SUTTER BIPOLAR FORCEPS - SUPERGLISS

K131012 · Sutter Medizintechnik GmbH · GEI · Aug 23, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131012
• Device Name: SUTTER BIPOLAR FORCEPS - SUPERGLISS
• Applicant: Sutter Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.

Device Story

Sutter Bipolar Forceps - SuperGliss are electrosurgical tweezers used to grasp, manipulate, and coagulate tissue. The device consists of stainless steel branches coated with Polyamide (PA) 11 insulation and silver alloy tips. It connects to an electrosurgical generator via a bipolar cable. Operated by surgeons in clinical settings (e.g., OR), the device delivers bipolar electrical energy to target tissue to achieve coagulation. The device is reusable and requires steam sterilization by the user before each procedure. It provides a mechanical tool for precise tissue handling during various surgical specialties, aiding in hemostasis and tissue management.

Clinical Evidence

Bench testing only. Non-clinical laboratory performance testing was conducted on various meat types to determine coagulation areas for different tip sizes, supported by statistical analysis. Compliance with IEC 60601 series standards was verified.

Technological Characteristics

Electrosurgical bipolar forceps; stainless steel branches; Polyamide (PA) 11 insulation; silver alloy tips; PEEK/stainless steel connectors. Dimensions: 110-280mm length, 0.2-2.5mm tip size. Max peak voltage 500 Vp. Reusable; steam-sterilized by user. Complies with IEC 60601-2-2.

Indications for Use

Indicated for general, orthopaedic, thoracic, neurosurgical, gynaecological (excluding female sterilisation), urological, and ENT surgery for tissue coagulation. Contraindicated for tubal sterilisation or tubal coagulation for sterilisation procedures.

Regulatory Classification

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.

Predicate Devices

• Egon Faulhaber Surgical Instruments Pinzetten, Bipolar, Nonstick bipolar forceps (K101080)
• Guenter Bissinger, Claris Non-Stick Bipolar Forceps (K051429)

Submission Summary (Full Text)

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K131012

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### APPLICANT: SUTTER MEDIZINTECHNIK GMBH AFTERS: SUTTER BIPOLAR FORCEPS - SUPERGLISS

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Section 807.92(c)

