AURORA Evacuator +Coag
Device Facts
| Record ID | K203745 |
|---|---|
| Device Name | AURORA Evacuator +Coag |
| Applicant | Rebound Therapeutics |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Dec 2, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
Device Story
AURORA Evacuator +Coag is a sterile, single-use, battery-powered handheld instrument for minimally invasive surgery. Device features a wand with a distal side-aspiration window containing an internally rotating 301 stainless steel whisk to break up and aspirate soft tissue/fluids via external vacuum source. Bipolar electrodes at the distal tip provide tissue coagulation when connected to an external electrosurgical generator. An integrated irrigation line allows saline delivery to clear the surgical field. Operated by surgeons in OR settings; suction pressure controlled via handle vent; whisk activated by handle button. Device provides fluid/tissue removal and coagulation, aiding visualization and surgical access. Benefits include improved site clearance and hemostasis in limited-access procedures.
Clinical Evidence
Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, 60601-2-2), EMC (IEC 60601-1-2), particulate testing (USP <788>), and sterilization validation. Ex-vivo studies on porcine tissues (heart, liver, kidney, brain) confirmed comparable thermal damage/coagulation zones to the primary predicate.
Technological Characteristics
Handheld, battery-powered (6V alkaline). Wand (7-13 cm, 12F). Materials: 301 SS (whisk), Polyphenylsulfone (insulation). Bipolar electrodes (2 rectangular components). Connectivity: External vacuum, irrigation line, electrosurgical generator cable. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, USP <788>, ASTM F1980-16.
Indications for Use
Indicated for removal of soft tissue and fluids and coagulation of tissue under direct visualization in laparoscopic, pelviscopic, endoscopic, percutaneous, and open surgical procedures, including those with limited access such as neurosurgery.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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December 2, 2021
Rebound Therapeutics Naomi Gong, RAC Vice President of Regulatory Affairs 13900 Alton Pkwy Suite 120 Irvine, California 92618
# Re: K203745
Trade/Device Name: AURORA Evacuator +Coag Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 1, 2021 Received: November 2, 2021
# Dear Naomi Gong:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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)
K203745
Device Name AURORA Evacuator +Coag
### Indications for Use (Describe)
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
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 (K203745)
### SUBMITTER
Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618
| Contact Person: | Naomi Gong, RAC |
|--------------------|------------------------------------------------------------|
| | Vice President of Regulatory Affairs |
| Telephone: | (949) 523-6510 |
| Email: | naomi.gong@integralife.com |
| Date Prepared: | December 2, 2021 |
| DEVICE | |
| Name of Device: | AURORA Evacuator +Coag |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Name: | Electrosurgical Cutting & Coagulation Device & Accessories |
### PREDICATE DEVICE
II
GEI
Regulatory Class:
Product Code:
K960455, Bipolar Suction Coagulator, Kirwan Surgical Products (primary predicate) K201637, AURORA Evacuator +Coag, Rebound Therapeutics (secondary predicate) K190075/K180372, AURORA Evacuator, Rebound Therapeutics (reference)
### DEVICE DESCRIPTION
The AURORA Evacuator +Coag device is provided sterile, for single use only. It is a disposable, handheld, battery powered instrument that combines the ability to remove fluids and soft tissue, apply bipolar energy for the coagulation of tissue, and apply irrigation directly to clear the surgical site during minimally invasive surgical procedures.
It consists of a wand and handle with connection ports for a bipolar electrode cable, vacuum source (for aspiration) and irrigation line. At the distal tip of the wand, a side aspiration window with an internally rotating whisk is provided to break up and aspirate soft tissue and fluids. The battery and motor that powers the whisk is contained in the device handle. Bipolar electrodes are located at the distal tip of the wand and can be activated to coagulate tissue when connected to an electrosurgical generator. When desired, an irrigation line may be connected to the handle and saline can be delivered to clear the surgical field as a procedural aid.
Bipolar electrosurgical generator/cables, vacuum source, and irrigation source are not provided with the device. Prior to use, the device is to be connected to electrosurgical generator, external vacuum source (i.e. operating room suction) and irrigation source (i.e. drip).
A green power indicator light is located on the top portion of the handle to show that power is available to the device. A suction control vent for the user to control vacuum pressure and a button for activating the whisk are located conveniently on the handle.
