(19 days)
Not Found
No
The summary describes a standard electrosurgical system and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section states the device is indicated "to treat symptomatic patients with contained herniated discs," which describes a therapeutic purpose.
No
The 'Intended Use / Indications for Use' section states that the device is indicated for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels," and for "ablation, coagulation, and decompression of disc material." These are therapeutic or surgical procedures, not diagnostic ones. There is no mention of identifying or diagnosing a condition.
No
The device description explicitly lists hardware components: an electrosurgical generator (Controller), disposable Wands, and a reusable Patient Cable. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed on the patient's body (resection, ablation, coagulation of soft tissue and blood vessels, decompression of disc material). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device is an electrosurgical system used for surgical procedures. This aligns with a surgical device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the ArthroCare System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare System is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Product codes
GEI
Device Description
The ArthroCare 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The modified ArthroCarc System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
040338
ArthroCare
CORPORATION
MAR - 1 2004
510(k) Summary
040338
Page 1 of 2
ArthroCare Corporation ArthroCare System
2951580
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Director, Regulatory Affairs
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
Predicate Devices ArthroCare® System 2000 ArthroCare® System
Valerie Defiesta-Ng
February 9, 2004
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Product Description
The ArthroCare 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.
1
Page ② of ②
Intended Uses
The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
The ArthroCare System 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 a modification in the performance specifications and labeling for the ArthroCare System 2000, which was previously cleared in K020832 on April 9, 2002 and K030954 on April 16, 2003. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare System remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified ArthroCarc System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K040338
Trade/Device Name: ArthroCare System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 9, 2004 Received: February 11, 2004
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. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html
Sincerely yours,
Mark N Milburn
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 System Device Name
510(k) Number: KO40338
Indications for Use:
- 요 The ArthroCare System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.
- The ArthroCare System is indicated for ablation, coagulation, and decompression of 트 disc material to treat symptomatic patients with contained herniated discs.
Mark N Milham
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOYO338
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDSED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use