| Date:<br>807.92(a)(1) | August 20, 2013 | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Submitter:<br>807.92(a)(1) | Name:<br>Address: | SUTTER MEDIZINTECHNIK GmbH<br>Tullastrasse 87<br>79108 Freiburg<br>Germany | |
| | Managing Director:<br>Telephone:<br>Fax:<br>Contact person:<br>Telephone:<br>E-mail: | Bert Sutter<br>[phone]<br>[phone]<br>Dr. Sabine Klugbauer<br>[phone]<br>[e-mail] | AUG 2 3 2013 |
| Product:<br>807.92(a)(2) | Trade Name:<br>Classification:<br>Common Name:<br>Product Code and<br>Classification Name: | Sutter Bipolar Forceps - SuperGliss<br>Class II; CFR 21 § 878.4400<br>Electrosurgical Instruments and Accessories<br>GEI - Electrosurgical Cutting & Coagulation<br>Device & Accessories | |
| Predicate<br>Device:<br>807.92(a)(3) | Predicate devices to which Sutter Bipolar Forceps SuperGliss are<br>claimed to be substantially equivalent are manufactured by<br>• Egon Faulhaber Surgical Instruments Pinzetten, Bipolar, Nonstick<br>bipolar forceps (K101080)<br>• Guenter Bissinger, Claris Non-Stick Bipolar Forceps (K051429) | | |
| Device<br>Description:<br>807.92(a)(4) | Sutter Bipolar Forceps - SuperGliss is an electrosurgical tool in<br>tweezers configuration with differences in tip size and branches styles.<br>It is constructed with medical grade stainless steel (branches), coated<br>with Polyamid PA 11 as electrical insulator and possesses a tip made of<br>silver alloy that is not insulated. The forceps can be connected through<br>an appropriate bipolar cable with the bipolar output of an electrosurgical<br>generator. As an electrosurgical accessory it is designed to grasp,<br>manipulate and coagulate selected tissue. The maximum peak voltage<br>to use the forceps is 500 Vp. The forceps are provided non-sterile, are<br>reusable and must be sterilized prior initial and subsequent use. | | |
| Intended<br>Use:<br>807.92(a)(5) | Intended Use: Sutter Bipolar Forceps SuperGliss are designed to<br>grasp, manipulate and coagulate selected tissue. They are to be<br>connected to the bipolar output of an electrosurgical generator with an<br>appropriate bipolar cable and must only be used with parameters for<br>bipolar coagulation.<br>Indications: General surgery, Orthopaedic coagulation, Thoracic<br>coagulation, Neurosurgical coagulation, Gynaecological coagulation<br>(except for use in female sterilisation), Urological coagulation, Ear- | | |
| Nose- and Throat coagulation.<br>Contraindications: Sutter Bipolar Forceps SuperGliss have not been<br>shown to be effective for tubal sterilisation or tubal coagulation for<br>sterilisation procedures and should not be used for this purpose. | | | |
| Performance<br>Testing:<br>807.92(b)(1) | Non-clinical laboratory performance testing was done on different types<br>of meat with determination of coagulation areas for various tip sizes and<br>statistical analysis of the results. Bench testing according to standards<br>series IEC 60601 has also been performed. | | |
| Substantial<br>Equivalence:<br>807.92(b)(3) | Comparison of Basic Features, design, testing results and intended<br>uses show that Sutter Bipolar Forceps SuperGliss are substantial<br>equivalent to the predicate devices. | | |
| | Feature | Sutter SuperGliss | Predicate devices<br>K101080/K051429 |
| | Intended Use | As shown above under<br>Intended Use | Same/Same |
| | Branches Style | Straight, angled, bayonet | Same/Same |
| | Dimensions<br>Length [mm]:<br>Tip size [mm]: | 110 - 280<br>0.2 - 2.5 | 110 - 250 / 110 - 240<br>0.25 - 2.0 / 0.25 - 2.0 |
| | Material<br>Tips:<br>Coating:<br>Connector:<br>Branches: | Silver Alloy<br>Polyamide (PA) 11<br>Stainless steel/PEEK<br>Stainless steel | Same/Same |
| | Bipolar | yes | Same/Same |
| | Meets IEC 60601-2-2 | yes | Same/Same |
| | Maximum peak voltage | 500 Vp | Same/Same |
| | Sterility | Non-sterile, reusable | Same/Same |
| | Sterilization method | Steam-sterilisation by user | Same/Same |

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#### APPLICANT: SUTTER MEDIZINTECHNIK GMBH SUTTER BIPOLAR FORCEPS - SUPERGLISS DEVICES:

必,

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is facing right and is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 23, 2013

Sutter Medizintechnik GmbH % Dr. Sabine Klugbauer Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg, Germany

Re: K131012

Trade/Device Name: Sutter Bipolar Forceps - SuperGliss Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagnlation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2013 Received: July 12, 2013

Dear Dr. Klugbauer:

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 docs 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Sabine Klugbauer

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES:

## Indications for Use Form

Indications for Use

K131012 510(k) Number (if known):

Device Name:

Sutter Bipolar Forceps - SuperGliss

Indications for Use:

Intended Use:

Sutter Bipolar Forceps SuperGliss are designed to grasp, manipulate and coagulate selected tissue. They are to be connected to the bipolar output of an electrosurgical generator with an appropriate bipolar cable and must only be used with parameters for bipolar coagulation.

Indications:

General surgery, Orthopaedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynaecological coagulation (except for use in female sterilisation), Urological coagulation, Ear-, Nose- and Throat coagulation.

Contraindications:

Sutter Bipolar Forceps SuperGliss have not been shown to be effective for tubal sterilisation or tubal coagulation for sterilisation procedures and should not be used for this purpose.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use_
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| DSD-DIVISION SIGN-OFF | Joshua C. Nipper |
|------------------------------|------------------|
| Division of Surgical Devices | -S |
| 510(k) Number: K131012 | |