Who is the manufacturer of AURORA Evacuator +Coag?

Rebound Therapeutics filed the 510(k) submission for AURORA Evacuator +Coag (K203745).

What is the FDA product code for AURORA Evacuator +Coag?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for AURORA Evacuator +Coag?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AURORA Evacuator +Coag?

Bipolar Suction Coagulator (K960455); AURORA Evacuator +Coag (K201637).

Who can help prepare an FDA 510(k) submission like AURORA Evacuator +Coag?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AURORA Evacuator +Coag

K203745 · Rebound Therapeutics · GEI · Dec 2, 2021 · General, Plastic Surgery

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

Intended 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

Bipolar Suction Coagulator (K960455)
AURORA Evacuator +Coag (K201637)

Reference Devices

AURORA Evacuator (K190075/K180372)

Related Devices

K201637 — Aurora Evacuator +Coag · Rebound Therapeutics · Aug 12, 2020
K180372 — Aurora Evacuator · Rebound Therapeutics · Apr 9, 2018
K190075 — Aurora Evacuator · Rebound Therapeutics · Feb 12, 2019
K965241 — BIPOLAR SUCTION COAGULATOR · Kirwan Surgical Products, Inc. · Feb 28, 1997
K033003 — SUCTION COAGULATOR · Modern Medical Equipment Mfg., Ltd. · May 13, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ ### 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 Device | Reference Device | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | AURORA Evacuator +Coag | Kirwan Bipolar Suction Coagulator | AURORA Evacuator +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 +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. | Disposable device designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and lower energy output for the coagulation of the tissue i.e. neurosurgery, endoscopic, sinusoidal, ENT, OB-GYN and plastic surgery. | 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. | The AURORA Evacuator with coagulation is a powered instrument with a handpiece intended for removal of soft tissue and fluids 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/Spinal and ENT/Otolaryngological. | | Technological characteristics - Summary | 1. Removal of fluid by suction lumen (wall vacuum source) - Rotating whisk incorporated in suction lumen at distal tip for removal of soft tissue (i.e. blood clot) 2. Bipolar electrodes at distal tip for coagulation of tissue 3. Irrigation lumen for saline | 1. Removal of fluid by suction lumen (wall vacuum source) 2. Same as Subject device 3. N/A | 1. Same as Subject device 2. Same as Subject device 3. Same as Subject device | 1. Same as Subject device 2. N/A 3. N/A | | Description | Subject Device | Primary Predicate Device | Secondary Predicate Device | Reference Device | | | | Aspiration Characteristics | | | | Wand Working length OD | 7 – 13 cm 12 F (4.0 mm) | 14 -19 cm 8 - 15 F | Same as Subject device | 7 - 13 cm 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 within inner lumen at aspiration window Flat member with notches 301 SS | N/A (Evacuation through suction only) | Same | Same Two wire loops (perpendicular) Nitinol | | Power Source for Motor | Battery located in handle - one 6V Alkaline | N/A | Same | Batteries located in handle - two AAA 1.5V Alkaline | | Vacuum source (external) | Connect to barb on device handle to Operating Room suction (i.e. wall) | Same | Same | Same | | Vacuum control | Suction vent on handle that is fingertip controlled | Same | Same | Same | | | | Bipolar Electrodes Characteristics | | | | Electrodes 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 Bipolar electrodes | Cable to electrosurgical generator (external) connected to AC mains. - Cable and Electrosurgical generator are not provided | Same | Same | N/A | | | | Irrigation | | | | Irrigation lumen with luer connector | Capability for saline drip irrigation delivery to distal tip. Connection on device handle to saline bag with line clamp for clinician to control irrigation rate. | N/A | Same | N/A | | Other Characteristics | | | | | | Use | Single use, sterile | Same | Same | Same | | Sterilization Method | Ethylene oxide gas SAL 10-6 | Irradiation | Same as Subject device | Same as Subject device | | Biocompatibility | ISO 10993-1 | Same | Same | Same | | EMC, Immunity, and Electrical Safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | Same | Same | Same | | | | Same | Same | Same | | | | Same | Same | N/A | | Accessories | None | Same | Same | Same | ### Comparison to Predicate/Reference Devices {5}------------------------------------------------ {6}------------------------------------------------ # 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: - Cytotoxicity (MEM Elution) - Sensitization (Kligman Maximization) - Irritation (intracutaneous Injection) - Systemic toxicity (Systemic Injection) - Materials Mediated Pyrogenicity | ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Pass | | Electrical safety and Enclosure Protection | IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Pass | | Emissions and Immunity | 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 | Pass | | Particulate Testing | USP <788> Particulate Matter in Injections | Pass | | Sterilization Validation (SAL of 10-6) | ISO 11135-1 Sterilization of health care products – Ethylene oxide – Part 1: requirements for development, validation and routine control of a sterilization process for medical devices | Pass | | Packaging and Shelf Life | ISTA 2A simulation performance test procedure ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Pass | | In-vitro verification of product specifications | Verification of materials, multiple bonds evaluations, physical characteristics, performance characteristics and tissue thermal effects (coagulation of tissue). | Pass | | Ex-vivo tissue studies (porcine heart, liver, and kidney) | Demonstrated comparable thermal damage effect (coagulation zone) using the bipolar electrodes when compared with the primary predicate under the | Pass | | Test | Test method summary | Results | | | same test parameters and conditions. Thermal damage as a function of temperature and time with the 3 tissue types also supported comparability. | | | Ex-vivo tissue studies (porcine brain) | Demonstrated comparable thermal damage effect (coagulation zone) using the bipolar electrodes when compared with the primary predicate device under the same test parameters and conditions for neurosurgical applications. | Pass | | Validation of product performance | Validation of product using surrogate soft tissue materials and fluids | Pass | {7}------------------------------------------------ ## 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.