Who is the manufacturer of Sutter Swyng non-stick bipolar forceps, single-use?

Sutter Medizintechnik GmbH filed the 510(k) submission for Sutter Swyng non-stick bipolar forceps, single-use (K193587).

What is the FDA product code for Sutter Swyng non-stick bipolar forceps, single-use?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Sutter Swyng non-stick bipolar forceps, single-use?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Sutter Swyng non-stick bipolar forceps, single-use?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Sutter Swyng non-stick bipolar forceps, single-use

K193587 · Sutter Medizintechnik GmbH · GEI · Feb 10, 2020 · General, Plastic Surgery

Device Facts

Record ID	K193587
Device Name	Sutter Swyng non-stick bipolar forceps, single-use
Applicant	Sutter Medizintechnik GmbH
Product Code	GEI · General, Plastic Surgery
Decision Date	Feb 10, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue.

Device Story

Sutter Swyng non-stick bipolar forceps are single-use electrosurgical instruments; bayonet-style design with straight or angled tips. Device connects to an electrosurgical generator via a bipolar cable to deliver electrical energy for tissue coagulation. Used by clinicians in surgical settings. The device functions by applying high-frequency current to tissue held between the forceps tips. Non-stick properties facilitate tissue handling during coagulation. Benefits include effective hemostasis and reduced tissue adhesion during surgical procedures.

Clinical Evidence

No clinical data. Bench testing only. Testing included electromagnetic compatibility, electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2), mechanical strength, and thermal effects on tissue. Thermal testing compared coagulation performance against the predicate using histology and morphometric measurements, demonstrating equivalence.

Technological Characteristics

Materials: Silver and rhodium-plated aluminum tips/branches/handle, Polyamide (PA 11) insulation. Design: Bayonet-style, single-use. Energy: Electrosurgical (max 500 Vp). Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 10993-1, ISO 11137, ISO 11607-1, IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2.

Indications for Use

Indicated for use in electrosurgery for coagulation of tissue in patients requiring such 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

CODMAN VersaTru™ Disposable Non-Stick Bipolar Forceps (K162469)

