Electro Lube NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue adhesion and eschar on electrosurgical instruments.

Device Description

Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to prevent sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.

Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the anti-stick solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.

AI/ML Overview

The provided text describes the regulatory filing for a medical device (Electro Lube NXT) and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It is not an AI/ML device, so information like sample size for training set, number of experts for ground truth, or MRMC studies are not applicable. However, I can extract the acceptance criteria and the "study" (non-clinical tests) that proves the device meets the criteria.

Acceptance Criteria and Reported Device Performance

The "study" in this context refers to a series of non-clinical tests performed to demonstrate the safety and effectiveness of the Electro Lube NXT, and its substantial equivalence to the predicate device.

Test	Acceptance Criterion	Reported Device Performance/Conclusion
Evaluation of Appearance	The material is clear and homogeneous without any particulate.	Pass
Evaluation of Product Odor Profile	Odor profile of Electro Lube NXT is equivalent or better than the odor profile of the predicate.	Pass
Evaluation of Product Viscosity and Coating	The material visually coats the electrode as well or superior to the coating applied by the predicate and that Electro Lube NXT does not drip more frequently than the predicate.	Pass
Evaluation of Cutting Force and Impedance	The cutting force required for an electrode coated in Electro Lube NXT is not more than the cutting force required for a bare electrode.	Pass
Evaluation of Electrode Adherence to Tissue	No greater weight loss when an electrode coated in Electro Lube NXT is removed from the tissue as compared to that which occurs when the bare electrode is removed from tissue.	Pass
Evaluation of Ease of Product Removal	Percentage of product removed by wiping is higher or not statistically different from the predicate device removal.	Pass
Evaluation of Ease of Eschar Removal	Percentage of eschar removal after tissue burns using a blade electrode is with product is higher or not significantly different from the eschar removed from an uncoated blade.	Pass
Evaluation of Potential for the Evolution of Hazardous Scenario	No observance of hazardous situations (fire, ESU fault) resulting from repeated use of product to cut tissue.	Pass
Flash Point Determination - Closed Cup Method	Flashpoint greater than 200°F.	Pass
Evaluation of Pourability/Dispensing	Pourability equivalent or better than predicate.	Pass
Evaluation of Sponge Interaction	Applicator sponge incorporates product, does not become discolored, exhibits no damage and does not leave particulate on electrosurgical instruments.	Pass
Reprocessing Validation Testing	Use of product does not prevent cleaning of electrosurgical instruments to accepted thresholds.	Pass
Thermal Spread Evaluation	Thermal damage associated with the tested electrosurgery tools (irrigating bipolar forceps and blade electrodes) were not negatively impacted by the use of Electro Lube NXT.	Pass
Biocompatibility	Cytotoxicity: MEM ElutionSensitization: Skin Sensitization Study in Guinea Pigs by Guinea Pig Maximization TestIrritation: EL201 Intracutaneous Reactivity Test in New Zealand White RabbitsAcute Systemic Toxicity: Acute Systemic Toxicity Test in Wistar RatsHemocompatibility: ASTM Hemolysis Direct Contact and Extract MethodsPyrogenicity: Material Mediated Pyrogenicity Test in New Zealand White Rabbits	All Pass

Study Details:

Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes for each non-clinical test (e.g., number of electrodes tested, number of tissue samples, number of animals for biocompatibility).
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be a pre-market non-clinical validation conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA), rather than a clinical trial. The tests are likely performed in controlled laboratory settings. The nature of these tests is prospective in the sense that they are specifically designed experiments to evaluate the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-AI/ML device. The "ground truth" for these tests isn't established by human experts interpreting data. Instead, it's determined by objective measurements and standardized protocols for physical and chemical properties, and biological responses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where inter-reader variability needs to be resolved for establishing ground truth. For non-clinical device performance testing, results are based on direct measurement against defined criteria.
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 is not an AI/ML device, and no MRMC study or assessment of human reader improvement is mentioned or relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device involving an algorithm. The "performance" is the device's physical, chemical, and biological interaction, not an algorithmic prediction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's non-clinical performance is defined by established scientific and engineering principles, material science, and biological compatibility standards. For example:
  - Physical/Chemical Properties: Measured values (e.g., flash point, viscosity) compared to specified thresholds.
  - Functional Performance: Observations of the device's behavior (e.g., coating ability, eschar removal, cutting force) under controlled experimental conditions, often compared to an uncoated or predicate substance.
  - Biocompatibility: Standardized in vitro and in vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity) with results compared against acceptable biological response criteria.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that undergoes a "training" phase.
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned for this 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 31, 20224

