(14 days)
Not Found
No
The summary describes a standard electrosurgical device for arthroscopic procedures and makes no mention of AI or ML technology.
Yes
The device is indicated for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels, which are procedures aimed at treating conditions within arthroscopic and orthopedic contexts.
No
Explanation: The device is described as an electrosurgical device indicated for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels. These are all therapeutic and surgical actions, not diagnostic ones. There is no mention of it being used to identify or diagnose medical conditions.
No
The device description explicitly states that the ArthroCare ArthroWands are "bipolar, single use, high frequency electrosurgical devices," indicating they are hardware devices used for surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description and Intended Use: The ArthroCare ArthroWands are described as bipolar, single-use, high-frequency electrosurgical devices used for surgical procedures (resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels) within joints. They are used directly on the patient's tissue during surgery, not for testing specimens outside the body.
The information clearly indicates a surgical device used for treatment and manipulation of tissue within the body, which is the opposite of an in vitro diagnostic device.
N/A
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:
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)
- Meniscectomy (Knee)
- 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)
Joint Specific or All Joints include: ankle, elbow, hip, knee, shoulder, and wrist.
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): 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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. Below the logo is the text "K030551" and a horizontal line. Under the line is the text "510(k) Summary".
MAR 0 7 2003
ArthroCare Corporation ArthroCare ArthroWands
| General Information | |
|---|---|
| Submitter Name/Address: | ArthroCare Corporation |
| 680 Vaqueros Avenue | |
| Sunnyvale, CA 94085-2936 | |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng |
| Director, Regulatory Affairs | |
| Date Prepared: | February 20, 2003 |
| Device Description | |
| Trade Name: | ArthroCare® ArthroWands® |
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation |
| Device and Accessories (21 CFR | |
| 878.4400) | |
| Predicate Devices | |
| ArthroCare ArthroWands | K020557 |
Product Description
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
1
Intended 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 | |
| • Meniscectomy | Knee | |
| • 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 | |
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints (ankle, elbow, hip, knee, shoulder, and wrist) | |
| 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 |
2
Continued
Substantial Equivalence
This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare ArthroWands, which were previously cleared under K020557 on March 21, 2002. The indications for use, technology, principle of operation, performance specifications, materials, and sterilization parameters of the ArthroWands remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified ArthroWands, as described in this submission, are substantially equivalent to the predicate ArthroWands. The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
MAR 0 7 2003
Re: K030551
Trade/Device Name: ArthroCare® ArthroWands® Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 20, 2003 Received: February 21, 2003
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
4
Page 2 – Ms. Valerie Defiesta-Ng
(21 CFR Part 807); labeling (21 CFR Part 801); 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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
.
Device Name: ArthroCare ArthroWands
510(k) Number: K_030551
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 |
| • Meniscectomy | Knee |
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 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
OR
Over-the-Counter Use
(Per 21 CFR
801.109)
iriam C. Provost
(Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K630551
İX