The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.

Device Description

The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.

AI/ML Overview

The provided text is a 510(k) Summary for the GENICON Aquas Probes. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and non-clinical performance data. Since this is a submission for an electrosurgical device for general surgery, it does not involve AI/ML technology or studies typically associated with AI device performance such as those listed in your prompt.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as these types of studies were not conducted or described.

Here's what can be extracted:

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

The document mentions that "Non-clinical tests were conducted to verify that the GENICON Reusable Electrosurgical Probe product line met all acceptance criteria and specifications as the substantially equivalent predicate device and any additional test that were required." The specific acceptance criteria are not explicitly detailed as numerical targets but are implied through equivalence to predicate devices and compliance with international standards.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent overall use/performance to predicate devices (Stryker Stiletto Electrosurgical Probe K052141 and Pajunks HF Electrodes K062047)	"Performance of the GENICON Reusable Electrosurgical Probe product showed that the device performed equivalent or better and is therefore substantially equivalent in performance to the predicate devices."
Electrical safety and effectiveness compliant with standards	"Electrical safety complies with IEC 60601." (Referring to predicate, and then implies the same for GENICON)"Electrical performance of the device was completed following FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' issued August 15, 2016. This requires testing on three different tissue types. The spread is then measured under magnification, and TCO (thermal coagulation) is compared using different tissue types and maximum generator power in order to simulate thermal spread with the predicate product. Results showed an equivalent."
Mechanical performance, ergonomic forces	The GENICON Aquas Probes product line was also compared to the predicate device through bench testing which included visual & operational use, ergonomic forces, and electrical safety. Testing demonstrated that the devices met the same requirements as the predicate product.
Autoclave sterilization validation (for reusability)	"Autoclave Sterilization Validation" (Listed as a non-clinical test conducted). Device is intended to be reused up to 50 times and sterilized by high-pressure steam autoclave.
Biocompatibility	"Conforms to ISO 10993"
Cycle Count Testing	"Cycle Count Testing" (Listed as a non-clinical test conducted)
Compliance with specific IEC standards	IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-2-2:2009, IEC 60601-2-18:2009, ISO 17655-1:2006 (Are listed as standards applied in testing)

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

Not applicable. The document describes non-clinical bench testing, not human subject testing with a "test set" in the context of an AI/ML algorithm. The testing involved "three different tissue types" for electrical performance evaluation, but no further details on sample size or provenance for this non-human tissue testing are provided.

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 information pertains to studies with human expert interpretation (e.g., for medical imaging or diagnostics), which is not relevant to this electrosurgical probe submission.

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

Not applicable. This is relevant for studies involving human expert assessment, not for the technical bench testing described.

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

Not applicable. This type of study is for evaluating AI-assisted human performance, which is not relevant to this device.

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

Not applicable. This is not an AI/ML device. The "performance" described refers to the physical and electrical characteristics of the electrosurgical probe.

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

Not applicable. The "ground truth" for this device's performance would be the experimentally measured physical and electrical characteristics as compared to predefined specifications and predicate device performance. It doesn't involve clinical "ground truth" derived from patient data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this information is not relevant.

Summary

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March 14, 2019

GENICON, Inc. Ms. Katlyn Kachman Director of Quality and Regulatory Compliance 6869 Stapoint Court Suite 114 Winter Park, Florida 32792

Re: K190168

Trade/Device Name: GENICON Aquas Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 23, 2019 Received: January 31, 2019

Dear Ms. Kachman:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows a digital signature for Long H. Chen -S, dated 2019.03.14 at 10:49:57 -04'00'. The signature is for Binita S. Ashar, M.D., M.B.A., F.A.C.S. The name Long H. Chen -S is also present on the left side of the image.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190168

Device Name GENICON Aquas Probes

Indications for Use (Describe)

Indications for Use (Describe)
The GENICON Aquas Probes are instruments insulated for optional monopolar consembly as annonio I the GENCON Aquas I 100-3 are martine internal tissue or organs while performing laparoscopic procedures.

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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Image /page/3/Picture/0 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, and there is a curved line underneath it. The font is a dark color, and the background is white. There is a registered trademark symbol to the right of the word.

K190168

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K190168 510(k) Summary

Contact Information 1. GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Director of Quality January 23, 2019

1. Device Name
- Trade Name GENICON Aquas Probes 0
- Trade Name OLNOON Aquao Probe, Electrocautery Probe, Electrosurgical Probe e
- Common Name Monopolar Electrourgical, Cutting & Coagulation & Accessories (21 CFR e
- 878.4400, Product Code GEI)
Substantially Equivalent Device 3. Substantially Equivalent Devices: Stryker Stiletto Electrosurgical Probe, K052141
Legally Marketed (unmodified) Devices: Stryker Stilettos (1800017 Paiunks HF Electrodes, K062047

