(59 days)
Not Found
No
The description focuses on standard RF electrosurgical generator technology and does not mention any AI or ML components. The performance studies listed are standard electrical safety, biocompatibility, and software validation tests, not AI/ML model training or validation.
Yes
The device is intended for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures, which are therapeutic actions to treat medical conditions.
No
The device is described as an electrosurgical generator used for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels, which are interventional and therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a radiofrequency (RF) electrosurgical generator, which is a hardware device that produces and delivers energy. It also includes physical components like push buttons, lamps, digital displays, and connections for accessories. While it mentions software verification and validation, this is for software contained within the hardware device, not a standalone software product.
Based on the provided information, the Ellusa Generator and Ellusa Monopolar Tips are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the device is for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures." This describes a device used on the patient's body during surgery, not for testing samples outside the body.
- Device Description: The description details a radiofrequency electrosurgical generator and electrodes used to deliver energy to tissue for cutting and coagulation. This is consistent with surgical equipment, not IVD equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ellusa system is a surgical tool used for therapeutic purposes (cutting, coagulating, stopping bleeding) directly on the patient.
N/A
Intended Use / Indications for Use
The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches.
Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Non-Clinical Testing:
- . AAMI ANSI ES60601-1 - Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance
- . IEC 60601-1-2 - Medical Electrical Equipment, Part I-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
- IEC 60601-2-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 62366 Medical devices Application of usability engineering to medical devices. .
Sterilization of Monopolar Tips:
- . ISO 11135 - Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- . ISO 11737-2 - Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process /
- . ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Biocompatibility Testing:
- . ISO 10993-1 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7 - Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals
- . ISO 10993-10 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Shelf Life Testing:
- . ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Performance Testing: - . Software verification and validation in accordance with IEC 62304 and the FDA Final Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- . Energy output verification of each of the five modes and comparison to predicate.
- . Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue.
- . A design verification /validation was conducted to validate the design and functionality of the generator and Monopolar Tip accessories. Tests included output power test, Hipot test, pull test, lateral heat spread in tissue test, evaluation of temperature profile, and final test. All tests passed their applicable acceptance criteria.
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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 2, 2020
Ellusa, LLC Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist 2473 Grand Avenue Baldwin, New York 11510
Re: K202562
Trade/Device Name: Ellusa Generator and Monopolar Tips
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2020 Received: September 4, 2020
Dear Ms. Lucas:
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.
1
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 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 (QS) 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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202562
Device Name Ellusa Generator and Monopolar Tips
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
Image /page/3/Picture/1 description: The image shows the word "ellusa" in a stylized font. The word is in black and is set against a white background. There are three curved lines to the left of the word, which appear to be a design element. The font is sans-serif and has rounded edges.
510(k)SUMMARY (As required by 21 CFR 807.92(a)) (K202562)
October 28, 2020
Submitter's Information (807.92(a)(1))
Company Name and Address: Ellusa, LLC 2473 Grand Avenue Baldwin, NY 11510 Phone: (516) 866-0001 www.ellusa.com
Establishment Registration 3016087306
Contact Information:
Ms. Suzanne Lucas Sr. Regulatory Affairs Specialist Phone: (516) 866-0001 Email: slucas@ellusa.com
Device Information (807.92(a)(2))
Trade Name: Ellusa Generator and Monopolar Tips
Common/Usual Name
Electrosurgical unit and accessories, electrosurgical cutting and coagulation device and accessories
Classification Name and Regulation
Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400
Classification Panel
General and Plastic Surgery Device
Device Class/Product Code
FDA Classification: Class II FDA Product Code: GEI
4
Predicate Device (807.92(a)(3))
Soniquence RF Generator & Monopolar Electrodes (K183611)
Use of Guidance Documents
The content provided within this 510k follows the FDA guidance document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" issued on March 9, 2020.
Device Description (807.92(a)(4))
The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators.
All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches.
Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel).
These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
Intended Use:
The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.
5
Comparison of Technological Characteristics
The subject devices are substantially equivalent to the predicate devices based on a comparison of physical and performance characteristics. There are no technological differences between the subject device as compared to the predicate devices, and the indications for use are identical to the predicate devices.
