(214 days)
Not Found
No.
The document describes a physical medical accessory (a lubricating solution and applicator for electrosurgical instruments) with no mention of computational or software components.
No
The device is described as an accessory for electrosurgical instruments, intended to reduce tissue sticking and eschar. It does not directly treat a disease or condition in a patient but rather improves the performance of another medical device during a surgical procedure.
No
The description explicitly states its purpose is to "reduce tissue sticking and eschar on electrosurgical instruments," implying a therapeutic or accessory function during surgery rather than a diagnostic one.
No
The device is a physical product (a solution, foam pad, and packaging) intended to be applied to electrosurgical instruments. It is explicitly described as a "single-use sterile electrosurgical accessory device" and undergoes nonclinical tests related to its physical properties and performance when applied to instruments. There is no mention of software components, algorithms, data processing, or any other characteristic typical of a software-only medical device.
No.
The device is used to reduce tissue sticking and eschar on electrosurgical instruments during surgery, which is a therapeutic purpose, not for obtaining information from a specimen derived from the human body.
N/A
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.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Electro Lube NXT
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
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"
Page 2
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).
Page 3
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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
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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."
Page 5
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060-1834 USA
440-354-2600
K242773 Page 1 of 6
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 Page 1 of 6
Page 6
Electro Lube NXT K242773
K242773 Page 2 of 6
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 |
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Electro Lube NXT K242773
K242773 Page 3 of 6
| 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 | • 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 EL NXT 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 |
Page 8
Electro Lube NXT K242773
K242773 Page 4 of 6
| 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.
Page 9
Electro Lube NXT K242773
K242773 Page 5 of 6
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 |
Page 10
Electro Lube NXT K242773
K242773 Page 6 of 6
| 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.