(347 days)
Not Found
No
The summary describes a standard electrosurgical system with different operating modes and does not mention any AI or ML capabilities.
Yes
The device is used for resection, ablation, and coagulation of soft tissues, and hemostasis of blood vessels in various arthroscopic and orthopedic procedures, which are all therapeutic interventions.
No
The provided text states that the device is indicated for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels," and describes it as an "electrosurgical system." These functions are therapeutic, not diagnostic.
No
The device description explicitly states it is an electrosurgical system consisting of a bipolar radiofrequency Controller, a sterile, disposable, single-use Wand, and a non-sterile, reusable Foot Control. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details an electrosurgical system used for tissue manipulation and hemostasis during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
Therefore, the RF20000a Coblation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RF2000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
Ablation/Debridement | Excision/Resection | |
---|---|---|
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) | ■ Articular Cartilage ■ Bursectomy ■ Chondroplasty ■ Fascia ■ Ligament ■ Scar Tissue ■ Soft Tissue ■ Synovectomy ■ Tendon | ■ Articular Labrum ■ Capsule ■ Cysts ■ Ligament ■ Loose Bodies ■ Plica Removal ■ Scar Tissue ■ Soft Tissue ■ Synovial Membrane ■ Tendon |
Hip | ■ Acetabular Labrum | |
Knee | ■ ACL/PCL ■ Notchplasty | ■ Capsular Release ■ Cartilage Flaps ■ Discoid Meniscus ■ Lateral Release ■ Meniscal Cystectomy ■ Meniscectomy ■ Villusectomy |
Shoulder | ■ Acromioplasty ■ Subacromial Decompression | ■ Frozen Shoulder Release ■ Glenoid Labrum |
Wrist | ■ Triangular Fibrocartilage (TFCC) |
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The RF20000a Coblation System is an electrosurgical system consisting of a bipolar radiofrequency Controller with Integrated Fluid Outflow Regulator; a sterile, disposable, single-use FLOW 50 Wand; and a non-sterile, reusable Foot Control. This System utilizes bipolar technology specifically designed for the resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in various arthroscopic and orthopedic procedures. The System offers five distinct Modes of operation: Hi (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis). Each Ablation (Coblation) mode allows for precise ablation with minimal damage to surrounding healthy tissue. The COAG mode allows for consistent and precise hemostasis of blood vessels.
The FLOW 50 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the RF20000a Controller and the Fluid Outflow Regulator, respectively. The handle has finger switches that enable Ablation Mode switching (Lo. Med, Hi) as well as activation of the Wand (Vac, Coag, or Ablate). The Foot Control provides an alternate means of controlling these same functions. The Wand is provided sterile and is single-use only.
The RF20000a Controller is designed to deliver radiofrequency energy to the electrodes of the FLOW 50 Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels, volume, etc. Ports for connecting the FLOW 50 Wand and the Foot Control Pedal are located on the front panel. The Controller incorporates a peristaltic integrated Fluid Outflow Regulator, which provides dynamic control of the rate of removal of conductive irrigating solution and/or fine, less dense, free-floating debris.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow)
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)
Non-clinical performance data such as design verification, software validation, tissue effect testing (histology, thermal margins), and peak temperature testing demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
ArthroCare Corporation Ashley J. Dawson, PhD Manager, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735
Re: K143235
Trade/Device Name: RF20000a Coblation System, RF20000a Controller and FLOW 50 Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 21, 2015 Received: September 23, 2015
Dear Dr. Dawson:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
p. 1 of 2
510(k) Number (if known) K143235
Device Name RF20000a Coblation System: RF20000a Controller and FLOW 50 Wand
Indications for Use (Describe) Please see attached.