Comparison of Generator models
| Characteristic | Soniquence Generator
K183611
PREDICATE | Ellusa Generator
Type 1
Proposed Device | Ellusa Generator
Type 2
Proposed Device | Ellusa Generator
Type 3
Proposed Device | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Photo | Image: Soniquence Generator K183611 PREDICATE | Image: Ellusa Generator Type 1 Proposed Device | Image: Ellusa Generator Type 2 Proposed Device | Image: Ellusa Generator Type 3 Proposed Device | |
| Model
numbers
available | (Type 1 models)
IEC6-SESP120, IEC6-IESP170,
IEC6-IENSP170, IEC6-SESP170,
IEC6-SENSP170
(Type 2 models)
IEC6-IESU120, IEC6-IENSU120,
IEC6-SENSU120, IEC6-
SESU120, IEC6-IESU170, IEC6-
IENSU170, IEC6-SESU170,
IEC6-SENSU170
(Type 3 models)
IEC6-IESV120, IEC4-SEN120,
IEC6-SENSV120, IEC6-
SESV120, IEC6-IESV170, IEC6-
IENSV170, IEC6-SESV170,
IEC6-SENSV170 | IEC6-SEEP120
IEC6-IEEP170
IEC6-IENEP170
IEC6-SEEP170
IEC6-SENEP170
IEC4-ESM120
IEC4-ESP
IEC3A-ES30W | IEC6-IEEU120
IEC6-IENEU120
IEC6-SENEU120
IEC6-SEEU120
IEC6-IEEU170
IEC6-IENEU170
IEC6-SEEU170
IEC6-SENEU170 | IEC6-IEEV120
IEC4-SEN120
IEC6-SENEV120
IEC6-SEEV120
IEC6-IEEV170
IEC6-IENEV170
IEC6-SEEV170
IEC6-SENEV170
IEC4-EJSM120 | |
| Principle of
Operation | Conversion of electrical
energy to high-frequency
RF energy (monopolar and
bipolar) | Identical to predicate | Identical to predicate | Identical to predicate | |
| Characteristic | | Soniquence Generator
K183611
PREDICATE | Ellusa Generator
Type 1
Proposed Device | Ellusa Generator
Type 2
Proposed Device | Ellusa Generator
Type 3
Proposed Device |
| Modes of
operation /
mechanism of
action | Cut | 4.0 MHz
square wave
envelope
150W max.
output | All Identical to
predicate except
models
IEC4-ESM120, IEC4-
ESP, &
IEC3A-ES30W are max
120W output | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is max 120W output |
| | Blend | 4.0 MHz
square wave
envelope
110W max.
output | All Identical to
predicate except
models
IEC4-ESM120, IEC4-
ESP, &
IEC3A-ES30W are max
90W output and the
mode is called
Cut/Coag | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is 90W output and
the mode is called
Cut/Coag. |
| | Hemo | 4.0 MHz
square wave
envelope
60W max.
output | Identical to predicate | Identical to predicate | Identical to predicate |
| | Bipolar | 1.7 MHz CW
sinusoidal
wave
40W max
output | Identical to predicate
except models
IEC4-ESM120, IEC4-
ESP, &
IEC3A-ES30W mode is
called Bipolar Hemo
(minor change in
nomenclature only,
function and
performance stay the
same) | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is Fulgurate
(Monopolar) and 4.0
MHz
Sinusoidal wave
40W max. output |
| | Bipolar
Turbo | 1.7 MHz
square wave
envelope
170W max.
output | All Identical to
predicate except
models
IEC4-ESM120, IEC4-
ESP, &
IEC3A-ES30W are max
120W output | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is max120W output
and mode is Bipolar |
| Output
frequency | | 4 MHz (monopolar)
1.7 MHz (bipolar) | Identical to predicate | Identical to predicate | Identical to predicate |
| Maximum
power output | | 170W | All Identical to
predicate except
models
IEC4-ESM120, IEC4-
ESP, &
IEC3A-ES30W | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is 120W |
| | Soniquence Generator
K183611
PREDICATE | Ellusa Generator
Type 1
Proposed Device | Ellusa Generator
Type 2
Proposed Device | Ellusa Generator
Type 3
Proposed Device | |
| Characteristic | | | | | |
| | | IEC3A-ES30W are
120W | | | |
| Voltage
(peak-to-peak) | 1,200V | Identical to predicate | Identical to predicate | Identical to predicate | |
| Power
activation
control | Footswitch and/or
fingerswitch | Identical to predicate | Identical to predicate | Identical to predicate | |
| Electrical
safety and
EMC testing
standards | AAMI ANSI ES60601-1
IEC 60601-1-2
IEC 60601-2-2 | Identical to predicate | Identical to predicate | Identical to predicate | |
| Applied part
type | CF | All Identical to
predicate except
models
IEC4-ESM120,
IEC4-ESP, &
IEC3A-ES30W are
type BF | Identical to predicate | All Identical to
predicate except
model IEC4-EJSM120
is type BF | |
6
7
Comparison of Monopolar Tips
| Predicate Information | Soniquence Monopolar Electrodes
(K183611) | Ellusa Monopolar Tips |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PREDICATE | PROPOSED DEVICE |
| Intended Use | The Soniquence Monopolar Electrodes are
intended for use by a physician familiar with
resection, dissection, incision, and hemostasis
in soft tissue surgical procedures. | The Ellusa Monopolar Tips are intended for
use by a physician familiar with resection,
dissection, incision, and hemostasis in soft
tissue surgical procedures. |
| Product Code | GEI | Identical to predicate |
| Device Classification | Class II | Identical to predicate |
