(22 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in 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), 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).
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
The provided text describes a 510(k) summary for the ArthroCare ArthroWands. However, it does not contain any information about acceptance criteria, device performance metrics, or details of a study (such as sample sizes, ground truth establishment, or expert involvement) that proves the device meets specific criteria.
The document states that the ArthroCare ArthroWands are substantially equivalent to predicate devices (K070958 and K040338). The current submission (K071963) is a Special 510(k) for modifications in performance specifications and labeling, noting that "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." It explicitly states, "The proposed modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices."
Therefore, based solely on the provided text, I cannot fill out the requested information about acceptance criteria or a study proving those criteria are met. The FDA's determination of substantial equivalence implies that the device is deemed safe and effective because it is similar to devices already legally marketed, rather than through a new, comprehensive performance study outlined in this document.
To briefly address each point based on the absence of information:
- A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to predicate devices.
- Sample sized used for the test set and the data provenance: Not provided. No specific test set or study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable. This is an electrosurgical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electrosurgical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not applicable; not a machine learning device.
- How the ground truth for the training set was established: Not applicable; not a machine learning device.
{0}------------------------------------------------
K071963
510(k) Summary
Page 1 of 3
ArthroCare Corporation ArthroCare ArthroWands
AUG - 7 2007
General Information
| Submitter Name/Address: | ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523 |
|---|---|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-NgDirector, Regulatory Affairs |
| Date Prepared: | July 13, 2007 |
Device Description
| Trade Name: | ArthroCare ® ArthroWands ® |
|---|---|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and CoagulationDevice and Accessories (21 CFR 878.4400) |
Predicate Devices
| ArthroCare ® ArthroWands ® | K070958 |
|---|---|
| ArthroCare System | K040338 |
Product Description
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
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Ko 7 1963
Image /page/1/Picture/1 description: The image shows the text "Page 2 of 3" written in cursive. The word "Page" is written in a flowing script, followed by the number "2". The word "of" is written in a smaller font, and the number "3" is enclosed in a circle. The text appears to be a page number indicator, suggesting that it is the second page of a three-page document.
Intended Uses
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 AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) | |
|---|---|---|
| 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 |
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Page 3 of (3)
| Continued | |
|---|---|
| Arthroscopic and Orthopedic Procedures | Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) |
| • 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 performance specifications and labeling for the ArthroCare ArthroWands, which were previously cleared in K070958 (April 23, 2007) and K040338 (March 1, 2004). 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 modification in the material is a not substantial change or modification, and does not significantly affect the safety or efficacy of the devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three intertwined snakes ascending towards the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCcare Corporation % Ms. Valerie DeFiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K071963
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: July 13, 2007 Received: July 16, 2007
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 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.
AUG - 7 2007
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Page 2 - Ms. Valerie DeFiesta-Ng
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 A. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
KO 71963
ArthroCare® ArthroWands® Device Name
Page 1 of 2
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 AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) |
|---|---|
| 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 |
Mall. n Millan
on Sign-Off)
on of General, Restorative,
Neurological Devices
·
{6}------------------------------------------------
Ko 71963
Page 2 of ②
| Continued | |
|---|---|
| Arthroscopic and Orthopedic Procedures | Joint Specific or AllJoints (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) 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)
Mark M. Mckenna
X
(Division Sign-Off) Division of General, Resterative, and Neurological Devices
510(k) Number_
§ 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.