The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

Device Description

The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a family of disposable, bipolar, single use Wands; and a reusable Patient Cable.

AI/ML Overview

This 510(k) submission (K022543) for the ArthroCare® Bipolar Loop Electrosurgery System is a Special 510(k). This type of submission is used to declare modifications to a previously cleared device. Therefore, the focus is on demonstrating that the modifications do not significantly affect the safety or efficacy of the System and that it remains substantially equivalent to its predicate devices (K955531 and K010568).

Crucially, this document does not contain acceptance criteria or detailed study data proving the device meets specific performance metrics in the way a de novo or traditional 510(k) might for a wholly new device or significant design change.

Instead, the "study" demonstrating that the device meets acceptance criteria is implied by the nature of a Special 510(k): the modifications are not substantial enough to require new clinical performance testing or completely redefined acceptance criteria beyond those already established for the predicate devices. The acceptance criteria are, essentially, that the modified device's performance is still within the bounds of what was deemed safe and effective for the predicate devices, and that the changes do not introduce new safety or effectiveness concerns.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) focusing on minor modifications to an already cleared device, formal quantitative acceptance criteria and a detailed table of reported device performance values in the context of new testing are not explicitly provided in the document.

Instead, the "acceptance criteria" are broad and qualitative, centered around the concept of substantial equivalence to the predicate devices. The reported "performance" is implicitly stated by asserting that the modifications do not "significantly affect the safety or efficacy of the System."

Acceptance Criteria (Implied for Special 510(k))	Reported Device Performance (Summary Statement)
Safety: Does not introduce new safety concerns.	"The proposed modifications... do not significantly affect the safety or efficacy of the System."
Efficacy: Maintains the effectiveness for its intended uses.	"The proposed modifications... do not significantly affect the safety or efficacy of the System."
Substantial Equivalence: Features remain aligned with predicate devices.	"The modified Bipolar Loop Electrosurgery System... is substantially equivalent to the predicate device."
Intended Use: Continues to meet the defined indications for use.	"The indications for use... remain the same as in the predicate cleared 510(k)."
Technology/Principle of Operation: No fundamental changes.	"The technology, principle of operation... remain the same as in the predicate cleared 510(k)."

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

This document does not mention a test set, sample size, or data provenance in the context of new clinical or performance testing for the Special 510(k). The basis for the substantial equivalence claim relies on the unchanged aspects of the device and the minor nature of the modifications.

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

Given that no new test set or clinical study data is presented for this Special 510(k), there is no information regarding experts establishing ground truth. The initial ground truth (safety and effectiveness) would have been established during the original 510(k) clearances (K955531 and K010568) for the predicate devices.

4. Adjudication Method for the Test Set

As no new test set data is presented, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this Special 510(k) document. This type of study is more common for diagnostic imaging or AI-assisted diagnostic devices, and not typically for an electrosurgical system modification focused on substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is an electrosurgical system operated by a human surgeon, not an algorithm, and therefore the concept of "standalone performance" for an algorithm does not apply in this context.

7. The Type of Ground Truth Used

For this Special 510(k), the "ground truth" is based on the previously established safety and efficacy of the predicate devices (ArthroCare® Bipolar Loop Electrosurgery System, K955531 and K010568). The claim is that the modifications do not alter this established ground truth. There is no new "ground truth" derived from expert consensus, pathology, or outcomes data presented in this specific document.

8. The Sample Size for the Training Set

This document does not involve a training set as it's not an AI/machine learning device.

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

This question is not applicable as there is no training set for an electrosurgical device.

Summary of the "Study" Proving Acceptance Criteria for this Special 510(k):

The "study" or justification for meeting acceptance criteria in this Special 510(k) is a comparative analysis against its predicate devices. The submitter states that:

The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the modified device remain the same as the predicate cleared 510(k).
The modifications are specifically described as changes in performance specifications, dimensional specifications, and labeling, which are considered minor.
The conclusion is that these proposed modifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

Therefore, the "proof" is declarative: the changes are minor, and because the original device was safe and effective, the modified one remains safe and effective due to the non-substantial nature of the alterations. This type of submission typically relies on engineering analysis, bench testing demonstrating equivalence of the modified components to the original, and a strong argument for the non-impact of the changes, rather than new clinical trials with patient sample sizes.

Summary

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X022543
pg 1 of 2

AUG 3 0 2002

510(k) Summary

ArthroCare Corporation ArthroCare® Bipolar Loop Electrosurgery System

General Information

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-2936
Phone Number:	(408) 736-0224
Contact Person:	Bruce ProthroVice President,Operational Planning, Quality andRegulatory Affairs
Date Prepared:	July 30, 2002

Device Description

Trade Name:	ArthroCare® Bipolar Loop ElectrosurgerySystem
Generic/Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and CoagulationDevice and Accessories (21 CFR 878.4400)
Predicate Devices	ArthroCare® Bipolar LoopElectrosurgery SystemK955531 and K010568

Product Description

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Intended Uses

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Substantial Equivalence

This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, and labeling for the Bipolar Loop Electrosurgery System, which was previously cleared in K955531 on February 21, 1996 and K010568 on March 27, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare Bipolar Loop Electrosurgery System remain the same as in the predicate cleared 510(k).

Summary of Safety and Effectiveness

The modified Bipolar Loop Electrosurgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2002

Re: K022543

Trade/Device Name: ArthroCare® Bipolar Loop Electrosurgery System Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II

Product Codes: 78 FAS and KNS Dated: July 30, 2002 Received: August 1, 2002

Dear Ms. Defiesta-Ng:

Ms. Valerie Defiesta-Ng

ArthroCare® Corporation

SUNNYVALE CA 94085

680 Vaqueros Avenue

Director, Regulatory Affairs

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 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

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21 CFR 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,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

ArthroCare® Bipolar Loop Electrosurgery System Device Name

K022543 510(k) Number:

Indications for Use:

The ArthroCare® Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as non-malignant turnors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	X	OR	Over-the-Counter Use
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(Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K022543

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).