The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.

Device Description

The GENICON X-Surge monopolar laparoscopic instruments are sterile packaged Single Use Mono-Polar attachments intended for use in combination with a compatible reposable handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The device diameter has a range of 3 - 5mm, and connects to a handle with the appropriate configuration. The handle has a male cautery connector that will be utilized for cauterizing soft tissue when attached to standard monopolar cautery cables and their generators.

The disposable shaft and tips are composed of an aluminum outer shaft, and a stainless steel drive rod which connects to the scissor blades and interacts with the handle activation rod. The outer insulation consists of fluorinated ethylene which is an insulation with functional material properties that are improved over Polytetrafluoroethylene PTFE, and is less rigid than Radel insulation. The disposable shafts and tips are to be supplied sterile in single unit trays with Tyvek lid, similar to the current GENICON electrosurgical instrumentation line. The Reposable handle is sterilized by the user using an autoclave process and is then connected to the sterile disposable shaft or tip. Once the procedure is completed, the instrument ends are disassembled from the handle, and are disposed of appropriately, and the handle is cleaned and sterilized for the next procedure.

AI/ML Overview

The provided text describes the 510(k) submission for the GENICON X-Surge Electrosurgical Instrument, comparing it to a predicate device (GENICON Electrosurgical Instrumentation, K061417). The submission focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria related to AI or diagnostic performance. Therefore, many of the requested elements for an AI/diagnostic study (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types) are not applicable or detailed in this document.

However, I can interpret "acceptance criteria" based on the provided performance testing for a medical device and highlight what information is available. The study described focuses on non-clinical performance and safety testing to show equivalence to a predicate device.

Here's an attempt to answer the questions based only on the provided document, noting where information is not available due to the nature of the device and submission:

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

The document doesn't explicitly list specific quantitative "acceptance criteria" in a table format for performance beyond "equivalent or better" compared to the predicate. Instead, it describes performance studies conducted to demonstrate equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Cut Performance	Equivalent or better than the predicate device.	"Testing showed the X-Surge device performed equivalent or better than the predicate Genicon product." (Regarding instances of slipping, overall cut length, scissor geometry)
Electrical Performance (Thermal Spread)	Equivalent or less thermal spread than the predicate device under same conditions.	"Results showed an equivalent or less area of thermal spread under the same conditions across the different tissue types and power settings."
Bench Testing (Visual & Operational Use, Ergonomic Forces)	Met the same requirements as the predicate product.	"Testing on performance and general ergonomic use showed that the X-Surge device met the same requirements as the predicate product in terms of closure force, opening angle, finger spacing, and rotation knob interaction."
Biocompatibility	Conforms to ISO10993	"Conforms to ISO10993"
Sterilization	Equivalent to predicate (Irradiation or Ethylene Oxide)	"SAME" as predicate (Irradiation or Ethylene Oxide)
Materials	Equivalent or comparable to predicate (specific list provided).	Patient Contact: AISI Stainless Steel, FEP; Non-Patient Contact: Aluminum, Polycarbonate, Nylon, ABS, HDPE/LDPE, TPE. (Predicate used Radel instead of FEP for patient contact)
Diameter	SAME as predicate (3mm to 5mm)	"SAME" as predicate
Intended Use	SAME as predicate (General & Plastic Surgery, GEI)	"SAME" as predicate
Prescription Only	YES	"SAME" as predicate

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: The document mentions "three tissue samples of different origin" for cut performance testing and "three different tissue types" for electrical performance testing. Specific quantities beyond "three" for these tissue samples are not provided. For bench testing, no specific sample size is mentioned.
Data Provenance: Not specified (e.g., country of origin).
Retrospective or Prospective: The testing described appears to be prospective lab/bench testing conducted for the purpose of this submission rather than analysis of existing data.

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 is not a study requiring expert ground truth for diagnostic performance like an AI algorithm. The performance evaluation is based on objective measurements (e.g., thermal spread under magnification, force measurements, visual inspection of cuts) directly from the device's function.