		Pajunks HF Electrodes, K062047
Device	Stryker Stiletto ElectrosurgicalProbe (K052141)	Pajunks HF Electrodes (K062047)	GENICON Aquas Probes
ComponentDesign	A. Electrosurgical TipB. InsulationC. Insulation Control KnobD. HF PostE. Handle	A. Electrosurgical TipB. InsulationC. Insulation Control KnobD. HF PostE. Handle	A. Electrosurgical TipB. InsulationC. Insulation Control KnobD. HF PostE. Handle
Design	The Stryker Stiletto Electrosurgical Probe is asuction/irrigation probe with electrosurgicalcapability indicated for use in laparoscopicsurgical procedures.The device allows for suction and irrigation ofsterile irrigant solution. In addition, the deviceis intended to be used for electrosurgicalcutting/coagulation during laparoscopicprocedures.Products include optional retractable insulationand are also provided without thesuction/irrigation functions.	The Pajunk adaptable and retractable HFElectrodes are multiple use, non-steriledelivered and latex free medical devices. Theinstruments are insulated for optionalmonopolar coagulation which enables asurgeon to manipulate, dissect, retrieve,biopsy, cut, or coagulate internal tissue ororgans while performing laparoscopicprocedures.Pajunk provides electrodes with and withoutsuction and irrigation element and electrodeswith suction and irrigation capacity withretractable/extendable tips.	The GENICON Reusable Electrosurgical Probeare multiple use, non-sterile delivered medicaldevices. The instruments are insulated foroptional monopolar coagulation which enables asurgeon to manipulate, cut, or coagulate softtissue or organs while performing laparoscopicprocedures.GENICON provides electrodes with and withoutsuction and irrigation element and electrodeswith suction and irrigation capacity withretractable/extendable tips.
Diameter	5 mm	5 mm	5 mm
WorkingLength	33 to 45 cm	34 to 44 cm	20 to 45 cm
ElectrosurgicalTips	Spatula, L-Hook, J-Hook, Ball,Needle, Spoon	Spatula, L-Hook, J-Hook, Knife,Needle, 45 Deg	Spatula, L-Hook, J-Hook, Knife,Needle, 45 Deg

TEL 407.657.4851 --- WWW.GENICONENDO.COM -- FAX 407.677.9773

US OFFICE • 6869 Stapoint Court #114, Winter Park, Florida USA 32792 —— EU OFFICE • 44 Airedale Avenue, Chiswick, London U.K W4 2NW

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Image /page/4/Picture/1 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, with the left side of the word being higher than the right side. There is a curved line underneath the word, which is thicker on the left side and thinner on the right side. The registered trademark symbol is located to the right of the word.

			K190168
Materials	Stainless Steel, Polyimide, PTFE,Silicone, Rubber	Stainless Steel, Polyamide orCeramic	Stainless Steel, PEEK, POM, PPSU,PTFE/FEP, Silicone
Testing	Electrical and mechanicalperformance of the predicatedevices were evaluated andbenchmarks established.	Electrical and mechanicalperformance of the predicatedevices were evaluated andbenchmarks established.	Performance of the GENICONReusable Electrosurgical Probeproduct showed that the deviceperformed equivalent or better and istherefore substantially equivalent inperformance to the predicate devices.
Performance	The Stryker Stiletto ElectrosurgicalProbe allows for suction andirrigation of sterile irrigant solutionand is intended to be used forelectrosurgical cutting/coagulationduring laparoscopic procedures.Electrical safety complies with IEC60601.	SAME	SAME
Sterilization	Sterile/Single-Use and Non-Sterile/Reusable	Non-Sterile/Reusable	Non-Sterile/Reusable
PrescriptionOnly	Yes	Yes	SAME
Biocompatibility	Unknown	Unknown	Conforms to ISO 10993

Device Description 4.

Device Description
The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The The GENICON Aquas Prodes product line are multiple aco modious a surgeon to manipulate, cut, or probes are insulated for optionwhile performing laparoscopic procedures.

The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and The GENCON Aquas Probes nave an outside on up to 45 cm. Common the configurations include La the connigurations. Volking lengths fange from 20 to the other on the more of the more of the many of Hook (Right Angle), 3-100K, Spatula, 40 , Kinic, Bar, Nostal, and on channel for suction and irigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include sterlie inrigant solution when attached to a compansion and insulation at the digression of the user.

Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.

Intended Use 5.

Interiod Use
The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable The GENCON Aquas Probes are instrancents modiated for optional more of the mail the or organs while performing laparoscopic procedures.

1. Technological Characteristics of the Subject Device Compared to the Predicate Device l echnological Characteristics of the Subject Device to the predicate in terms of finished device.
  There are no new technologies being added to the predicate in terms of fini There are no new teennologics bother and application as the predicate device.

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Image /page/5/Picture/0 description: The image shows the word "GENICON" in a bold, sans-serif font. The word is slightly curved, and there is a curved line underneath it. The registered trademark symbol is located to the right of the word.

Non-Clinical Tests 7.
K190168

Non-clinical tests were conducted to verify that the GENICON Reusable Electrosurgical Probe product Non cimical tosts were contactions as the substantially equivalent predicate device and any additional test ime met an acongin opomodiations as i recluded in this submission include the following:

· Medical Electrical Equipment Testing
Autoclave Sterilization Validation

IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-2-2:2009 IEC 60601-2-18:2009 ISO 17655-1:2006 Cycle Count Testing

In addition the GENICON Aquas Probes product line has been compared to the predicate device through m adultion the OENTOON Aqadoral use/performance and electrical safety and effectiveness.

Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued August 15, 2016. This (210(K)) Submissions for Licclosurgiour Donost for General Cally and maximum generator power in requires testing on three unferent tissue types. The spread is then measured under order to simular themal opread with the predicate product. Results showed an equivalent maginlication, and TCOrdou to be occipared the different tissue types and power settings.

The GENICON Aquas Probes product line was also compared to the predicate device through bench THE SENION Aqual & operational use, ergonomic forces, and electrical safety. Testing on testing which included visual a operations that the devices met the same requirements as the predicate product.

1. Clinical Tests
  Ollinian Fests
  There were no clinical trials performed on the GENICON Reusable Electrosurgical Probe product line.
1. Conclusions
  Conclusions The Subject device has herformance and bench testing of the GENICON Aquas Probes Characteristics, non-cinical testing and portomiane and meets the same performance standard. product life show that the device to as enostantially equivalent to the predicate.

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.