The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in . otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage.
The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of . soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
The ENTec Surgery System is intended for ablation and coagulation of soft tissue in . otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, . ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
The ArthroCare Electrosurgery System is indicated for resection, ablation, and . coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline.
The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for . general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as . well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

Device Description

The ArthroCare Electrosurgery Systems are bipolar, high frequency electrosurgical Systems consisting of three components: an electrosurgical generator called the System 2000 Controller, a disposable bipolar single use Wand designed for specific indications, and the reusable patient Cable.

AI/ML Overview

This 510(k) submission, K011634, focuses on a modification in materials for the Wand component of several ArthroCare Electrosurgery Systems. It is a "Special 510(k)," meaning it relies on the predicate devices' prior clearances to demonstrate substantial equivalence, rather than new extensive studies. Therefore, much of the information typically found in a full effectiveness study is not present in this summary.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a material modification, specific quantitative acceptance criteria and performance metrics for the modified device are not detailed in this summary. The core claim is substantial equivalence to the predicate devices. The document explicitly states:

"The technology, principle of operation, intended uses, performance specifications, dimensional specifications, labeling, packaging, and sterilization parameters of the Electrosurgery Systems remain the same as in the previously cleared 510(k)s."

This implies that the modified device is expected to perform identically to the predicate devices and meet their original performance specifications. Because the performance specifications are unchanged, there are no new "reported device performance" values to present for this specific submission.

Acceptance Criteria	Reported Device Performance
Maintain prior performance specifications (as per predicate devices K000778, K001588, K001936, K003624, K010568)	Unchanged from predicate devices; substantial equivalence demonstrated through material modification assessment.
Safety and Efficacy not significantly affected by material modification	Assessed, and FDA determined no significant effect on safety or efficacy.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or sample size for an effectiveness study are mentioned. The "study" here is the assessment of the material modification. This type of submission relies on bench testing and material characterization to demonstrate that the new material does not negatively impact the device's function or safety. Details of such testing (e.g., biocompatibility testing, mechanical testing) are typically performed, but are not summarized in this FDA 510(k) document. The data provenance would be internal laboratory testing from ArthroCare Corporation. It would be prospective with respect to the material change but would not involve patient-specific data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. There is no "ground truth" that would be established by external experts in the context of clinical interpretation. The "ground truth" for the material modification is its compliance with specifications and regulatory standards, which is assessed internally by the manufacturer and reviewed by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the sense of expert review for diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC study. These devices are electrosurgical tools, not AI-powered diagnostic systems, so MRMC studies are not relevant.

6. Standalone (Algorithm Only) Performance Study

No. These are physical electrosurgical devices, not algorithms.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance specifications and safety profile of the predicate devices. The material modification is assessed against these established parameters. This would involve:

Engineering specifications and testing (e.g., electrical safety, mechanical strength, material compatibility).
Biocompatibility data for the new material.
Risk assessment to ensure the change does not introduce new hazards.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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KO11634

510(k) Summary of Safety and Effectiveness ArthroCare Corporation ENTec® ReFlex™ Wand, ArthroCare® System 2000, ENTec® Surgery System , ArthroCare® Orthopedic Surgery System, ArthroCare® Electrosurgery System, Visage® Cosmetic Surgery System, and ArthroCare® Bipolar Loop (Electrosurgery Systems)

General Information Manufacturer:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description Classification Name:

Trade Name:

ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94085-2936

2951580

Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research

May 25, 2001

Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)

ENTec® ReFlex Wand ArthroCare® System 2000 ENTec® Surgery System ArthroCare® Orthopedic Electrosurgery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop

Generic/Common Name:

Electrosurgical Device and Accessories

Predicate Devices ENTec ReFlex Wand K000778 . K001588 ArthroCare System 2000 . ENTec Surgery System, ArthroCare . Orthopedic Electrosurgery System, and K001936 ArthroCare Electrosurgery System Visage Cosmetic Surgery System K003624 K010568

ArthroCare Bipolar Loop

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Intended Uses

The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in . otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway ototal firger by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage.
The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of . The Firth o Car by Stears of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
The ENTec Surgery System is intended for ablation and coagulation of soft tissue in . otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, . ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
The ArthroCare Electrosurgery System is indicated for resection, ablation, and . coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline.
The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for . general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as . well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

Product Description

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Substantial Equivalence

This Special 510(k) proposes a modification in materials to the Wand component of the Electrosurgery Systems, which were previously cleared in K000778 (May 3, 2000), Election 19 19 2000), K001936 (July 19, 2000), K003624 (December 20, 2000), and K010568 (March 27, 2001). The technology, principle of operation, intended uses, performance specifications, dimensional specifications, labeling, packaging, and sterilization parameters of the Electrosurgery Systems remain the same as in the previously cleared 510(k)s.

Summary of Safety and Effectiveness

The modified Wand component of the Electrosurgery Systems, as described in this submission, is substantially equivalent to the predicate Wands. The proposed modification in materials is not a substantial change or modification, and does 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 features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's mission and purpose.

Public Health Service

JUN 1 9 2001

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

Re: K011634

Trade/Device Name: ENTec® ReFlex Wand

ArthroCare® System 2000 ENTec® Surgery System ArthroCare® Orthopedic Electrosurgery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop

Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: May 25, 2001 Received: May 29, 2001

Dear Mr. Prothro:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

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Page 2 - Mr. Bruce Prothro

comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Bsmt clutter work

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 Statement

Device Names:

ENTec® ReFlex™ Wand ArthroCare® System 2000 ENTec® Surgery System ArthroCare® Orthopedic Electrosurgery System ArthroCare® Electrosurgery System Visage® Cosmetic Surgery System ArthroCare® Bipolar Loop

510(k) Number:

KO11634

Indications for use:

The ENTec ReFlex Wand is indicated for ablation and coagulation of soft tissue in . otolaryngological (ENT) procedures, including the treatment of snoring, nasal airway obstruction by reduction of hypertrophic nasal turbinates, and submucosal tissue shrinkage.
The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of . soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
The ENTec Surgery System is intended for ablation and coagulation of soft tissue in . otorhinolaryngology (ENT) surgery including head, neck, oral, and sinus surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, . ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
The ArthroCare Electrosurgery System is indicated for resection, ablation, and . coagulation of soft tissue and hemostasis of blood vessels in general, plastic, and reconstructive surgery. It is intended to be used in procedures using conductive solutions, such as normal saline.
The Visage Cosmetic Surgery System is a bipolar electrosurgical device intended for . general dermatologic surgery that may include skin resurfacing for the treatment of wrinkles, rhytids, and furrows, as well as soft tissue resection/removal and hemostasis/coagulation. It is intended to be used in procedures using conductive solutions such as normal saline.
The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as . well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.

İX

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(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

Over-the-Counter Use

NThhkeeeorOKn

(Division Sign-Off) (Division Sign Off), Restorative Division ological Devices

510(k) Number K011634

Regulation Number and Section

§ 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.