| Functions | Cutting/coagulation | Identical to predicate |
| Energy type/ operating
principle | Monopolar | Identical to predicate |
| Design Specifications | Integrated sterile components; handle, cable,
connector, shaft, monopolar electrode | Identical to predicate |
| Shaft forms | Straight, Bayonet, angled, and curved | Identical to predicate |
| Shaft malleability | Fixed and malleable models | Identical to predicate |
| Shaft lengths | 1.9 – 60 cm | Identical to predicate |
| Shaft diameter | 1/16" | Identical to predicate |
| Tip Configurations | Loop (round, diamond), ball, and blade (needle,
fine wired, spatula) | Identical to predicate |
8
| Material Composition | Identical to predicate | |
|---|---|---|
| Handle | Molded Plastic | |
| Surgical Stainless Steel/Brass | ||
| Shaft | Surgical Stainless Steel/ Tungsten/Brass | |
| Electrode | Surgical stainless steel / PFA insulation | |
| Patient contacting | ||
| materials | Medical grade stainless steel, brass, tungsten, | |
| Loctite, PFA, and PTFE | Identical to predicate | |
| Coating | None | Identical to predicate |
| Biocompatibility | ISO 10993 | Identical to predicate |
| Sterilization Methods | Gamma or Ethylene Oxide | Identical to predicate |
| Expiration Dating | Yes | Identical to predicate |
| Packaging | Sterile, Blister Tray | |
| Sterile, Peel Pouch | Identical to predicate | |
| Activation Method | Fingerswitch/Footswitch | Identical to predicate |
| Manual Controls | No, all power settings established on generator | Identical to predicate |
| Min., Max., Default | ||
| output Values (Wattage) | 0-170 | Identical to predicate |
| Cable Length (m) | 3 | Identical to predicate |
| Temperature Probe | No | Identical to predicate |
| Cooling Function | None | Identical to predicate |
Summary of Technological Characteristics
The Ellusa Generator and Monopolar Tips are equivalent in intended use, technological characteristics, operating principle, and technical specifications to the predicate device Soniquence Generator and Monopolar Electrodes (K183611).
The differences of minor changes in nomenclature of operating modes does not affect the function or performance of the devices. In addition, the reduced output power on some models does not introduce new risks or affect the safety and effectiveness of the devices.
Non-Clinical Testing (807.92(b)(1))
The Ellusa Generator and Monopolar Tips will be manufactured in accordance with the design control requirements of 21 CFR 820.30. Appropriate non- clinical verification and validation activities were planned and conducted in order to address identified risks and ensure the safety and effectiveness of the device. The following tests were successfully performed:
- . AAMI ANSI ES60601-1 - Medical Electrical Equipment, Part I: General requirements for basic safety and essential performance
9
- . IEC 60601-1-2 - Medical Electrical Equipment, Part I-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
- IEC 60601-2-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 62366 Medical devices Application of usability engineering to medical devices. .
Sterilization of Monopolar Tips:
- . ISO 11135 - Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- . ISO 11737-2 - Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process /
- . ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Biocompatibility Testing:
- . ISO 10993-1 - Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7 - Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals
- . ISO 10993-10 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Shelf Life Testing:
- . ASTM F1980-07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Performance Testing:
- . Software verification and validation in accordance with IEC 62304 and the FDA Final Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- . Energy output verification of each of the five modes and comparison to predicate.
10
- . Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue.
- . A design verification /validation was conducted to validate the design and functionality of the generator and Monopolar Tip accessories. Tests included output power test, Hipot test, pull test, lateral heat spread in tissue test, evaluation of temperature profile, and final test. All tests passed their applicable acceptance criteria.
Conclusion (807.92(b)(3))
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate devices in terms of technology, performance, and indications for use, Ellusa, LLC concludes that the Ellusa Generator and Monopolar Tips are substantially equivalent to and as safe and effective as the predicate devices described above. The only difference between the subject devices of this 510k and the predicate devices is a rebranding with the Ellusa name. The technology remains the same.