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.

Device Description

The subject device, AURORA Evacuator +Coag, 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

The provided text describes the AURORA Evacuator +Coag device, its indications for use, and a comparison to predicate and reference devices. It then lists a summary of non-clinical testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a structured format. However, it describes several tests performed and states that the device was found to be "substantially equivalent" or demonstrated "comparable" effects.

Here's an interpretation of potential "acceptance criteria" and "reported device performance" based on the text:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility per ISO 10993-1	Testing performed and results supported safe use (implied, as conclusion states "safe and effective use"). Specific tests conducted: Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Materials Mediated Pyrogenicity.
Electrical Safety per IEC 60601-1 and IEC 60601-2-2	Testing performed and results supported safe use (implied).
Emissions and Immunity per IEC 60601-1-2	Testing performed and results supported safe use (implied).
Particulate Testing per USP <788>	Testing performed and results supported safe use (implied).
Sterilization per ISO 11135-1	Validated a Sterility Assurance Level (SAL) of 10-6.
Packaging and Shelf-life per ISTA 2A and ASTM F1980-16	Testing performed and results supported safe use (implied).
Verification of product specifications (materials, bonds, physical, performance)	Verification performed and results supported safe use (implied).
Comparable thermal damage effect (coagulation zone) to predicate	Ex-vivo tissue studies (porcine heart, liver, and kidney) demonstrated comparable thermal damage effect (coagulation zone) when compared with the primary predicate under the same test parameters and conditions.
Comparable thermal damage as a function of temperature and time	Thermal damage as a function of temperature and time with the 3 tissue types supported comparability with the primary predicate.
Validation of product performance using surrogate soft tissue materials and fluids	Validation performed and results supported safe use (implied).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- For the ex-vivo tissue studies, the sample size is only specified as "porcine heart, liver, and kidney". The number of individual samples or replicates is not provided.
- For other tests like biocompatibility, electrical safety, etc., no specific sample sizes are mentioned.
Data Provenance: The studies are described as "ex-vivo tissue studies" and "non-clinical testing." This implies laboratory-based testing rather than clinical data from human patients. There is no information regarding the country of origin of the data. Given it's non-clinical, the terms "retrospective" or "prospective" don't directly apply in the same way they would to human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish "ground truth" for the non-clinical tests. Non-clinical tests typically rely on standardized methods and measurements rather than expert consensus on subjective interpretations. For tests like thermal damage assessment, the ground truth would be based on scientific measurements and comparative analysis with a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information is provided about any adjudication methods. This is consistent with non-clinical testing where subjective expert interpretation and adjudication are generally not primary components.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or mentioned. The device is a surgical instrument (Electrosurgical Cutting and Coagulation Device and Accessories), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The AURORA Evacuator +Coag is a physical medical device intended for surgical use. It is operated by a human and is not an algorithm. Therefore, "standalone" performance in the sense of an algorithm operating independently doesn't apply. Its performance is evaluated in conjunction with human operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" would be established by:

Comparability to Predicate Device: For thermal damage, the ground truth was the established performance of the predicate device under the same conditions.
Standardized Test Methods: For biocompatibility, electrical safety, sterilization, etc., the ground truth is defined by the specific parameters and requirements of the referenced ISO standards (e.g., ISO 10993-1, ISO 11135-1, IEC 60601 series, USP <788>, ASTM F1980-16). These standards specify acceptable limits or methodologies.
Physical and Performance Specifications: Internal product specifications verified through direct measurement.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm. The non-clinical studies described are for verification and validation of the device's physical and functional properties, not for training a model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 12, 2020

Rebound Therapeutics Ms. Naomi Gong VP of Regulatory Affairs 13900 Alton Parkway, Suite 120 Irvine. California 92618

Re: K201637

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: June 15, 2020 Received: June 16, 2020

Dear Ms. 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.

{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 medical devices and radiation-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) K201637

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.

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}------------------------------------------------

SUBMITTER

Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine, CA 92618

Contact Person:	Ms. Naomi Gong, RAC
	Vice President of Regulatory Affairs
Telephone:	(949) 305-8111
Email:	naomi.gong@integralife.com
Date Prepared:	August 11, 2020
DEVICE
Name of Device:	AURORA Evacuator +Coag
Regulation Number:	21 CFR 878.4400
Regulation Name:	Electrosurgical Cutting & Coagulation Device & Accessories
Regulatory Class:	II
Product Code:	GEI

PREDICATE DEVICE

Primary:	K960455, Bipolar Suction Coagulator, Kirwan Surgical Products
Reference:	K190075/K180372, AURORA Evacuator, Rebound Therapeutics

DEVICE DESCRIPTION

{4}------------------------------------------------

INDICATIONS FOR USE

COMPARISON TO PREDICATE

The subject device, the AURORA Evacuator +Coag, are new models of the reference device, AURORA Evacuator, to which bipolar electrodes have been added for the coagulation of tissue. The subject device incorporates the same bipolar technology to perform the coagulation of tissue as the primary predicate device.