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### INDICATIONS FOR USE
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
# COMPARISON TO PREDICATE
The subject device, the AURORA Evacuator +Coag, was previously cleared under 510(k) K201637. In this 510(k), the same predicate and references devices are utilized for the addition of neurosurgical indications.
| Description | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Reference Device |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | AURORA Evacuator +Coag | Kirwan Bipolar Suction<br>Coagulator | AURORA Evacuator<br>+Coag | AURORA Evacuator |
| 510(k) | K203745 | K960455 | K201637 | K190075/K180372 |
| Product Code | GEI (21CFR 878.4400) | Same | Same | Same |
| Rx or OTC | Rx | Same | Same | Same |
| Indications for Use | The AURORA Evacuator<br>+Coag is a powered<br>instrument with a handpiece<br>intended for removal of soft<br>tissue and fluids, and<br>coagulation of tissue under<br>direct visualization. Types of<br>direct visualization may<br>include laparoscopic,<br>pelviscopic, endoscopic,<br>percutaneous, and open.<br>Applications include those<br>when access to the surgical<br>site is limited, such as<br>neurosurgical. | Disposable device<br>designed to be used in<br>soft tissue surgical<br>procedures that require<br>slow to rapid fluid<br>evacuation and lower<br>energy output for the<br>coagulation of the tissue<br>i.e. neurosurgery,<br>endoscopic, sinusoidal,<br>ENT, OB-GYN and plastic<br>surgery. | The AURORA Evacuator<br>+Coag is a powered<br>instrument with a<br>handpiece intended for<br>removal of soft tissue<br>and fluids, and<br>coagulation of tissue<br>under direct<br>visualization. Types of<br>direct visualization may<br>include laparoscopic,<br>pelviscopic, endoscopic,<br>percutaneous, and<br>open. | The AURORA Evacuator<br>with coagulation is a<br>powered instrument<br>with a handpiece<br>intended for removal of<br>soft tissue and fluids<br>under direct<br>visualization. Types of<br>direct visualization may<br>include laparoscopic,<br>pelviscopic, endoscopic,<br>percutaneous, and<br>open.<br>Applications include<br>those when access to<br>the surgical site is<br>limited, such as<br>Neurosurgical/Spinal<br>and<br>ENT/Otolaryngological. |
| Technological<br>characteristics -<br>Summary | 1. Removal of fluid by<br>suction lumen (wall<br>vacuum source)<br>- Rotating whisk<br>incorporated in suction<br>lumen at distal tip for<br>removal of soft tissue<br>(i.e. blood clot)<br>2. Bipolar electrodes at distal<br>tip for coagulation of<br>tissue<br>3. Irrigation lumen for saline | 1. Removal of fluid by<br>suction lumen (wall<br>vacuum source)<br>2. Same as Subject device<br>3. N/A | 1. Same as Subject<br>device<br>2. Same as Subject<br>device<br>3. Same as Subject<br>device | 1. Same as Subject<br>device<br>2. N/A<br>3. N/A |
| Description | Subject Device | Primary Predicate Device | Secondary Predicate<br>Device | Reference Device |
| | | Aspiration Characteristics | | |
| Wand<br>Working length<br>OD | 7 – 13 cm<br>12 F (4.0 mm) | 14 -19 cm<br>8 - 15 F | Same as Subject device | 7 - 13 cm<br>9 - 11 F (3.0 - 3.6 mm) |
| Aspiration Window | Window at side of distal end | At distal end | Same as Subject device | Same as Subject device |
| Whisk | Located and fully contained<br>within inner lumen at<br>aspiration window<br>Flat member with notches<br>301 SS | N/A (Evacuation through<br>suction only) | Same | Same<br>Two wire loops<br>(perpendicular)<br>Nitinol |
| Power Source for<br>Motor | Battery located in handle -<br>one 6V Alkaline | N/A | Same | Batteries located in<br>handle - two AAA 1.5V<br>Alkaline |
| Vacuum source<br>(external) | Connect to barb on device<br>handle to Operating Room<br>suction (i.e. wall) | Same | Same | Same |
| Vacuum control | Suction vent on handle that is<br>fingertip controlled | Same | Same | Same |
| | | Bipolar Electrodes Characteristics | | |
| Electrodes<br>Type | Bipolar | Same | Same as Subject device | N/A |
| Shape | 2 rectangular components | 2 concentric tubes | | |
| Insulation | Polyphenylsulfone | High temp polymer | | |
| Rated Voltage | 450 Vp-p | 1200 V p-p | | |
