The Monopolar Sinqle Use Laparoscopic Instruments of Getsch + Hiller is available in two different designs. It is available as system consisting of two parts and as a system consisting of four parts.

The 2-part system is available with reusable handle assembled with a completely insulated shaft on which only a single use tip has to be fixed by the user. This has a working length of 330 mm.

The 4-part system consists of a reusable handle and a reusable shaft insulated, a connection rod with easy snap lock and a single use tip. The system has to be assembled by the user. The 4-part system is available with a working length of 330 mm and 450 mm.

Different types of single use tips are offered for both systems, Maryland grasping forceps, Endoclinch grasping forceps, Aggressive grasping forceps and Johan grasping forceps. Furthermore Metzenbaum scissors in different sizes, straight or curved, are available.

The systems are intended to be used in laparoscopy is an optical examination and diagnostic procedure in which the abdominal cavity and the organs contained therein (liver, gall bladder, spleen, uterus, etc.) are mirrored with an endoscope. During a laparoscopy, in addition to the diagnosis, surgical procedures and biopsies are also made possible whereby surgical micro-instruments are utilized. The Monopolar Single Use Laparoscopic Instruments have to be used in combination with a monopolar HF connector.

The Monopolar Single Use Laparoscopic Instruments can be connected to U.S. FDA cleared Electrosurgical HF-Generator (e.g. K02464, K053290, K94519 and other FDA cleared HFgenerators) which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Monopolar Single Use Laparoscopic Instruments. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI device.

Therefore, many of the requested categories regarding acceptance criteria, extensive study details for a new device, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of submission. This document highlights a comparison of a new device to existing legally marketed devices, demonstrating similar technological characteristics and performance through testing against established standards for medical devices, rather than a novel AI algorithm's performance.

Here's an analysis based on the provided text, indicating where information is not applicable:

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

Since this is a 510(k) for a medical instrument (not an AI device), the "acceptance criteria" are primarily related to safety, effectiveness, and functional specifications, as demonstrated by adherence to recognized standards and comparison to predicate devices, rather than a quantifiable performance metric for an AI algorithm.

Acceptance Criteria (Demonstrated through standards/predicate comparison)	Reported Device Performance (as summarized in the submission)
Biocompatibility:	Evaluated according to ISO 10993-1. Tested for Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity. Evaluation "proofs the biological safety of the device."
Electrical Safety:	Tested according to EN 60601-1 and EN 60601-2-2.
Sterilization and Shelf-Life (Reusable Parts):	Reprocessing validated (cleaning/disinfection). Steam sterilization validated.
Sterilization and Shelf-Life (Disposable Tips):	EO-sterilization validated. Tested for Ethylene oxide sterilization residuals (passed ISO 10993-7 limits). Sterile packaging tested for peel ability, seal strength, and leakage (all passed).
Technological Characteristics:	Substantial Equivalence shown to predicate devices for: Regulation Number, Class, Code, Indication for Use, Prescription/OTC, Device Design, Handle Design, Tip Design, Shaft Diameter, Working Length, Tip Length, HF-mode, Generators, Rated Voltage, Single Use/Reusable components, Delivered Condition, Sterilization Method. The device performs "as intended" and is "substantially equivalent" to predicate device K160706.

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: Not explicitly stated in terms of numerical units for each test (e.g., number of instruments tested for biocompatibility, electrical safety, or sterilization). The testing is described qualitatively.
Data Provenance: Not specified. Testing likely occurred at the manufacturer's facilities or a certified testing lab. Given the manufacturer is in Germany, some testing may have occurred there.
Retrospective or Prospective: Not applicable in the context of device performance testing. These are direct product tests.

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)

This question is not applicable. This submission is for a physical surgical instrument, not an AI diagnostic device where expert ground truth is required. The "ground truth" for this device's performance is established by objective engineering and biological safety standards (e.g., ISO, EN standards) and functional testing, not expert consensus on medical images or diagnoses.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for medical data, which is not relevant for the functional and safety testing of a physical surgical instrument.

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

This question is not applicable. An MRMC study is designed for AI-assisted diagnostic tools involving human readers interpreting medical cases. This device is a surgical instrument and does not involve AI assistance or human readers in this context.

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

This question is not applicable. This device is a manual surgical instrument, not an AI algorithm.

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

The "ground truth" for this device's performance is based on objective engineering standards, biological safety standards (e.g., ISO 10993-1, EN 60601-1, EN 60601-2-2), and validated test methods. It is not derived from expert consensus, pathology, or outcomes data in the sense typically associated with diagnostic algorithms.

