(57 days)
No
The description focuses on mechanical and electrical functions (whisk, bipolar energy, suction, irrigation) and does not mention any computational or learning capabilities.
Yes
The device is intended for the removal of soft tissue and fluids and the coagulation of tissue, which are medical treatments for disease or injury.
No
The device is described as a powered surgical instrument intended for removal of soft tissue and fluids, and coagulation of tissue. Its function is to perform surgical actions (ablation, coagulation, aspiration, irrigation), not to diagnose conditions.
No
The device description clearly states it is a "disposable, handheld, battery powered instrument" with physical components like a wand, handle, whisk, electrodes, battery, and motor. It is a hardware device with mechanical and electrical functions.
Based on the provided information, the AURORA Evacuator +Coag 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, and coagulation of tissue under direct visualization during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a powered surgical instrument designed for physical manipulation of tissue and application of energy for coagulation. It connects to external sources like vacuum, irrigation, and an electrosurgical generator.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis or testing of samples outside the body.
The device is clearly a surgical tool used directly on the patient during a procedure, which falls under the category of surgical instruments or electrosurgical devices, not IVDs.
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. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open.
Product codes
GEI
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.
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
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.
Key Metrics
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.
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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
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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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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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
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.
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.
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 Suction | |
| Coagulator | AURORA Evacuator | ||
| 510(k) | K201637 | K960455 | K190075/K180372 |
| Product Code | GEI (21CFR 878.4400) | 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. | 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 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
drip | 1. Removal of fluid by suction
lumen (wall vacuum
source) - Same as Subject device
- N/A | 1. Same as Subject device
- N/A
- N/A |
| Description | Subject Device | Predicate Device | Reference Device |
| Aspiration Characteristics | | | |
| Wand
Material
Working length
OD | 304 SS
7 – 13 cm
12 F | Copper alloy
14 -19 cm
8 – 15 F | Same as Subject device
7 - 13 cm
9 - 11 F |
| Aspiration Window | Window at side of distal end | At distal end | Same as Subject device |
| Whisk | Located internal at aspiration
window
Flat member with notches
301 SS | N/A (Evacuation through
suction only) | Same
Two wire loops
Nitinol |
| Power Source for
Motor | Battery located in handle - one
6V Alkaline | N/A | 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 |
| Vacuum control | Suction vent on handle that is
fingertip 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 for
Bipolar electrodes | Cable to electrosurgical
generator (external) connected
to AC mains.
- Cable and Electrosurgical
generator are not
provided | 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 | N/A |
| Other Characteristics | | | |
| Use | Single use, sterile | Same | Same |
| Sterilization Method | Ethylene oxide gas
SAL 10-6 | Irradiation | Same as Subject device
Same |
| Biocompatibility | ISO 10993-1 | Same | Same |
| Description | Subject Device | Predicate Device | Reference Device |
| EMC, Immunity, and
Electrical Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | Same | Same
Same
N/A |
| Accessories | None | Same | Same |
Comparison to Predicate/Reference Devices
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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
- 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.