(29 days)
No
The summary describes a standard electrosurgical device and its compatibility with existing controllers. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels" to treat various conditions in different joints. These are direct therapeutic interventions.
No
The device is described as an electrosurgical device for resection, ablation, coagulation, and hemostasis of soft tissues and blood vessels. These are therapeutic, not diagnostic, functions.
No
The device description clearly states it is a bipolar, RF electrosurgical device consisting of a handle, shaft, integrated cable, and suction tubing, which are all physical 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 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 procedure performed directly on the patient's body.
- Device Description: The description details a "bipolar, RF electrosurgical device" designed for surgical intervention.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The FLOW 90◊ Wand, used with Qualified 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)
- Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon)
- Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane,Tendon)
Hip
- Excision/Resection - (Acetabular Labrum)
Knee
- Ablation/ Debrideement - (ACL/PCL, Notchplasty)
- Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy)
Shoulder
- Ablation/ Debrideement - (Subacromial Decompression)
- Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)
Wrist
- Excision/Resection - (Triangular Fibrocartilage)
Product codes
GEI
Device Description
The FLOW 90 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. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)).
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 Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified 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)
Hip (Acetabular Labrum)
Knee (ACL/PCL, Notchplasty, Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release, Meniscal Cystectomy, Meniscectomy, Villusectomy)
Shoulder (Subacromial Decompression, Frozen Shoulder Release, Glenoid Labrum)
Wrist (Triangular Fibrocartilage)
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)
Electrical Safety: Basic safety and performance testing was performed on the proposed FLOW 90 Wand to demonstrate electrical, mechanical and functional capabilities in accordance with IEC 60601-1 and IEC 60601-2-2.
Bench testing: Mechanical Integrity and Functional Testing was performed, including testing results for flow rate, fluid ingress, suction tube kinking, and finger switch testing which are identified in the attachments.
Additionally, the new packaging tray was validated in accordance with ASTM D4169-DC13. ISO 11607-1, and ISO 11607-2.
Testing demonstrated the safety and efficacy of subject FLOW 90 Wand is substantially equivalent to its predicate device. All design inputs have been met and the testing performed did not introduce any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K162074, K192027, K210423, K232290
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
May 8, 2024
ArthroCare Corporation Srividya Pothana Senior Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735
Re: K240964
Trade/Device Name: FLOW 90° Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 8, 2024 Received: April 9, 2024
Dear Srividya Pothana:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510/k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.05.08 13:53:41 -04'00'
Long H. 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
2
3
Indications for Use
Submission Number (if known)
Device Name
FLOW 90◊ Wand
Indications for Use (Describe)
The FLOW 90 Wand, used with Qualified 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)
-
Ablation/ Debrideement - (Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Scar, Tissue, Soft Tissue, Synovectomy, Tendon)
-
Excision/Resection (Articular Labrum, Capsule, Cysts, Ligament, Loose Bodies, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane,Tendon)
Hip
- Excision/Resection - (Acetabular Labrum)
Knee
-
Ablation/ Debrideement - (ACL/PCL, Notchplasty)
-
Excision/Resection - (Capsular Release, Cartilage Flaps, Discoid Meniscus, Lateral Release,
Meniscal Cystectomy, Meniscectomy, Villusectomy)
Shoulder
-
Ablation/ Debrideement - (Subacromial Decompression)
-
Excision/Resection - (Frozen Shoulder Release, Glenoid Labrum)
Wrist
- Excision/Resection - (Triangular Fibrocartilage)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
Image /page/4/Picture/0 description: The image contains the logo for ArthroCare. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines in a dark red color, arranged in a circular pattern. The word "ArthroCare" is written in a dark gray sans-serif font, with the registered trademark symbol (®) placed after the word.
