(56 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components, material properties, and basic functional verification. There is no mention of AI, ML, image processing, or data sets for training/testing algorithms.
No
The device is intended for the removal of soft tissue and fluids during surgical procedures, not for treating or preventing a disease or condition.
No
The device is described as a powered instrument intended for the removal of soft tissue and fluids during surgical procedures. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly outlines physical hardware components including a handpiece, suction wand, motor, batteries, electrical circuitry, and suction tubing. It is a powered instrument for tissue and fluid removal, not a software-only device.
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 from the body during surgical procedures. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a powered instrument designed for aspiration and tissue removal within the surgical site. This aligns with a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue biopsies) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AURORA Evacuator's function is to physically remove material from the body during surgery.
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
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.
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 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 :
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 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
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Indications for Use
510(k) Number (if known) K180372
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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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 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.
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 :
- 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
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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.