(30 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, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Facia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoidale Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).
The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
The provided 510(k) summary for the ArthroCare ArthroWands is a submission that proposes modifications in the materials specification of a previously cleared device (K082323). This is a "Special 510(k)" submission.
For Special 510(k)s, substantial equivalence is claimed when design or manufacturing changes are made to a manufacturer's own legally marketed device, and the changes do not significantly affect the safety or effectiveness of the device. Therefore, the "study" demonstrating that the device meets acceptance criteria is typically a demonstration that the new materials do not negatively impact the performance of the device or pose new safety risks, rather than a clinical performance study against specific acceptance criteria. The existing performance of the predicate device is assumed to be acceptable.
Based on the provided text, the specific details regarding acceptance criteria and a study proving performance as one might expect for a de novo device or a traditional 510(k) for a novel device are not explicitly stated in this summary. Instead, the document focuses on demonstrating that the modifications do not change the safety and effectiveness relative to the predicate.
Here's how to interpret the request in the context of this Special 510(k):
1. A table of acceptance criteria and the reported device performance
Since this is a Special 510(k) for material changes, there are no new performance acceptance criteria outlined. The acceptance criterion is effectively that the device's performance, safety, and effectiveness remain unchanged from the predicate device despite the material specification modifications.
| Acceptance Criteria (Inferred from Special 510(k)) | Reported Device Performance (Inferred) |
|---|---|
| Indications for Use remain unchanged. | Remains identical to predicate K082323. |
| Technology remains unchanged. | Remains identical to predicate K082323. |
| Principle of operation remains unchanged. | Remains identical to predicate K082323. |
| Sterilization parameters remain unchanged. | Remains identical to predicate K082323. |
| Safety is not significantly affected. | Modifications are not substantial; safety not significantly affected. |
| Efficacy is not significantly affected. | Modifications are not substantial; efficacy not significantly affected. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" or clinical data provenance. The assessment for a Special 510(k) regarding material changes typically involves bench testing, biocompatibility testing, and potentially some limited non-clinical performance testing to ensure the new materials meet specifications and do not negatively impact the device. The specific sample sizes for such engineering or materials tests are not provided in this summary.
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 applicable. The submission is about material changes and relies on bench and non-clinical testing, not expert-adjudicated clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication is described.
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 applicable. This device is an electrosurgical tool, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical tool, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a Special 510(k) involving material changes, the "ground truth" would be established specifications and standards for the materials themselves (e.g., biocompatibility standards, mechanical property specifications, electrical performance safety standards). The summary does not detail the specific standards or how compliance was achieved.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
Summary of the Study Proving Device Meets Acceptance Criteria (as per the Special 510(k) context):
The "study" in this context is the design control process and testing performed by ArthroCare Corporation to ensure that the proposed material changes do not affect the safety or efficacy of the ArthroWands. The document states:
"The proposed modifications in the materials is not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
This statement serves as the conclusion of their internal assessment and testing (e.g., bench testing, biocompatibility, electrical safety, performance testing specific to the material change) that would have been conducted to demonstrate continued substantial equivalence to the predicate device K082323. The 510(k) summary itself does not provide the detailed results or methodology of these tests, but rather asserts their outcome. The FDA's clearance (K082980) indicates that they reviewed this assessment and agreed with the manufacturer's conclusion.
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K0 82980
NOV - 5 2008
510(k) Summary
ArthroCare Corporation ArthroCare ArthroWands
Page 1 of 3
General Information
Submitter Name/Address:
Establishment Registration Number: Contact Person:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
2951580
Valerie Defiesta-Ng Director, Regulatory Affairs
October 3, 2008
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.
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0 82980
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 |
.
: 上一篇:
:
. . .
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KO 82 980
Page 3 of 3
| 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 |
Substantial Equivalence
This Special 510(k) proposes modifications in the materials specification for the ArthroCare ArthroWands, which were previously cleared in K082323 (August 28, 2008). 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 modifications in the materials is not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2008
ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K082980
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: October 3, 2008 Received: October 6, 2008
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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Millen
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:
RK082 480
Device Name
ArthroCare ArthroWands®
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, awrist) |
|---|---|
| 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 |
| 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 |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
(082980
10
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Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
X
Over-The-Counter Use (21 CFR 801 Subpart C)
D
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
ime Ople for ntm
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of General, and Neurological 082980
510(k) Number K08298
§ 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.