Special 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
| Submitter Name | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person | Srividya Pothana |
| Senior Regulatory Affairs Specialist | |
| Arthrocare Corporation | |
| 7000 West William Cannon Drive | |
| Austin, TX 78735 | |
| Phone: 512-391-3900 | |
| Email: Srividya.pothana@smith-nephew.com | |
| Fax: 512-391-3901 | |
| Date Prepared | April 8, 2024 |
DEVICE NAME
| Subject Device Proprietary Name | FLOW 90° Wand |
|---|---|
| Model/Catalog Number | 72290038 |
| 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 |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρέας 512.391.3901 | www.arthrocare.com
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Image /page/5/Picture/0 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 lines in a deep red color, arranged in a circular pattern. The word "ArthroCare" is written in a dark gray sans-serif font, with the "®" symbol in superscript next to the word.
PREDICATE DEVICE(S)
FLOW 90° Wand cleared under K183346.
SUBJECT DEVICE DESCRIPTION
The FLOW 90 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. The FLOW 90° Wand is compatible with Qualified controllers (WEREWOLF® COBLATION® Systems (includes WEREWOLF® (K162074), WEREWOLF® ENT, (K192027) and WEREWOLF® + (K210423)) and INTELLIO® SHIFT ® System (K232290)).
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 Qualified Controller and the Fluid Outflow Regulator of the Controller, respectively. No design changes have been made to the Qualified Controllers to support the use of the modified FLOW 90 Wand.
INTENDED USE/INDICATIONS FOR USE
The FLOW 90 Wand, used with a qualified 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 | ||
|---|---|---|
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | • Articular | |
| • Cartilage | ||
| • Bursectomy | ||
| • Chondroplasty | ||
| • Fascia | ||
| • Ligament | • Scar Tissue | |
| • Soft Tissue | ||
| • Synovectomy | ||
| • Tendon | ||
| Knee | • ACL/PCL | |
| • Notchplasty | ||
| Shoulder | • Subacromial Decompression | |
| Excision/Resection | ||
| All Joints (Hip, Knee, | ||
| Shoulder, Wrist, | ||
| Ankle, Elbow) | • Articular | |
| • Labrum | ||
| • Capsule | ||
| • Cysts | ||
| • Ligament | ||
| • Loose Bodies | • Plica Removal | |
| • Scar Tissue | ||
| • Soft Tissue | ||
| • Synovial | ||
| Membrane | ||
| • Tendon |
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
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Image /page/6/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left, composed of several curved red lines. To the right of the graphic is the word "ArthroCare" in a gray, sans-serif font. A small registered trademark symbol is located to the upper right of the word "Care".
| Knee | Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release | Meniscal Cystectomy Meniscectomy Villusectomy |
|---|---|---|
| Shoulder | Frozen Shoulder Release Glenoid Labrum | |
| Wrist | Triangular Fibrocartilage |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE(S)
Technological Differences with Predicate
This Special 510(k) submission supports the design changes within the subject device's handle assembly and interface between finger switches and button pad to improve the device's ability to withstand clinical conditions related to fluid exposure and finger switch (button) actuation. A new packaging tray was also qualified as part of this submission to better secure the wand at its proximal end during transit.
Some additional differences between subject FLOW 90 Wand and predicate FLOW 90 (K183346) included as part of Letter to Files submissions are:
- Indications for use Shoulder acromioplasty is removed as an indication of use, this change does . not affect the intended use, safety, and effectiveness of the device.
- . Controller - The compatible qualified controllers include WEREWOLF ENT, WEREWOLF+ and INTELLIO SHIFT.
