The ARROWtip™ Single-Use monopolar electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.

Device Description

Sutter ARROW tip™ Monopolar Electrodes are electrosurgical instruments. The electrodes are provided with different angled electrode front parts and in different lengths. They are to be connected through an appropriate monopolar handpiece with the monopolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.

AI/ML Overview

The provided text describes the 510(k) submission for the Sutter ARROWtip™ Monopolar Electrodes. It is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies or establishing complex acceptance criteria for AI/ML-driven performance.

Therefore, the information required to populate the fields regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device's performance, as outlined in your request, is not present in the provided document.

The document discusses:

Bench Testing: Performance testing in line with FDA guidance for electrosurgical devices, including Electromagnetic Compatibility and Electrical Safety, Mechanical strength and functionality, and Thermal effects on tissue.
Sterilization and Shelf Life Testing: Validation of the sterilization cycle and shelf-life.
Biocompatibility Testing: Evaluation according to ISO standards.
Comparison to Predicate: A table comparing technological characteristics with the predicate device (Stryker Leibinger Colorado MicroDissection Needles® (K033232)).

It explicitly states:

No animal studies have been performed.
No clinical studies have been performed.

The "Acceptance Criteria" in this context are related to meeting these engineering and biological safety standards, and demonstrating substantial equivalence to the predicate device, not statistical performance metrics for an AI/ML algorithm.

Therefore, I cannot provide the requested table and details for an AI/ML-driven device's performance, as the provided text pertains to a traditional electrosurgical instrument without AI/ML components.

Summary

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October 4, 2019

SUTTER MEDIZINTECHNIK GmbH Mr. Ulrike Zeissler Manager, Regulatory Affairs Tullastrasse 87 79108 Freiburg, Germany

Re: K192128

Trade/Device Name: Sutter ARROWtip Monopolar Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 1, 2019 Received: August 7, 2019

Dear Mr. 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.

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

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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 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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) K192128

Device Name Sutter ARROWtip™ Monopolar Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× 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:	October 2nd, 2019
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:Classification name:Product Code:Regulation Number:Classification:Classification Panel:	Sutter ARROW tip™ Monopolar ElectrodesMonopolar ElectrodesElectrosurgical, cutting & coagulation & AccessoriesGEICFR 21 § 878.4400Class IIGeneral and Plastic Surgery
Predicate Device:	Predicate device to which Sutter ARROWtip™ Monopolar Electrodes are claimed to be substantially equivalent is manufactured by Stryker Leibinger, Stryker Leibinger Colorado MicroDissection Needles® (K033232)
Device Description:	Sutter ARROW tip™ Monopolar Electrodes are electrosurgical instruments. The electrodes are provided with different angled electrode front parts and in different lengths. They are to be connected through an appropriate monopolar handpiece with the monopolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments.
Intended Use:	The ARROWtip™ Single-Use monopolar electrode is an electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.
TechnologicalCharacteristics:	The table below provides a comparison between the subject deviceand the predicate device
	Sutter ARROWtip™Monopolar Electrodes	Predicate deviceK033232
	Straight / angled	Straight / angled
	Ø 0.8	Ø 0.5 mm
	Tungsten, stainlesssteel, PTFE	Tungsten, stainlesssteel, PTFE, Polyolefin
	yes	yes
	yes	yes
	yes	yes
	yes	yes
	10-6	10-6
	Ethylene Oxide	Ethylene Oxide
Non-ClinicalPerformanceData:	The following performance data has been obtained for thesubstantial equivalence determination.
	Bench Testing
	Performance 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
	Electromagnetic Compatibility and Electrical Safety Testing
	Electrical 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 testing
	Mechanical strength and functionality performance testing was
	Mechanical stress tests showed that the design specification aremet.Thermal effects on tissueThermal effects on tissue testing was performed to determinethermal effects cased by the Sutter ARROW tip™ MonopolarElectrodes at different modes and power levels in comparison tothe predicate device. Three different types of tissue were used andtests were performed in triplicate. Visual comparison as well asdigital morphometric measurement using histology showedequivalent coagulation / cutting performance of subject device andpredicate device.
	SterilizationSutter ARROW tip™ Monopolar Electrodes are sterilized by using avalidated ethylene oxide cycle. The sterilization cycle has beenvalidated to ensure a sterility level of (SAL) 10-6 in accordance withISO 11135.
	Shelf Life TestingShelf-life testing has been conducted in accordance ISO 11607-1.The aging studies established that the Sutter ARROW tip™Monopolar Electrodes and packaging remain functional andmaintain sterility for up to 3 years.
	Biocompatibility TestingBiological evaluation and Biocompatibility testing has beenperformed in compliance to ISO 10993-1Fourth edition 2009-10-15, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management 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 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.
Conclusion:	Sutter ARROW tip™ Monopolar Electrodes are substantiallyequivalent to the predicate device since the intended use, design,material and basic features are the same. The minor differencesraise no new issues of safety and effectiveness, as the designdifferences have no effect on the performance, function or intendeduse.

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH

DEVICES: SUTTER ARROWtip™ MONOPOLAR ELECTRODES

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APPLICANT: SUTTER MEDIZINTECHNIK GMBH

DEVICES: SUTTER ARROWtip™ MONOPOLAR ELECTRODES

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.