(15 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 provided text is a 510(k) summary for the ArthroCare ArthroWands, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to a predicate device (K032504) rather than presenting a study proving that the device meets specific acceptance criteria through performance validation.
Therefore, many of the requested details about acceptance criteria, the study design, sample sizes, expert involvement, and ground truth are not present in this document.
Here's the breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Not present. The document explicitly states: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies that no new performance testing was conducted against new acceptance criteria. Instead, the device's performance is assumed to be equivalent to the predicate device due to the nature of the modifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No specific test set or associated data is described as part of this 510(k) submission, as it relies on substantial equivalence to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not present. Ground truth establishment is not relevant in this context because no performance study on a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No test set or related adjudication process is mentioned.
5. 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 present. This document discusses an electrosurgical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This is not an algorithm, but a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No ground truth is established for a new performance study.
8. The sample size for the training set
- Not present. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
- Not present. Not applicable.
Summary of the document's content relevant to performance and equivalence:
- Basis for Equivalence: The submission is a "Special 510(k)" proposing "modifications in materials for the ArthroCare ArthroWands."
- Key Statement on Equivalence: "The proposed modifications in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This means that the manufacturer is asserting that the changes are minor enough that new specific performance testing isn't required to assure safety and effectiveness, as the device is considered substantially equivalent to its predicate.
- Predicate Device: ArthroCare® System (K032504), cleared on August 21, 2003.
- Attributes Remaining the Same: "The indications for use, technology, principle of operation, packaging, sterilization parameters, and labeling of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k)."
In essence, this 510(k) relies on the premise that because the changes are only material modifications and do not alter the fundamental operation or intended use, the device inherently meets its (unchanged) performance expectations, which were previously established for the predicate device. No new "acceptance criteria" or a new "study proving device meets acceptance criteria" are detailed in this specific document.
{0}------------------------------------------------
NOV 2 8 2003
ArthroCare
CORPORATION
K0 33584
510(k) Summary
510(k) Summary
ArthroCare Corporation ArthroCare ArthroWands
Page ① of 3
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Establishment Registration Number: Contact Person:
Valerie Defiesta-Ng Director, Regulatory Affairs
2951580
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® ArthroWands®
November 12, 2003
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices ArthroCare® System
Product Description
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
{1}------------------------------------------------
Page ② of 3
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 |
| • Meniscectomy | Knee |
{2}------------------------------------------------
Page ③ g 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 materials for the ArthroCare ArthroWands, which were previously cleared in K032504 on August 21, 2003. The indications for use, technology, principle of operation, packaging, sterilization parameters, and labeling of the ArthroCare ArthroWands remain the same as in the predicate cleared 510(k).
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 modifications in materials 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a wavy line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2003
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K033584
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: November 12, 2003 Received: November 13, 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 (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 - 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
sincerely yours,
Mark N Melbers
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
Page ① of 2
Device Name ArthroCare ArthroWands
K 033584 510(k) Number:
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 |
Muhn Millen
ision Sign-Off)
icon el Cuponi. Restorative
od Neurological Devices
{6}------------------------------------------------
Page (3) of 2
| 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 (Per 21 CFR 801.109) X
OR
Over-the-Counter Use
fo Mark A Milkerson
(Division Mir-Off)
Division (1) Coperal, Restorative 1 Neurological Devices
Number K033584
X
§ 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.