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
The RF20000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
Ablation/Debridement | Excision/Resection | |
---|---|---|
All Joints (Hip, | ||
Knee, Shoulder, | ||
Wrist, Ankle, | ||
Elbow) | ■ Articular Cartilage | |
■ Bursectomy | ||
■ Chondroplasty | ||
■ Fascia | ||
■ Ligament | ||
■ Scar Tissue | ||
■ Soft Tissue | ||
■ Synovectomy | ||
■ Tendon | ■ Articular Labrum | |
■ Capsule | ||
■ Cysts | ||
■ Ligament | ||
■ Loose Bodies | ||
■ Plica Removal | ||
■ Scar Tissue | ||
■ Soft Tissue | ||
■ Synovial Membrane | ||
■ Tendon | ||
Hip | ■ Acetabular Labrum | |
Knee | ■ ACL/PCL | |
■ Notchplasty | ■ Capsular Release | |
■ Cartilage Flaps | ||
■ Discoid Meniscus | ||
■ Lateral Release | ||
■ Meniscal Cystectomy | ||
■ Meniscectomy | ||
■ Villusectomy | ||
Shoulder | ■ Acromioplasty | |
■ Subacromial Decompression | ■ Frozen Shoulder Release | |
■ Glenoid Labrum | ||
Wrist | ■ Triangular Fibrocartilage | |
(TFCC) |
4
510(k) Summary
ArthroCare® Corporation
RF20000a Coblation System: RF20000a Controller with FLOW 50 Wand
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
Submitter Name: | ArthroCare Corporation |
---|---|
Address | 7000 West William Cannon Drive |
Austin, TX 78735 | |
Contact Person: | Ashley J. Dawson, PhD |
Manager, Regulatory Affairs | |
Phone: 512-358-5773 | |
Fax: 512-895-1489 | |
Date Prepared: | January 28, 2015 |
Device Name
| Proprietary Name: | RF20000a Coblation System:
RF20000a Controller
FLOW 50 Wand | |
|--------------------|-------------------------------------------------------------------|--|
| Common Name: | Electrosurgical cutting and Coagulation Device and Accessories | |
| Regulation Name: | Electrosurgical cutting and Coagulation Device and Accessories | |
| Regulatory Class: | II | |
| Product Code: | GEI | |
| Regulation Number: | 21 CFR 878.4400 | |
Predicate Devices
ArthroCare® System 12000 (Quantum 2) ArthroCare ArthroWands® (Ambient Super MultiVac 50) K082666 K083306
Description
RF20000a Coblation System
The RF20000a Coblation System is an electrosurgical system consisting of a bipolar radiofrequency Controller with Integrated Fluid Outflow Regulator; a sterile, disposable, single-use FLOW 50 Wand; and a non-sterile, reusable Foot Control.
5
This System utilizes bipolar technology specifically designed for the resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in various arthroscopic and orthopedic procedures.
The System offers five distinct Modes of operation: Hi (Ablation), Lo (Ablation), Vac (Vacuum), and COAG (Hemostasis). Each Ablation (Coblation) mode allows for precise ablation with minimal damage to surrounding healthy tissue. The COAG mode allows for consistent and precise hemostasis of blood vessels.
FLOW 50 Wand
The FLOW 50 Wand consists of a handle, shaft, integrated cable, and suction tubing. The integrated cable and suction tubing are attached at the proximal end of the handle and connect to the RF20000a Controller and the Fluid Outflow Regulator, respectively. The handle has finger switches that enable Ablation Mode switching (Lo. Med, Hi) as well as activation of the Wand (Vac, Coag, or Ablate). The Foot Control provides an alternate means of controlling these same functions. The Wand is provided sterile and is single-use only.
RF20000a Controller
The RF20000a Controller is designed to deliver radiofrequency energy to the electrodes of the FLOW 50 Wand. The Controller is an enclosed unit with incorporated software that runs both the delivery of radiofrequency energy as well as a Graphical User Interface with which the user can control various modes, levels, volume, etc. Ports for connecting the FLOW 50 Wand and the Foot Control Pedal are located on the front panel.
