The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

Device Description

The Wands are bipolar, single use, high frequency electrosurgical devices.

AI/ML Overview

This 510(k) submission (K091228) for the ArthroCare® SpineWand® is a Special 510(k) and primarily focuses on modifications to the dimensional specifications, materials, and packaging. The key statement regarding performance is: "The indications for use, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)."

Therefore, this submission does not contain a new study demonstrating the device meets acceptance criteria. Instead, it relies on the safety and effectiveness established for the predicate devices. The information provided is insufficient to answer the detailed questions regarding a new performance study.

Here's a breakdown of why this submission doesn't provide the requested information and what it would look like if it did:

Why the requested information is not available in this document:

Type of Submission: This is a "Special 510(k)". Special 510(k)s are for modifications to a manufacturer's own legally marketed device where the modifications do not require scientific review of clinical data, such as minor design changes or material changes that do not significantly alter the fundamental scientific technology or intended use.
Reliance on Predicate: The submission explicitly states that "The indications for use, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)." This means ArthroCare is not presenting new performance data for this specific submission. They are asserting that the modifications made do not impact the previously established performance.
Lack of New Performance Study: The document does not describe any new testing, such as clinical trials, bench testing (beyond that related to the minor modifications), or analytical studies, to establish new performance metrics for the modified device.

What to look for if a new performance study were present (and why it's not here):

If this 510(k) were a traditional 510(k) or involved significant changes requiring new performance data, it would typically include a section titled "Performance Data," "Summary of Non-Clinical Testing," or "Summary of Clinical Testing." This section would then detail a study or studies designed to demonstrate the device's efficacy and safety against predefined acceptance criteria.

To answer your questions as best as possible, based only on the provided text, and acknowledging the absence of a new performance study:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated for this submission as no new performance study was conducted. The implied acceptance criterion is that the modified device's performance is equivalent to the predicate devices.
- Reported Device Performance: Not reported for this specific submission as no new performance study was conducted. The document states, "The proposed modifications to the Wands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices."
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No new test set or data provenance mentioned as no new performance study was conducted.
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. No new ground truth establishment mentioned as no new performance study was conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new test set mentioned as no new performance study was conducted.
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 diagnostic/imaging device. Therefore, an MRMC study is completely irrelevant. No such study was performed or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrosurgical tool, not an algorithm. No standalone performance study was done or mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No new ground truth mentioned as no new performance study was conducted.
The sample size for the training set
- Not applicable. No training set mentioned as no new performance study was conducted.
How the ground truth for the training set was established
- Not applicable. No training set mentioned as no new performance study was conducted.

In summary: This 510(k) document is for a minor modification and explicitly states that the performance specifications remain the same as the predicate. Therefore, it does not contain the details of a new study proving the device meets acceptance criteria, as no such new study was required or performed for this particular submission. To find such details, one would need to refer to the predicate 510(k)s (K072089, K011634, K001588) or earlier submissions for the ArthroCare SpineWand line.

Summary

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K091228

SEP 2 8 2009

510(k) Summary

ArthroCare Corporation ArthroCare® SpineWand®

General Information

Submitter Name/Address:

ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Trade Name:

Generic/Common Name:

Classification Name:

Predicate Devices

ArthroCare SpineWand ArthroCare System 2000 ArthroCare System 2000 2951580

Valerie Defiesta-Ng Director, Regulatory Affairs

April 22, 2009

ArthroCare® SpineWand®

Electrosurgical Device and Accessories

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

K072089 (August 17, 2007) K011634 (June 19, 2001) K001588 (August 17, 2000)

Product Description

The Wands are bipolar, single use, high frequency electrosurgical devices.

Intended Use

The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

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Substantial Equivalence

This Special 510(k) proposes modifications to the dimensional specifications, materials and package of the ArthroCare SpineWands. The indications for use, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k).

Summary of Safety and Effectiveness

The proposed modifications to the Wands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping shapes. To the left of the figure, the text "DEPARTMENT OF HEALTH &" is arranged vertically, followed by "HUMAN SERVICES" below it.

SEP 2 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

ArthroCare Corporation % Ms. Valerie Defiesta-Ng 680 Vaqueros Avenue Sunnyvale, California 94085-3523

Re: K091228

Trade/Device Name: ArthroCare® SpineWand® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 18, 2009 Received: September 23, 2009

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, ilsting 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. Yourmust comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/uccr1111800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 milli Isse note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFFR Proct 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 frea no (800) 638-2041 or (301) 796-7100 or at its Internet address . http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M. Milliman

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

Device Name:

ArthroCare® SpineWand®

Indications for use:

The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON
(Division Sign-Off)

rivision of Surgical, Orthopedic, I Restorative Devices

310(k) Number K09/228

ರಿ

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.