Electro Lube NXT

{0} FDA U.S. FOOD & DRUG ADMINISTRATION April 15, 2025 Steris Steve Elliott Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834 Re: K242773 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: September 13, 2024 Received: March 26, 2025 Dear Steve 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242773 - Steve Elliott Page 2 (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). 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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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-reporting-combination-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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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). {2} K242773 - Steve Elliott Page 3 Sincerely, James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.04.15 23:13:42 -04'00' For 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 {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K242773 | | | 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 sticking and eschar on electrosurgical instruments, including robotic assisted 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) | | | 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 Drug 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." | | {4} STERIS® K242773 510(k) Summary For Electro Lube NXT STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 Contact: Steven Elliott Senior Manager, Regulatory Affairs Telephone: (223) 267-9228 e-mail: Steven_Elliott@steris.com Summary Date: April 15, 2025 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 K242773 {5} Electro Lube NXT K242773 # 1. Device Name Trade Name: Electro Lube NXT Device Class: Class II Common/usual Name: Electrosurgical Non-stick Coating Accessory Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Classification Number: 21 CFR 878.4400 Product Code: GEI # 2. Predicate Device K241055 Electro Lube NXT Table 1. Device Comparison Table for Electro Lube NXT and Predicate | Feature | Electro Lube NXT (Proposed Device) | Electro Lube NXT (Predicate Device/K241055) | | --- | --- | --- | | Indications for Use | Electro Lube™ NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue sticking and eschar on electrosurgical instruments, including robotic assisted electrosurgical instruments. | 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 | | Intended Use | Electro Lube™ NXT is intended to be used on electrodes to reduce sticking and eschar. | Electro Lube™ NXT is intended to be used on electrodes to reduce sticking and eschar. | | Components | • Electro Lube Vial containing 4mL of Electro Lube • Foam applicator pad with adhesive backing and barium strip | • Electro Lube Vial containing 4mL of Electro Lube • Foam applicator pad with adhesive backing and barium strip | | Materials of Construction | • Electro Lube NXT - Lexolube® CQ-3000 • Accessory Foam Sponge - Polyester Polyurethane Foam; Medical Double-Coated Tape; Barium Cord • Electro Lube Bottle – Medium Density Polyethylene | • Electro Lube NXT - Lexolube® CQ-3000 • Accessory Foam Sponge - Polyester Polyurethane Foam; Medical Double-Coated Tape; Barium Cord • Electro Lube Bottle – Medium Density Polyethylene | | Sterile | Yes - Irradiation | Yes - Irradiation | | SAL | 10^{-6} | 10^{-6} | | Performance | • Evaluation of Tissue Adhesion – reduced sticking of probe versus uncoated control | • Evaluation of Tissue Adhesion – reduced sticking of probe versus uncoated control | K242773 {6} Electro Lube NXT K242773 | Feature | Electro Lube NXT (Proposed Device) | Electro Lube NXT (Predicate Device/K241055) | | --- | --- | --- | | | • Evaluation of Eschar removal – reduced eschar on probe after wiping. • Evaluation of Appearance – visual inspection of color, clarity and absence of particulates. • Evaluation of Product Odor Profile – odor profile of EL NXT 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 EL NXT coated electrodes vs uncoated. • Evaluation of Ease of Product Removal – Comparison of removal of EL NXT 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 EL NXT 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 EL NXT, predicate device and uncoated electrode. Thermal spread impact of ELNXT on thermal spread must be equivalent or smaller than predicate. • Evaluation of Sponge Interaction – determination that no damage or degradation occurs during use-life and conditions. Reprocessing | • Evaluation of Eschar removal – reduced eschar on probe after wiping. • Evaluation of Appearance – visual inspection of color, clarity and absence of particulates. • Evaluation of Product Odor Profile – odor profile of EL NXT 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 EL NXT coated electrodes vs uncoated. • Evaluation of Ease of Product Removal – Comparison of removal of EL NXT 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 EL NXT 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 ELNXT, predicate device and uncoated electrode. Thermal spread impact of ELNXT on thermal spread must be equivalent or smaller than predicate. • Evaluation of Sponge Interaction – determination that no damage or degradation occurs during use-life and conditions. Reprocessing | K242773 Page 3 of 6 {7} Electro Lube NXT K242773 | Feature | Electro Lube NXT (Proposed Device) | Electro Lube NXT (Predicate Device/K241055) | | --- | --- | --- | | | conditions. Reprocessing Validation Test – Demonstration of effective cleaning of electrosurgical instruments after simulated use with ELNXT • Cleaning Evaluation – Use of Electro Lube NXT does not impede cleaning of non-robotic electrosurgery instruments | Validation Test – Demonstration of effective cleaning of electrosurgical instruments after simulated use with ELNXT • Cleaning Evaluation – Use of Electro Lube NXT does not impede cleaning non-robotic electrosurgery instruments | | Performance Testing for Updated Claims | • Cleaning Evaluation – Electro Lube NXT impact on cleaning of robotic instruments. Electro Lube NXT does not impact cleaning of robotic electrosurgery instruments. • Thermal Spread Evaluation - Comparison of thermal spread profiles between EL NXT and uncoated electrode on robotic assisted surgery system. | N/A | | Biocompatibility | Acute Systemic Toxicity Dermal Sensitization Intracutaneous Reactivity In Vitro Cytotoxicity Rabbit Pyrogenicity Hemolysis | Acute Systemic Toxicity Dermal Sensitization Intracutaneous Reactivity In Vitro Cytotoxicity Rabbit Pyrogenicity Hemolysis | ## 3. Description of Device Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to reduce 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 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. K242773 Page 4 of 6 {8} Electro Lube NXT K242773 ## 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 sticking and eschar on electrosurgical instruments, including robotic-assisted electrosurgical instruments. ## 5. 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 | | --- | --- | | Evaluation of Appearance | The material is clear and homogenous without any particulate | | Evaluation of Product Odor Profile | odor profile of Electro Lube NXT is equivalent or better than the odor profile of the predicate | | 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. | | 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. | | 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 | | Evaluation of Ease of Product Removal | Percentage of product removed by wiping is higher or not statistically different from the predicate device removal | | 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 | | 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 | | Flash Point Determination- Closed Cup Method | Flashpoint greater that 200°F | | Evaluation of Pourability/Dispensing | Pourability equivalent or better than predicate. | | Evaluation of Sponge Interaction | Applicator sponge incorporates product, does not become discolored, exhibits no damage and does not leave particulate on electrosurgical instruments | | Reprocessing Validation Testing | Use of product does not prevent cleaning of electrosurgical instruments, including robotic assisted surgical instruments, to accepted thresholds | | Thermal Spread Evaluation | Thermal damage associated with the tested electrosurgery tools (irrigating bipolar forceps, blade electrodes, IS4000 | K242773 {9} Electro Lube NXT K242773 | Test | Criterion | | --- | --- | | | Cautery Spatula) were not negatively impacted by the use of Electro Lube NXT | | Biocompatibility | Cytotoxicity – MEM Elution | | | Sensitization – Skin Sensitization Study in Guinea Pigs by Guinea Pig Maximization Test | | | Irritation – EL201 Intracutaneous Reactivity Test in New Zealand White Rabbits | | | Acute Systemic Toxicity – Acute Systemic Toxicity Test in Wistar Rats | | | Hemocompatibility – ASTM Hemolysis Direct Contact and Extract Methods | | | Pyrogenicity – Material Mediated Pyrogenicity Test in New Zealand White Rabbits | 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 K241055, Class II (21 CFR 878.4400), product code GEI. 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