8. The sample size for the training set

This question is not applicable. This device is a physical surgical instrument, not an AI algorithm that requires a training set.

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

This question is not applicable. Since there is no AI algorithm or training set, the concept of establishing ground truth for a training set does not apply.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a government office or agency.

August 22, 2017

Getsch + Hiller Medizintechnik GmbH Werner Hiller CEO Sattlerstraße 20 Tuttlingen, 78532 Germany

Re: K171523

Trade/Device Name: Monopolar Single Use Laparoscopic Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 22, 2017 Received: May 25, 2017

Dear Werner Hiller:

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 Actinclude 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 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

{1}------------------------------------------------

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 (DICE) 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. 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

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 (DICE) 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.

Sincerely,

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black and is set against a white background. The letters are clear and easy to read.

For 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171523

Device Name

Monopolar Single Use Laparoscopic Instruments

Indications for Use (Describe)

Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surigcal Procedures

Type of Use (Select one or both, as applicable)

	XPrescription 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 Druq 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."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

{3}------------------------------------------------

DATE OF APPLICATION:	22.05.2017
----------------------	------------

APPLICANT:

Getsch + Hiller Medizintechnik GmbH Sattlerstraße 20 78532 Tuttlingen Germany Tel: + 49 (0) 7461 - 130510 Fax: +49 (0) 7461 - 1305150 E-Mail: info@getsch-hiller.de

CONTACT PERSON:

Werner Hiller CEO Tel.: +49 (0) 7461 - 130512 E-Mail: werner.hiller@getsch-hiller.de

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside, followed by the company name in gray and blue text. The word "GETSCH+HILLER" is in gray, and the word "MEDIZINTECHNIK" is in blue.

1. Device Name

Trade Name:	Monopolar Single Use Laparoscopic Instruments
Common Name:	Manual Detachable Surgical Instruments
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories

2. Classification / Product Code

Monopolar Single Use Laparoscopic Instruments can be classified according to following device name and product code:

Device	RegulationDescription	RegulationMedicalSpecialty	ReviewPanel	ProductCode	RegulationNumber	DeviceClassification
Electrosurgical,Cutting &Coagulation &Accessories	Electrosurgicalcutting andcoagulationdevice andaccessories	General &PlasticSurgery	General &PlasticSurgery	GEI	878.4400	2

3. Predicate Device / Reference Device

Device	Predicate Device	Reference Device	510(k)Number	510(k) Holder
Monopolar Single UseLaparoscopicInstruments	ReNew V HandpieceLaparoscopicInstruments	-	K160706	Microline SurgicalInc.
	-	Disposable Re-NewForceps	K974066	Microline Pentax,Inc.

4. Device Description

The Monopolar Sinqle Use Laparoscopic Instruments of Getsch + Hiller is available in two different designs. It is available as system consisting of two parts and as a system consisting of four parts.

The 2-part system is available with reusable handle assembled with a completely insulated shaft on which only a single use tip has to be fixed by the user. This has a working length of 330 mm.

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside, followed by the company name in gray and blue text. The words "GETSCH+HILLER" are in gray, and the word "MEDIZINTECHNIK" is in blue.

laparoscopy, in addition to the diagnosis, surgical procedures and biopsies are also made possible whereby surgical micro-instruments are utilized. The Monopolar Single Use Laparoscopic Instruments have to be used in combination with a monopolar HF connector.

5. Indication for Use

Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surgical Procedures.

6. Technological Characteristics

The technological characteristics of our Monopolar Single Use Laparoscopic Instruments are the same as the technological characteristics of the predicate device.

