The AURORA Evacuator 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, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/ Otolaryngological.

Device Description

The AURORA Evacuator is provided sterile, for single-use only. It is a disposable, handheld, aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures. The AURORA Evacuator consists of a stainless-steel suction wand connected to a plastic handle. The stainless-steel suction wand is configured with an aspiration window, near its distal end, for fluid and soft tissue to enter. Internal to the suction wand is a shaft with a whisk-shaped configuration at its distal end. The whisk-shaped configuration is aligned with the aspiration window. The proximal end of the shaft is connected to a battery powered motor in the handle. The interior of the plastic handle contains the battery powered motor, batteries, electrical circuitry and the suction tubing. The suction tubing connects the stainless-steel suction wand to operating room vacuum. On the exterior of the handle is a tear-dropped shaped vent for user control of vacuum strength, a green light that illuminates when power is available, and a button for user activation of the motor. The AURORA Evacuator is shipped in a non-functional state that requires removal of a pull tab from the handle to initiate power to the device. There are three (3) configurations of the AURORA Evacuator; AURORA Evacuator -13, AURORA Evacuator -10 and AURORA Evacuator -7. All configurations are fabricated from the same materials and electrical components. The only difference among the configurations is the working length of the wand component. The wand working lengths are 13cm, 10cm, and 7cm, respectively.

AI/ML Overview

The provided text is a 510(k) premarket notification for the "AURORA Evacuator" device. It outlines the device's intended use, design, and comparison to predicate devices, along with a summary of the conducted testing. However, it does not include specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or similar quantitative measures for medical devices that rely on diagnostic or interpretative capabilities) nor detailed study results proving a device meets such criteria if they were for a diagnostic or AI-driven device.

The "AURORA Evacuator" is described as a powered surgical instrument for tissue and fluid removal, not a diagnostic device or an AI-powered system that requires high-level performance metrics based on data analysis or image interpretation. The testing summarized is primarily related to safety, biocompatibility, electrical safety, manufacturing quality, and basic operational verification (e.g., rotational speeds, duration of use), which are typical for surgical tools.

Therefore, many of the requested items (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable or not present in this document because the device is a physical surgical tool and not a diagnostic or AI-driven system.

Nonetheless, I can extract the relevant information regarding the device's validation:

Acceptance Criteria and Study for the AURORA Evacuator

Based on the provided document, the "acceptance criteria" are implicitly tied to the safety and functionality standards for a surgical instrument, and the "study" refers to the verification and validation (V&V) testing performed to demonstrate substantial equivalence to predicate devices and satisfy regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a surgical tool and not a diagnostic or AI device, the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or accuracy. Instead, they are met through adherence to established standards and successful completion of specific tests demonstrating safety, functionality, and manufacturing quality. The "reported device performance" is the successful completion of these tests.

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Biocompatibility	ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity	Successful (Implied, as submission states safe and effective use shown)
Electrical Safety	IEC 60601-1 and IEC 60529-1	Successful (Implied)
Emissions & Immunity	IEC 60601-1-2	Successful (Implied)
Particulate Testing	USP 36 <788>	Successful (Implied)
Sterilization	ISO 11135-1 (SAL of 10^-6^)	Validated (Implied)
Packaging & Shelf-life	ISTA 2A and ASTM F1980	Successful (Implied)
Product Specifications	Materials, multiple bonds evaluations, physical characteristics, audible characteristics, rotational speeds, duration of use, operational temperatures	Verified (Implied)
Product Performance	Use with surrogate soft tissue and fluid materials	Validated (Implied)
Substantial Equivalence	Comparison to Predicate Device (NICO Myriad) for vacuum source, energy source, and tissue cutting mechanism	Results show no new or different questions of safety and effectiveness.

2. Sample Size for Test Set and Data Provenance

Sample Size: The document does not specify quantitative sample sizes for each test (e.g., how many units were tested for electrical safety or how many batches for sterilization). The testing appears to follow standard medical device V&V protocols, which typically involve testing a statistically representative sample of manufactured units or materials.
Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. The testing would have been conducted in a controlled lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a surgical instrument. The "ground truth" for its performance is determined by meeting engineering specifications, safety standards, and functional requirements, not by expert interpretation of data like in diagnostic imaging.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments (e.g., image interpretation). For a surgical tool, performance is determined by objective physical and electrical measurements, and adherence to standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic or AI-assisted interpretation, where human readers interact with image data. This device is a physical surgical tool and does not involve human readers interpreting data.

