Sutter Bipolar Forceps - Calvian is an electrosurgical tool available in different handle styles and tip sizes. It is constructed with medical grade stainless steel, coated with Polyamide PA 11 as electrical insulator and possesses tips made of stainless steel that are partly not insulated. The forceps can be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. As an electrosurgical accessory it is intended to remove tissue and control bleeding. The maximum peak voltage to use the forceps is 500 Vp. The forceps are provided non-sterile, are reusable and must be sterilized prior initial and subsequent use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Sutter Bipolar Forceps - Calvian), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them in the context of AI/ML, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and adherence to relevant standards for electrosurgical cutting and coagulation devices.

Summary

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

September 10, 2015

Sutter Medizintechnik GmbH Ulrike Zeissler Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg Germany

Re: K150959

Trade/Device Name: Sutter Bipolar Forceps - Calvian Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 1, 2015 Received: April 1, 2015

Dear Zeissler:

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

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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 (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.

for

Sincerely yours,

David Krause -S

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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Indications for Use

510(k) Number (if known) K150959

Device Name Sutter Bipolar Forceps - Calvian

Indications for Use (Describe)
--------------------------------

Intended Use:	Sutter Bipolar Forceps- Calvian are intended to remove tissue and control bleeding.
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Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER BIPOLAR FORCEPS - Calvian

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Section 807.92(c)

Date:807.92(a)(1)	March 31, 2015
Submitter:807.92(a)(1)	Name:	SUTTER MEDIZINTECHNIK GmbH
	Address:	Tullastrasse 8779108 FreiburgGermany
	Managing Director:	Bert Sutter
	Telephone:	+49 (0) 761 51551-0
	Fax:	+49 (0) 761 51551-30
	Contact person:	Ulrike Zeissler
	Telephone:	+49 (0) 761 51551-14
	E-mail:	zeissler@sutter-med.de
Product:807.92(a)(2)	Trade Name:	Sutter Bipolar Forceps - Calvian
	Classification:	Class II; CFR 21 § 878.4400
	Common Name:	Electrosurgical Instruments and Accessories
	Product Code andClassification Name:	GEI - Electrosurgical Cutting & CoagulationDevice & Accessories
PredicateDevice:807.92(a)(3)	Predicate device to which Sutter Bipolar Forceps - Calvian are claimedto be substantially equivalent is manufactured by• Xomed Surgical Products, Microfrance Electrosurgical Instruments,various, (K993655)
DeviceDescription:807.92(a)(4)	Sutter Bipolar Forceps - Calvian is an electrosurgical tool available indifferent handle styles and tip sizes. It is constructed with medical gradestainless steel, coated with Polyamide PA 11 as electrical insulator andpossesses tips made of stainless steel that are partly not insulated. Theforceps can be connected through an appropriate bipolar cable with thebipolar output of an electrosurgical generator. As an electrosurgicalaccessory it is intended to remove tissue and control bleeding. Themaximum peak voltage to use the forceps is 500 Vp. The forceps areprovided non-sterile, are reusable and must be sterilized prior initial andsubsequent use.
IntendedUse:807.92(a)(5)	Intended Use: Sutter Bipolar Forceps - Calvian are intended to removetissue and control bleeding.
SubstantialEquivalence:	Sutter Bipolar Forceps - Calvian are substantial equivalent to thepredicate devices since the basic features, design and intended usesare the same.
	Feature	Sutter Calvian	Predicate deviceK993655
	Intended Use	As shown above underIntended Use	Same
	Branches Style	Angled	Straight, angled
	DimensionsTip size [mm]:	0.7-2.5	1.3 - 2.5
	MaterialTips:Coating:Connector:Base material:	Stainless steelPolyamide (PA) 11Stainless steel/Plastic materialStainless steel	Same
	Bipolar	yes	Same
	Meets IEC 60601-2-2	yes	Same
	Maximum peak voltage	500 Vp	833 Vp
	Sterility	Non-sterile, reusable	Same
	Sterilization method	Steam-sterilisation by user	Same

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510(k) Summary for K150959

APPLICANT: SUTTER MEDIZINTECHNIK GMBH DEVICES: SUTTER BIPOLAR FORCEPS - Calvian

Regulation Number and Section

§ 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.