(104 days)
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.
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.
The acceptance criteria and study proving the device meets them are summarized below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Requirements | Reported Device Performance |
|---|---|---|
| Mechanical Testing | - Monopolar and Return Plug Insertion/Extraction Force- Snap Fit Strength- Weld Integrity Test- Probe Flexural Test- Probe Axial Pull Force | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with 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) |
| Electrical Testing | - Bench-top validation testing for relevant components (HF Leakage Current, HF Dielectric Strength Test, Mains Frequency Dielectric Strength Test, Housing Temperature Verification, Continuity & Activation Switch Resistance) | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) |
| Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 | The results demonstrated compliance of the application device to current IEC 60601-1-2, Ed 4.1: 2017 + AM1:2020 standard requirements. |
| Biocompatibility | - Compliance with ISO 10993-1 and FDA's modified ISO guidelines | Biocompatibility verification was performed in accordance with requirements of ISO 10993-1 and FDA's modified ISO guidelines. |
| Bench-top Validation Testing (General) | - Cable Dynamic Strain Relief- Cable Static Strain Relief- Anchorage Test- Fluid Ingress Test- Visual Inspection- Function Test- Activation Force- 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 | All test requirements were met as specified by applicable standards and the test protocols. |
| Thermal Performance (Tissue Effect) | - Measurement of thermal damage zone in ex vivo tissue compared to predicate device under same generator mode and power settings. | 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. In all cases there was no clinical difference between the thermal damage caused by the Eblator Device and the predicate. Validation was conducted in three different tissues (porcine muscle, liver, and kidney). |
| Packaging Tests | - Burst Test- Seal Strength Test- Bubble Leak Test- Dye Leak Test | All test requirements were met as specified by applicable standards and the test protocols. (Compliance with ISO 11607-1, ISO 11607-2) |
| Shelf Life/Aging | - Accelerated Aging Evaluation Test (2-year storage) | An accelerated aging evaluation test demonstrated compliance of the Eblator Device to meet the defined product specifications after 2 year storage. (Compliance with ASTM F1980) |
| Regulatory Guidance Compliance | - 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). | 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). |
Missing Information from the Provided Text:
The provided text describes a 510(k) premarket notification for a medical device (Eblator Device). Such submissions primarily focus on demonstrating substantial equivalence to a predicate device through various engineering and performance tests, rather than clinical trials or AI performance evaluations with human readers. Therefore, several points from the request are not applicable or not present in this type of document.
The document does not describe a study involving humans, AI, or ground truth developed by experts in the context of diagnostic performance. It focuses on the physical and electrical performance of an electrosurgical device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of device performance testing described. The tests involve multiple units of the Eblator Device for various mechanical, electrical, and functional evaluations. For the thermal performance test, three different ex vivo tissues (porcine muscle, liver, and kidney) were used, but the number of samples or repetitions for each tissue type is not specified.
- Data Provenance: The study was a bench-top validation and ex vivo tissue study. The specific country of origin of the data is not mentioned, but it's an industry-sponsored submission to the FDA (U.S.). It is retrospective in the sense that the tests were conducted prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. The ground truth for the performance tests (e.g., proper function, electrical compliance, thermal damage size) is established by adherence to engineering specifications and recognized standards, not by expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no expert review or adjudication process for the type of engineering and bench-top performance tests described. Test results are compared against predefined numerical and qualitative specifications outlined in standards and internal protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., imaging AI) and involves human readers interpreting cases. The Eblator Device is an electrosurgical tool, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Not applicable. The device is a surgical instrument; there is no embedded algorithm in the diagnostic sense that would perform "standalone" without human interaction. Its performance is measured as a direct physical and electrical output.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is defined by engineering specifications, international and recognized consensus standards (e.g., IEC 60601 series, ISO 10993-1, ISO 11135, ISO 11607, ASTM F1980), and the FDA's specific guidance for electrosurgical devices. For the thermal performance, the ground truth was the comparative thermal damage zone to the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device requiring a training set. The "training" in this context refers to the development and iterative testing of the device during its design phase, which is not quantified by a "training set" in the sense of data science.
9. How the Ground Truth for the Training Set Was Established
- Establishing Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The device design and performance targets are driven by engineering principles, clinical needs, and regulatory requirements.
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: K231126
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | E SURGICAL, LLC150 Isidor CourtUnit 203 Sparks, Nevada 89441 |
| Correspondent ContactInformation: | Mr. Craig CoombsPresidentCoombs Medical Device Consulting1100 Pacific Marina, Suite 806Alameda, California 94501Tel: 650-380-2474Email: 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 878.4400Electrosurgical, Cutting & CoagulationDevice 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 878.4400Electrosurgical, Cutting & CoagulationDevice and Accessories |
| Predicate Device 2 Classification &Product Code: | Class 2,GEI |
B. Date Summary Prepared
1 August 2023
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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.
