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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the AURORA Evacuator +Coag device. It describes the device, its intended use, and a comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain information related to software or AI/ML components. Therefore, I cannot provide an answer based on the prompt's request for acceptance criteria and studies related to a device's AI/ML performance.

The document lacks the following information which are critical to answer your request:

Acceptance criteria for AI/ML performance: The document details acceptance criteria for the physical device's performance (e.g., biocompatibility, electrical safety, sterilization, in-vitro verification, ex-vivo tissue studies), but not for any AI/ML components.
Study that proves the device meets acceptance criteria for AI/ML: No studies related to AI/ML performance are mentioned.
Sample size used for the test set and data provenance (AI/ML): Not applicable as no AI/ML component is discussed.
Number of experts used to establish ground truth (AI/ML): Not applicable.
Adjudication method (AI/ML): Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study (AI/ML): Not applicable.
Standalone (algorithm only) performance study (AI/ML): Not applicable.
Type of ground truth used (AI/ML): Not applicable.
Sample size for the training set (AI/ML): Not applicable.
How the ground truth for the training set was established (AI/ML): Not applicable.

Therefore, no table of acceptance criteria and reported device performance for an AI/ML component can be created from this document. The document focuses on regulatory approval for the physical medical device and its electrosurgical, aspiration, and irrigation functionalities.

Summary

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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)

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

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

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 PredicateDevice	Reference Device
Device	AURORA Evacuator +Coag	Kirwan Bipolar SuctionCoagulator	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 poweredinstrument with a handpieceintended for removal of softtissue and fluids, andcoagulation of tissue underdirect visualization. Types ofdirect visualization mayinclude laparoscopic,pelviscopic, endoscopic,percutaneous, and open.Applications include thosewhen access to the surgicalsite is limited, such asneurosurgical.	Disposable devicedesigned to be used insoft tissue surgicalprocedures that requireslow to rapid fluidevacuation and lowerenergy output for thecoagulation of the tissuei.e. neurosurgery,endoscopic, sinusoidal,ENT, OB-GYN and plasticsurgery.	The AURORA Evacuator+Coag is a poweredinstrument with ahandpiece intended forremoval of soft tissueand fluids, andcoagulation of tissueunder directvisualization. Types ofdirect visualization mayinclude laparoscopic,pelviscopic, endoscopic,percutaneous, andopen.	The AURORA Evacuatorwith coagulation is apowered instrumentwith a handpieceintended for removal ofsoft tissue and fluidsunder directvisualization. Types ofdirect visualization mayinclude laparoscopic,pelviscopic, endoscopic,percutaneous, andopen.Applications includethose when access tothe surgical site islimited, such asNeurosurgical/SpinalandENT/Otolaryngological.
Technologicalcharacteristics -Summary	1. Removal of fluid bysuction lumen (wallvacuum source)- Rotating whiskincorporated in suctionlumen at distal tip forremoval of soft tissue(i.e. blood clot)2. Bipolar electrodes at distaltip for coagulation oftissue3. Irrigation lumen for saline	1. Removal of fluid bysuction lumen (wallvacuum source)2. Same as Subject device3. N/A	1. Same as Subjectdevice2. Same as Subjectdevice3. Same as Subjectdevice	1. Same as Subjectdevice2. N/A3. N/A
Description	Subject Device	Primary Predicate Device	Secondary PredicateDevice	Reference Device
		Aspiration Characteristics
WandWorking lengthOD	7 – 13 cm12 F (4.0 mm)	14 -19 cm8 - 15 F	Same as Subject device	7 - 13 cm9 - 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 containedwithin inner lumen ataspiration windowFlat member with notches301 SS	N/A (Evacuation throughsuction only)	Same	SameTwo wire loops(perpendicular)Nitinol
Power Source forMotor	Battery located in handle -one 6V Alkaline	N/A	Same	Batteries located inhandle - two AAA 1.5VAlkaline
Vacuum source(external)	Connect to barb on devicehandle to Operating Roomsuction (i.e. wall)	Same	Same	Same
Vacuum control	Suction vent on handle that isfingertip controlled	Same	Same	Same
		Bipolar Electrodes Characteristics
ElectrodesType	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 forBipolar electrodes	Cable to electrosurgicalgenerator (external)connected to AC mains.- Cable andElectrosurgicalgenerator are notprovided	Same	Same	N/A
		Irrigation
Irrigation lumenwith luer connector	Capability for saline dripirrigation delivery to distal tip.Connection on device handleto saline bag with line clampfor clinician to controlirrigation rate.	N/A	Same	N/A
Other Characteristics
Use	Single use, sterile	Same	Same	Same
Sterilization Method	Ethylene oxide gasSAL 10-6	Irradiation	Same as Subject device	Same as Subject device
Biocompatibility	ISO 10993-1	Same	Same	Same
EMC, Immunity, andElectrical Safety	IEC 60601-1IEC 60601-1-2IEC 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:- Cytotoxicity (MEM Elution)- Sensitization (Kligman Maximization)- Irritation (intracutaneous Injection)- Systemic toxicity (Systemic Injection)- Materials Mediated Pyrogenicity	ISO 10993-1 Biological evaluation ofmedical devices - Part 1: Evaluation andtesting within a risk managementprocess	Pass
Electrical safety and EnclosureProtection	IEC 60601-1 Medical electricalequipment - Part 1: Generalrequirements for basic safety andessential performance,IEC 60601-2-2 Medical electricalequipment - Part 2-2: Particularrequirements for the basic safety andessential performance of high frequencysurgical equipment and high frequencysurgical accessories	Pass
Emissions and Immunity	IEC 60601-1-2 Medical electricalequipment - Part 1-2: Generalrequirements for basic safety andessential performance - Collateralstandard: Electromagnetic disturbances- Requirements and tests	Pass
Particulate Testing	USP <788> Particulate Matter inInjections	Pass
Sterilization Validation (SAL of 10-6)	ISO 11135-1 Sterilization of health careproducts – Ethylene oxide – Part 1:requirements for development,validation and routine control of asterilization process for medical devices	Pass
Packaging and Shelf Life	ISTA 2A simulation performance testprocedureASTM F1980-16 Standard Guide forAccelerated Aging of Sterile BarrierSystems for Medical Devices	Pass
In-vitro verification of productspecifications	Verification of materials, multiple bondsevaluations, physical characteristics,performance characteristics and tissuethermal effects (coagulation of tissue).	Pass
Ex-vivo tissue studies (porcine heart,liver, and kidney)	Demonstrated comparable thermaldamage effect (coagulation zone) usingthe bipolar electrodes when comparedwith the primary predicate under the	Pass
Test	Test method summary	Results
	same test parameters and conditions.Thermal damage as a function oftemperature and time with the 3 tissuetypes also supported comparability.
Ex-vivo tissue studies (porcine brain)	Demonstrated comparable thermaldamage effect (coagulation zone) usingthe bipolar electrodes when comparedwith the primary predicate device underthe same test parameters andconditions for neurosurgicalapplications.	Pass
Validation of product performance	Validation of product using surrogatesoft 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.

Regulation Number and Section

§ 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.