Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard electrosurgical device for tissue manipulation and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The device is used for resection, ablation, and coagulation of soft tissue, which are surgical procedures and not considered therapeutic.

Diagnostic

No

The device description clearly states its purpose is for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels," which are therapeutic actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "bipolar, single use, high frequency electrosurgical device," which are hardware components.

IVD (In Vitro Diagnostic)

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 "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
Device Description: The description confirms it's a "bipolar, single use, high frequency electrosurgical device designed for specific indications in arthroscopic and orthopedic procedures." This further reinforces its role as a surgical instrument.
Anatomical Site: The listed anatomical sites (Ankle, elbow, hip, knee, shoulder, and wrist) are all locations within the human body where surgical procedures are performed.

In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro means "in glass").

This device is used within the body during a surgical procedure, making it a surgical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
Ablation and Debridement
• ACL/PCL	Knee
• Acromioplasty	Shoulder
• Articular Cartilage	All Joints
• Bursectomy	All Joints
• Chondroplasty	All Joints
• Facia	All Joints
• Ligament	All Joints
• Notchplasty	Knee
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Subacromial Decompression	Shoulder
• Synovectomy	All Joints
• Tendon	All Joints
Excision and Resection
• Acetabular Labrum	Hip
• Articular Labrum	All Joints
• Capsule	All Joints
• Capsular Release	Knee
• Cartilage Flaps	Knee
• Cysts	All Joints
• Discoid Meniscus	Knee
• Frozen Shoulder Release	Shoulder
• Glenoidale Labrum	Shoulder
• Lateral Release	Knee
• Ligament	All Joints
• Loose Bodies	All Joints
• Meniscal Cystectomy	Knee
Continued
Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist
Prescription Use (Part 21 CFR 801 Subpart D) X AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

Product codes

GEI

Device Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ankle, elbow, hip, knee, shoulder, wrist

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082980

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

This Special 510(k) proposes modifications in the materials specification for the ArthroCare ArthroWands, which were previously cleared in K082980 (November 5, 2008). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s.

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.

Summary

0

K083306

510(k) Summary

ArthroCare Corporation ArthroCare ArthroWands

Page 1 of 3

DEC 1 D., 200 Y

General Information

Submitter Name/Address:

Establishment Registration Number: Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523

2951580

Valerie Defiesta-Ng Director, Regulatory Affairs

November 6, 2008

ArthroCare ArthroWands®

Electrosurgical Device and Accessories

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

Predicate Devices ArthroCare ArthroWands®

K082980

Product Description

The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

1

K083306

Intended Uses

, ←

.

(2) દિવેલું છે. જીવની સુરત દિવસ છે. જીવની સાથે છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 2

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

| Arthroscopic Joints (ankle, elbow,
hip, knee, shoulder, and
wrist) |
|---------------------- | Ablation and Debridement | • ACL/PCL | • Acromioplasty | • Articular Cartilage | • Bursectomy | • Chondroplasty | • Facia | • Ligament | • Notchplasty | • Scar Tissue | • Soft Tissue | • Subacromial Decompression | • Synovectomy | • Tendon | Excision and Resection | • Acetabular Labrum | • Articular Labrum | • Capsule | • Capsular Release | • Cartilage Flaps | • Cysts | • Discoid Meniscus | • Frozen Shoulder Release | • Glenoidale Labrum | • Lateral Release | • Ligament | • Loose Bodies | • Meniscal Cystectomy | • Meniscectomy and Orthopedic Procedures | Joint Specific or All
------------------|--------------------------------------------------------------------------------------|
| |
| Knee |
| Shoulder |
| All Joints |
| All Joints |
| All Joints |
| All Joints |
| All Joints |
| Knee |
| All Joints |
| All Joints |
| Shoulder |
| All Joints |
| All Joints |
| |
| Hip |
| All Joints |
| All Joints |
| Knee |
| Knee |
| All Joints |
| Knee |
| Shoulder |
| Shoulder |
| Knee |
| All Joints |
| All Joints |
| Knee |
| Knee |

2

K083306

Page 3 of 3

Continued
Arthroscopic and Orthopedic Procedures	Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist

Substantial Equivalence

This Special 510(k) proposes modifications in the materials specification for the ArthroCare ArthroWands, which were previously cleared in K082980 (November 5, 2008). The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)s.

Summary of Safety and Effectiveness

The modified ArthroCare ArthroWands, as described in this Special 510(k), are substantially equivalent to the predicate device. The proposed modifications in the materials is not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

DEC 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrocare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vasqueros Avenue Sunnyvale, California 94085-3523

Re: K083306

Trade/Device Name: ArthroCare ArthroWands Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 6, 2008 Received: November 10, 2008

Dear Ms. Defiesta-Ng:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set.

4

Page 2 - Ms. Valerie Defiesta-Ng

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH) s) Office of Compliation at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OBB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use Statement

510(k) Number:

K_083306

Device Name

ArthroCare ArthroWands®

Indications for Use:

The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthonedic groadores:

	Arthroscopic and Orthopedic Procedures	Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, wrist)
	Ablation and Debridement
•	ACL/PCL	Knee
•	Acromioplasty	Shoulder
•	Articular Cartilage	All Joints
•	Bursectomy	All Joints
•	Chondroplasty	All Joints
•	Facia	All Joints
•	Ligament	All Joints
•	Notchplasty	Knee
•	Scar Tissue	All Joints
•	Soft Tissue	All Joints
•	Subacromial Decompression	Shoulder
•	Synovectomy	All Joints
•	Tendon	All Joints
	Excision and Resection
•	Acetabular Labrum	Hip
•	Articular Labrum	All Joints
•	Capsule	All Joints
•	Capsular Release	Knee
•	Cartilage Flaps	Knee
•	Cysts	All Joints
•	Discoid Meniscus	Knee
•	Frozen Shoulder-Release	Shoulder
•	Glenoidale Labrum	Shoulder
•	Lateral Release	Knee
•	Ligament	All Joints
•	Loose Bodies	All Joints
•	Meniscal Cystectomy	Knee

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083306

10

6

Continued
Arthroscopic and Orthopedic Procedures	Joint Specific or All
Joints (ankle, elbow,
hip, knee, shoulder, and
wrist)
• Plica Removal	All Joints
• Scar Tissue	All Joints
• Soft Tissue	All Joints
• Synovial Membrane	All Joints
• Tendon	All Joints
• Triangular Fibrocartilage (TFCC)	Wrist
• Villusectomy	Knee
Coagulation
• ACL/PCL	Knee
• Articular Cartilage	All Joints
• Carpal Ligaments	Wrist
• Glenohumeral Capsule	Shoulder
• Ligament	All Joints
• Medial Retinaculum	Knee
• Rotator Cuff	Shoulder
• Tendon	All Joints
• Wrist Tendons	Wrist

· Prescription Use (Part 21 CFR 801 Subpart D)

X AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Net Re dyke Forman

(Division Sign-Off)" Division of General, Restorative, and Netrological Devices

510(k) Number K083306