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E. Comparison to Predicate Device
| Feature | Application Device:Eblator Device | Predicate Device:Bovie DisposableBipolar Ablator(K152777) | Predicate Device:Bovie DisposableBipolar Ablator(K161558) | Pertinence of Feature toConsideration ofSubstantial Equivalence. |
|---|---|---|---|---|
| Indications for Use | The Eblator Device isintended for generalarthroscopic applications,which include cutting,vaporization, andcoagulation. This device isintended to be used inconjunction with a generalpurpose electrosurgicalgenerator via a standardactive lead and a standardreturn lead connection.The device is onlyoperable when activatedin an appropriateconductive media, such asa standard saline solution. | This device is intended tobe used for cutting,vaporization, andcoagulation of soft tissueduring arthroscopicsurgical procedures. Thisdevice is intended to beused with a standardelectrosurgical generatorwith footswitch controland a standard returnelectrode connection, andthe electrode is to beactivated only whenimmersed in a conductivemedia such as standardsaline solution. | Same as K152777 | The difference is that thecompatible electrosurgicalgenerator used with thepredicates must have afootswitch pedal. Theapplication device uses itsintegrated hand switch ora footswitch to control thecurrent. As this differencedoes not impact the safetyand efficacy of the device,it is determined theindication for use forthese three devices areidentical. |
| Product Code | GEI | GEI | GEI | Identical |
| Model Versions | RB4050A-01:4.0 mm 50°AspiratingBipolar Ablator, Single UseRB4050-01:4.0 mm 50°Bipolar Ablator, Single UseRB4090A-01:4.0 mm 90° AspiratingBipolar Ablator, Single Use | BA3350A:3.3 mm DisposableBipolar Ablator 50°,AspiratingBA3350NA:3.3 mm DisposableBipolar Ablator 50°, Non-Aspirating | BA2455NA:2.4 mm DisposableBipolar Ablator 55°, Non-AspiratingBA1860NA:1.8 mm DisposableBipolar Ablator 60°, Non-AspiratingBA3390A: | The application devicepresents a subset ofmodels that are present inthe predicate devices. |
| Feature | Application Device:Eblator Device | Predicate Device:Bovie DisposableBipolar Ablator(K152777) | Predicate Device:Bovie DisposableBipolar Ablator(K161558) | Pertinence of Feature toConsideration ofSubstantial Equivalence. |
| RB4090-01:4.0 mm 90°Bipolar Ablator, Single Use | 3.3 mm DisposableBipolar Ablator 90°,AspiratingBA3390NA:3.3 mm DisposableBipolar Ablator 90°, Non-Aspirating | |||
| Technology | ||||
| Energy Use | Radiofrequency | Same | Same | Identical |
| Operation Principle | Use RF power to generatearcing through bubblesformed between an activeelectrode and tissue withthe tissue being vaporizedby the arcing. | Same | Same | Identical |
| Equipment Mated | General purposeelectrosurgical generatorwith standard returnelectrode connection.Compatible foot switchcontroller is optional.Aspiration:Adequate vacuum source | Standard electrosurgicalgenerator with andstandard return electrodeconnection. Compatiblefoot switch controller isrequired.Aspiration:Adequate vacuum sourcefor procedure | Standard electrosurgicalgenerator with standardreturn electrodeconnection. Compatiblefoot switch controller isrequired.Aspiration:Adequate vacuum sourcefor procedure | Almost identical.The one small differenceis the predicate devicerequires a foot controlpedal to connect to anelectrosurgical generatorThe application device canbe hand or footcontrolled.Otherwise, identical. |
| Use only in ConductiveMedia | for procedureThe electrode is to beactivated only whenimmersed in a conductivemedia such as standardsaline solution | Same | Same | Identical |
| Feature | Application Device:Eblator Device | Predicate Device:Bovie DisposableBipolar Ablator(K152777) | Predicate Device:Bovie DisposableBipolar Ablator(K161558) | Pertinence of Feature toConsideration ofSubstantial 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 (withoutcable and tube) | 13.5" (343 mm) | 11.85" (301.0 mm) | 11.85" (301.0 mm) | Similar |
| Cable Length from theHandle | 12 feet | 10 feet | 10 feet | Functionally identical |
| User interface | Handswitch integrated inthe handle or Footswitch | Footswitch | Footswitch | Functionally identical |
| Aspirating and Non-Aspirating Models | Yes | Yes | Yes | Identical |
| Outer Diameter at end ofthe 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 thepredicates |
| 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 60601-1IEC 60601-1-2IEC 60601-2-2FDA RF Guidance | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Almost identical,application device is inconformance with latestversion of the standards |
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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 ●
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- 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.
| StandardsBody & # | Standard Name | Standard Version |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment — Part 1: General requirements for basicsafety and essential performance | 2005 + AM1:2012+AM2:2020 |
| IEC 60601-1-2 | Medical electrical equipment — Part 1-2: General requirements forbasic 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 forthe safety of high frequency surgical equipment | 2017 |
| ISO 10993-1 | Biological Evaluation of Medical Devices — Part 1: Evaluation andtesting within a risk management process. | 2018 |
| ISO 11135 | Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control of asterilization 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:
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| StandardsBody & # | Standard Name | Standard Version |
|---|---|---|
| ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1:Requirements for materials, sterile barrier systems and packagingsystems; | 2019 |
| ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validationrequirements for forming, sealing and assembly processes | 2019 |
| ASTM F1980 | Standard Guide for Accelerated Aging of Sterile Barrier Systems forMedical 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).
§ 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.