Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical aspects of bipolar forceps for electrosurgery and does not mention any AI or ML components or functionalities.

Therapeutic

No
This device is an electrosurgical instrument used for coagulation of tissue, which is a surgical procedure, not a therapeutic treatment in itself.

Diagnostic

No

The device is intended for the coagulation of tissue, which is a therapeutic function, not a diagnostic one. The performance studies focus on thermal effects and coagulation performance, not diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an electrosurgical instrument, specifically bipolar forceps, which are hardware components used in surgery. It also mentions connection to an electrosurgical generator via a cable.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for use in electrosurgery for coagulation of tissue." This describes a surgical procedure performed directly on a patient's body (in vivo).
Device Description: The description details an electrosurgical instrument used to apply electrical current to tissue. This is a therapeutic/surgical device, not a device used to examine specimens outside the body.
IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.

The information provided clearly indicates a surgical instrument used for a therapeutic purpose, not a diagnostic test performed on specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GEI

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.

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)

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.
Tests were carried out with respect to following subject areas:

Electromagnetic Compatibility and Electrical Safety: Pass
Mechanical strength and functionality performance testing: Pass
Thermal effects on tissue: Pass

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 was performed to demonstrate that design specification are met. Mechanical stress tests showed that the design specification are met.

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.

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.

K162469

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

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.

Summary

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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.

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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

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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)

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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.

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| 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.

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| 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.

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