(345 days)
No
The description focuses on mechanical and electrical functions (aspiration, coagulation, irrigation, motor, battery, bipolar electrodes) and does not mention any AI/ML components or capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is described as a powered instrument for the removal of soft tissue and fluids, and coagulation of tissue, which are surgical procedures rather than therapeutic interventions aimed at curing or treating a disease.
No
The device is described as an instrument for the removal of soft tissue and fluids, and coagulation of tissue during surgical procedures. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly outlines a physical, handheld, battery-powered instrument with mechanical components (whisk, motor), electrical components (bipolar electrodes, battery, indicator light), and connection ports for external hardware (electrosurgical generator, vacuum source, irrigation source). It is a hardware device with some electrical and mechanical functions, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal of soft tissue and fluids, and coagulation of tissue under direct visualization" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical instrument with features for aspiration, coagulation, and irrigation, all used directly on tissue within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical instrument used in vivo (within the living body) for therapeutic and procedural purposes, not for diagnostic testing of samples in vitro (in a lab setting).
N/A
Intended Use / 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 may include laparoscopic, pelviscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, neurosurgical, brain
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 non-clinical testing was conducted to demonstrate the safe and effective use of the AURORA Evacuator +Coag:
- Biocompatibility: Tested for Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization), Irritation (intracutaneous Injection), Systemic toxicity (Systemic Injection), and Materials Mediated Pyrogenicity according to ISO 10993-1. Results: Pass.
- Electrical safety and Enclosure Protection: Tested according to IEC 60601-1 and IEC 60601-2-2. Results: Pass.
- Emissions and Immunity: Tested according to IEC 60601-1-2. Results: Pass.
- Particulate Testing: Tested according to USP Particulate Matter in Injections. Results: Pass.
- Sterilization Validation (SAL of 10-6): Tested according to ISO 11135-1. Results: Pass.
- Packaging and Shelf Life: Tested according to ISTA 2A simulation performance test procedure and ASTM F1980-16. Results: Pass.
- In-vitro verification of product specifications: Verification of materials, multiple bonds evaluations, physical characteristics, performance characteristics and tissue thermal effects (coagulation of tissue). Results: Pass.
- 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. Results: Pass.
- Ex-vivo tissue studies (porcine brain): Demonstrated comparable thermal damage effect (coagulation zone) using the bipolar electrodes when compared with the primary predicate device under the same test parameters and conditions for neurosurgical applications. Results: Pass.
- Validation of product performance: Validation of product using surrogate soft tissue materials and fluids. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
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/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
2
Indications for Use
510(k) Number (if known)
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. Applications include those when access to the surgical site is limited, such as neurosurgical.
Type of Use (Select one or both, as applicable)
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
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
II
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
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.
4
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 Predicate
Device | Reference Device |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | AURORA Evacuator +Coag | Kirwan Bipolar Suction
Coagulator | 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 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. | Disposable device
designed to be used in
soft tissue surgical
procedures that require
slow to rapid fluid
evacuation and lower
energy output for the
coagulation of the tissue
i.e. neurosurgery,
endoscopic, sinusoidal,
ENT, OB-GYN and plastic
surgery. | 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. | The AURORA Evacuator
with coagulation 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. |
| Technological
characteristics -
Summary | 1. Removal of fluid by
suction lumen (wall
vacuum source)
- Rotating whisk
incorporated in suction
lumen at distal tip for
removal of soft tissue
(i.e. blood clot)
- Bipolar electrodes at distal
tip for coagulation of
tissue - Irrigation lumen for saline | 1. Removal of fluid by
suction lumen (wall
vacuum source) - Same as Subject device
- N/A | 1. Same as Subject
device - Same as Subject
device - Same as Subject
device | 1. Same as Subject
device - N/A
- N/A |
| Description | Subject Device | Primary Predicate Device | Secondary Predicate
Device | Reference Device |
| | | Aspiration Characteristics | | |
| Wand
Working length
OD | 7 – 13 cm
12 F (4.0 mm) | 14 -19 cm
8 - 15 F | Same as Subject device | 7 - 13 cm
9 - 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 contained
within inner lumen at
aspiration window
Flat member with notches
301 SS | N/A (Evacuation through
suction only) | Same | Same
Two wire loops
(perpendicular)
Nitinol |
| Power Source for
Motor | Battery located in handle -
one 6V Alkaline | N/A | Same | Batteries located in
handle - two AAA 1.5V
Alkaline |
| Vacuum source
(external) | Connect to barb on device
handle to Operating Room
suction (i.e. wall) | Same | Same | Same |
| Vacuum control | Suction vent on handle that is
fingertip controlled | Same | Same | Same |
| | | Bipolar Electrodes Characteristics | | |
| Electrodes
Type | 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 for
Bipolar electrodes | Cable to electrosurgical
generator (external)
connected to AC mains.
- Cable and
Electrosurgical
generator are not
provided | Same | Same | N/A |
| | | Irrigation | | |
| Irrigation lumen
with luer connector | Capability for saline drip
irrigation delivery to distal tip.
Connection on device handle
to saline bag with line clamp
for clinician to control
irrigation rate. | N/A | Same | N/A |
| Other Characteristics | | | | |
| Use | Single use, sterile | Same | Same | Same |
| Sterilization Method | Ethylene oxide gas
SAL 10-6 | Irradiation | Same as Subject device | Same as Subject device |
| Biocompatibility | ISO 10993-1 | Same | Same | Same |
| EMC, Immunity, and
Electrical Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | Same | Same | Same |
| | | Same | Same | Same |
| | | Same | Same | N/A |
| Accessories | None | Same | 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:
| 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 of
medical devices - Part 1: Evaluation and
testing within a risk management
process | Pass |
| Electrical safety and Enclosure
Protection | IEC 60601-1 Medical electrical
equipment - Part 1: General
requirements for basic safety and
essential performance,
IEC 60601-2-2 Medical electrical
equipment - Part 2-2: Particular
requirements for the basic safety and
essential performance of high frequency
surgical equipment and high frequency
surgical accessories | Pass |
| Emissions and Immunity | IEC 60601-1-2 Medical electrical
equipment - Part 1-2: General
requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic disturbances - Requirements and tests | Pass |
| Particulate Testing | USP Particulate Matter in
Injections | Pass |
| Sterilization Validation (SAL of 10-6) | ISO 11135-1 Sterilization of health care
products – Ethylene oxide – Part 1:
requirements for development,
validation and routine control of a
sterilization process for medical devices | Pass |
| Packaging and Shelf Life | ISTA 2A simulation performance test
procedure
ASTM F1980-16 Standard Guide for
Accelerated Aging of Sterile Barrier
Systems for Medical Devices | Pass |
| In-vitro verification of product
specifications | Verification of materials, multiple bonds
evaluations, physical characteristics,
performance characteristics and tissue
thermal effects (coagulation of tissue). | Pass |
| 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 | Pass |
| Test | Test method summary | Results |
| | same test parameters and conditions.
Thermal damage as a function of
temperature and time with the 3 tissue
types also supported comparability. | |
| Ex-vivo tissue studies (porcine brain) | Demonstrated comparable thermal
damage effect (coagulation zone) using
the bipolar electrodes when compared
with the primary predicate device under
the same test parameters and
conditions for neurosurgical
applications. | Pass |
| Validation of product performance | Validation of product using surrogate
soft tissue materials and fluids | Pass |
7
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.