E Blator

{0} FDA U.S. FOOD & DRUG ADMINISTRATION New Deantronics Taiwan Ltd. % Coombs Craig President Coombs Medical Device Consulting, Inc. 427 14th Ave San Francisco, California 94118 October 1, 2025 Re: K251899 Trade/Device Name: E Blator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 2, 2025 Received: September 2, 2025 Dear Coombs Craig: 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} K251899 - Coombs Craig 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} K251899 - Coombs Craig Page 3 Sincerely, Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2025.10.01 14:46:58 -04'00' Colin Kejing Chen, Ph.D. Acting 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} E Blator Page 9 of 38 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251899 | ? | | Please provide the device trade name(s). | | ? | | E Blator | | | | Please provide your Indications for Use below. | | ? | | The E Blator 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. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} NEW DEANTRONICS K251899: E Blator 510(k) Summary # 510(k) Summary for K251899 A. Device Information: | Category | Comments | | --- | --- | | Sponsor: | New Deantronics Taiwan Ltd. 12F. No.51, Sec. 4, Zhongyang Rd., Tucheng Dist., New Taipei City, 236 Taiwan | | Correspondent Contact Information: | Mr. Craig Coombs President Coombs Medical Device Consulting, Inc. 427 14^{th} Ave, San Francisco, CA, 94118 Tel: 650-380-2474 Email: craigJcoombs@gmail.com | | Common Name | Electrosurgical accessory | | Classification Number | 21 CFR 878.4400 | | Classification & Product Code | Class II, GEI | | Proprietary Name | E Blator | Predicate Device Information: | Predicate Device | Eblator Device | | --- | --- | | Manufacturer | E Surgical, LLC | | Common Name | Electrosurgical Ablator | | Premarket Notification # | K231126 | | Classification | 21 CFR 878.4400 | | Classification & Product Code | Class 2, GEI | Reference Device 1: | Reference Device | Bovie Disposable Bipolar Ablator | | --- | --- | | Manufacturer | Bovie Medical Corporation | | Common Name | Electrosurgical Generator Accessory | | Premarket Notification # | K161558 | | Classification | 21 CFR 878.4400 | | Classification & Product Code | Class 2, GEI | {5} NEW DEANTRONICS K251899: E Blator 510(k) Summary Reference Device 2: | Reference Device | Arthrex Synergy RF System | | --- | --- | | Manufacturer | Arthrex, Inc. | | Common Name | Electrosurgical, Cutting & Coagulation device and accessories | | Premarket Notification # | K161581 | | Classification | 21 CFR 878.4400 | | Classification & Product Code | Class 2, GEI | Reference Device 3: | Reference Device | Arthrex OPES Electrodes and Accessories Ablator | | --- | --- | | Manufacturer | Arthrex, Inc | | Common Name | High Frequency Devices and Accessories | | Premarket Notification # | K023986 | | Classification | 21 CFR 878.4400 | | Classification & Product Code | Class 2, GEI | ## B. Date Summary Prepared 1 October 2025 ## C. Description of Device The device is equipped with a patented stainless steel electrode tip encased in a thermal insulator. When used in combination with a compatible electrosurgical generator, the device provides radio frequency (RF) energy for cutting, vaporizing, and coagulating soft tissue. The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect with handswitch control, said current then returns back to the electrosurgical unit through the return electrode and connector. This provides the capability for the surgeon to balance tissue dissection and hemostatic effects as needed during a given surgical case. For aspirating models, when coupled with a vacuum system, the surgical field can be cleared of undesirable debris simultaneously by using the aspiration port located at the bottom of the face of the electrode. Removing this debris can facilitate the surgeon's visualization of the surgical field. Page 2 {6} NEW DEANTRONICS K251899: E Blator 510(k) Summary ## D. Indications for Use The E Blator 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. Page 3 {7} NEW DEANTRONICS K251899: E Blator 510(k) Summary ## E. Comparison to Predicate Device This section presents the justification for the substantial equivalence between the subject device, the New Deantronics E Blator, and the predicate and reference devices, including the E Surgical Eblator (K231126, predicate), Bovie Disposable Bipolar Ablator (K161558, reference 1), Arthrex Synergy RF System (K161581, reference 2), and Arthrex OPES Electrodes and Accessories Ablator (K023986, reference 3). The tabular comparison of E Blator is thus split up into three tables in accordance with the different electrode tip configurations. Page 4 {8} NEW DEANTRONICS K251899: E Blator 510(k) Summary (I) Classic Tip | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 1 Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Indications for Use | The E Blator 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. | The E Surgical Eblator device is intended for general arthroscopic applications, which includes cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator active lead and 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. | Identical to predicate and reference 1, except for the name of the device. | | Product Code | GEI | GEI | GEI | Identical | Page 5 {9} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 1 Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Device Category | Classic Tip RB4050A-01 (4.0mm), RB4050-01 (4.0mm), RB4090A-01 (4.0mm), RB4090-01 (4.0mm), RB4090A-02 (4.0mm), RB4090-02 (4.0mm), RB4050A-02 (4.0mm), RB3455-01 (3.4mm), RB3490-01 (3.4mm), RB2790-01 (2.7mm), RB2760-01 (2.7mm), RB2790-00 (2.7mm), RB2760-00 (2.7mm) | Classic Tip RB4050A-01 (4.0mm), RB4050-01 (4.0mm), RB4090A-01 (4.0mm), RB4090-01 (4.0mm) | Classic Tip BA2455NA (2.4mm), BA1860NA (1.8mm) | The application device presents a subset of models (Classic Tip) that are the same as the predicate and the reference 1 devices. | | Technology | | | | | | Energy Use | Radiofrequency electrical energy | Same | Same | Identical to both | | Power output | From monopolar port | Same | Same | Identical to both | | Operation Mode | Bipolar | Same | Same | Identical to both | | 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 to both | | Equipment Mated | General purpose electrosurgical | General purpose electrosurgical | Standard electrosurgical generator | Identical to the predicate | Page 6 {10} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 1 Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | | generator with standard return electrode connection. Compatible foot switch controller is optional. **Aspiration:** Adequate vacuum source for procedure (Applicable to these models: RB4050A-01, RB4090A-01, RB4090A-02, RB4050A-02) | generator with standard return electrode connection. Compatible foot switch controller is optional. **Aspiration:** Adequate vacuum source for procedure (Applicable to these models: RB4050A-01, RB4090A-01) | with standard return electrode connection. Compatible foot switch controller is required. **Aspiration:** Adequate vacuum source for procedure | | | Use only in Conductive Media | The electrode is to be activated only when immersed in a conductive media such as standard saline solution | Same | Same | Identical to both | | Design – Mechanism | | | | | | Main Component | Insulated handle, Active electrode, Aspirating tube, Cable with ESU plug and return connector | Insulated handle, Active electrode, Aspirating tube Cable with ESU plug and return connector | Insulated handle, Active electrode, Aspirating tube, Return connector Footswitch connector | Identical to the predicate. | | Handle Width | 1” (25.2 mm) | 1” (25.2 mm) | 0.82” (20.8 mm) | Identical to the predicate. | | Device Length (without cable and tube) | 9.76” (248 mm), 13.5” (343 mm), 14.49” (368 mm) | 13.5” (343 mm) | 11.85” (301.0 mm) | Functionally identical to both | | Cable Length | 12 feet | 12 feet | 10 feet | Identical to the predicate | | User interface | Handswitch integrated in the handle or Footswitch | Handswitch integrated in the handle or Footswitch | Footswitch | Identical to the predicate | Page 7 {11} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 1 Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Aspirating Feature | *Classic Tip:* Aspirating or non-aspirating | Aspirating or non-aspirating | Aspirating or non-aspirating | Identical to both | | Shaft Diameter | 3.6 mm, 4.4 mm | 4.4 mm | 3.6 mm, 4.4mm | Functionally identical to both. Identical to the reference 1 | | Outer Diameter at end of the ceramic insulator | *Classic Tip* 2.7mm, 3.4mm, 4.0mm | *Classic Tip* 4.0mm | *Classic Tip* 2.7mm, 3.4mm | Functionally identical to both | | Electrode Angle | *Classic Tip:* 50°, 60°, 90° | *Classic Tip:* 50°, 90° | *Classic Tip:* 55°,60° | Functionally identical to both | | Working Length | 65mm, 160mm, 185mm | 155 mm | 160 mm | Functionally identical to both as demonstrated in Thermal Testing | | **Design- Electrical Feature** | | | | | | Maximum Allowable Voltage | 1800 V_{p} | 1800 V_{p} | 1800 V_{p} | Identical to both | | Electrical Safety | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Follow IEC 60601-2-2 requirement | Identical to the predicate | | **Design- Material** | | | | | | Electrode | SUS 304 | Same | Same | Identical to both | | Insulator | Ceramic | Same | Same | Identical to both | | Aspiration Tube | PVC | PVC | Tygon™ | Identical to the predicate | | Aspiration Adaptor | ABS | Same | Same | Identical to both | Page 8 {12} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 1 Bovie Disposable Bipolar Ablator (K161558) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Heat Shrink Tube | PVDF, POF | Same | Same | Identical to both | | Inner Tube | SUS 304 | Same | Same | Identical to both | | Outer Tube | SUS 304 | Same | Same | Identical to both | | Adhesive | Epoxy | Same | Same | Identical to both | | Other Attributes | | | | | | Single Use or Reusable | Single use | Same | Same | Identical to both | | Sterilization | Ethylene Oxide | Same | Same | Identical to both | | Standards 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 FDA RF Guidance | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 FDA RF Guidance | Identical to both | Page 9 {13} NEW DEANTRONICS K251899: E Blator 510(k) Summary (II) Hook | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 2 Arthrex Synergy RF System (K161581) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Indications for Use | The E Blator 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. | The E Surgical Eblator device is intended for general arthroscopic applications, which includes cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator active lead and standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. | The RF Probe are accessories to the Synergy RF Console and are intended for use as a complete system in the resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in arthroscopic and orthopedic procedures. Specifically, the RF probes, Synergy RF Console and their accessories are used for arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, foot and ankle. | Identical to the predicate, except for the name of the device. The applications of the E Blator are clinically equivalent (cutting, vaporization, coagulation) to that of the reference devices. | | Product Code | GEI | GEI | GEI | Identical to both | | Device Category | Hook RB0700-21 (0.75 mm, 0°) | Classic Tip RB4050A-01 (4.0mm, 50°), RB4050-01 (4.0mm, 50°), RB4090A-01(4.0mm, 90°), RB4090-01 (4.0mm, 90°) | Hook AR-9825 (0.75 mm, 0°) | The application device includes Hook-type model that is identical to Reference Device 2. | | Technology | | | | | | Energy Use | Radiofrequency electrical energy | Same | Same | Identical to both | | Power Output | From monopolar port | Same | Same | Identical to both | | Operation Mode | Bipolar | Same | Same | Identical to both | | Operation Principle | Use RF power to generate arcing through bubbles formed between an active electrode and tissue with the | Same | Same | Identical to both | Page 10 {14} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 2 Arthrex Synergy RF System (K161581) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | | tissue being vaporized by the arcing. | | | | | Equipment Mated | General purpose electrosurgical generator with standard return electrode connection. Compatible foot switch controller is optional. | General purpose electrosurgical generator with standard return electrode connection. Compatible foot switch controller is optional. **Aspiration:** Adequate vacuum source for procedure (Applicable to these models: RB4050A-01, RB4090A-01) | Specific electrosurgical generator (SynergyRF™ Bipolar Ablation System) | Identical to the predicate | | Use only in Conductive Media | The electrode is to be activated only when immersed in a conductive media such as standard saline solution | Same | Same | Identical to both | | **Design – Mechanism** | | | | | | Main Component | Insulated handle, Active electrode, Aspirating tube, Cable with ESU plug and return connector | Insulated handle, Active electrode, Aspirating tube Cable with ESU plug and return connector | Insulated handle, Active electrode, Cable with integrated plug | Identical to the predicate. | | Handle Width | 1” (25.2 mm) | 1” (25.2 mm) | 0.95” (24 mm) | Identical to the predicate. | | Device Length (without cable and tube) | 13.5” (343 mm) | 13.5” (343 mm) | 12.6” (320 mm) | Functionally identical to both | | Cable Length | 12 feet | 12 feet | 10 feet | Identical to the predicate | | User interface | Handswitch integrated in the handle or Footswitch | Handswitch integrated in the handle or Footswitch | Handswitch integrated in the handle or Footswitch | Identical to both | Page 11 {15} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 2 Arthrex Synergy RF System (K161581) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Aspirating Feature | *Hook*: Non-Aspirating | Aspirating or Non-Aspirating | Non-Aspirating | Identical to both | | Shaft Diameter | 4.4 mm | 4.4 mm | 4.15 mm | Identical to the predicate | | Outer Diameter at end of the ceramic insulator | *Hook*: 0.75 mm | *Classic Tip*: 4.0 mm | *Hook*: 0.75 mm | Identical to the Ref #2. Functionally identical to both | | Electrode Angle | *Hook*: 0° | *Classic Tip*: 50°, 90° | *Hook*: 0° | Identical to the reference 2 device. Functionally identical