(203 days)
Not Found
No
The description focuses on standard electrothermal generator technology with temperature and impedance monitoring for energy delivery control, without mentioning AI or ML capabilities.
Yes
The device is described as an electrothermal generator used for "coagulation, ablation, and hemostasis of soft tissues" and to maintain "effective tissue heating during temperature controlled applications," which are therapeutic actions.
No
Explanation: The device description states it is an "electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue." This describes therapeutic rather than diagnostic functions.
No
The device description clearly states it is a "single channel, 200-watt, electrothermal generator" and lists physical accessories like an AC power cord, probe extension cable, and footswitch. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vulcan EAS ElectroThermal Arthroscopy System is an electrosurgical generator used for surgical procedures (coagulation, ablation, and hemostasis of soft tissues) within the body. It directly interacts with tissue during surgery, rather than analyzing samples taken from the body.
- Intended Use: The intended use clearly states "general surgical purposes, including orthopedic and arthroscopic applications," which are in-vivo procedures.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.
The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use:
The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
Product codes
GEI
Device Description
The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.
Accessories provided with the Vulcan EAS include:
- AC power cord .
- Probe extension cable .
- Dual-pedal footswitch control .
Each generator is also accompanied by Instructions for Use and a warranty registration card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgical equipment.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
OCT 2 5 1999
Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a stylized representation of a human torso, with curved lines suggesting the contours of the body. Below the torso image, there is text that appears to be part of the brand name, although the full name is not visible in the image. The overall design is simple and modern.
- This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Summary
K991140 The assigned 510(k) number is:
- A. Submitter: ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
Phone: (650) 369-9904 (650) 369-9902 Fax:
Sheila Ramerman Contact: Date Prepared: October 7, 1999
- B. Device Names: ORATEC Interventions, Inc., VULCANTM EASTM Proprietary Name: ElectroThermal Arthroscopy System and Accessories Common Name: Electrosurgical generator and accessories Electrosurgical and Coagulation Unit and Accessories Classification Name:
- C. Legally Marketed Device:
The ORATEC Vulcan EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator (K944602), currently manufactured and distributed by ValleyLab Inc.
- D. Device Description:
The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.
Accessories provided with the Vulcan EAS include:
- AC power cord .
- Probe extension cable .
- Dual-pedal footswitch control .
Phone: Each generator is also accompanied by Instructions for Use and a warranty registration card. (650) 369-9904 fax: (650) 369-9905
ORATEC Interventions, Inc.
3700 Haven Court Menlo Park, CA 94025
1
Vulcan EAS Premarket Notification 510(k) Summary of Safety & Effectiveness Page 2
- E. Intended Use:
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.
The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use:
The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
-
F. Comparison with the Predicate Device:
The Vulcan EAS and the ValleyLab Force FX are similar in that: -
Both can be used for coagulation (fulguration), cutting, or ablation (dessication) of . tissues
-
. Both can be used with monopolar and bipolar electrosurgical devices;
-
Both measure impedance (resistance) to control power output; .
-
. Both offer preset temperature and power combinations;
-
. Both offer neutral electrode monitoring circuits;
-
Both are software-controlled RF generators. .
The Vulcan EAS and the ValleyLab Force FX differ in that:
- The Vulcan offers temperature control, whereas the Force FX does not .
- The Vulcan offers auto probe recognition, whereas the Force FX does not; .
- The Vulcan offers a remote control of generator settings, whereas the Force FX does . not:
- . The Vulcan offers a remote display of generator settings, whereas the Force FX does not:
- . The Vulcan can accommodate an auxiliary thermocouple, whereas the Force FX cannot;
- . The Vulcan is designed for electrosurgery only, whereas the Force FX is also capable of ultrasonic surgery.
Based on the data and information presented here, the ORATEC VULCAN EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator manufactured and distributed by Valley Lab Inc.
7
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
Re: K991140
Trade Name: VULCAN™ EASTM ElectroThermal Arthroscopy System and Accessories Regulatory Class: II Product Code: GEI Dated: July 26, 1999 Received: July 27, 1999
Dear Ms. Ramerman:
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.
3
Page 2 - Ms. Sheila Ramerman
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K991140 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.
The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use:
The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
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 | 991140 |
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)