(347 days)
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: All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow), Hip, Knee, Shoulder, Wrist.
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.
Since the provided document is a 510(k) premarket notification for an electrosurgical device rather than an AI/ML medical device, it does not contain the specific information requested in the prompt regarding acceptance criteria and studies for AI/ML performance.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on electrical safety, software validation, and tissue effect testing (histology, thermal margins) to demonstrate substantial equivalence to predicate devices, which is typical for electrosurgical devices. It does not involve AI or algorithms that require such performance metrics.
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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
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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
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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)
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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) |
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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 DriveAustin, TX 78735 |
| Contact Person: | Ashley J. Dawson, PhDManager, Regulatory AffairsPhone: 512-358-5773Fax: 512-895-1489 |
| Date Prepared: | January 28, 2015 |
Device Name
| Proprietary Name: | RF20000a Coblation System:RF20000a ControllerFLOW 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.
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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.
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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■ MeniscalCystectomy■ Meniscectomy■ Villusectomy |
| Shoulder | ■ Acromioplasty■ SubacromialDecompression | ■ Frozen ShoulderRelease■ Glenoid Labrum |
| Wrist | ■ TriangularFibrocartilage(TFCC) |
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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: RF20000aWand: FLOW 50 | |
|---|---|---|
| Intended Use | Resection, Ablation, and Coagulation ofSoft Tissue and Hemostasis of BloodVessels in Arthroscopic and OrthopedicProcedures | Same |
| Electrical Safety/EMC | IEC 60601-1 CompliantIEC 60601-2-2 Compliant | Same |
| Controller Specifications/Features | ||
| Input Power | 100-240V50/60Hz | Same |
| Fuse Rating | 8 A | 15 A |
| Output Frequency(Fundamental) | 100kHz | Same |
| Default AblationSet Point / OutputVoltage (Vrms) | Set Point 7/ 260 | Med-/ 279 |
| Ablation Set PointRange / OutputVoltage (Vrms) | Set Points 1 to 9/ 100-314 | Lo⁻ to Hi⁺ / 257-340 |
| Coagulation Set PointRange / OutputVoltage (Vrms) | Set Points 1 to 2/65-100 | Coag - Coag Plus/65-85 |
| Outflow ControlMechanism | Hospital Suction with Roller clamp toadjust flow control. Recommendedsuction:200-400 mmHg | Controller has an integrated lowpressure rotational peristaltic pumpRange: 0-600 rpm |
| Software Program | Software forQuantum 2, V 2.03 | Graphic User Interface V 0.2RF controller software for RF20000a, V1.0 |
| Weight | <5 kg | 10 kg |
| Controller InputPower | 442 W (217 ohms) | 460 W (290 ohms) |
| Controller OutputPower (Ablation, 350ohm load) | 26 – 261 W | 45 – 298 W |
| Controller OutputPower (Coagulation,350 ohm load) | 12 - 27 W | 8 – 30 W |
| Controller CrestFactor (350 ohm load) | 1.4 | Same |
| Controller Waveforms | Square | Same |
| PREDICATE:Controller: Quantum 2 (K082666)Wand: Ambient Super MultiVac(K083306) | SUBJECT:Controller: RF20000aWand: FLOW 50 | |
| Wand Materials | ||
| Electrode | Tungsten | Same |
| Shaft | 304 Stainless Steel | Same |
| Outer Shaft Insulation | Black PET Heat Shrink Tubing | Black Pebax |
| Spacer | Ceramic (Alumina) | Same |
| Adhesive | Epoxy (Loctite 3981) | Epoxy (Loctite 3984) |
| Handle Material | Lexan 104 | Iupilon S3001R |
| Wand Suction Line | PVC | Same |
| Wand Specifications/Features | ||
| Shaft Length | $5.34 \pm 0.08$ inches | $5.31 \pm 0.20$ inches |
| Distal Bend Angle | 50° | 40° |
| Handle Length | 6.03 inches | 6.13 inches |
| Number of Electrodes | 1 active & 1 return | Same |
| Number of InternalSuction Ports | 2 | 1 |
| Suction | Yes | Same |
| Shaft RigidConstruction | Yes | Same |
| Use Limiting Feature | Yes | Yes |
| Temperature Measure | 20 to 60 °C | 10 to 60 °C |
| Finger SwitchActivation | Yes | Same |
| Foot SwitchActivation | Yes | Same |
| Software in Wand | No | Yes |
| Packaged Sterile | Yes | Same |
| Single Use Disposable | Yes | Same |
| Operates inConductive MediaEnvironment | Yes | Same |
| Bipolar/Monopolar | Bipolar | Same |
| Sterilization | Radiation | Same |
| Recommended ActiveAblation Time | 5 minutes(cumulative ablation) at set point 7 | Lo Mode: 10 minutesMed Mode: 4 minutesHi Mode: 2 minutes |
| Rated Wand Voltage | 320 Vrms | 340 Vrms |
| Wand Output Power(Ablation, 350 ohmload) | 26 - 255 W | 189 - 298 W |
| PREDICATE:Controller: Quantum 2 (K082666)Wand: Ambient Super MultiVac(K083306) | SUBJECT:Controller: RF20000aWand: FLOW 50 | |
| Wand Output Power(Coagulation, 350 ohmload) | 12 – 27 W | 12 – 21 W |
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Substantial Equivalence
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.
Summary
The RF20000a Coblation System is substantially equivalent to the predicate devices. The differences between the ArthroCare RF20000a Coblation System and the predicate devices do not raise any new concerns about the safety or effectiveness of the subject devices.
§ 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.