(27 days)
No
The device description and performance studies focus on mechanical and electrical components for tissue and fluid removal, with no mention of AI or ML capabilities.
No
The device is described as an aspiration device designed to remove fluids and soft tissue during minimally invasive surgical procedures, which is a surgical tool, not a therapeutic device.
No.
The device description indicates it is a surgical tool for removing soft tissue and fluids, not for diagnosing conditions.
No
The device description clearly outlines a physical, powered instrument with a handpiece, suction wand, motor, and batteries, indicating it is a hardware device, not software-only.
Based on the provided information, the AURORA Evacuator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the removal of soft tissue and fluids under direct visualization during surgical procedures. This is a surgical tool used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description details a powered surgical instrument with a suction wand and rotating wire loops designed to physically remove tissue and fluids from a surgical site. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect biomarkers, or provide any diagnostic information about a patient's condition.
- Anatomical Site: The device is used directly on anatomical sites (Neurosurgical/Spinal and ENT/Otolaryngological) during surgery.
- Performance Studies: The performance studies focus on the device's physical and operational characteristics (biocompatibility, electrical safety, sterilization, performance with surrogate materials), not on the accuracy or reliability of diagnostic results.
In summary, the AURORA Evacuator is a surgical instrument designed for tissue and fluid removal during procedures, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for 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, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/ Otolaryngological.
Product codes
GEI
Device Description
There is a total of nine (9) devices in the AURORA Evacuator product line; three (3) from the original 510(k), K180372, and six (6) in this 510(k). All members of the product line have the same design and mode of operation.
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 with an exiting vacuum tube. A barb connector at the end of the exiting vacuum tube is intended to connect to operating room suction.
The 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 rotatable shaft with wire loops. The wire loops are aligned with the aspiration window and are intended to physically break-up soft tissue. The rotatable shaft is connected to a battery powered motor.
The motor and batteries are housed in the ergonomically designed handle. A green power indicator light is located on the top portion of the handle to show that power is available to the device. The handle also contains a suction control vent for user vacuum control and a motor control button for user activation of the rotating wire loops.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted or adopted to demonstrate the safe and effective use of the modified AURORA Evacuators and substantial equivalence to the predicate.
- Biocompatibility Testing per ISO 10993-1, including Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Material Mediated Pyrogenicity was adopted from the predicate since materials of construction are identical.
- Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 60529-1 was adopted from the predicate since the electrical configuration and design has not changed.
- Emissions and Immunity per IEC 60601-1-2 was adopted from the predicate since the electrical configuration has not changed.
- Particulate Testing per USP 36 was adopted from the predicate since there is no change to configuration accept for wand diameter.
- Sterilization per ISO 11135-1 to validate a SAL of 10-6 was adopted using the predicate data.
- Packaging and Shelf-life per ISTA 2A and ASTM F1980 were adopted from the predicate since there are no changes to packaging configuration or package design.
- 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 material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AURORA Evacuator-7, AURORA Evacuator-10, AURORA Evacuator-13, cleared under 510(k) #K180372
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2019
Rebound Therapeutics Corporation Mr. Donald Atienza Director of Quality Assurance and Regulatory Affairs 13900 Alton Parkway, Suite 120 Irvine, California 92618
Re: K190075
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: January 9, 2019 Received: January 16, 2019
Dear Mr. Atienza:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Radiological Health
Digitally signed by Long H. Chen Long H. Chen -S Date: 2019.02.12 14:42:41 -05'00' fOI 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
Enclosure
2
Indications for Use
510(k) Number (if known) K190075
Device Name AURORA Evacuator
Indications for Use (Describe)
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.
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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3
1) SUBMITTER
Rebound Therapeutics Corporation 13900 Alton Parkway, STE 120 Irvine, CA 92618
Contact Person: Jane Metcalf, Vice President of Regulatory Affairs Telephone: (949) 525-1493 Email: jmetcalf@reboundtx.com
Contact Person: Donald Atienza, Director Quality Assurance and Regulatory Affairs Telephone: (949) 305-8111 ext. 108 Email: datienza@reboundtx.com
Date Prepared: February 11, 2019
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 Predicates: AURORA Evacuator-7, AURORA Evacuator-10, AURORA Evacuator-13, cleared under 510(k) #K180372 Secondary Predicate(s): None
4) PURPOSE OF SUBMISSION
The purpose of this submission is to achieve market clearance for two (2) modifications to the AURORA Evacuator. The primary modification is a product line extension to include two (2) larger diameter suction wands with an elongated whisk. This change adds six (6) new configurations to the original 3 configurations. See Table 5-1 below. The other modification is to change the identification label on the device handle to include French size.
