(104 days)
Not Found
No
The summary describes a standard electrosurgical device for arthroscopic procedures, focusing on mechanical and electrical performance, not AI/ML capabilities. There are no mentions of AI, ML, or related concepts like image processing or training/test sets.
Yes
The device is described as an electrosurgical ablator intended for general arthroscopic applications, providing cutting, vaporization, and coagulation of target tissue, which are all therapeutic actions.
No
The device is described as an electrosurgical ablator intended for cutting, vaporization, and coagulation of tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical electrosurgical ablator with different electrode configurations and aspiration designs, intended to be used with a generator and aspiration system. It undergoes mechanical, electrical, and biocompatibility testing, which are characteristic of hardware devices, not software-only devices.
Based on the provided text, the Eblator Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general arthroscopic applications, which include cutting, vaporization, and coagulation." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details an "electrosurgical ablator" that uses radio frequency energy to "provide cutting, vaporization and coagulation of target tissue." This is a therapeutic device used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Eblator Device performs a surgical function directly on the patient's tissue.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ●
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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).