(241 days)
Not Found
No
The description focuses on the electrosurgical function and physical characteristics of the forceps, with no mention of AI or ML.
No
The device is described as an electrosurgical tool intended to remove tissue and control bleeding, which are surgical functions rather than therapeutic ones aimed at treating a disease or condition.
No
The device's intended use is to remove tissue and control bleeding, which are interventional/therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a physical tool (forceps) with different handles and tip designs, intended for surgical procedures, and requires sterilization. It also mentions electrical safety testing according to hardware standards (IEC 60601-1 and IEC 60601-2-2). There is no mention of software as the primary or sole 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 "remove tissue and control bleeding." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "electrosurgical tool" used with an "electrosurgical generator." This further confirms its use in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of these samples.
The device is clearly intended for direct surgical intervention on a patient, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.
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)
Verification and validation results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate device K150959.
Biocompatibility: The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity. The evaluation proofs the biological safety of the Bipolar Micro-Coagulation Forceps.
Electrical Safety: The Bipolar Micro-Coagulation Forceps has been tested according to IEC 60601-1 and IEC 60601-2-2. The test setup included: Mechanical stability, Insulation of active equipment, High frequency leakage current, High frequency electrical strength, Power frequency (50 Hz). The device had passed all performed tests.
Sterilization and Shelf Life: The devices are supplied in non-sterile condition and have to be cleaned prior to the first and every further use. A cleaning procedure as well as a sterilization procedure have been validated.
Thermal Effects on Tissue: To evaluate the thermal effects on tissue a comparison the Bipolar Micro-Coagulation forceps of Bissinger and the predicate device was performed. Three different tissue types were used. Each tissue type was tested with different power settings. Afterwards the thermal damage was analyzed. The comparison of the two devices showed that they are both substantially equivalent. Their functions and characteristics did not display any major difference throughout the tests.
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
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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
April 5. 2018
Gunter Bissinger Medizintechnik GmbH Mr. Matthias Bissinger CEO Hans-Theisen-Str. 1 D-79331 Teningen, DE Baden-Wurttemberg, Germany
Re: K172368
Trade/Device Name: Bipolar Micro-Coagulation Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 2, 2018 Received: March 12, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
Page 2 - Mr. Bissinger
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172368
Device Name Bipolar Micro-Coagulation Forceps
Indications for Use (Describe)
Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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Image /page/3/Picture/0 description: The image shows the logo for Bissinger. The logo features a stylized letter 'b' in red, with an eye incorporated into the design. Below the symbol, the word 'bissinger' is written in a simple, sans-serif font.
510(k) Notification
K172368
510(k) Summary
DATE OF APPLICATION: 2017-08-04
| APPLICANT: | Günter Bissinger Medizintechnik GmbH
Hans-Theisen-Str. 1
D-79331 Teningen
Germany
Tel.: +49 7641 914330
Fax: +49 7641 9143333
E-Mail: info@bissinger.com
Internet: www.bissinger.com |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Matthias Bissinger
Managing Director
Tel.: +49 7461 914330
E-Mail: bissinger@bissinger.com |
| CONTACT PERSON: | Maria Goertz
Quality Management Representative
Tel.: +49 7461 91433210
E-Mail: m.goertz@bissinger.com |
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Image /page/4/Picture/0 description: The image shows a logo for a company called "bissinger". The logo features a stylized lowercase "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 company name "bissinger" in a simple, sans-serif font.
510(k) Notification
1. Device Name
| Product code: | GEI |
|---|---|
| Trade Names: | Bipolar Micro-Coagulation Forceps |
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
2. Classification Product Code / Subsequent Code
Bipolar Micro-Coagulation Forceps can be classified according to following device name and product code
| Device | Medical Specialty | Review Panel | Product Code | Device Class | Regulation Number |
|---|---|---|---|---|---|
| Electrosurgical, | |||||
| Cutting & Coagula- | |||||
| tion & Accessories | General & Plastic | ||||
| Surgery | General & Plastic | ||||
| Surgery | GEI | 2 | 878.4400 |
Prior Submissions 3.
There have been no prior submissions of the subject devices so far.
4. Predicate Device
| Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|
| Sutter Bipolar Forceps - Calvian | K150959 | Sutter Medizintechnik GmbH |
Device Description 5.
Bipolar Micro-Coagulation Forceps are electrosurgical tools available with different handles and different tip designs. The Bipolar Micro-Coagulation Forceps can be connected through an appropriate bipolar cable to an electrosurgical generator. The Bipolar Micro-Coagulation Forceps can be disassembled for cleaning and sterilization. The Bipolar Micro-Coagulation Forceps are delivered in unsterile condition and have to be sterilized prior to each use.
