Who is the manufacturer of Eblator Device?

E Surgical, LLC filed the 510(k) submission for Eblator Device (K231126).

What is the FDA product code for Eblator Device?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Eblator Device?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Eblator Device?

Bovie Disposable Bipolar Ablator (K152777); Bovie Disposable Bipolar Ablator (K161558).

Who can help prepare an FDA 510(k) submission like Eblator Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Eblator Device

K231126 · E Surgical, LLC · GEI · Aug 2, 2023 · General, Plastic Surgery

Device Facts

Record ID	K231126
Device Name	Eblator Device
Applicant	E Surgical, LLC
Product Code	GEI · General, Plastic Surgery
Decision Date	Aug 2, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

Device Story

Electrosurgical ablator for arthroscopic surgery; utilizes radiofrequency (RF) energy to generate arcing through bubbles formed between active electrode and tissue; results in tissue vaporization/coagulation. Device comprises insulated handle, active electrode, optional aspiration tube, and return connector. Operated by physician in clinical setting; controlled via integrated hand switch or optional footswitch connected to general-purpose electrosurgical generator. Requires immersion in conductive media (saline) for activation. Single-use, sterile device; provides surgical precision for arthroscopic procedures; benefits patient through controlled tissue ablation.

Clinical Evidence

Bench-top testing only. Evaluated thermal effects on ex vivo porcine muscle, liver, and kidney tissue; compared thermal damage zones against predicate devices. Results showed no clinical difference in thermal damage. Mechanical, electrical, EMC, and biocompatibility testing performed per ISO 10993-1 and IEC 60601 standards. Accelerated aging confirmed 2-year shelf life.

Technological Characteristics

Bipolar RF electrosurgical ablator; 50° and 90° electrode angles; aspirating and non-aspirating models. Materials sterilized via Ethylene Oxide (ISO 11135). Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (HF surgical equipment). Connectivity via standard active/return leads to external generator.

Indications for Use

Indicated for general arthroscopic applications including cutting, vaporization, and coagulation of soft tissue. Contraindicated for use outside of appropriate conductive media (e.g., saline solution).

Regulatory Classification

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.

Predicate Devices

Bovie Disposable Bipolar Ablator (K152777)
Bovie Disposable Bipolar Ablator (K161558)