Description	Subject Device	Predicate Device	Reference Device
Device	AURORA Evacuator +Coag	Kirwan Bipolar SuctionCoagulator	AURORA Evacuator
510(k)	K201637	K960455	K190075/K180372
Product Code	GEI (21CFR 878.4400)	Same	Same
Indications for Use	The AURORA Evacuator +Coagis a powered instrument with ahandpiece intended forremoval of soft tissue andfluids, and coagulation of tissueunder direct visualization.Types of direct visualizationmay include laparoscopic,pelviscopic, endoscopic,percutaneous, and open.	Disposable device designed tobe used in soft tissue surgicalprocedures that require slowto rapid fluid evacuation andlower energy output for thecoagulation of the tissue i.e.neurosurgery, endoscopic,sinusoidal, ENT, OB-GYN andplastic surgery.	The AURORA Evacuator withcoagulation is a poweredinstrument with a handpieceintended for removal of softtissue and fluids under directvisualization. Types of directvisualization may includelaparoscopic, pelviscopic,endoscopic, percutaneous,and open. Applicationsinclude those when access tothe surgical site is limited,such as Neurosurgical/Spinaland ENT/Otolaryngological.
Technologicalcharacteristics -Summary	1.Removal of fluid by suctionlumen (wall vacuum source)▪ Rotating whiskincorporated in suctionlumen at distal tip forremoval of soft tissue (i.e.blood clot)2. Bipolar electrodes at distaltip for coagulation of tissue3. Irrigation lumen for salinedrip	1. Removal of fluid by suctionlumen (wall vacuumsource)2. Same as Subject device3. N/A	1. Same as Subject device2. N/A3. N/A
Description	Subject Device	Predicate Device	Reference Device
Aspiration Characteristics
WandMaterialWorking lengthOD	304 SS7 – 13 cm12 F	Copper alloy14 -19 cm8 – 15 F	Same as Subject device7 - 13 cm9 - 11 F
Aspiration Window	Window at side of distal end	At distal end	Same as Subject device
Whisk	Located internal at aspirationwindowFlat member with notches301 SS	N/A (Evacuation throughsuction only)	SameTwo wire loopsNitinol
Power Source forMotor	Battery located in handle - one6V Alkaline	N/A	Batteries located in handle -two AAA 1.5V Alkaline
Vacuum source(external)	Connect to barb on devicehandle to Operating Roomsuction (i.e. wall)	Same	Same
Vacuum control	Suction vent on handle that isfingertip controlled	Same	Same
Bipolar Electrodes Characteristics
Electrodes
Type	Bipolar	Same	N/A
Shape	2 rectangular components	2 concentric tubes
Material	Silver	Copper alloy
Insulation	Polyphenylsulfone	High temp polymer
Rated Voltage	450 Vp-p	1200 V p-p
Power Source forBipolar electrodes	Cable to electrosurgicalgenerator (external) connectedto AC mains.- Cable and Electrosurgicalgenerator are notprovided	Same	N/A
Irrigation
Irrigation lumen withluer connector	Capability for saline dripirrigation delivery to distal tip.Connection on device handleto saline bag with line clampfor clinician to controlirrigation rate.	N/A	N/A
Other Characteristics
Use	Single use, sterile	Same	Same
Sterilization Method	Ethylene oxide gasSAL 10-6	Irradiation	Same as Subject deviceSame
Biocompatibility	ISO 10993-1	Same	Same
Description	Subject Device	Predicate Device	Reference Device
EMC, Immunity, andElectrical Safety	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	Same	SameSameN/A
Accessories	None	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:

Biocompatibility Testing per ISO 10993-1, including Cytotoxicity (MEM Elution), Sensitization ● (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Materials Mediated Pyrogenicity
Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 660601-2-2 ●
Emissions and Immunity per IEC 60601-1-2
Particulate Testing per USP <788>
Sterilization per ISO 11135-1 to validate a SAL of 10-6 ●
Packaging and Shelf-life per ISTA 2A and ASTM F1980-16
. Verification of product specifications including materials, multiple bonds evaluations, physical characteristics, performance characteristics and tissue thermal effects (coagulation of tissue).

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 same test parameters and conditions. Thermal damage as a function of temperature and time with the 3 tissue types also supported comparability.

Validation of product performance using surrogate soft tissue materials and fluids.

CONCLUSION

Based upon the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characteristics, the AURORA Evacuator +Coag has been determined to be substantially equivalent to the predicate device.

The ex-vivo tissue studies (porcine heart, liver, and kidney) demonstrated comparable thermal damage effect (coagulation zone and tissue temperature studies) using the bipolar electrodes when compared with the primary predicate under the same test parameters and conditions.

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.