6. Indications for Use
The Bipolar Micro-Coaqulation Forceps are intended to remove tissue and control bleeding.
Technological Characteristics 7.
The technological characteristics of our Bipolar Micro-Coagulation Forceps are the same as the technological characteristics of the predicate device.
7.1. Device characteristics table
| Company | Günter Bissinger Medizin-
technik GmbH | Sutter Medizintechnik GmbH | Result |
|--------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------|
| Device Name | Bipolar Micro-Coagulation For-
ceps | Sutter Bipolar Forceps - Calvian | - |
| Regulation Number | 878.4400 | 878.4400 | Substantially Equivalent |
| Code | GEI | GEI | Substantially Equivalent |
| Class | II | II | Substantially Equivalent |
| 510(k) number | - | K150959 | - |
| Indication for Use | Bipolar Micro-Coagulation For-
ceps are intended to remove
tissue and control bleeding | Sutter Bipolar Forceps - Calvian
are intended to remove tissue
and control bleeding | Substantially Equivalent |
| Prescription / OTC | Prescription | Prescription | Substantially Equivalent |
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Bipolar Micro-Coagulation Forceps
| Company | Günter Bissinger Medizin-
technik GmbH | Sutter Medizintechnik GmbH | Result |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Device Design | Bipolar Micro-Coagulation For-
ceps are electrosurgical tools
available with different handles
and different tip designs. | Sutter Bipolar Forceps - Calvian
is an electrosurgical tool availa-
ble in different handle styles and
tip sizes. | Substantially Equivalent |
| Material | Stainless Steel
Plastic Material | Stainless Steel
Plastic Material | Substantially Equivalent |
| Tip size [mm] | 0.35 – 2.8 | 0.7 - 2.5 | Substantially Equivalent |
| Shaft Length [mm] | 15 | 18 | Substantially Equivalent |
| HF-mode | bipolar | bipolar | Substantially Equivalent |
| Maximum peak voltage [Vp] | 300 | 500 | Substantially Equivalent |
| Delivered Condition | unsterile | unsterile | Substantially Equivalent |
| single use | no | no | Substantially Equivalent |
| Meets IEC 60601-2-2 | yes | yes | Substantially Equivalent |
7.2. Summary of technological characteristics
The proposed device is similar in terms of design, operating principles and intended use and has similar technological characteristics as the predicate devices are bipolar forceps with the same intended use. Both devices are available with different handles and different tip sizes. They are both reusable devices which are delivered in unsterile condition. The subjected device as well as the predicate devices meet the requirements of IEC 60601-2-2.
8. Performance Data
Verification and validation results demonstrate that the device performs as intended and that the device is substantially equivalent to the predicate device K150959.
8.1. Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity ■
- . Sensitization
- I Irritation or Intracutaneous Reactivity
The evaluation proofs the biological safety of the Bipolar Micro-Coagulation Forceps.
Electrical Safety 8.2.
The Bipolar Micro-Coagulation Forceps has been tested according to IEC 60601-1 and IEC 60601-2-2. The test setup included:
- Mechanical stability
- l Insulation of active equipment
- I High frequency leakage current
- l High frequency electrical strength
- I Power frequency (50 Hz)
The device had passed all performed tests.
8.3. Sterilization and Shelf Life
The devices are supplied in non-sterile condition and have to be cleaned prior to the first and every further use. A cleaning procedure as well as a sterilization procedure have been validated.
6
Image /page/6/Picture/0 description: The image shows the logo for Bissinger. The logo features a stylized red letter 'b' with an eye shape incorporated into its design. Below the symbol, the word "bissinger" is written in a simple, sans-serif font.
Bipolar Micro-Coagulation Forceps
8.4. Thermal Effects on Tissue
To evaluate the thermal effects on tissue a comparison the Bipolar Micro-Coagulation forceps of Bissinger and the predicate device was performed. Three different tissue types were used. Each tissue type was tested with different power settings. Afterwards the thermal damage was analyzed.
The comparison of the two devices showed that they are both substantially equivalent. Their functions and characteristics did not display any major difference throughout the tests.
9. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, Bipolar Micro-Coagulation Forceps are considered substantially equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications. The performed tests show that the subjected device is in compliance with the applicable recognized standards. Performed comparison testing with the predicate device shows substantial equivalence to the FDA-cleared predicate device Sutter Bipolar Forceps – Calvian.
There are no differences between the devices which would raise new issues of safety or effectiveness. The Bipolar Micro-Coagulation Forceps is substantially equivalent to predicate device Sutter Bipolar Forceps - Calvian cleared under 510(k) #K150959