Related Devices

K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating · Bovie Medical Corporation · Jul 29, 2016
K251899 — E Blator · New Deantronics Taiwan , Ltd. · Oct 1, 2025
K020579 — AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 · Aaron Medical Industries · May 13, 2002
K171391 — Stryker 90-S Max SERFAS Energy Probe · Stryker · Jan 26, 2018
K170703 — Single Use Arthroscopic Electrode (with Pencil) · Modern Medical Equipment Manufacturing Limited · May 31, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 2, 2023 E Surgical, LLC % Mr. Craig Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda. California 94501 Re: K231126 Trade/Device Name: Eblator Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 18, 2023 Received: April 20, 2023 Dear Mr. Coombs: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, Image /page/1/Picture/5 description: The image shows the name "Mark Trumbore -S" in large font on the left side of the image. On the right side of the image, the text "Digitally signed by Mark Trumbore -S Date: 2023.08.02 08:05:27 -04'00'" is present. This indicates that the document has been digitally signed by Mark Trumbore on August 2, 2023, at 8:05:27 AM with a time zone offset of -04'00'. Mark Trumbore, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231126 Device Name Eblator Device Indications for Use (Describe) The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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." {3}------------------------------------------------ # 510(k) Summary: K231126 ## A. Device Information: | Category | Comments | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | E SURGICAL, LLC 150 Isidor Court Unit 203 Sparks, Nevada 89441 | | Correspondent Contact Information: | Mr. Craig Coombs President Coombs Medical Device Consulting 1100 Pacific Marina, Suite 806 Alameda, California 94501 Tel: 650-380-2474 Email: CraigJCoombs@gmail.com | | Device Common Name: | Electrosurgical Ablator | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification & Product Code: | Class II, GEI | | Device Proprietary Name: | Eblator Device | ## Predicate Device Information: | Predicate Device 1: | Bovie Disposable Bipolar Ablator | |------------------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device 1 Manufacturer: | Bovie Medical Corporation | | Predicate Device 1 Common Name: | Electrosurgical Ablator | | Predicate Device 1 Premarket Notification #: | K152777 | | Predicate Device 1 Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Predicate Device 1 Classification & Product Code: | Class 2, GEI | | Predicate Device 2: | Bovie Disposable Bipolar Ablator | |------------------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device 2 Manufacturer: | Bovie Medical Corporation | | Predicate Device 2 Common Name: | Electrosurgical Ablator | | Predicate Device 2 Premarket Notification #: | K161558 | | Predicate Device 2 Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Predicate Device 2 Classification & Product Code: | Class 2, GEI | ## B. Date Summary Prepared 1 August 2023 {4}------------------------------------------------ ## C. Description of Device The application device, the Eblator Device, is an electrosurgical ablator for general arthroscopic applications. In conjunction with a general purpose electrosurgical generator, the Eblator Device provides cutting, vaporization and coagulation of target tissue by radio frequency electrosurgical energy. As with most hand-controlled surgical pencils, the Eblator Device can also be used with footswitch control when a footswitch is connected to a generator designed for footswitch control. The Eblator Device is requesting clearance for 4 models of Eblator Device, representing different combinations of electrode configurations and aspiration design. The Eblator Device models include 2 different electrode angles, 90° and 50°, as well as with or without aspiration design. Except for these characteristics, these 4 models are all identical. The Eblator Device is designed to be used with a compatible electrosurgical generator and aspiration system (aspiration model only). These devices are single use and are sold sterile. #### D. Indications for Use The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. {5}------------------------------------------------ ## E. Comparison to Predicate Device | Feature | Application Device: Eblator Device | Predicate Device: Bovie Disposable Bipolar Ablator (K152777) | Predicate Device: Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence. | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. | This device is intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. This device is intended to be used with a standard electrosurgical generator with footswitch control and a standard return electrode connection, and the electrode is to be activated only when immersed in a conductive media such as standard saline solution. | Same as K152777 | The difference is that the compatible electrosurgical generator used with the predicates must have a footswitch pedal. The application device uses its integrated hand switch or a footswitch to control the current. As this difference does not impact the safety and efficacy of the device, it is determined the indication for use for these three devices are identical. | | Product Code | GEI | GEI | GEI | Identical | | Model Versions | RB4050A-01: 4.0 mm 50°Aspirating Bipolar Ablator, Single Use RB4050-01: 4.0 mm 50° Bipolar Ablator, Single Use RB4090A-01: 4.0 mm 90° Aspirating Bipolar Ablator, Single Use | BA3350A: 3.3 mm Disposable Bipolar Ablator 50°, Aspirating BA3350NA: 3.3 mm Disposable Bipolar Ablator 50°, Non- Aspirating | BA2455NA: 2.4 mm Disposable Bipolar Ablator 55°, Non- Aspirating BA1860NA: 1.8 mm Disposable Bipolar Ablator 60°, Non- Aspirating BA3390A: | The application device presents a subset of models that are present in the predicate devices. | | Feature | Application Device: Eblator Device | Predicate Device: Bovie Disposable Bipolar Ablator (K152777) | Predicate Device: Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence. | | | RB4090-01: 4.0 mm 90° Bipolar Ablator, Single Use | | 3.3 mm Disposable Bipolar Ablator 90°, Aspirating BA3390NA: 3.3 mm Disposable Bipolar Ablator 90°, Non- Aspirating | | | Technology | | | | | | Energy Use | Radiofrequency | Same | Same | Identical | | Operation Principle | Use RF power to generate arcing through bubbles formed between an active electrode and tissue with the tissue being vaporized by the arcing. | Same | Same | Identical | | Equipment Mated | General purpose electrosurgical generator with standard return electrode connection. Compatible foot switch controller is optional. Aspiration: Adequate vacuum source | Standard electrosurgical generator with and standard return electrode connection. Compatible foot switch