has to be
connected - with the appropriate
cable - to the bipolar output of an
HF generator.
Supra Non-Stick Bipolar Forceps
may not be used for tubal
sterilization or tubal coagulation. | The Bissinger CLARIS Non-Stick
bipolar forceps are designed to
grasp, manipulate and coagulate
selected tissue. It is to be
connected through a suitable
bipolar cable with the bipolar
output of an electro-surgical
generator. Bipolar For-ceps must
only be used with bipolar
coagulation current.
The Bissinger CLARIS Non-Stick
bipolar forceps has not been shown
to be effective
for tubal sterilization or tubal
coagulation for sterilization
procedures and should not be
used for these procedures. | Substantially Equivalent |
| Prescription / OTC | Prescription | Prescription | Substantially Equivalent |
| Device Design | Insulated forceps with plug | Insulated forceps with plug | Substantially Equivalent |
| Tip Size [mm] | 0.5-1.5 | 0.25-2.0 | Substantially Equivalent |
| Shaft Length [mm] | 101-229 | 110-240 | Substantially Equivalent |
| HF Mode | Bipolar | Bipolar | Substantially Equivalent |
| Maximum peak voltage [Vp] | Ref. no. 91511106: 300
Ref. no. 906xxxxx, 91512601: 500 | 300 | Substantially Equivalent |
| Delivered condition | Sterile | Unsterile | Substantially Equivalent |
| Single use | Yes | No | Substantially Equivalent |
| Materials | Stainless Steel
Plastic Material
Ag800 | Stainless Steel
Plastic Material
Ag800 | Substantially Equivalent |
Summary of Technological Characteristics 6.2
The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.
7 Sterilization and Shelf Life
The product is delivered in sterile condition. No treatment is required prior to its shelf life is 5 years. It is intended for single-use only and as such, is not intended to be reprocessed and sterilized. Appropriate packaging, shelf-life, and sterilization validations were carried out, which prove the sterility of the products.
8 Biocompatibility
The devices have been evaluated concerning their biological safety (according to ISO 10993-1). The material, the manufacturing process, as well as the packaging have been considered within this biological safety evaluation. Based on the evaluation of the material constituents, the devices meet the requirements of ISO 10993-1. The biological safety of the devices is therefore considered to be satisfactory demonstrated.
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Image /page/6/Picture/2 description: The image shows a logo for Bissinger. The logo features a stylized letter 'b' in red, with the loop of the 'b' forming an eye shape. The pupil of the eye is black. Below the eye is the word 'bissinger' in a simple, sans-serif font.
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9 Electrical Safety
Tests according to IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-2 have been performed. The device had passed all performed tests.
10 Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, our SUPRA Non-Stick Bipolar Forceps are considered to be substantially equivalent to the predicate device Claris Non-Stick Bipolar Forceps in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.