(59 days)
The ArthroCare System 15000 is 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 |
| • Meniscectomy | Knee |
| 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 |
The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.
The provided text is a 510(k) summary for the ArthroCare System 15000, an electrosurgical device. It outlines the device description, predicate devices, and intended use. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy, concordance rates).
The summary states: "The modified ArthroCare System 15000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to a previously cleared predicate device (K090393), rather than the presentation of a new study with explicit performance acceptance criteria and results.
Therefore, the requested information cannot be extracted from the provided document.
Here's a breakdown of why each point cannot be fulfilled based on the given text:
- A table of acceptance criteria and the reported device performance: Not available. The document focuses on substantial equivalence to a predicate device, not on specific performance metrics with acceptance criteria.
- Sample sized used for the test set and the data provenance: No test set information is provided as no new clinical or analytical study with a test set is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is mentioned.
- 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. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electrosurgical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance study requiring ground truth is detailed.
- The sample size for the training set: Not applicable, as no algorithmic training is involved.
- How the ground truth for the training set was established: Not applicable, as no algorithmic training is involved.
{0}------------------------------------------------
DEC - 4 2009
510(k) Summary
ArthroCare Corporation ArthroCare System 15000
General Information
Submitter Name/Address:
Establishment Registration Number: Contact Person:
2951580
October 5, 2009
Valerie Defiesta-Ng Director, Regulatory Affairs
ArthroCare Corporation
680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare System 15000
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare System 15000
Product Description
The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.
{1}------------------------------------------------
Intended Use
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
The ArthroCare System 15000 is 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 |
| • Meniscectomy | Knee |
21
۱ ,
{2}------------------------------------------------
| 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) is requesting modifications in the material, physical specifications, performance and labeling for the ArthroCare System 15000 which consists of the ArthroCare 15000 RF Controller and specific ArthroCare ArthroWands (the Wands). The ArthroCare System 15000 was previously cleared in K090393 on June 23, 2009. The indications for use, technology, principle of operation, and sterilization parameters of the ArthroCare System 15000 remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified ArthroCare System 15000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in 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 consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
DEC - 4 2009
Re: K093165
Trade/Device Name: ArthoCare System 15000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 10, 2009 Received: November 12, 2009
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 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); medical device reporting (reporting of medical
{4}------------------------------------------------
Page 2 - Ms. Valerie Defiesta-Ng
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
N. Melkerson
Dic
D.C.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
510(k) Number: K
ArthroCare System 15000® Device Name
Indications for Use:
The ArthroCare System 15000 is 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 |
| • | Meniscectomy | Knee |
H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.H.
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093165
{6}------------------------------------------------
| 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 |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X
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)
FOR M-MELKERSON
(Division Sign-Off) (Division Sign-On) Orthopedic, Division of Surgical Mishorative Devices
510(k) Number K093165
§ 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.