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.

AI/ML Overview

The provided text describes a 510(k) submission for the Sutter Swyng® non-stick bipolar forceps, single-use. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against pre-defined acceptance criteria for a new AI/software device.

Therefore, many of the requested categories related to AI/software performance (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.

However, I can extract the acceptance criteria and performance data relevant to this medical device's physical and functional properties, as described in the "Non-Clinical Performance Data" section.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Test Category)	Reported Device Performance (Conclusion)
Electromagnetic Compatibility and Electrical Safety Testing	Pass (Compliance to IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2 shown)
Mechanical Strength and Functionality Performance Testing	Pass (Design specifications met)
Thermal Effects on Tissue	Pass (Equivalent coagulation performance to predicate device shown through visual comparison and digital morphometric measurement using histology)
Sterilization	Pass (Sterility Assurance Level (SAL) 10^-6 achieved in accordance with ISO 11137 via validated gamma irradiation cycle)
Shelf Life Testing	Pass (Functional and maintain sterility for up to 3 years in accordance with ISO 11607-1)
Biocompatibility Testing	Pass (Compliance to ISO 10993-1)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size:
- For "Thermal effects on tissue," tests were performed in triplicate for three different types of tissue.
- For other tests (Electromagnetic Compatibility, Electrical Safety, Mechanical Strength, Functionality, Sterilization, Shelf Life, Biocompatibility), specific numerical sample sizes are not explicitly stated in the provided text. The text refers to "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."
Data Provenance: The studies were internal to Sutter Medizintechnik GmbH (Germany). The type of study (retrospective or prospective) for the bench tests is not specified, but given their nature, they would be considered controlled laboratory experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This submission pertains to physical medical devices and their functional and safety characteristics, not AI/software performance requiring expert ground truth for classification or diagnosis. "Thermal effects on tissue" involved "visual comparison as well as digital morphometric measurement using histology," implying expert evaluation, but the number and qualifications are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/software device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For "Thermal effects on tissue," the ground truth involved histology for digital morphometric measurement and visual comparison against the predicate device.
For other tests, the "ground truth" refers to compliance with established international standards (IEC, ISO) and internal design specifications for safety and performance.

8. The sample size for the training set:

Not applicable. This is not an AI/software device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/software device.

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 GmbHTullastrasse 8779108 FreiburgGermany
	Contact person:Titel:Telephone:Fax:	Ulrike ZeisslerManager Regulatory Affairs+49 (0) 761 51551-14+49 (0) 761 51551-30
Product:	Trade Name:Common Name:Classificationname:Product Code:RegulationNumber:Classification:ClassificationPanel:	Sutter Swyng® non-stick bipolar forceps,single-useBipolar forcepsElectrosurgical, Cutting & Coagulation &AccessoriesGEICFR 21 § 878.4400Class IIGeneral and Plastic Surgery
PredicateDevice:	Predicate device to which Sutter Swyng® non-stick bipolar forceps,single-use are claimed to be substantially equivalent ismanufactured by Medos International SARL as CODMANVersaTru™ Disposable Non-Stick Bipolar Forceps (K162469).
DeviceDescription:	Sutter Swyng® non-stick bipolar forceps, single-use areelectrosurgical instruments. The bipolar forceps are provided withbayonet-style handle design with straight or angled tips anddifferent total lengths. They are to be connected through anappropriate bipolar cable with the bipolar output of anelectrosurgical generator. The electrodes are provided sterile andare single-use instruments.
Indications forUse:	Swyng® non-stick bipolar forceps, single-use are intended for usein electrosurgery for coagulation of tissue.

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TechnologicalCharacteristics:	The table below provides a comparison between the subject deviceand the predicate device
	Sutter Swyng® non-stick bipolar forceps,single-use	Predicate deviceK162469
	Product Code	GEI
	Classification	Class II – 21 CFR878.4400
	Classification Name	Electrosurgical, Cutting& Coagulation &Accessories
	Forceps design	Bayonet Style
	Product Line	Standard, Slim
	Tip size	Ø 0.5 mm, 1.0 mm, 1.5mm
	Material• Tips, Branches, Handle• Insulation	Silver and rhodiumplated aluminiumPolyamide (PA 11)
	Meets IEC 60601-1	Yes
	Meets IEC 60601-2-2	Yes
	Meets IEC 60601-1-2	Yes
	Maximum peakvoltage	500 Vp
	Meets ISO 10993-1	yes
	Sterility AssuranceLevel (SAL)	10-6
	Sterilization Method	Gamma irradiation
Non-ClinicalPerformanceData:	The following performance data has been obtained for thesubstantial equivalence determination.Bench TestingPerformance testing has been executed in line with the internalR&D process and in compliance with the proposals andrecommendations of the FDA guidance: "Premarket Notification[510(k)] Submissions for Electrosurgical Devices for GeneralSurgery" - Guidance for Industry and Food and Drug AdministrationStaff, August 15, 2016.In particular, tests were carried out with respect to following subjectareas:
	Performance Data Bench Tests
	Test	Conclusion
	Electromagnetic Compatibility andElectrical Safety	Pass
	Mechanical strength andfunctionality performance testing	Pass
	Thermal effects on tissue	Pass

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Electromagnetic Compatibility and Electrical Safety TestingElectrical and electromagnetic tests were performed to demonstratethat design specifications and performance requirements are met.Compliance to the voluntary standards IEC 60601-1 (AAMI/ANSIES60601-1:2005), IEC 60601-2-2 and IEC 60601-1-2 has beenshown.
Mechanical strength and functionality performance testingMechanical strength and functionality performance testing wasperformed to demonstrate that design specification are met.Mechanical stress tests showed that the design specification aremet.
Thermal effects on tissueThermal effects on tissue testing was performed to determinethermal effects caused by the Sutter Swyng® non-stick bipolarforceps, single-use at different power levels and application times incomparison to the predicate device. Three different types of tissuewere used and tests were performed in triplicate. Visual comparisonas well as digital morphometric measurement using histologyshowed equivalent coagulation performance of subject device andpredicate device.
SterilizationSutter Swyng® non-stick bipolar forceps, single-use are sterilizedby using a validated gamma irradiation cycle. The sterilization cyclehas been validated to ensure a sterility level of (SAL) 10-6 inaccordance with ISO 11137.
Shelf Life TestingShelf-life testing has been conducted in accordance ISO 11607-1.The aging studies established that the Sutter Swyng® non-stickbipolar forceps, single-use and packaging remain functional andmaintain sterility for up to 3 years.
Biocompatibility TestingBiological evaluation and Biocompatibility testing has beenperformed in compliance to ISO 10993-1 “Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process”.
Animal StudiesNo animal studies have been performed as appropriate verificationand validation of the subject device has been achieved based oncomparison to the predicate device and from results of the benchtesting, biocompatibility evaluation, and electrical / safety testing.
Clinical StudiesNo 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 benchtesting, biocompatibility evaluation, and electrical / safety testing.
Conclusion:	Sutter Swyng® non-stick bipolar forceps, single-use aresubstantially equivalent to the predicate device since the intendeduse, design, material and basic features are the same. The minordifferences raise no new issues of safety and effectiveness, as thedesign differences have no effect on the performance, function orintended use.

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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.