to both | | Working Length | 160 mm | Same | Same | Identical to both | | **Design- Electrical Feature** | | | | | | Maximum Allowable Voltage | 1800 V_{p} | 1800 V_{p} | 550V (round) | Identical to the predicate | | Electrical Safety | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Follow IEC 60601-2-2 requirement | Identical to the predicate | | **Design- Material** | | | | | | Electrode | SUS 304 | Same | Same | Identical to the predicate | | Insulator | Ceramic | Same | Same | Identical to the predicate | | Aspiration Tube | (N/A) | (N/A) | (N/A) | Identical to both. The hook electrode model does not include an aspiration tube is identical to the non-aspirating versions of the predicate | Page 12 {16} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 2 Arthrex Synergy RF System (K161581) | Pertinence of Feature to Consideration of Substantial Equivalence | | --- | --- | --- | --- | --- | | Aspiration Adaptor | (N/A) | (N/A) | (N/A) | Identical to both. The hook electrode model does not include an adaptor is identical to the non-aspirating versions of the predicate device. | | Heat Shrink Tube | PVDF, POF | Same | Same | Identical to both | | Inner Tube | SUS 304 | Same | Same | Identical to both | | Outer Tube | SUS 304 | Same | Same | Identical to both | | Adhesive | Epoxy | Same | Same | Identical to both | | Other Attributes | | | | | | Single Use or Reusable | Single use | Same | Same | Identical to both | | Sterilization | Ethylene Oxide | Same | Same | Identical to both | | Standards 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 FDA RF Guidance | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 FDA RF Guidance | Identical to both | Page 13 {17} NEW DEANTRONICS K251899: E Blator 510(k) Summary (III) Ball | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 3 Arthrex OPES Electrodes and Accessories Ablator (K023986) | Pertinence of Feature to Consideration of Substantial Equivalence. | | --- | --- | --- | --- | --- | | Indications for Use | The E Blator 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. | The E Surgical Eblator device is intended for general arthroscopic applications, which includes cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator active lead and standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution. | The Arthrex electrosurgical cutting and coagulation devices and accessories are monopolar in structure, allowing for use in a range of surgical procedures. The Arthrex electrosurgical ablation devices and accessories are intended for use in resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels and tissue in general, arthroscopic, and orthopedic procedures. Specifically, these devices and their accessories will be used for general surgeries, and open and arthroscopic surgery of the shoulder, wrist, hand, elbow, hip, knee, and ankle. | Identical to the predicate, except for the name of the device. The applications of the E Blator are clinically equivalent (cutting, vaporization, coagulation) to that of the reference devices. | | Product Code | GEI | GEI | GEI | Identical to both | Page 14 {18} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 3 Arthrex OPES Electrodes and Accessories Ablator (K023986) | Pertinence of Feature to Consideration of Substantial Equivalence. | | --- | --- | --- | --- | --- | | Device Category | Ball RB2000-11 (2.0 mm, 0°), RB2040-11 (2.0 mm, 40°) | Classic Tip RB4050A-01 (4.0mm, 50°), RB4050-01 (4.0mm, 50°), RB4090A-01(4.0mm, 90°), RB4090-01 (4.0mm, 90°) | Ball AR-9808SJ-45 (0.8 mm, 45°), AR-9808SJ (0.8 mm, 0°) | The application device presents a subset of models (Ball) that are present in the reference 3 device. | | Technology | | | | | | Energy Use | Radiofrequency electrical energy | Same | Same | Identical to both | | Power output | From monopolar port | Same | Same | Identical to both | | Operation Mode | Bipolar | Bipolar | Monopolar | Identical to the predicate. Technically identical to the reference 3 device | | 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 to both | | Equipment Mated | General purpose electrosurgical generator with standard return electrode connection. Compatible foot switch controller is optional. | General purpose electrosurgical generator with standard return electrode connection. Compatible foot switch controller is optional. **Aspiration:** Adequate vacuum source for procedure (Applicable to these models: RB4050A-01, RB4090A-01) | General purpose electrosurgical generator with standard return electrode connection | Identical to both | Page 15 {19} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 3 Arthrex OPES Electrodes and Accessories Ablator (K023986) | Pertinence of Feature to Consideration of Substantial Equivalence. | | --- | --- | --- | --- | --- | | Use only in Conductive Media | The electrode is to be