Note that model numbers have also changed. The original three (3) model numbers submitted in K180372 were "Aurora Evacuator-13", "Aurora Evacuator-10" and "Aurora Evacuator-7". These model numbers have been changed to "AURORA Evacuator-9Fx13cm", "AURORA Evacuator-9Fx10cm", and "AURORA Evacuator-9Fx7cm", respectively
5) DEVICE DESCRIPTION
There is a total of nine (9) devices in the AURORA Evacuator product line; three (3) from the original 510(k), K180372, and six (6) in this 510(k). All members of the product line have the same design and mode of operation. See Table 5-1 below.
4
| | Model # | Wand
Working
Length
(cm) | Wand OD
(mm) | Wand ID
(mm) |
|----------------------------------|---------------------------|-----------------------------------|-----------------|-----------------|
| Predicates | AURORA Evacuator-9Fx7cm | 7 | 3.0 | 2.6 |
| | AURORA Evacuator-9Fx10cm | 10 | 3.0 | 2.6 |
| | AURORA Evacuator-9Fx13cm | 13 | 3.0 | 2.6 |
| Subject of
this
Submission | AURORA Evacuator-10Fx7cm | 7 | 3.4 | 3.0 |
| | AURORA Evacuator-10Fx10cm | 10 | 3.4 | 3.0 |
| | AURORA Evacuator-10Fx13cm | 13 | 3.4 | 3.0 |
| | AURORA Evacuator-11Fx7cm | 7 | 3.6 | 3.2 |
| | AURORA Evacuator-11Fx10cm | 10 | 3.6 | 3.2 |
| | AURORA Evacuator-11Fx13cm | 13 | 3.6 | 3.2 |
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 with an exiting vacuum tube. A barb connector at the end of the exiting vacuum tube is intended to connect to operating room suction.
The 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 rotatable shaft with wire loops. The wire loops are aligned with the aspiration window and are intended to physically break-up soft tissue. The rotatable shaft is connected to a battery powered motor.
The motor and batteries are housed in the ergonomically designed handle. A green power indicator light is located on the top portion of the handle to show that power is available to the device. The handle also contains a suction control vent for user vacuum control and a motor control button for user activation of the rotating wire loops.
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.
6) 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.
7) SUMMARY OF TESTING
The following testing was conducted or adopted to demonstrate the safe and effective use of the modified AURORA Evacuators and substantial equivalence to the predicate.
- Biocompatibility Testing per ISO 10993-1, including Cytotoxicity (MEM Elution), Sensitization . (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Material Mediated Pyrogenicity was adopted from the predicate since materials of construction are identical.
5
- Electrical Safety and Enclosure Protection per IEC 60601-1 and IEC 60529-1 was adopted from . the predicate since the electrical configuration and design has not changed.
- Emissions and Immunity per IEC 60601-1-2 was adopted from the predicate since the electrical . configuration has not changed
- Particulate Testing per USP 36 was adopted from the predicate since there is no change to configuration accept for wand diameter.
- Sterilization per ISO 11135-1 to validate a SAL of 106 was adopted using the predicate data. ●
- Packaging and Shelf-life per ISTA 2A and ASTM F1980 were adopted from the predicate since there are no changes to packaging configuration or package design.
- . 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 material.
8) SUMMARY TECHNOLOGICAL CHARACTERISTICS
The AURORA Evacuator has two (2) modes of operation and one (1) for aspiration and one (1) for breaking up tissue. For aspiration, the AURORA Evacuator uses an external vacuum source present in the operating room. To aspirate, the surgeon covers the suction control vent and positions the aspiration window so that vacuum draws fluid and smaller pieces of soft tissue through the window, into the wand, through the exiting vacuum tube and into a collection receptacle.
For breaking-up soft tissue the AURORA Evacuator uses rotating wire loops that are located inside the wand. Batteries in the handle of the device power a micro gear motor that causes the wire loops to rotate when the motor control button is pushed. The surgeon positions the aspiration window against the tissue to be removed, covers the suction control vent (completely or partially) to draw the tissue into the aspiration window, then depresses the motor control button. The tissue is mechanically broken-up and evacuated via vacuum into the collection receptacle. The wire loops stop rotating when the motor control button is released. The mechanical break-up of tissue can only occur inside of the wand.
9) COMPARISON TO PREDICATE
Comparing the modified devices to the predicate devices shows that the primary difference is the rate of aspiration. The modified devices have aspiration rates that are faster than those of the predicate. This is due to the larger diameter wands that are less restrictive to flow. Since lower aspirations rates represent worse case performance, no new questions of safety and effectiveness are introduced by the modified devices.
10) CONCLUSION
Upon reviewing the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characteristics, the modified AURORA Evacuators have been determined, by Rebound Therapeutics Corporation, to be substantially equivalent to the primary predicate.