controller is required. Aspiration: Adequate vacuum source for procedure | Standard electrosurgical generator with standard return electrode connection. Compatible foot switch controller is required. Aspiration: Adequate vacuum source for procedure | Almost identical. The one small difference is the predicate device requires a foot control pedal to connect to an electrosurgical generator The application device can be hand or foot controlled. Otherwise, identical. | | Use only in Conductive Media | for procedure The electrode is to be activated only when immersed in a conductive media such as standard saline solution | Same | Same | Identical | | Feature | Application Device: Eblator Device | Predicate Device: Bovie Disposable Bipolar Ablator (K152777) | Predicate Device: Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence. | | Design -Mechanism | | | | | | Main Component | insulated handle, active electrode, aspirating tube, return connector, footswitch connector (optional) | insulated handle, active electrode, aspirating tube, return connector, footswitch connector | insulated handle, active electrode, aspirating tube, return connector, footswitch connector | Similar | | Handle Width | 1" (25.2 mm) | 0.82" (20.8 mm) | 0.82" (20.8 mm) | Similar | | Device Length (without cable and tube) | 13.5" (343 mm) | 11.85" (301.0 mm) | 11.85" (301.0 mm) | Similar | | Cable Length from the Handle | 12 feet | 10 feet | 10 feet | Functionally identical | | User interface | Handswitch integrated in the handle or Footswitch | Footswitch | Footswitch | Functionally identical | | Aspirating and Non- Aspirating Models | Yes | Yes | Yes | Identical | | Outer Diameter at end of the ceramic insulator | 4.0 mm | 4.0 mm | 4.0 mm (90° Ablator) | Identical | | Electrode Face Angle | 50, 90 degrees | 50 degrees | 55, 60, and 90 degrees | Identical to a subset of the predicates | | Working Length | 160 mm | Same | Same | Identical | | Other Attributes | | | | | | Single Use or Reusable | Single use | Same | Same | Identical | | Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical | | Standard Met | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 FDA RF Guidance | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | Almost identical, application device is in conformance with latest version of the standards | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## F. Summary of Supporting Data Performance testing was completed to demonstrate substantial equivalence of the application device to the predicates. The application device was subjected to the following verification and validation tests, as applicable: ### Mechanical testing Mechanical verification testing was conducted for the proposed device to ensure compliance with mechanical requirements of IEC-60601-1, Ed 3.2, 2005 + AM1:2012 + AM2:2020; IEC 60601-2-2, Ed 6.0: 2017, and E Surgical self-enforced requirements. - Monopolar and Return Plug Insertion/Extraction Force - Snap Fit Strength - Weld Integrity Test - . Probe Flexural Test - Probe Axial Pull Force ### Electrical testing Electrical verification testing was conducted for the relevant components of the application device to ensure compliance with current electrical standard requirements described above. ### Electromagnetic compatibility Electromagnetic compatibility (EMC) testing has been completed for the applicable components of the proposed device. The results demonstrated compliance of the application device to current IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 standard requirements. #### Biocompatibility Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines. ## Bench-top validation testing Standard Tests: - Cable Dynamic Strain Relief - Cable Static Strain Relief - Anchorage Test - Fluid Ingress Test - HF Leakage Current - HF Dielectric Strength Test - Mains Frequency Dielectric Strength Test - Housing Temperature Verification Non-Standard Tests: - Visual Inspection - Function Test - Activation Force ● {9}------------------------------------------------ - Continuity & Activation Switch Resistance - Activation Over Time - Aspiration Tube Dynamic Strain Relief - Aspiration Tube Static Strain Relief - Distal Fluid Ingress Test - Active Electrode to Inner Tube Torque Test - Fluid Leak Test - Activation Thermal Performance Test Packaging Tests: - Burst Test - . Seal Strength Test - Bubble Leak Test - Dye Leak Test An accelerated aging evaluation test demonstrated compliance of the Eblator Device to meet the defined product specifications after 2 year storage. The thermal effects of the Eblator Device on ex vivo tissue was evaluated by measuring the size of the thermal damage zone caused by the Eblator Device compared to the size of thermal damage zone caused by the predicate device under the same generator mode and power settings. Validation was conducted in three different tissues (porcine muscle, liver, and kidney). In all cases there was no clinical difference between the thermal damage caused by the Eblator Device and the predicate. All test requirements were met as specified by applicable standards and the test protocols. | Standards Body & # | Standard Name | Standard Version | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | IEC 60601-1 | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance | 2005 + AM1:2012 +AM2:2020 | | IEC 60601-1-2 | Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests | 2017 + AM1:2020 | | IEC 60601-2-2 | Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment | 2017 | | ISO 10993-1 | Biological Evaluation of Medical Devices — Part 1: Evaluation and testing within a risk management process. | 2018 | | ISO 11135 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | 2014 + AM1: 2018 | The application Eblator Device was tested and found to be in compliance with the pertinent portions of the following standards: {10}------------------------------------------------ | Standards Body & # | Standard Name | Standard Version | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems; | 2019 | | ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | 2019 | | ASTM F1980 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | 2016 | In addition, the Eblator Device was fully tested and found to be in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020). ## G. Conclusion After comparing the indications for use, technology and design of the Eblator Device and the predicate devices, along with all electrical safety (including IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) and performance testing (including the thermal effects of the devices on three different tissues), and in accordance with the FDA's guidelines and FDArecognized consensus standards for such devices, E Surgical concludes that the Eblator Device is substantially equivalent to the predicate Bovie Disposable Bipolar Ablators (K152777, K161558).