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

Not Applicable. The AURORA Evacuator is a physical device operated by a human, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. Its performance is inherent to its mechanical and electrical function.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is adherence to engineering specifications, established biocompatibility standards (ISO 10993-1), electrical safety standards (IEC 60601-1, IEC 60529-1, IEC 60601-1-2), sterilization standards (ISO 11135-1), packaging/shelf-life standards (ISTA 2A, ASTM F1980), and functional performance verification using surrogate materials. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As per point 8, there is no "training set" for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2018

Rebound Therapeutics Ms. Jane Metcalf Vice President of Regulatory Affairs 13900 Alton Parkway, Suite 120 Irvine, California 92618

Re: K180372

Trade/Device Name: Aurora Evacuator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 7, 2018 Received: February 12, 2018

Dear Ms. Metcalf:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180372

Device Name AURORA Evacuator

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)

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

1) SUBMITTER

Rebound Therapeutics Corporation 13900 Alton Parkway, STE 120 Irvine, CA 92618

Contact Person: Jeffrey J. Valko, President and CEO Telephone: (949) 633-2747 Email: jvalko@reboundtx.com

Contact Person: Jane Metcalf, Vice President of Regulatory Affairs Telephone: (949) 525-1493 Email: jmetcalf@reboundtx.com

Date Prepared: April 3, 2018

2) DEVICE

Name of Device: AURORA Evacuator Common or Usual Name: Aspirator Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: II Product Code: GEI

3) PREDICATE DEVICE

Primary Predicate: NICO Myriad, 11GA, K161307 Secondary Predicate: ConMed Corporation, Frazier 8Fr, Class II, 510(k) Exempt

4) DEVICE DESCRIPTION

The stainless-steel suction wand is configured with an aspiration window, near its distal end, for fluid and soft tissue to enter. Internal to the suction wand is a shaft with a whisk-shaped configuration at its distal end. The whisk-shaped configuration is aligned with the aspiration window. The proximal end of the shaft is connected to a battery powered motor in the handle.

The interior of the plastic handle contains the battery powered motor, batteries, electrical circuitry and the suction tubing. The suction tubing connects the stainless-steel suction wand to operating room vacuum. On the exterior of the handle is a tear-dropped shaped vent for user control of vacuum strength, a green light that illuminates when power is available, and a button for user activation of the motor.

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

The AURORA Evacuator is shipped in a non-functional state that requires removal of a pull tab from the handle to initiate power to the device.

There are three (3) configurations of the AURORA Evacuator; AURORA Evacuator -13, AURORA Evacuator -10 and AURORA Evacuator -7. All configurations are fabricated from the same materials and electrical components. The only difference among the configurations is the working length of the wand component. The wand working lengths are 13cm, 10cm, and 7cm, respectively.

5) STATEMENT OF INTENDED USE

The AURORA Evacuator 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.

6) SUMMARY OF TESTING

The following testing was conducted to demonstrate the safe and effective use of the AURORA Evacuator and its' substantial equivalence to the primary predicate.

Biocompatibility Testing per ISO 10993-1 Cytotoxicity (MEM Elution), Sensitization . (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection, Material Mediated Pyrogenicity)
Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 60529-1 ●
Emissions and Immunity per IEC 60601-1-2
Particulate Testing per USP 36 <788>:
Sterilization per ISO 11135-1 to validate a SAL of 10-6
Packaging and Shelf-life per ISTA 2A and ASTM F1980
. Verification of product specifications including, materials, multiple bonds evaluations, physical characteristics, audible characteristics, rotational speeds, duration of use and operational temperatures
Validation of product performance using surrogate soft tissue materials and surrogate fluid materials

7) SUMMARY TECHNOLOGICAL CHARACTERISTICS

The AURORA Evacuator has two (2) modes of operation: one (1) for aspiration and another for cutting. For aspiration, the AURORA Evacuator connects to an external vacuum source that is present in the operating room. For cutting, the AURORA Evacuator utilizes a rotating whisk that is internal to the wand.

To aspirate, the surgeon covers the suction vent on the device's handle and positions the aspiration window so that vacuum draws fluid and soft tissue through the window and into the wand. The aspirant travels through the wand, into the suction tubing and is deposited into the waste receptacle connected to the operating room vacuum-line.

To cut soft tissue, the surgeon pushes the motor activation on the exterior of the handle causing the whisk to rotate. Vacuum is used to draw soft tissue through the aspiration window and into the rotating whisk. The soft tissue is cut by the rotating whisk and transported to a collection

{5}------------------------------------------------

receptacle connected to the operating room vacuum-line. Soft tissue cutting can only occur inside of the wand.

8) COMPARISON TO PREDICATE

Comparing the AURORA Evacuator to the primary predicate shows that there are three main technological differences; vacuum source, energy source, and tissue cutting. The primary predicate uses an internally controlled vacuum source instead of an external vacuum source. Its energy source is from a wall outlet rather than direct current from internal batteries. Finally, the primary predicate cuts both soft tissue and solid tissue using a scissoring action. The AURORA Evacuator only cuts soft tissue and uses a rotating whisk rather than scissoring. All three of these differences have been analyzed and tested. Results show no new or different questions of safety and effectiveness.

9) CONCLUSION

Upon reviewing the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characteristics, the AURORA Evacuator has been determined, by Rebound Therapeutics Corporation, to be substantially equivalent to the primary predicate.

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.