(28 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
The provided text describes a Special 510(k) submission for a modification to the ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™. This typically means the device is being compared to its own previously cleared versions, and the focus is on demonstrating that the modifications do not significantly affect safety or efficacy. Therefore, the "study" referenced would be the justification for how these modifications maintain substantial equivalence, rather than a clinical trial proving new performance criteria.
Based on the provided text, the acceptance criteria and study information are significantly different from what would be expected for a typical AI/ML device submission that requires performance metrics. This is a 510(k) submission for an electrosurgical device, and the criteria are related to maintaining substantial equivalence after material and performance specification modifications, not to establishing performance for diagnostic accuracy or similar AI model outputs.
Here's an interpretation based solely on the provided document, acknowledging that it addresses a different type of device and regulatory pathway than what the prompt's questions typically imply:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "The proposed modification in performance specifications and materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies the "acceptance criteria" are that the modified device's performance remains congruent with or within the established safety and efficacy profile of the predicate devices. No specific quantitative performance metrics are provided for the modified device itself, nor are there explicit "acceptance criteria" tables in the manner of diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Modifications do not substantially change the device. | The modifications are to "performance specifications and materials." The indications for use, technology, principle of operation, dimensional specifications, packaging, labeling, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s. |
| Modifications do not significantly affect the safety or efficacy of the devices. | The submission asserts that the modified Wands are "substantially equivalent to the predicate devices" and that the changes "do not significantly affect the safety or efficacy of the devices." No new safety or efficacy data from studies are presented. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document as it's not a study testing a new device feature or performance. The submission is about modifications to an already cleared device. Clinical studies with test sets are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The regulatory review in a Special 510(k) focuses on the impact of device modifications on established safety and efficacy, not on clinical performance metrics evaluated by experts against a ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. This is not a study assessing human reader performance with or without AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not provided. The device is an electrosurgical wand, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable and not provided. The "ground truth" here is the established safety and efficacy profile of the predicate device, and the submission argues that the modifications do not alter this.
8. Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of an electrosurgical device modification.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this Special 510(k) submission for the ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™ is a comparison to predicate devices (K011083 and K011279). The manufacturer submitted documentation to demonstrate that modifications made to the device's performance specifications and materials are not substantial and do not significantly affect the device's safety or efficacy. The core argument for acceptance is substantial equivalence to the previously cleared predicate devices, meaning the modified device continues to meet the established safety and performance characteristics of its predecessors. This is a documentation-based justification rather than a new clinical study.
{0}------------------------------------------------
K 013463
NOV 1 5 2001
Special 510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™
Manufacturer:
ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:
Contact Person:
2951580
October 17, 2001
Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research
Date Prepared:
Device Description
Classification Name:
Trade Name:
878.4400) ArthroCare ArthroWands®
Electrosurgical Device and Accessories
Device and Accessories (21 CFR
Electrosurgical Cutting and Coagulation
ENTec® EVac™ Plasma Wand™
Generic/Common Name:
Predicate Devices
ArthroCare ArthroWands ENTec EVac Plasma Wand K011083 K011279
Intended Use
ArthroCare ArthroWands
- The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of . soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
{1}------------------------------------------------
| 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 |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
.
、
:
04
100 - 100 -
{2}------------------------------------------------
ENTec EVac Plasma Wand
- The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis . of soft tissue in tonsillectomy and adenoidectomy procedures.
Product Description
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
Substantial Equivalence
This Special 510(k) proposes a modification in performance specifications and materials for the Wands, which were previously cleared under K011083 and K011279 on June 28, 2001 and July 19, 2001, respectively. The indications for use, technology, principle of operation, dimensional specifications, packaging, labeling, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s.
Summary of Safety and Effectiveness
The modified Wands, as described in this submission, are substantially equivalent to the predicate devices. The proposed modification in performance specifications and materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085-2936
Re: K013463
K013403
Trade/Device Name: ArthroCare ArthroWands®, ENTec® Evac™ Plasma Wand™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 17, 2001 Received: October 18, 2001
NOV 1 5 2001
Dear Mr. Prothro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosuly to regars) at tegally and the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that do not requent of the general controls provisions of the Act. The 1 ou may, therefore, mailes of the Act include requirements for annual registration, listing of general controls provisions of the ling, 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 classinod (600 wor of als. Existing major regulations affecting your device can Inay oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Over cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3155aantes over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I coclar statutes and regulations and admited to: registration and listing (21 comply with an the 71ct 31equirements, neller, each, ence, except station requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
{4}------------------------------------------------
Page 2 - Mr. Bruce Prothro
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in you'ls comming of substantial equivalence of your device to a legally premailed predicated 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 deeline operate the vitro diagnostic devices), please contact the Office of additionally 21 (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 59 - t 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 Oiner general informational 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,
Susan Walker, MD
Image /page/4/Picture/5 description: The image contains what appears to be a signature or stylized initials. The writing is cursive and somewhat abstract, with looping strokes and sharp angles. It is difficult to discern specific letters or words without additional context.
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}------------------------------------------------
NOV 1 5 2001
Indications Statement
Device Name:
ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™
K 013463 510(k) Number:
Indications for use:
ArthroCare ArthroWands
- The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of . The ArthroCare Arthro Wanas are menous are menomen 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 |
{6}------------------------------------------------
| • 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 |
ENTec EVac Plasma Wand
- . The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.
(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 |
Susan Wall
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
KOI'S 4
510(k) Number -
§ 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.