(30 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on its electrosurgical function.
Yes.
The device is indicated for treatment of symptomatic patients with contained herniated discs via ablation, coagulation, and decompression of disc material, which are therapeutic actions.
No
The device is described as an electrosurgical device indicated for ablation, coagulation, and decompression, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states "The Wands are bipolar, single use, high frequency electrosurgical devices," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Perc-D™ SpineWand™ is an electrosurgical device used for ablation, coagulation, and decompression of disc material within the body. It directly interacts with tissue during a surgical procedure.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the patient.
Therefore, based on the provided information, the Perc-D™ SpineWand™ is a surgical device, not an in vitro diagnostic device.
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
GEI, HRX
Device Description
The Wands are bipolar, single use, high frequency electrosurgical 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
The modified Perc-D Wands, as described in this submission, are substantially equivalent to the producere, sifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
ArthrocCare
CORPORATION
MAR 2 8 2002
510(k) Summary K 020621 ArthroCare Corporation Perc-D™ SpineWand™
General Information
Contact Person:
Phone Number:
Date Prepared:
Trade Name:
Device Description
Generic/Common Name:
Classification Name:
Submitters Name/Address:
ArthroCare Corporation 680 Vaqueros Ave Sunnyvale, CA 94085-2936
Establishment Registration Number:
2951580
Valerie Defiesta-Ng Director, Regulatory Affairs
(408) 736-0224
February 25, 2002
Perc-DTM SpineWand™
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare Perc-D SpineWand
K010811; cleared on May 30, 2001
Product Description
The Wands are bipolar, single use, high frequency electrosurgical 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.
680 Vaqueros Avenue • Sunnyvale, CA 94085 • (408) 736-0224 • Fax: (408) 736-0226
ix
1
Substantial Equivalence
This Special 510(k) proposes a modification in dimensional and performance I mis bposted o receipes , and labeling for the Wands, which were previously cleared spoonlood 1 on May 30, 2001. The indications for use, technology, principle of under 1001 on 1127 of 1127 at 1127 of the Wands remain the same as in the predicate cleared 510(k)s.
Summary of Safety and Effectiveness
The modified Perc-D Wands, as described in this submission, are substantially equivalent The modified Fore D Wands. The proposed modification in dimensional and to the producere, sifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
X
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
MAR 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthoCare Corporation Ms. "Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K020621
Trade Name: Perc-D™ SpineWand™ Regulation Number: 878.4400; 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Arthroscope Regulatory Class: II Product Code: GEI; HRX Dated: February 26, 2002 Received: February 26, 2002
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket 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 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. Valerie 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 and additionally 21 CFR Part 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 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,
Muriam C. Provost
tol 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
4
Indications for Use Statement
ArthroCare® Perc-D™ SpineWand™ Device Name:
510(k) Number:
K_030621
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.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO20621 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use
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