(29 days)
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 |
| 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 ArthroCare ArthroWands are electrosurgical devices indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Here's an analysis of the acceptance criteria and supporting study information:
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and performance data for a new, independent study.
- Acceptance Criteria: No specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) were explicitly stated for the ArthroCare ArthroWands in this document. The primary "acceptance criterion" for this 510(k) submission was to demonstrate substantial equivalence to the previously cleared ArthroWands (K013463).
- Reported Device Performance: The document states, "The modified ArthroWands, as described in this submission, are substantially equivalent to the predicate ArthroWands. The proposed modification in performance specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies that the performance characteristics of the modified device are considered to be within acceptable limits as defined by the predicate device, although specific performance metrics (e.g., operating temperature range, tissue ablation rate, coagulation effectiveness) are not detailed.
Since the submission is for modifications to an already cleared device and focuses on substantial equivalence, the "study" proving acceptance criteria is a comparison to the predicate device and an assessment that the modifications do not negatively impact safety or efficacy. No new clinical or performance study data is presented.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document is a 510(k) summary for modifications to a previously cleared device, focusing on substantial equivalence. It does not present data from a new test set or clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There is no mention of a new test set requiring expert ground truth establishment in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a new test set requiring adjudication in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document does not describe an MRMC study. The device is a surgical tool, not an AI-assisted diagnostic tool, so such a study would not typically be relevant for its approval.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an electrosurgical device, not an algorithm, so standalone performance in the context of AI is not relevant. Its performance is intrinsically linked to its intended use in arthroscopic and orthopedic procedures with human operators.
7. Type of Ground Truth Used
Not applicable. As this 510(k) submission focuses on substantial equivalence for product modifications, it relies on the established safety and efficacy data of the predicate device (K013463). There is no new ground truth established for a new clinical study in this document.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, the concept of a training set is not relevant.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML device, the concept of a training set is not relevant.
In summary, the provided document is a 510(k) summary for a modified electrosurgical device. The primary "acceptance criterion" demonstrated is substantial equivalence to a predicate device, arguing that the modifications do not significantly alter its safety or efficacy. It does not contain information about new clinical studies, test sets, or ground truth establishment typically associated with performance evaluations of AI/ML or novel diagnostic devices.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. The logo features a stylized letter "A" in a large, bold font, followed by the text "rthroCare" in a smaller, but still prominent font. Below "rthroCare" is the word "CORPORATION" in a smaller, sans-serif font.
MAR 2 1 2002
510(k) Summary
ArthroCare Corporation ArthroCare ArthroWands
02055 T
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
2951580
Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research
Date Prepared:
Contact Person:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
February 19, 2002
ArthroCare® ArthroWands®
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare ArthroWands
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 |
xi
{2}------------------------------------------------
Continued
Substantial Equivalence
This Special 510(k) proposes modifications in performance specifications, materials, and I ma openare on Arthro Wands, which were previously cleared under K013463 lucember 15, 2001. The indications for use, technology, principle of operation, dimensional specifications, packaging, 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 performance specifications, materials, and labeling are 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 features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Re: K020557
Trade/Device Name: ArthroCare® Arthro Wands® Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 19, 2002 Received: February 20, 2002
Dear Mr. Prothro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de noos mat have been that do not require approval of a premarket approval application (PMA). and Oosmeter For (110) kes the device, subject to the general controls provisions of the Act. The r ou may, dicrorere, mains 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 If your device is olassined (600 aboverols. 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has mas and regulations administered by other Federal agencies. You must or any I vith 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.
{4}------------------------------------------------
Page 2 -- Mr. Bruce Prothro
This letter will allow you to begin marketing your device as described in your Section 510(k) r ms letter with ation. The FDA finding of substantial equivalence of your device to a legally premaince hourier 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 and 11 you desire specific and 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 O wision 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,
Muriane C. Rivort
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}------------------------------------------------
MAR 2 1 2002
Indications for Use Statement
Device Name:
ArthroCare ArthroWands
510(k) Number:
Indications for use:
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of The Firmoodie Tirano is 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
| Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) | |
|---|---|
| Arthroscopic and Orthopedic Procedures | |
| • 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)
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Muriann C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020559
İX
§ 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.