(52 days)
No
The summary describes a standard electrosurgical device and its intended use, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes.
The device is used for resection, ablation, coagulation, and hemostasis of soft tissues and blood vessels in arthroscopic and orthopedic procedures, which are therapeutic interventions.
No
Explanation: The device is indicated for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels," typically surgical procedures, not diagnostic ones.
No
The device description explicitly states it is a bipolar, RF electrosurgical device consisting of a handle, shaft, integrated cable, and suction tubing, which are all hardware components. It is designed to be used with a hardware system (WEREWOLF COBLATION System).
Based on the provided information, the FLOW 90° Wand is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "bipolar, RF electrosurgical device" designed for use in surgical procedures.
- Lack of IVD Characteristics: An IVD device is 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. The FLOW 90° Wand does not perform this function. It is a surgical instrument used in vivo (within the body).
Therefore, the FLOW 90° Wand is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FLOW 90 Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
| Joint | 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 | ||
| Knee | • ACL/PCL | |
| • Notchplasty | • Acetabular Labrum | |
| • Capsular Release | ||
| • Cartilage Flaps | ||
| • Discoid Meniscus | ||
| • Lateral Release | ||
| • Meniscal Cystectomy | ||
| • Meniscectomy | ||
| • Villusectomy | ||
| Shoulder | • Acromioplasty | |
| • Subacromial | ||
| Decompression | • Frozen Shoulder Release | |
| • Glenoid Labrum | ||
| Wrist | • Triangular Fibrocartilage |
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The FLOW 90 Wand (Wand) is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Similar to the predicate device FLOW 50 Wand (K162074), FLOW 90 Wand is designed to be exclusively used with WEREWOLF® COBLATION® System (K162074). The FLOW 90 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 WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the WEREWOLF Controller to support the use of the Flow 90 Wand.
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)
Performance testing including software verification and validation, non-clinical testing (Ambient accuracy, ablation testing, use-limiting testing, design verification, electrical safety testing and biocompatibility testing) and pre-clinical testing were performed on the FLOW 90 Wand in conjunction with the WEREWOLF (RF20000) Controller to demonstrate the subject wand meets the established design criteria and supports substantial equivalence with the predicate device. Pre-clinical bench testing (ex vivo testing) was performed across multiple tissue models (muscle, tendon, cartilage and meniscus) to verify substantial equivalence to the predicate device in terms of thermal effects.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
January 24, 2019
ArthroCare Corporation Ms. Shruthi Bhat Regulatory Affairs Specialist II 7000 West William Cannon Drive Austin, Texas 78735
Re: K183346
Trade/Device Name: FLOW 90º Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 30, 2018 Received: December 3, 2018
Dear Ms. Bhat:
We have reviewed vour 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
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
for
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name FLOW 90 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"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."
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Image /page/3/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red, circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that are arranged in a spiral pattern. The word "ArthroCare" is written in a sans-serif font, and the "R" symbol is located at the top right of the word.
INDICATIONS FOR USE for FLOW90° Wand
The FLOW 90 Wand, used with the WEREWOLF COBLATION System, is indicated for the resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures:
| Joint | 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 | ||
| Knee | • ACL/PCL | |
| • Notchplasty | • Acetabular Labrum | |
| • Capsular Release | ||
| • Cartilage Flaps | ||
| • Discoid Meniscus | ||
| • Lateral Release | ||
| • Meniscal Cystectomy | ||
| • Meniscectomy | ||
| • Villusectomy | ||
| Shoulder | • Acromioplasty | |
| • Subacromial | ||
| Decompression | • Frozen Shoulder Release | |
| • Glenoid Labrum | ||
| Wrist | • Triangular Fibrocartilage |
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Image /page/4/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved, parallel lines that create a sense of movement or flow. The word "ArthroCare" is written in a clean, sans-serif font, with the "®" symbol indicating that it is a registered trademark.
510(k) Summary
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 1.
| Submitter Name: | ArthroCare Corporation | |
|---|---|---|
| Address | 7000 West William Cannon Drive | |
| Austin, TX 78735 | ||
| Contact Person: | Shruthi Bhat M.Sc., MS | |
| Regulatory Affairs Specialist II | ||
| Arthrocare Corporation | ||
| 7000 West William Cannon Drive | ||
| Austin, TX 78735 | ||
| Phone: (512) 895-1295 | ||
| Email: shruthi.bhat@smith-nephew.com | ||
| Fax: 512-895-1489 | ||
| Date Prepared | 30 November 2018 | |
| 2. | Device Name | |
| Proprietary Name: | FLOW 90° Wand | |
| Common Name: | Electrosurgical devices and accessories | |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories | |
| Device Class: | Class II | |
| Product Code: | GEI | |
| CFR Section: | 21 CFR 878.4400 |
3. Predicate Device
FLOW® 50 Wand cleared under K162074.
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Image /page/5/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved, parallel lines in a reddish-brown color, arranged in a circular or semi-circular shape. The text "ArthroCare" is in a dark gray or black sans-serif font, with a small registered trademark symbol next to the word "Care".
4. Description
The FLOW 90 Wand (Wand) is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Similar to the predicate device FLOW 50 Wand (K162074), FLOW 90 Wand is designed to be exclusively used with WEREWOLF® COBLATION® System (K162074). The FLOW 90 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 WEREWOLF Controller (part of the WEREWOLF Coblation System) and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the WEREWOLF Controller to support the use of the Flow 90 Wand.