activated only when immersed in a conductive media such as standard saline solution | Same | Same | Identical to both | | Design – Mechanism | | | | | | Main Component | Insulated handle, Active electrode, Aspirating tube, Cable with ESU plug and return connector | Insulated handle, Active electrode, Aspirating tube Cable with ESU plug and return connector | Insulated handle, Active electrode Cable with ESU plug | Identical to the predicate. | | Handle Width | 1” (25.2 mm) | 1” (25.2 mm) | 0.95” (24 mm) | Identical to the predicate. | | Device Length (without cable and tube) | 13.5” (343 mm) | 13.5” (343 mm) | 8.86” (225 mm) | Functionally identical to both | | Cable Length | 12 feet | 12 feet | 10 feet | Identical to the predicate | | User interface | Handswitch integrated in the handle or Footswitch | Handswitch integrated in the handle or Footswitch | Handswitch integrated in the handle or Footswitch | Identical to both | | Aspirating Feature | *Ball:* Non-Aspirating | Aspirating or non-aspirating | Non-Aspirating | Identical to both | | Shaft Diameter | 4.4 mm | 4.4 mm | 4.15 mm | Identical to the predicate | | Outer Diameter at end of the ceramic insulator | *Ball:* 2.0 mm | *Classic Tip:* 4.0 mm | *Ball:* 0.8 mm | Identical geometry to the reference 3 device. Functionally identical to predicate in Thermal Testing. | Page 16 {20} NEW DEANTRONICS K251899: E Blator 510(k) Summary | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 3 Arthrex OPES Electrodes and Accessories Ablator (K023986) | Pertinence of Feature to Consideration of Substantial Equivalence. | | --- | --- | --- | --- | --- | | Electrode Angle | Ball: 40°, 0° | Classic Tip: 50°, 90° | Ball: 45°, 0° | Functionally identical to both | | Working Length | 160 mm | 160 mm | 65 mm | Identical to the predicate | | Design- Electrical Feature | | | | | | Maximum Allowable Voltage | 1800 V_{p} | 1800 V_{p} | 6750_{p} | Identical to the predicate | | Electrical Safety | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Withstand 2160 V_{p} (120% of 1800V_{p}) for High Frequency breakdown Withstand 2800 V_{p} (1000+1800V_{p}) at Main Frequency (60Hz) breakdown | Follow IEC 60601-2-2 requirement | Identical to the predicate | | Design- Material | | | | | | Electrode | SUS 304 | Same | Same | Identical to both | | Insulator | Heatshrink | Ceramic | Heatshrink | Functionally identical to both | | Aspiration Tube | (N/A) | (N/A) | (N/A) | Identical to both. The ball electrode models do not include an aspiration tube are identical to the non-aspirating versions of the predicate device. | | Aspiration Adaptor | (N/A) | (N/A) | (N/A) | Identical to both. The ball electrode models do not include an adaptor and are identical to the non-aspirating versions of | Page 17 {21} NEW K251899: E. Blator | Feature | Application Device New Deantronics E Blator | Predicate Device E Surgical Eblator (K231126) | Reference Device 3 Arthrex OPES Electrodes and Accessories Ablator (K023986) | Pertinence of Feature to Consideration of Substantial Equivalence. | | --- | --- | --- | --- | --- | | | | | | the predicate device. | | Heat Shrink Tube | PVDF, POF | Same | Same | Identical to both | | Inner Tube | SUS 304 | Same | Same | Identical to both | | Outer Tube | SUS 304 | Same | Same | Identical to both | | Adhesive | Epoxy | Same | Same | Identical to both | | Other Attributes | | | | | | Single Use or Reusable | Single use | Same | Same | Identical to both | | Sterilization | Ethylene Oxide | Same | Same | Identical to both | | Standards 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 FDA RF Guidance | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 FDA RF Guidance | Identical to both | Page 18 {22} NEW DEANTRONICS K251899: E Blator 510(k) Summary # F. Summary of Supporting Data The E Blator was tested and found to be in compliance with the pertinent portions of the following standards: | Standards | Title | Version | | --- | --- | --- | | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2005 + AMD1:2012 +AMD2:2020 | | 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 | 2014 +AMD1:2020 | | IEC 60601-2-2 | Medical electrical equipment –Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | 2017 + AMD1:2023 | | 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 + AMD1: 2018 | | ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems | 2019 + AMD1:2023 | | ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | 2019+ AMD1:2023 | In addition, the E Blator was fully tested and 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 E Blator, along with all electrical safety and performance testing, in accordance with the FDA's guidelines and FDA-recognized consensus standards for electrical safety, New Deantronics concludes that the E Blator is substantially equivalent to the predicate and reference devices.