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

Not applicable. Not a diagnostic study with human interpretation requiring adjudication.

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 device is an electrosurgical instrument, not an AI-assisted diagnostic tool for human readers. 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 a physical electrosurgical device, not a standalone algorithm.

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

Not applicable. Ground truth, in the sense of a diagnostic benchmark, is not relevant here. The "ground truth" for performance is the objective measurement of the device's physical and electrical properties against its intended function and comparison to the predicate device. For example:

Cut performance: measured cut length, observation of slipping, geometry measurements.
Electrical performance: measured area of thermal spread.
Ergonomic forces: objective force measurements, angle measurements, finger spacing measurements.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable. As above, this is a physical medical device, not an AI model.

Summary

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October 17, 2017 GENICON, Inc. Ms. Katlyn Kachman Director of Quality 6869 Stapoint Court Suite 114 Winter Park, Florida 32792

Re: K171752

Trade/Device Name: X-Surge Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 2, 2017 Received: October 3, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 of medical device-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.

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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, Jennifer R. Stevenson -S3 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

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Indications for Use

510(k) Number (if known) K171752

Device Name X-Surge

Indications for Use (Describe)

Indeathis surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterized soft tissue.

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 logo for GENICON. The logo is in blue and features the company name in a bold, sans-serif font. A curved line in shades of blue and green runs beneath the name, adding a dynamic element to the design.

K171752 Page 1 of 3

K171752 510(k) Summary

Contact Information GENICON 6869 Stapoint Court, Suite 114, Winter Park, FL 32792 Phone (407) 657-4851 Fax (407) 677-9773 Katlyn Kachman, Director of Quality July 7, 2017

1. Device Name
- Trade Name X-Surge ●
- Common Name Laparoscopic Instruments .
- Classification Name Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, ● Product Code GEI)
1. Substantially Equivalent Device

Legally Marketed (unmodified device) GENICON Electrosurgical Instrumentation, K061417

Device	GENICON Electrosurgical Instrumentation 510(k)K061417	GENICON X-Surge 510(k): K171752
Intended Use	General & Plastic Surgery (GEI)	General & Plastic Surgery (GEI)
ComponentDesign	Current Electrosurgical InstrumentAssemblyImage: Current Electrosurgical Instrument AssemblyA. Insulated ShaftB. Rotation KnobC. Monopolar PostD. HandleE. Jaw assembly	Shaft and Handle assemblyImage: Shaft and Handle assemblyA. Insulated ShaftB. Shaft Locking KnobC. Rotation KnobD. Monopolar PostE. HandleF. Jaw AssemblyTip and Handle assemblyImage: Tip and Handle assemblyA. Insulated TipB. Insulated ShaftC. Rotation KnobD. Monopolar PostE. HandleF. Jaw Assembly
Design	The GENICON disposable electrosurgicalinstruments are single use sterile instruments madefrom biocompatible plastic and stainless steel witha working length of 33cm. Current may be suppliedby an approved electrosurgical generator whichprovides the ability for the coagulation of tissuewhen used with an appropriate ground electrode.	GENICON X-Surge instrumentation line is composed ofsingle use sterile instruments (Reposable handle optionavailable), made from biocompatible plastic, aluminumand stainless steel. When combined the working length is20cm to 45cm. Current may be supplied by an approvedelectrosurgical generator which provides the ability for thecoagulation of tissue when used with an appropriateground electrode.

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Image /page/4/Picture/0 description: The image shows the logo for Genicon. The word "GENICON" is written in large, bold, blue letters. Underneath the word is a curved line that is blue on top and fades into green on the bottom. The logo is simple and professional.