The Controller incorporates a peristaltic integrated Fluid Outflow Regulator, which provides dynamic control of the rate of removal of conductive irrigating solution and/or fine, less dense, free-floating debris.
6
Intended Use/Indications for Use
There are no added procedures to the Indications for Use for the subject devices as compared to the predicate Ambient Super MultiVac Wand (K083306) and the Quantum 2 Controller (K082666). However, previously cleared procedures that utilized the Coagulation setting in order to thermally shrink tissue (e.g., Coagulation of Medial Retinaculum) were removed since the FLOW 50 Wand is not designed to be used in that manner. Removal of previously cleared procedures has no effect on the safety and effectiveness of the device when used as labeled.
The RF2000a Coblation System, comprised of the FLOW 50 Wand and the RF20000a Controller, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
Ablation/Debridement | Excision/Resection | |
---|---|---|
All Joints | ||
(Hip, Knee, | ||
Shoulder, | ||
Wrist, | ||
Ankle, | ||
Elbow) | ■ Articular Cartilage | |
■ Bursectomy | ||
■ Chondroplasty | ||
■ Fascia | ||
■ Ligament | ||
■ Scar Tissue | ||
■ Soft Tissue | ||
■ Synovectomy | ||
■ Tendon | ■ Articular Labrum | |
■ Capsule | ||
■ Cysts | ||
■ Ligament | ||
■ Loose Bodies | ||
■ Plica Removal | ||
■ Scar Tissue | ||
■ Soft Tissue | ||
■ Synovial Membrane | ||
■ Tendon | ||
Hip | ■ Acetabular Labrum | |
Knee | ■ ACL/PCL | |
■ Notchplasty | ■ Capsular Release | |
■ Cartilage Flaps | ||
■ Discoid Meniscus | ||
■ Lateral Release | ||
■ Meniscal | ||
Cystectomy | ||
■ Meniscectomy | ||
■ Villusectomy | ||
Shoulder | ■ Acromioplasty | |
■ Subacromial | ||
Decompression | ■ Frozen Shoulder | |
Release | ||
■ Glenoid Labrum | ||
Wrist | ■ Triangular | |
Fibrocartilage | ||
(TFCC) |
7
Summary of Technological Characteristics
The subject devices have the same technological characteristics (i.e., design, material, chemical composition, and energy source) as the predicate devices with the following exceptions (in bold font):
| | PREDICATE:
Controller: Quantum 2 (K082666)
Wand: Ambient Super MultiVac
(K083306) | SUBJECT:
Controller: RF20000a
Wand: FLOW 50 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Intended Use | Resection, Ablation, and Coagulation of
Soft Tissue and Hemostasis of Blood
Vessels in Arthroscopic and Orthopedic
Procedures | Same |
| Electrical Safety/EMC | IEC 60601-1 Compliant
IEC 60601-2-2 Compliant | Same |
| Controller Specifications/Features | | |
| Input Power | 100-240V
50/60Hz | Same |
| Fuse Rating | 8 A | 15 A |
| Output Frequency
(Fundamental) | 100kHz | Same |
| Default Ablation
Set Point / Output
Voltage (Vrms) | Set Point 7/ 260 | Med-/ 279 |
| Ablation Set Point
Range / Output
Voltage (Vrms) | Set Points 1 to 9/ 100-314 | Lo⁻ to Hi⁺ / 257-340 |
| Coagulation Set Point
Range / Output
Voltage (Vrms) | Set Points 1 to 2/65-100 | Coag - Coag Plus/65-85 |
| Outflow Control
Mechanism | Hospital Suction with Roller clamp to
adjust flow control. Recommended
suction:
200-400 mmHg | Controller has an integrated low
pressure rotational peristaltic pump
Range: 0-600 rpm |
| Software Program | Software for
Quantum 2, V 2.03 | Graphic User Interface V 0.2
RF controller software for RF20000a, V
1.0 |
| Weight |