Related Devices

K213042 — Supra Non-Stick Bipolar Forceps · Guenter Bissinger Medizintechnik GmbH · Nov 17, 2022
K162469 — CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps · Medos International SARL · Oct 26, 2016
K051429 — CLARIS NON-STICK BIPOLAR FORCEPS · Guenter Bissinger Medizintechnik GmbH · Jul 29, 2005
K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS · Synergetics, Inc. · Jul 10, 2012
K191847 — Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps · Adeor Medical AG · May 22, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". February 10, 2020 Sutter Medizintechnik GmbH Mr. Ulrike Zeissler Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg Germany Re: K193587 Trade/Device Name: Sutter Swyng non-stick bipolar forceps, single-use Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 17, 2019 Received: December 23, 2019 Dear Ulrike 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. 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. {1}------------------------------------------------ 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 and Part 809); 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 (QS) 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 medical devices and radiation-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. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193587 #### Device Name Sutter Swyng® non-stick bipolar forceps, single-use Indications for Use (Describe) Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue. Type of Use (Select one or both, as applicable) 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." {3}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Section 807.92 | Date: | February 10, 2020 | | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Name: Address: | Sutter Medizintechnik GmbH Tullastrasse 87 79108 Freiburg Germany | | | Contact person: Titel: Telephone: Fax: | Ulrike Zeissler Manager Regulatory Affairs +49 (0) 761 51551-14 +49 (0) 761 51551-30 | | Product: | Trade Name: Common Name: Classification name: Product Code: Regulation Number: Classification: Classification Panel: | Sutter Swyng® non-stick bipolar forceps, single-use Bipolar forceps Electrosurgical, Cutting & Coagulation & Accessories GEI CFR 21 § 878.4400 Class II General and Plastic Surgery | | Predicate Device: | Predicate device to which Sutter Swyng® non-stick bipolar forceps, single-use are claimed to be substantially equivalent is manufactured by Medos International SARL as CODMAN VersaTru™ Disposable Non-Stick Bipolar Forceps (K162469). | | | Device Description: | Sutter Swyng® non-stick bipolar forceps, single-use are electrosurgical instruments. The bipolar forceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments. | | | Indications for Use: | Swyng® non-stick bipolar forceps, single-use are intended for use in electrosurgery for coagulation of tissue. | | {4}------------------------------------------------ | Technological Characteristics: | The table below provides a comparison between the subject device and the predicate device | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | | Sutter Swyng® non- stick bipolar forceps, single-use | Predicate device K162469 | | | Product Code | GEI | | | Classification | Class II – 21 CFR 878.4400 | | | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | | | Forceps design | Bayonet Style | | | Product Line | Standard, Slim | | | Tip size | Ø 0.5 mm, 1.0 mm, 1.5 mm | | | Material • Tips, Branches, Handle • Insulation | Silver and rhodium plated aluminium Polyamide (PA 11) | | | Meets IEC 60601-1 | Yes | | | Meets IEC 60601-2-2 | Yes | | | Meets IEC 60601-1-2 | Yes | | | Maximum peak voltage | 500 Vp | | | Meets ISO 10993-1 | yes | | | Sterility Assurance Level (SAL) | 10-6 | | | Sterilization Method | Gamma irradiation | | Non-Clinical Performance Data: | The following performance data has been obtained for the substantial equivalence determination. Bench Testing Performance testing has been executed in line with the internal R&D process and in compliance with the proposals and recommendations of the FDA guidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016. In particular, tests were carried out with respect to following subject areas: | | | | Performance Data Bench Tests | | | | Test | Conclusion | | | Electromagnetic Compatibility and Electrical Safety | Pass | | | Mechanical strength and functionality performance testing | Pass | | | Thermal effects on tissue | Pass | {5}------------------------------------------------ | Electromagnetic Compatibility and Electrical Safety Testing Electrical and electromagnetic tests were performed to demonstrate that design specifications and performance requirements are met. Compliance to the voluntary standards IEC 60601-1 (AAMI/ANSI ES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 has been shown. | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Mechanical strength and functionality performance testing Mechanical strength and functionality performance testing was performed to demonstrate that design specification are met. Mechanical stress tests showed that the design specification are met. | | | Thermal effects on tissue Thermal effects on tissue testing was performed to determine thermal effects caused by the Sutter Swyng® non-stick bipolar forceps, single-use at different power levels and application times in comparison to the predicate device. Three different types of tissue were used and tests were performed in triplicate. Visual comparison as well as digital morphometric measurement using histology showed equivalent coagulation performance of subject device and predicate device. | | | Sterilization Sutter Swyng® non-stick bipolar forceps, single-use are sterilized by using a validated gamma irradiation cycle. The sterilization cycle has been validated to ensure a sterility level of (SAL) 10-6 in accordance with ISO 11137. | | | Shelf Life Testing Shelf-life testing has been conducted in accordance ISO 11607-1. The aging studies established that the Sutter Swyng® non-stick bipolar forceps, single-use and packaging remain functional and maintain sterility for up to 3 years. | | | Biocompatibility Testing Biological evaluation and Biocompatibility testing has been performed in compliance to ISO 10993-1 “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”. | | | Animal Studies No animal studies have been performed as appropriate verification and validation of the subject device has been achieved based on comparison to the predicate device and from results of the bench testing, biocompatibility evaluation, and electrical / safety testing. | | | Clinical Studies No clinical studies have been performed as appropriate verification and validation of the subject device has been achieved based on | | | | comparison to the predicate device and from results of the bench testing, biocompatibility evaluation, and electrical / safety testing. | | Conclusion: | Sutter Swyng® non-stick bipolar forceps, single-use are substantially equivalent to the predicate device since the intended use, design, material and basic features are the same. The minor differences raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function or intended use. | | | | {6}------------------------------------------------