K171752 Page 2 of 3

Diameter	3mm to 5mm	SAME
Materials	Patient Contact - AISI Stainless Steel, RadelNon-Patient Contact - Polycarbonate, Nylon, ABS,HDPE/LDPE	Patient Contact - AISI Stainless Steel, FEPNon-Patient Contact - Aluminum, Polycarbonate, Nylon,ABS, HDPE/LDPE, TPE
Testing	Fully assembled device was tested for cut andcoagulation performance on three tissue samplesof different origin. The test was performed at thelowest, default, and highest settings of a typicalsurgery center, and results were recorded.	Performance of the X-Surge product showed that thedevice performed equivalent or better and is thereforesubstantially equivalent in performance to the predicatedevice.
Performance	GENICON Disposable ElectrosurgicalInstrumentation is indicated for use in endoscopicsurgical procedures. It is a family of instrumentswhich includes graspers, dissectors, and scissors,which are intended to be used to grasp,manipulate, cut, and cauterize soft tissue.	SAME
Sterilization	Irradiation or Ethylene Oxide	SAME
Prescription Only	YES	SAME
Biocompatibility	Conforms to ISO10993	SAME

4. Device Description

1. Intended Use
  The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
1. Technological Characteristics of the Subject Device Compared to the Predicate Device
  There are no new technologies being added to the device from the predicate in terms of finished device. The device has the same intended use and application as the predicate device. The X-Surge device will have an additional connection point. The X-Surge device will also have a detachable shaft/tip from the handle, but the same technology is used when discussing function of the device. In both instances electrical current will be passed through an insulated shaft and applied to the appropriate tip assembly to grasp, manipulate, cut, and cauterize soft tissues.

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Image /page/5/Picture/0 description: The image shows the logo for Genicon. The word "GENICON" is written in large, bold, blue letters. Underneath the word is a curved line that is blue on top and fades into green on the bottom. The logo is simple and modern.

K171752 Page 3 of 3

7. Non-Clinical Tests

Non clinical tests were conducted to verify that the X-Surge met all design specifications as the substantially equivalent predicate device and any additional test needed to show equivalence. Testing included in this submission include the following:

· Biocompatibility Testing
- o Cytotoxicity Test -
- Skin Sensitization/Irritation Test o
- Acute System Toxicity Test o
· Medical Electrical Equipment testing
- For both single use and reusable o
Aging Study under ETO
Aging Study under Gamma
Autoclave testing verification

ISO 10993-11:2010 IEC 60601-1, IEC 60601-2

ISO 10993-5:2009

ISO 10993-10:2010

In addition the GENICON X-Surge instrumentation line has been compared to the predicate device through performance studies to test cutting performance and electrical safety and effectiveness.

Cut performance across different mediums using the predicate as a baseline was completed in order to compare any instances of slipping, overall cut length across testing mediums, and scissor geometry including: scissor length, scissor width, and opening and closing dimensions. Testing showed the X-Surge device performed equivalent or better than the predicate Genicon product.

Electrical performance of the device was completed following FDA guidance "Premarket Notification (510(k)) Submissions for Electrosural Devices for General Surgery" issued August 15, 2016. This requires testing on three different tissue types at minimum, default, and maximum generator power in order to simulate thermal spread across different tissue types. The spread is then measured under magnification, and recorded to be compared with the predicate product. Results showed an equivalent or less area of thermal spread under the same conditions across the different tissue types and power settings.

The GENICON X-Surge instrumentation line was also compared to the predicate device through bench testing which included visual & operational use, ergonomic forces (i.e. attachment, activation, etc.). Testing on performance and general ergonomic use showed that the X-Surge device met the same requirements as the predicate product in terms of closure force, opening angle, finger spacing, and rotation knob interaction.

8. Clinical Tests

There were no clinical trials performed on the GENICON X-Surge instrumentation line.

1. Conclusions
  The subject device has identical indications for use as the predicate device. The technological characteristics, non-clinical testing and performance and bench testing of the GENICON X-Surge instrumentation line show that the device is as safe, as effective, and meets the same performance standard. Therefore, the proposed GENICON X-Surge instrumentation is substantially 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.