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
HipKnee	• ACL/PCL• Notchplasty	• Acetabular Labrum• Capsular Release• Cartilage Flaps• Discoid Meniscus• Lateral Release• Meniscal Cystectomy• Meniscectomy• Villusectomy
Shoulder	• Acromioplasty• SubacromialDecompression	• Frozen Shoulder Release• Glenoid Labrum
Wrist		• Triangular Fibrocartilage

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "FLOW 90º Wand", an electrosurgical device. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the "FLOW® 50 Wand" (K162074).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing as establishing that the device meets "established design criteria and supports substantial equivalence with the predicate device." However, specific numerical acceptance criteria (e.g., pass/fail thresholds for ablation rate, thermal effects) are not explicitly stated in a table format. Instead, the document mentions the types of tests performed and the general conclusion that the device "meets all design and performance specifications."

Reported Device Performance (Qualitative):

Acceptance Criteria Type	Reported Device Performance
Overall Performance	"meets all design and performance specifications"
Thermal Effects	"substantial equivalence to the predicate device in terms of thermal effects"
Safety and Efficacy	"no new safety and efficacy issues were raised as compared to the predicate device."
As Intended Use	"performs as intended and has acceptable performance when used in accordance with its labeling."

2. Sample Size Used for the Test Set and Data Provenance:

The document states:

"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."

Sample Size: Not explicitly stated. The phrase "multiple tissue models" implies more than one instance of each tissue type but does not give a specific number.
Data Provenance: Ex vivo testing. This means the testing was performed on biological tissue outside of a living organism, typically in a laboratory setting. The country of origin for the data is not specified. It is retrospective in the sense that the device design was complete before these tests were conducted to demonstrate performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This device is an electrosurgical wand, and the performance testing described is hardware-based (e.g., ablation rate, thermal effects, electrical safety). There is no mention of human expert evaluation being used to establish ground truth for the device's functional performance in the way it might be for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As stated above, this is for hardware performance testing, not for subjective interpretation or diagnostic evaluation requiring adjudication between multiple human readers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "No clinical data are included in this submission." and "No animal data are included in this submission." This indicates that a human-in-the-loop study, such as an MRMC study, was not performed or included. This device is a surgical instrument, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Partially yes (for the device's functional performance). The performance testing described (software verification and validation, non-clinical, and preclinical bench testing) assesses the device's functional characteristics and safety without human-in-the-loop evaluation for diagnostic purposes. This is characteristic of standalone performance evaluation for a medical device. However, it's critical to note this is not an AI algorithm being evaluated in a standalone manner, but rather the electrosurgical wand itself.

7. The Type of Ground Truth Used:

The ground truth for the functional performance tests was established by objective measurements and comparisons to the predicate device. For example:

Ablation testing: Likely involved measuring the amount or rate of tissue removal.
Thermal effects: Involved measuring temperature changes in and around the tissue.
Electrical safety: Compliance with electrical safety standards.
Biocompatibility: Testing materials for biological compatibility.

The ground truth is based on objective physical and biological measurements in a controlled laboratory setting, not on expert consensus, pathology, or outcomes data in a clinical context.

8. The Sample Size for the Training Set:

Not applicable. This device is an electrosurgical wand with no mention of machine learning or AI algorithms requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.

Summary

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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

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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

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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)

K183346

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.

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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
HipKnee	• ACL/PCL• Notchplasty	• Acetabular Labrum• Capsular Release• Cartilage Flaps• Discoid Meniscus• Lateral Release• Meniscal Cystectomy• Meniscectomy• Villusectomy
Shoulder	• Acromioplasty• SubacromialDecompression	• 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 DriveAustin, TX 78735
	Contact Person:	Shruthi Bhat M.Sc., MSRegulatory Affairs Specialist IIArthrocare Corporation7000 West William Cannon DriveAustin, TX 78735Phone: (512) 895-1295Email: shruthi.bhat@smith-nephew.comFax: 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

5. Intended Use/Indications for Use

		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	■ SynovialMembrane
	■ Ligament
	■ Loose Bodies	■ Tendon
Hip	■ Acetabular Labrum
Knee	■ CapsularRelease	■ MeniscalCystectomy
	■ 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.

Regulation Number and Section

§ 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.