(18 days)
Not Found
No
The summary describes a bipolar electrosurgical device for disc ablation and decompression, with no mention of AI or ML capabilities.
Yes
The device is indicated for treatment (ablation, coagulation, and decompression) of disc material to treat symptomatic patients with contained herniated discs.
No
The device is described as an electrosurgical device indicated for "ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states "The Wands are bipolar, single use, high frequency electrosurgical devices," indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "bipolar, single use, high frequency electrosurgical device." Electrosurgical devices are used for cutting, coagulating, or ablating tissue during surgery.
- Anatomical Site: The anatomical site is the "Spine (disc material)," which is a part of the human body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Wands are bipolar, single use, high frequency clectrosurgical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material (spine)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for ArthroCare Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of several curved lines that resemble a stylized wave or abstract design. The text "ArthroCare" is written in a bold, sans-serif font, with the word "Corporation" appearing in a smaller font size below it.
DEC 2 7 2005
K 053447
510(k) Summary
Page 1 of ②
ArthroCare Corporation ArthroCare® PercD™ SpineWand™
| General Information | |
|---|---|
| Submitter Name/Address: | ArthroCare Corporation |
| 680 Vaqueros Avenue | |
| Sunnyvale, CA 94085-2936 | |
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng |
| Director, Regulatory Affairs | |
| Date Prepared: | December 9, 2005 |
| Device Description | |
| Trade Name: | ArthroCare ® PercD ™ SpineWand ™ |
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation |
| Device and Accessories (21 CFR | |
| 878.4400) | |
| Predicate Devices | |
| ArthroCare PercD SpineWand | K030954 |
Product Description
The Wands are bipolar, single use, high frequency clectrosurgical devices.
Intended Use
The Perc-D" SpineWand" is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Substantial Equivalence
This Special 510(k) proposes modifications in materials for the ArthroCare PercD SpineWand, which were previously cleared under K030954 on April 16, 2003. The indications for use, technology, principle of operation, performance specifications, packaging, and sterilization parameters of the SpineWands remam the same as in the predicate cleared 510(k)
1
K053 447
Summary of Safety and Effectiveness
Page 2 of 2
The modified SpineWands, as described in this submission, are substantially equivalent to the predicate SpineWands. The proposed modification in materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
DEC 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthoCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K053447
K055447
Trade/Device Name: ArthoCare® PercD™ SpineWand™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and Coagulation device and accessories. Regulatory Class: II
Product Code: GEI Dated: December 9, 2005 Received: December 9, 2005
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 9 ro(x) premainer is substantially equivalent (for the indications referenced above and nave decemblicated predicate devices marketed in interstate for use stated in the encrosule) to regally mances provided Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Foderal Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraance while to premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premissions of the A and Cosment Act (Act) that do not require approvince of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contr You may, therefore, market the devree, bacyer to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merelate read prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sec above) into e. Existing major regulations affecting your device. [UA it may be subject to such additional controls: "Litering Sty" and 800 to 898. In addition, FDA can be found in the Code of Featur Regarming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA s issualled of a basedia.complies with other requirements of the Act
that FDA has made a determination that your device complies with other may that TDA has Inade a delemination administered by other Federal agencies. You must or any Federal Statutes and regulations daminding, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: reg comply with an the Act s requirements, mercuses,
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice destractively attacted CPK Part 807), labeling (21 CFR Part 820); good and fapplicable, the clectronic form in the quality systems (Sections (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) This letter will allow you to begin marketing your averace of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of you premarket nouncation. The PDA miding of Subscanian or 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 note the requiration entitled If you desire specific advice for your device of the success note the regulation entitled, the move obtain contact the Office of Compliance at (216) 276 - 151 (216) FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (212) - 1 Sugar the Division "Misbranding by reference to premarket notification" (1) os tost from the Division of Small other general information on your responsionnes and to toll-fire mumber (800) 638-204 or manufacturers, html Manufacturers, Internet address http://www.fda.cov/cdrh/industry/support/index.html.
Sincerely yours,
farbare Bnehub
FN
Mark N. Melkerson 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
KO534-47 510(k) Number:
Device Name:
ArthroCare® Perc-D™ SpineWand™
Indications for use:
The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of The Perce - O treat symptomatic patients with contained herniated discs.
Over-the-Counter AND/OR X Prescription Usc Usc (21 CFR 807 Subpart (Part 21 CFR 801 ਂ Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Laubane Buchund for MXM
Division of General, Restornine, and Neurological Devices
510(k) Number K053447