(44 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of an anti-stick solution and application pad, with no mention of AI or ML technology.
No
The device is used to reduce tissue adhesion and eschar on electrosurgical instruments, which is an accessory function to the surgical procedure, not a direct therapeutic action on the patient's condition.
No
The device is an electrosurgical accessory used to reduce tissue adhesion and eschar on electrosurgical instruments, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "single-use sterile electrosurgical accessory device" and includes physical components like a bottle of solution and a foam pad. The performance studies also focus on physical and chemical properties of the solution and pad.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce tissue adhesion and eschar on electrosurgical instruments" during surgery. This is a direct interaction with surgical instruments and tissue during a medical procedure, not an analysis of samples taken from the body in vitro (outside the body).
- Device Description: The description focuses on its use as an accessory for electrosurgical electrodes to prevent sticking. This is a functional aid during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Electro Lube NXT does not fit this definition.
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 adhesion and eschar on electrosurgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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)
Nonclinical Tests:
- Evaluation of Appearance: The material is clear and homogenous without any particulate. Conclusion: Pass.
- Evaluation of Product Odor Profile: odor profile of Electro Lube NXT is equivalent or better than the odor profile of the predicate. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: Pass.
- Evaluation of Ease of Product Removal: Percentage of product removed by wiping is higher or not statistically different from the predicate device removal. Conclusion: 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. Conclusion: 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. Conclusion: Pass.
- Flash Point Determination- Closed Cup Method: Flashpoint greater that 200°F. Conclusion: Pass.
- Evaluation of Pourability/Dispensing: Pourability equivalent or better than predicate. Conclusion: Pass.
- Evaluation of Sponge Interaction: Applicator sponge incorporates product, does not become discolored, exhibits no damage and does not leave particulate on electrosurgical instruments. Conclusion: Pass.
- Reprocessing Validation Testing: Use of product does not prevent cleaning of electrosurgical instruments to accepted thresholds. Conclusion: 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. Conclusion: Pass.
Biocompatibility: - Cytotoxicity - MEM Elution. Conclusion: Pass.
- Sensitization - Skin Sensitization Study in Guinea Pigs by Guinea Pig Maximization Test. Conclusion: Pass.
- Irritation - EL201 Intracutaneous Reactivity Test in New Zealand White Rabbits. Conclusion: Pass.
- Acute Systemic Toxicity - Acute Systemic Toxicity Test in Wistar Rats. Conclusion: Pass.
- Hemocompatibility – ASTM Hemolysis Direct Contact and Extract Methods. Conclusion: Pass.
- Pyrogenicity - Material Mediated Pyrogenicity Test in New Zealand White Rabbits. Conclusion: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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).
1
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
2
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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3
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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
4
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 and |
| Accessories | |
| 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 patient
use device that is intended to be
used on electrodes to reduce
sticking. | 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. | Similar. The
Language has
been revised to
clarify the
intended use. |
| Intended Use | Electro Lube 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. | Same |
| Components | • Electro Lube Vial containing
4mL of Electro Lube
• Foam applicator pad with
adhesive backing and barium
strip | • Electro Lube NXT Vial
containing 4mL of Electro Lube
NXT
• Foam applicator pad with
adhesive backing and barium
strip | Same |
| Materials of
Construction | • Electro Lube –phospholipid
solution
• Accessory Foam Sponge -
Polyurethane Foam; Medical
Double-Coated Tape; Barium
Cord
• Electro Lube Bottle –
Polyethylene | • Electro Lube NXT - polyol ester
Accessory Foam Sponge -
Polyurethane Foam; Medical
Double-Coated Tape; Barium
Cord
• Electro Lube NXT Bottle –
Polyethylene | Electro Lube
formulation
changed. Other
materials of
construction are
the same |
| Sterile | Yes - Irradiation | Yes - Irradiation | Same |
| SAL | 10-6 | 10-6 | Same |
| Performance | • Evaluation of Tissue Adhesion
— reduced sticking of probe
versus uncoated control
• Evaluation of Eschar removal -
reduced eschar on probe after
wiping | • Evaluation of Tissue Adhesion –
reduced sticking of probe versus
uncoated control
• Evaluation of Eschar removal –
reduced eschar on probe after
wiping | Additional testing
performed to
support device
performance and
characterize the
proposed 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
5
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
6
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
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.
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 of | ||
| Appearance | The material is clear and homogenous 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 |
7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION Electro Lube NXT
| Test | Criterion | Conclusion |
|---|---|---|
| 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 that 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 Elution | Pass |
| Sensitization - Skin Sensitization Study in Guinea Pigs by | ||
| Guinea Pig Maximization Test | Pass | |
| Irritation - EL201 Intracutaneous Reactivity Test in New | ||
| Zealand White Rabbits | Pass | |
| Acute Systemic Toxicity - Acute Systemic Toxicity Test in | ||
| Wistar Rats | Pass | |
| Hemocompatibility – ASTM Hemolysis Direct Contact and | ||
| Extract Methods | Pass | |
| Pyrogenicity - Material Mediated Pyrogenicity Test in | ||
| New 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.