(21 days)
Not Found
No
The description focuses on standard electrosurgical technology (RF energy, bipolar electrodes) and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for soft tissue resection and ablation, and coagulation of blood vessels, which are procedures intended to treat medical conditions.
No
Explanation: The device is described as an electrosurgical system used for soft tissue resection, ablation, and coagulation of blood vessels during surgical procedures. Its function is to perform therapeutic actions, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly outlines hardware components including a generator (Controller), a cable, and a disposable wand, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples from the body in a lab setting.
- Device Description: The description details a system that delivers radio frequency (RF) energy to the patient via a cable and wand for surgical procedures. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures. The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during surgical procedures.
Product codes
GEI
Device Description
The ArthroCare Electrosurgery System is a bipolar, high frequency electrosurgical System designed for use in general surgical procedures where ablation and resection of soft tissue and coagulation of blood vessels is desired. The System consists of three components: an electrosugical generator called the Controller, the reusable Cable, and the disposable Wand. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to connect the Controller to the Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.
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)
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
K992972
Special 510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare® Electrosurgery System
Manufacturer:
ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, CA 94086-2916
Establishment Registration Number:
Contact Person:
Betty M. Johnson Manager, Regulatory Affairs
September 2, 1999
Device and Accessories (21 CFR 878.4400)
2951580
Date Prepared:
Device Description
Classification Name:
Trade Name:
Generic/Common Name:
Predicate Devices
ArthroCare Electrosurgery System
ArthroCare® Electrosurgery System
Electrosurgical Cutting and Coagulation
Electrosurgical Device and Accessories
K971532; cleared on July 23, 1997
Intended Use
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures.
Product Description
The ArthroCare Electrosurgery System is a bipolar, high frequency electrosurgical System designed for use in general surgical procedures where ablation and resection of soft tissue and coagulation of blood vessels is desired. The System consists of three components: an electrosugical generator called the Controller, the reusable Cable, and the disposable Wand. The Controller utilizes radio frequency (RF) energy as a power source. RF energy is delivered to the patient via the Cable and the Wand. The Cable is designed to connect the Controller to the Wand for patient treatment. The single use, sterile Wand
1
is the patient contacting component of the System, and is available with suction and/or irrigation. The Wand can be configured with single or multiple electrodes. The ArthroCare Electrosurgery System uses bipolar technology in the design of the Wand, eliminating the need for a patient contacting dispersive pad used in monopolar devices.
Substantial Equivalence
The ArthroCare Electrosurgery System was previously cleared under K971532, on July 23, 1997 for the following indications: soft tissue resection and ablation and coagulation of blood vessels during general surgical procedures. This special 510(k) proposes modifications in materials, performance specifications, and labeling for the ArthroCare Electrosurgery System. The proposed modifications are only applicable to the Wand components of the System. The technology, principle of operation and the intended use of the entire System remain the same as in the original cleared 510(k). The modified Wands have the following similarities to the ArthroCare Electrosurgery System Wand which was previously cleared in K971532:
- . the same indications for use
- the same operating principle .
- incorporate the same basic Wand design .
- . packaged and sterilized using the same materials and processes
Summary of Safety and Effectiveness
The ArthroCare Electrosurgery System modified Wands, described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in materials, performance specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the device.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Ms. Betty M. Johnson Manager, Regulatory Affairs Arthrocare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086-2916
Re: K992972
Trade Name: ArthroCare® Electrosurgery System Regulatory Class: II Product Code: GEI Dated: September 2, 1999 Received: September 3, 1999
Dear Ms. Johnson:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Betty M. Johnson
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications Statement
Device Name: 510(k) Number: ArthroCare® Electrosurgery System Koo Zaar
Indications for use:
The ArthroCare Electrosurgery System is indicated for soft tissue resection and ablation and coagulation of blood vessels during surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[Signature]
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992972 |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ---------------------- |