STERIS Corporation Steven Elliott Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K241055

Trade/Device Name: Electro Lube NXT Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 17, 2024 Received: April 17, 2024

Dear Steven Elliott:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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 H. Chen =S Digitally signed by Long H. Chen-S
Date: 2024.05.31 14:38:58 -04'00'

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

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Indications for Use

510(k) Number (if known) K241055

Device Name

Electro Lube NXT

Indications for Use (Describe)

Electro Lube NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue adhesion and eschar on electrosurgical instruments.

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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K240155

Image /page/3/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is an image of several horizontal, wavy lines in blue.

510(k) Summary For Electro Lube NXT

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Steven Elliott Contact: Senior Manager, Regulatory Affairs

Telephone: (223) 267-9228 e-mail: Steven_Elliott@steris.com

May 31, 2024 Summary Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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K240155

STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Electro Lube NXT

Device Name 1.

Trade Name:	Electro Lube NXT
Device Class:	Class II
Common/usual Name:	Electrosurgical Non-stick Coating Accessory
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Classification Number:	21 CFR 878.4400
Product Code:	GEI

2. Predicate Device

Electro Lube K033880

Feature	Electro Lube(Predicate Device/K033880)	Electro Lube NXT(Proposed device)	Comparison
Indications for Use	Electro Lube is a single patientuse device that is intended to beused on electrodes to reducesticking.	Electro Lube NXT is a singlepatient use device used in open andminimally invasive surgery toreduce tissue adhesion and escharon electrosurgical instruments.	Similar. TheLanguage hasbeen revised toclarify theintended use.
Intended Use	Electro Lube is intended to beused on electrodes to reducesticking and eschar.	Electro Lube NXT is intended tobe used on electrodes to reducesticking and eschar.	Same
Components	• Electro Lube Vial containing4mL of Electro Lube• Foam applicator pad withadhesive backing and bariumstrip	• Electro Lube NXT Vialcontaining 4mL of Electro LubeNXT• Foam applicator pad withadhesive backing and bariumstrip	Same
Materials ofConstruction	• Electro Lube –phospholipidsolution• Accessory Foam Sponge -Polyurethane Foam; MedicalDouble-Coated Tape; BariumCord• Electro Lube Bottle –Polyethylene	• Electro Lube NXT - polyol esterAccessory Foam Sponge -Polyurethane Foam; MedicalDouble-Coated Tape; BariumCord• Electro Lube NXT Bottle –Polyethylene	Electro Lubeformulationchanged. Othermaterials ofconstruction arethe same
Sterile	Yes - Irradiation	Yes - Irradiation	Same
SAL	10-6	10-6	Same
Performance	• Evaluation of Tissue Adhesion— reduced sticking of probeversus uncoated control• Evaluation of Eschar removal -reduced eschar on probe afterwiping	• Evaluation of Tissue Adhesion –reduced sticking of probe versusuncoated control• Evaluation of Eschar removal –reduced eschar on probe afterwiping	Additional testingperformed tosupport deviceperformance andcharacterize theproposed device.
Feature	Electro Lube(Predicate Device/K033880)	Electro Lube NXT(Proposed device)	Comparison
		Evaluation of Appearance – visual inspection of color, clarity and absence of particulates. Evaluation of Product Odor Profile – odor profile of ELII no worse than Electro Lube Evaluation of Product Viscosity and Coating – coat electrode without excessive dripping. Evaluation of Cutting Force and Impedance – cutting force is no greater in ELII coated electrodes vs uncoated. Evaluation of Ease of Product Removal – Comparison of removal of ELII verses predicate by wiping. Evaluation of Potential for the Evolution of Hazardous Scenario – observation of ignition potential of substrate using highest energy setting for successive burns Flash Point - Closed Cup Method – Demonstration that ELII has flash point greater than 200 °C. Evaluation of Pourability/Dispensing - Comparison in pourability to Predicate. Thermal Spread Evaluation - Comparison of thermal spread profiles between ELII, and uncoated electrode. Evaluation of Sponge Interaction – determination that no damage or degradation occurs during use-life and conditions. Reprocessing Validation Test - Demonstration of effective cleaning of electrosurgical instruments after simulated use with Electro Lube NXT
Biocompatibility	Acute Systemic Toxicity Dermal Sensitization Intracutaneous Reactivity	Acute Systemic Toxicity Dermal Sensitization Intracutaneous Reactivity In Vitro Cytotoxicity Rabbit Pyrogenicity Hemolysis	Additional tests performed to meet current biocompatibility test expectations

