(129 days)
Not Found
No
The description focuses on the electrosurgical technology and components, with no mention of AI or ML.
Yes
The device is indicated for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures," which are therapeutic actions.
No
The device is described as an electrosurgical system for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states the system consists of three hardware components: a generator (Controller), a disposable Wand, and a reusable Cable. It is a physical electrosurgical system, 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 clearly states that the device is used for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a system that delivers radio frequency (RF) energy to the patient via a Wand and Cable. This is a therapeutic device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform a surgical procedure directly on the body.
N/A
Intended Use / Indications for Use
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
Product codes
GEI
Device Description
The ArthroCare Orthopedic Electrosurgery System is a bipolar, high frequency electrosurgical system designed for use in orthopedic procedures where ablation and coagulation of soft tissue and hemostasis of blood vessels is desired. The System consists of three components: an electrosurgical generator called the Controller, the disposable Wand, and the reusable Cable. 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 attach to the Controller and Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System. The Wand configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The ArthroCare Orthopedic 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
soft tissues and blood vessels in orthopedic, arthroscopic, and spinal procedures.
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)
K943450, K963123, K973478, K980170
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness ArthroCare, Corporation ArthroCare Orthopedic Electrosurgery System
992581
General Information
| Manufacturer: | ArthroCare, Corporation
595 North Pastoria Avenue
Sunnyvale, CA 94086-2916 |
|------------------------------------|----------------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Bruce Prothro, Vice President Regulatory
Affairs and Quality Assurance |
| Date Prepared: | July 29, 1999 |
Device Description
| Classification Name: | Electrosurgical Cutting and Coagulation
Device and Accessories (21 CFR 878.4400) |
|----------------------|-------------------------------------------------------------------------------------|
| Trade Name: | ArthroCare Orthopedic Electrosurgery System |
| Generic/Common Name: | Electrosurgical Device and Accessories |
Predicate DevicesK943450 ArthroCare Arthroscopic Electrosurgery System 970 ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) K963123 K973478 ArthroCare ENTec Surgery System K980170 Ellman Surgitron
Intended Use
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
Product Description
The ArthroCare Orthopedic Electrosurgery System is a bipolar, high frequency electrosurgical system designed for use in orthopedic procedures where ablation and coagulation of soft tissue and hemostasis of blood vessels is desired. The System
1
Kgg 2581
consists of three components: an electrosurgical generator called the Controller, the disposable Wand, and the reusable Cable. 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 attach to the Controller and Wand for patient treatment. The single use, sterile Wand is the patient contacting component of the System. The Wand configuration ranges from single to multiple electrodes incorporating straight, screen, loop, and sheet shaped electrodes. The ArthroCare Orthopedic 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 Arthroscopic Electrosurgery System 980 (Model 2000) was previously cleared under K963123 on October 8, 1996 for the following indications: soft tissue resection and ablation during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip, and wrist. This premarket notification purposes to change the product name and expand the indication to include orthopedic and spinal procedures. The proposed indications for the ArthroCare Orthopedic Electrosurgery System are: resection, ablation and coagulation of soft tissues and hemostasis of blood vessels, in orthopedic, arthroscopic, and spinal procedures.
The ArthroCare Orthopedic Electrosurgery System has not modified the technology, principle of operation, design, manufacturing operations, and/or sterilization since the original approval of the ArthroCare Arthroscopic Electrosurgery System 980 (Model 2000) on October 8, 1996 (K963123) or the ArthroCare ENTec Surgery System on January 9, 1998 (K973478). The Arthrocare Arthroscopic Electrosurgery System 980 (Model 2000) and the ArthroCare ENTec Electrosurgery System are modifications of the initial predicate device, the Arthrocare Arthroscopic Electrosurgery System 970, which was cleared on March 10, 1995 (K943450). Additionally, the ArthroCare Orthopedic Electrosurgery System utilizes technology that is substantially equivalent to electrosurgical devices currently used in spinal applications such as the Ellman Surgitron cleared June 19, 1998 (K980170).
Summary of Safety and Effectiveness
In establishing substantial equivalence to the predicate devices, ArthroCare evaluated the indications for use, materials incorporated, product specifications and energy requirements of those systems. The expanded indication to include orthopedic and spinal procedures does not raise any new issues of safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Mr. Bruce Prothro Vice President, Regulatory Affairs and Quality Assurance ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086
Re: K992581
Trade Name: Orthopedic Electrosurgery System Regulatory Class: II Product Code: GEI Dated: November 3, 1999 Received: November 5, 1999
Dear Mr. Prothro:
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 (QS) 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.
3
Page 2 -- Mr. Bruce Prothro
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,
Russell V. Payne
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name: 510(k) Number:
ArthroCare Orthopedic Electrosurgery System K99 25 81
Indications for use:
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, and spinal procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Nummer 11. Ungern for 520
(Division Sign-Off) Division of General Restorative Devices 510(k) Number _