Company	Getsch + HillerMedizintechnikGmbH(New Device)	Microline SurgicalInc.(Predicate Device)	Microline Pentax,Inc.(Reference Device)	Result
Device Name	Monopolar Single UseLaparoscopicInstruments	ReNew V HandpieceLaparoscopicInstruments	Disposable Re-NewForceps	-
Regulation Number	878.4400	878.4400	878.4400	SubstantiallyEquivalent
Class	II	II	II	SubstantiallyEquivalent
Code	GEI	GEI	GEI	SubstantiallyEquivalent
510(k) number	-	K160706	K981389	-
Indication for Use	Cutting, Grasping andDissecting VariousAbdominal Tissueduring Endoscopic(inclusive oflaparoscopic) SurgicalProcedures	Cutting andDissecting VariousAbdominal Tissueduring Endoscopic(inclusive oflaparoscopic) SurgicalProcedures	Cutting, Grasping andDissection VariousAbdominal Tissueduring Endoscopic(inclusive oflaparoscopic) SurgicalProcedures	SubstantiallyEquivalent
Prescription / OTC	Prescription	Prescription	Prescription	SubstantiallyEquivalent
Device Design	Reusable handle anddisposable tip	Reusable handle anddisposable tips andreusable tips	Reusable handle anddisposable tips andreusable tips	SubstantiallyEquivalent
Handle Design	Non-ratcheted	Non-ratcheted/ratcheted	Non-ratcheted/ratcheted	SubstantiallyEquivalent
Tip Design	scissors or graspers	scissors tips	Graspers/Fenestrated forceps/"Dolphin Nose"Dissector/"Babock"/"Maryland" Dissector	SubstantiallyEquivalent
Shaft Diameter[mm]	5	5	5	SubstantiallyEquivalent

6.1. Device characteristics table

{6}------------------------------------------------

Monopolar Single Use Laparoscopic Instruments 510(k) Premarket Notification

Image /page/6/Picture/3 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside on the left, followed by the company name in gray and blue text on the right. The word "GETSCH+HILLER" is in gray, and the word "MEDIZINTECHNIK" is in blue.

Company	Getsch + HillerMedizintechnikGmbH(New Device)	Microline SurgicalInc.(Predicate Device)	Microline Pentax,Inc.(Reference Device)	Result
Working Length[mm]	330 / 450	250 / 340 / 420	250 / 340 / 420	SubstantiallyEquivalent
Tip Length [mm]	10.0 - 22.5	11.2 - 19.3	18.8 -22.6	SubstantiallyEquivalent
HF-mode	monopolar	monopolar	monopolar	SubstantiallyEquivalent
Generators	U.S. FDA clearedElectrosurgical High-Frequency (HF)Generator whichcomplies with the IEC60601-1-2 EMC(ElectromagneticCompatibility) testingrequirements	U.S. FDA clearedElectrosurgical High-Frequency (HF)Generator whichcomplies with the IEC60601-1-2 EMC(ElectromagneticCompatibility) testingrequirements	-	SubstantiallyEquivalent
Rated Voltage	max. 2kVp	800 Vp - 2,65 kVp	800 Vp - 2,65 kVp	SubstantialEquivalent
Single Use	Tips	Tips	Tips	SubstantialEquivalent
Reusable	Handle, insulatedshaft, connection rod	Tips, handle	Tips, handle	SubstantialEquivalent
Delivered Condition	Reusable handle isdelivered in unsterilecondition.Disposable tips aredelivered in sterilecondition.	Reusable handle andreusable tips aredelivered in non-sterile condition.Disposable tips aredelivered in sterilecondition.	Reusable handle andreusable tips aredelivered in non-sterile condition.Disposable tips aredelivered in sterilecondition.	SubstantialEquivalent
SterilizationMethod	EO	EO	EO	SubstantialEquivalent

7. Summary of technological characteristics

The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.

8. Performance Data

Verification and validation results demonstrate that the device performs as intended and that the Monopolar Single Use Laoaroscopic Instruments are substantially equivalent to the Predicate Device K160706.

8.1. Biocompatibility

The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:

Cytotoxicity .
. Sensitization
. Irritation or Intracutaneous Reactivity

The evaluation proofs the biological safety of the device.

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image contains the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside on the left. To the right of the circle, the text "GETSCH+HILLER" is written in gray, and below that, "MEDIZINTECHNIK" is written in blue.

8.2. Electrical Safety

To proof safety and effectiveness the device has been tested according to the requirements of EN 60601-1 and EN 60601-2-2

8.3. Sterilization and Shelf-Life

The reusable parts can be reprocessed using a validated cleaning and disinfection procedure. Steam sterilization of the reusable parts has been validated.

Disposable tips are delivered in sterile condition. EO-sterilization is used for the sterilization of the disposable tips. A sterilization validation has been conducted. Furthermore a test for Ethylene oxide sterilization residuals has been conducted. The devices passed the limits of ISO 10993-7. Sterile packaging has been tested for its peel ability of the seal, seal strength and leakage of the seal. All tests were passed by the used packaging.

9. Substantial Equivalence Summary / Conclusions

Based on available 510(k) information provided herein, our Monopolar Single Use Laparoscopic Instruments are considered to be substantially equivalent to the predicate device ReNew V Handpiece Laparoscopic Instruments and the Reference Device Disposable Re-New Forceps in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.

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.