5. Intended Use/Indications for Use
The FLOW 90° Wand, used with the WEREWOLF COBLATION System, 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 | ||
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | ■ Articular | ■ Scar Tissue |
| ■ Cartilage | ■ Soft Tissue | |
| ■ Bursectomy | ■ Synovectomy | |
| ■ Chondroplasty | ■ Tendon | |
| ■ Fascia | ||
| ■ Ligament | ||
| Knee | ■ ACL/PCL | |
| ■ Notchplasty | ||
| Shoulder | ■ Acromioplasty | |
| ■ Subacromial Decompression | ||
| Excision/Resection | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | ■ Articular | ■ Plica Removal |
| ■ Labrum | ■ Scar Tissue | |
| ■ Capsule | ■ Soft Tissue | |
| ■ Cysts | ■ Synovial | |
| Membrane | ||
| ■ Ligament | ||
| ■ Loose Bodies | ■ Tendon | |
| Hip | ■ Acetabular Labrum | |
| Knee | ■ Capsular | |
| Release | ■ Meniscal | |
| Cystectomy | ||
| ■ Cartilage Flaps | ■ Meniscectomy | |
| ■ Villusectomy |
700 W. William Cannon Drive | Building One | Austin, Texas 78735 | 2/00ne 512.391.390 | vove.arthrocare.com
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Image /page/6/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in black font on the right. The circular design is made up of several curved lines that create a sense of movement.
| Discoid Meniscus Lateral Release | |
|---|---|
| Shoulder | Frozen Shoulder Release Glenoid Labrum |
| Wrist | Triangular Fibrocartilage (TFCC) |
6. Comparison between subject device and predicate device:
The technological characteristics of the proposed FLOW 90 Wand are the same as the predicate FLOW 50 Wand.
The main technological similarities between the subject FLOW 90 Wand and predicate FLOW 50 wand are listed below:
- COMPATIBILITY WITH THE WEREWOLF COBLATION SYSTEM: Both the FLOW . 90 Wand and the FLOW 50 Wand are to be used in conjuction with the WEREWOLF COBLATION System.
- WAND FEATURES: Both the FLOW 90 Wand and the FLOW 50 Wand are bipolar, . have Ambient feature, use-limiting feature, suction feature and can be activated using either a fingerswitch or a footpedal.
- . W AND SPECIFICATIONS: Both the FLOW 90 Wand and the FLOW 50 Wand have identical wand specifications for suction ports, number of active electrodes, total length and handle length and outer diameter of the shaft.
- . PATIENT-CONTACTING MATERIALS: Except for the adhesive, both the FLOW 90 Wand and the FLOW 50 Wand have similar patient-contacting materials for the ceramic space, shaft, shaft insulation, internal suction tubing and suction tube set.
- . PACKAGING: Both the FLOW 90 Wand and the FLOW 50 Wand are sterile, disposable and are for single-use only.
No changes or modifications have been made to the intended use, fundamental scientific technology, or principle of operation which was previously cleared in 510(k) K162074.
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Image /page/7/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved, parallel lines in a reddish-brown color, arranged in a circular or spherical shape. The word "ArthroCare" is written in a bold, sans-serif font, and it appears to be in a dark gray or black color.
The main technological differences between the subject FLOW 90 Wand and predicate FLOW 50 wand are listed below:
- . DISTAL TIP: The distal tip of the FLOW 90 Wand was changed to optimize performance with respect to tissue effect, ablation rate, and visualization.
- . SHAFT: The shaft of the FLOW 90 Wand features a longer shaft length than the FLOW 50 Wand (137 mm vs 135 mm). The shaft has no angle and a 90° electrode orientation in comparison to the 40° angle and a 70° electrode orientation of the predicate FLOW 50 wand device. The design change provides a variety of clinical access to the clinicians.
- ADHESIVE: HV-10 single part heat cure epoxy will be used as the adhesive in lieu of . Loctite 3984 single part heat cure epoxy.
- . ELECTRODE: The FLOW 90 Wand uses a metal injection molded (MIM) electrode with 95% tungsten alloy and a single-piece electrode construction while the FLOW 50 Wand uses a tungsten sheet electrode. The MIM electrode design has been previously approved via 510(k) K161481 (Ambient HipVac 50 Wand with Integrated Finger Switches) and enables enhanced manufacturability. The FLOW 90 Wand also features a wider and thicker electrode when compared to the FLOW 50 wand.
- STERILIZATION: The FLOW 90 Wand will be sterilized using Ethylene Oxide unlike . FLOW 50, which is sterilized using Electron Beam.
7. Performance Testing
Performance testing including software verification and validation, non-clinical testing (Ambient accuracy, ablation testing, use-limiting testing, design verification, electrical safety testing and biocompatibility testing) and pre-clinical testing were performed on the FLOW 90 Wand in conjunction with the WEREWOLF (RF20000) Controller to demonstrate the subject wand meets the established design criteria and supports substantial equivalence with the predicate device. Pre-clinical bench testing (ex vivo testing) was performed across multiple tissue models (muscle, tendon, cartilage and meniscus) to verify substantial equivalence to the predicate device in terms of thermal effects.
Based on all the testing performed, the FLOW 90 Wand was found to meet all design and performance specifications and no new safety and efficacy issues were raised as compared to the predicate device.
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Image /page/8/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in black font on the right. The circular design is made up of several curved lines that create a sense of movement. The word "ArthroCare" is written in a bold, sans-serif font.
Performance Testing - Animal 8.
No animal data are included in this submission.
9. Performance Testing - Clinical
No clinical data are included in this submission.
10. Conclusion
All testing demonstrates that the FLOW 90 Wand performs as intended and has acceptable performance when used in accordance with its labeling.
Arthrocare Corporation evaluated the indications for use, materials, technology, design and performance specification requirements of the subject device to demonstrate that the FLOW 90 Wand is substantially equivalent to the predicate device for its intended use, principle for operation and fundamental scientific technology.