(27 days)
The ArthroCare Timer is an accessory, supplied separately, that can be used with the Electrosurgery System in the following indications:
- 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 Timer is an accessory that can be used with ArthroCare's Electrosurgery System. It is designed to control the duration of therapy treatment during soft tissue ablation procedures.
The provided document is a 510(k) Summary for the ArthroCare® Timer, an accessory to an electrosurgery system. This submission modifies the performance specifications and labeling for an already cleared electrosurgery system.
Crucially, the document explicitly states: "The proposed addition of the ArthroCare Timer performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System."
Therefore, this submission does not contain a new study proving the device meets acceptance criteria. Instead, it leverages the fact that the changes are deemed non-substantial and rely on the prior clearance of the predicate device (K020557 ArthroCare® ArthroWands). The acceptance criteria for the Timer accessory itself would likely be related to its function of timing, which would be tested internally against its design specifications rather than requiring a clinical study with patients or experts.
Given this, I cannot provide the information requested in your numbered points because a new study to prove the device meets acceptance criteria as typically understood for new medical devices (i.e., clinical trials, AI performance studies) was not conducted or reported in this 510(k) summary.
The document is primarily a regulatory filing asserting substantial equivalence based on the minor nature of the modification.
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Jun 6 2002
ArthroCare
CORPORATION
510(k) Summary K 081519 ArthroCare Corporation ArthroCare® Timer
General Information
Submitter Name/Address:
Phone Number:
Contact Person:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
(408) 736-0224
Valerie Defiesta-Ng Director, Regulatory Affairs
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
May 9, 2002
ArthroCare® Timer
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices ArthroCare® ArthroWands
Product Description
The ArthroCare Timer is an accessory that can be used with ArthroCare's Electrosurgery System. It is designed to control the duration of therapy treatment during soft tissue ablation procedures.
Intended Uses
The ArthroCare Timer is an accessory, supplied separately, that can be used with the Electrosurgery System in the following indications:
- u The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
{1}------------------------------------------------
| Continued | |
|---|---|
| Arthroscopic and Orthopedic Procedures | Joint Specific or AllJoints (ankle, elbow,hip, knee, shoulder, andwrist) |
| 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 to modify the performance specifications and labeling for the Electrosurgery System, which was previously cleared in K020557 on March 21, 2002. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the entire Electrosurgery System remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The addition of the ArthroCare Timer to the Electrosurgery System, as described in this Special 510(k), is substantially equivalent to the predicate devices. The proposed addition of the ArthroCare Timer performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 JUN
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Re: K021519
Trade/Device Name: ArthroCare® Timer Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 9, 2002 Received: May 10, 2002
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.
{3}------------------------------------------------
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 and additionally 21 CFR Part 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 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,
A Stip Rhodes
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
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Indications for Use Statement
ArthroCare® Timer Device Name
K021519 510(k) Number:
Indications for Use:
- The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of 피 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 |
7
Dagle
{5}------------------------------------------------
| 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
X
Over-the-Counter Use
(Per 21 CFR 801.109)
Stylo Plurdu
(Division Sign-Off) Division of General - storative and Neurological De . . Ces
KOZISI9 510(k) Number_
ixa
2 of 2
§ 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.