| Power Source for<br>Bipolar electrodes | Cable to electrosurgical<br>generator (external)<br>connected to AC mains.<br>- Cable and<br>Electrosurgical<br>generator are not<br>provided | Same | Same | N/A |
| | | Irrigation | | |
| Irrigation lumen<br>with luer connector | Capability for saline drip<br>irrigation delivery to distal tip.<br>Connection on device handle<br>to saline bag with line clamp<br>for clinician to control<br>irrigation rate. | N/A | Same | N/A |
| Other Characteristics | | | | |
| Use | Single use, sterile | Same | Same | Same |
| Sterilization Method | Ethylene oxide gas<br>SAL 10-6 | Irradiation | Same as Subject device | Same as Subject device |
| Biocompatibility | ISO 10993-1 | Same | Same | Same |
| EMC, Immunity, and<br>Electrical Safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | Same | Same | Same |
| | | Same | Same | Same |
| | | Same | Same | N/A |
| Accessories | None | Same | Same | Same |
### Comparison to Predicate/Reference Devices
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# SUMMARY OF NON-CLINICAL TESTING
The following testing was conducted to demonstrate the safe and effective use of the AURORA Evacuator +Coag:
| Test | Test method summary | Results |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Biocompatibility:<br>- Cytotoxicity (MEM Elution)<br>- Sensitization (Kligman Maximization)<br>- Irritation (intracutaneous Injection)<br>- Systemic toxicity (Systemic Injection)<br>- Materials Mediated Pyrogenicity | ISO 10993-1 Biological evaluation of<br>medical devices - Part 1: Evaluation and<br>testing within a risk management<br>process | Pass |
| Electrical safety and Enclosure<br>Protection | IEC 60601-1 Medical electrical<br>equipment - Part 1: General<br>requirements for basic safety and<br>essential performance,<br>IEC 60601-2-2 Medical electrical<br>equipment - Part 2-2: Particular<br>requirements for the basic safety and<br>essential performance of high frequency<br>surgical equipment and high frequency<br>surgical accessories | Pass |
| Emissions and Immunity | IEC 60601-1-2 Medical electrical<br>equipment - Part 1-2: General<br>requirements for basic safety and<br>essential performance - Collateral<br>standard: Electromagnetic disturbances<br>- Requirements and tests | Pass |
| Particulate Testing | USP <788> Particulate Matter in<br>Injections | Pass |
| Sterilization Validation (SAL of 10-6) | ISO 11135-1 Sterilization of health care<br>products – Ethylene oxide – Part 1:<br>requirements for development,<br>validation and routine control of a<br>sterilization process for medical devices | Pass |
| Packaging and Shelf Life | ISTA 2A simulation performance test<br>procedure<br>ASTM F1980-16 Standard Guide for<br>Accelerated Aging of Sterile Barrier<br>Systems for Medical Devices | Pass |
| In-vitro verification of product<br>specifications | Verification of materials, multiple bonds<br>evaluations, physical characteristics,<br>performance characteristics and tissue<br>thermal effects (coagulation of tissue). | Pass |
| Ex-vivo tissue studies (porcine heart,<br>liver, and kidney) | Demonstrated comparable thermal<br>damage effect (coagulation zone) using<br>the bipolar electrodes when compared<br>with the primary predicate under the | Pass |
| Test | Test method summary | Results |
| | same test parameters and conditions.<br>Thermal damage as a function of<br>temperature and time with the 3 tissue<br>types also supported comparability. | |
| Ex-vivo tissue studies (porcine brain) | Demonstrated comparable thermal<br>damage effect (coagulation zone) using<br>the bipolar electrodes when compared<br>with the primary predicate device under<br>the same test parameters and<br>conditions for neurosurgical<br>applications. | Pass |
| Validation of product performance | Validation of product using surrogate<br>soft tissue materials and fluids | Pass |
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## CONCLUSION
Based on the similarities of the intended use/indications for use, device design, principles of operation, technological characteristics and the results of the non-clinical performance testing, the subject device, AURORA Evacuator+Coag, is substantially equivalent to the legally marketed predicate devices.