Table 1. Device Comparison Table for Electro Lube NXT and Predicate

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Electro Lube NXT

The proposed device is similar to the predicate devices in terms of intended use and mode of operation. The proposed device and predicate device contain differences in

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Electro Lube NXT

indications for use to clarify the function of the proposed device. The proposed device and predicate differ in materials of construction as a new formulation is used for the proposed device. The proposed device, like the predicate device is a viscous liquid in a polyethylene vial with a foam applicator sponge. The proposed device is applied and used in the same manner as the predicate. The proposed device differs in the formulation of the non-stick agent.

3. Description of Device

4. Intended Use/Indications for Use

Electro Lube NXT is a single patient use device used in open and minimally invasive surgery to reduce tissue adhesion and eschar on electrosurgical instruments.

ર. Summary of Nonclinical Tests

Electro Lube NXT has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness as compared to the predicate device. Testing to assess and demonstrate substantial equivalence to the predicate is summarized below.

Test	Criterion	Conclusion
Evaluation ofAppearance	The material is clear and homogenous without anyparticulate	Pass
Evaluation of ProductOdor Profile	odor profile of Electro Lube NXT is equivalent or betterthan the odor profile of the predicate	Pass
Evaluation of ProductViscosity and Coating	The material visually coats the electrode as well or superiorto the coating applied by the predicate and that ElectroLube NXT does not drip more frequently than thepredicate.	Pass

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STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Electro Lube NXT

Test	Criterion	Conclusion
Evaluation of CuttingForce and Impedance	the cutting force required for an electrode coated in ElectroLube NXT is not more than the cutting force required for abare electrode.	Pass
Evaluation of ElectrodeAdherence to Tissue	no greater weight loss when an electrode coated in ElectroLube NXT is removed from the tissue as compared to thatwhich occurs when the bare electrode is removed fromtissue	Pass
Evaluation of Ease ofProduct Removal	Percentage of product removed by wiping is higher or notstatistically different from the predicate device removal	Pass
Evaluation of Ease ofEschar Removal	Percentage of eschar removal after tissue burns using ablade electrode is with product is higher or not significantlydifferent from the eschar removed from an uncoated blade	Pass
Evaluation of Potentialfor the Evolution ofHazardous Scenario	No observance of hazardous situations (fire, ESU fault)resulting from repeated use of product to cut tissue	Pass
Flash PointDetermination- ClosedCup Method	Flashpoint greater that 200°F	Pass
Evaluation ofPourability/Dispensing	Pourability equivalent or better than predicate.	Pass
Evaluation of SpongeInteraction	Applicator sponge incorporates product, does not becomediscolored, exhibits no damage and does not leaveparticulate on electrosurgical instruments	Pass
ReprocessingValidation Testing	Use of product does not prevent cleaning of electrosurgicalinstruments to accepted thresholds	Pass
Thermal SpreadEvaluation	Thermal damage associated with the tested electrosurgerytools (irrigating bipolar forceps and blade electrodes) werenot negatively impacted by the use of Electro Lube NXT	Pass
Biocompatibility	Cytotoxicity - MEM Elution	Pass
	Sensitization - Skin Sensitization Study in Guinea Pigs byGuinea Pig Maximization Test	Pass
	Irritation - EL201 Intracutaneous Reactivity Test in NewZealand White Rabbits	Pass
	Acute Systemic Toxicity - Acute Systemic Toxicity Test inWistar Rats	Pass
	Hemocompatibility – ASTM Hemolysis Direct Contact andExtract Methods	Pass
	Pyrogenicity - Material Mediated Pyrogenicity Test inNew Zealand White Rabbits	Pass

6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the proposed device is as safe, as effective and performs at least as well as the legally marketed predicate device K033880, Class II (21 CFR 878.4400), product code GEI.

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.