(74 days)
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or functionalities.
Yes
The device is used for debridement, resection, ablation, and hemostasis in arthroscopic and orthopedic procedures, which are therapeutic interventions.
No
Explanation: The device is described as an electrosurgical device indicated for debridement, resection, ablation, and hemostasis in arthroscopic and orthopedic procedures. These are treatment interventions, not diagnostic activities.
No
The device description explicitly states it is a bipolar, single-use, high-frequency electrosurgical device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "debridement, resection, ablation, and hemostasis of blood vessels in arthroscopic and orthopedic procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description confirms it's a "bipolar, single use, high frequency electrosurgical device designed for specific indications in arthroscopic and orthopedic procedures." This further reinforces its use as a surgical instrument.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological material.
Therefore, the ArthroCare Topaz ArthroWands are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, The Arthroom's ropas Firms and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Procedures | | Body Structure as
described below |
|----------------------------|--|----------------------------------------------|
| • Fasciotomy | | Foot |
| • Synovectomy | | Foot |
| • Tendonotomy | | Knee, Wrist, Elbow,
Ankle, Shoulder, Foot |
| • Rotator Cuff Tendonotomy | | Shoulder |
| • Capsulotomy | | Foot |
Product codes
HRX, GEI
Device Description
The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, Knee, Wrist, Elbow, Ankle, Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
MAR 5 2006
Page 1 of 2
510(k) Summary
ArthroCare Corporation ArthroCare® Topaz™ ArthroWands®
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|------------------------------------|---------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | December 21, 2005 |
Device Description
| Trade Name: | ArthroCare® Topaz™ ArthroWands® |
|---|---|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation |
| Device and Accessories (21 CFR 878.4400) |
Predicate Devices
| ArthroCare® ArthroWands® | K011083, K052686 |
|---|---|
| -------------------------- | ------------------ |
Product Description
The ArthroCare Topaz ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.
1
Page 2 of 2
Intended Uses
The ArthroCare Topaz ArthroWands are indicated for resection, ablation, and The Androom of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Substantial Equivalence
This 510(k) proposes a new indication and labeling for the ArthroCare Topaz ArthroWands. The technology, principle of operation, and sterilization parameters of the ArthroCare Topaz ArthroWands remain the same as those Wand cleared in the predicate 510(k)s.
Summary of Safety and Effectiveness
The ArthroCare Topaz ArthroWands, as described in this 510(k), are substantially equivalent to the predicate devices. The new proposed indication and labeling are not substantial changes, and do not significantly affect the safety or efficacy of the devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 6 2006
ArthroCare Corp. c/o Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K053567
Trade/Device Name: ArthroCare® Topaz™ ArthroWands® Regulation Number: 21 CFR 888.1100 and 21 CFR 878.4400 Regulation Name: Arthroscope, Elecrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX, GEI Dated: December 21, 2005 Received: December 22, 2005
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.
3
Page 2 - Ms. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.J.N. Malle, M.S.
Mark N. Melkerson, M.S Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K 053567 510(k) Number:
Device Name:
ArthroCare® Topaz™ ArthroWands®
Indications for Use:
The ArthroCare Topaz ArthroWands are indicated for debridement, resection, ablation, The Arthroom's ropas Firms and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
| Procedures | | Body Structure as
described below |
|----------------------------|--|----------------------------------------------|
| • Fasciotomy | | Foot |
| • Synovectomy | | Foot |
| • Tendonotomy | | Knee, Wrist, Elbow,
Ankle, Shoulder, Foot |
| • Rotator Cuff Tendonotomy | | Shoulder |
| • Capsulotomy | | Foot |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR X
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sigh Bigfice e ustion (ODE)
Division of General, Restorative and Neurological Devices
510(k) Number Kc53567
X