The modifications made to support the changes do not impact the device's intended use, fundamental scientific technology, and principle of operation and is substantially equivalent to previously cleared K183346 510(k) submission.
| Parameter | PREDICATE DEVICE:
FLOW 90° Wand
510(k) K183346 | SUBJECT DEVICE:
FLOW 90° Wand |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Product Code | GEI | Same |
| CFR | 21 CFR 878.4400 | Same |
| Prescription Use Only | Yes | Same |
| Representation | Image: Representation | Same |
| Intended Use | Resection, ablation, and coagulation of
soft tissues andhemostasis of blood
vessels inindicated arthroscopic and
orthopedic procedures. | Same |
| Compatible with
WEREWOLF◊
COBLATION◊ SYSTEM | Yes | Same |
| Specifications | | |
| Distal Tip | Image: Distal Tip | Same |
| Active Electrode
Configuration | 95% Tungsten alloy MIM (metal injection molded)
electrode with
four molded, raised
features to help provide
tactile feedback to the
surgeon. Mating features that
interact with spacer.
Electrode is bonded to
spacer with epoxy. | Same |
| Shaft Working Length | 137 mm | Same |
| Tubing/Shaft Angle near
the Wand Tip | No Angle | Same |
| Electrode Orientation
relative to Shaft | 90° | Same |
| Number of Suction Ports | 1 | Same |
| Number of Active
Electrodes | 1 | Same |
| Recommended Active
Ablation Time | Active ablation time per Mode (not
additive):
Lo Mode: 7 minutes.
Med Mode: 7 minutes
Hi Mode: 7 minutes | Same |
| Wand Features | | |
| Bipolar/ Monopolar | Bipolar | Same |
| Activation Method | Foot Pedal or Finger Switch | Same |
| Use-limiting Feature | Yes (software controlled) | Same |
| Sterilization and Packaging | | |
| Sterilization | Ethylene Oxide | Same |
| Packaged Sterile/ Single
Use Disposable | Sterile, Single Use, Disposable | Same |
Technological Similarities with Predicate
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | phone 512.391.3901 | www.arthrocare.com
7
Image /page/7/Picture/0 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, red lines that are arranged in a circular pattern. The word "ArthroCare" is written in a gray, sans-serif font. There is a registered trademark symbol to the right of the word "ArthroCare".
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρώονε 512.391.3901 | www.arthrocare.com
8
Image /page/8/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a circular graphic on the left and the word "ArthroCare" on the right. The circular graphic is made up of several curved lines in a dark red color. The word "ArthroCare" is written in a gray sans-serif font, with the "R" symbol next to it.
7000 W. William Cannon Drive | Building One | Austin, Texas 78735 | ρώονε 512.391.3901 | www.arthrocare.com
9
Image /page/9/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines in a dark red color, arranged in a circular pattern. The word "ArthroCare" is written in a dark gray sans-serif font, with a registered trademark symbol next to it.
Some additional similarities between subject FLOW 90 Wand and predicate K183346 510(k) submission include:
Patient Contacting Materials: Both subject and predicate FLOW 90 Wands have equivalent patient contacting materials for the ceramic spacer, shaft, shaft insulation, adhesive, internal suction tubing and suction tube set.
Wand Specifications: The subject and predicate have the same wand specifications for suction ports, number of electrodes and handle lengths and outer diameter of the shaft.
NON-CLINICAL Testing
Electrical Safety: Basic safety and performance testing was performed on the proposed FLOW 90 Wand to demonstrate electrical, mechanical and functional capabilities in accordance with IEC 60601-1 and IEC 60601-2-2.
Bench testing: Mechanical Integrity and Functional Testing was performed, including testing results for flow rate, fluid ingress, suction tube kinking, and finger switch testing which are identified in the attachments.
Additionally, the new packaging tray was validated in accordance with ASTM D4169-DC13. ISO 11607-1, and ISO 11607-2.
Testing demonstrated the safety and efficacy of subject FLOW 90 Wand is substantially equivalent to its predicate device. All design inputs have been met and the testing performed did not introduce any new questions of safety or effectiveness.
CONCLUSION
All testing demonstrates that the proposed device performs as intended and has acceptable performance when used in accordance with its labeling. As the intended use, principle of operation, performance and fundamental scientific technology are unchanged from the predicate device the subject FLOW 90 Wand is substantially equivalent to the predicate device.