(14 days)
Not Found
No
The summary describes a standard electrosurgical generator and scalpel using RF energy, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as an electrosurgical generator and scalpel intended for cutting and coagulation of soft tissues in general surgical procedures, which is a therapeutic function.
No
The device is described as an electrosurgical generator intended for cutting and coagulating soft tissues, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "Electrosurgical Generator" and "Electrosurgical Scalpel" which are hardware components that use RF energy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body (in vitro).
- Device Description: The description reinforces this by explaining it uses RF energy to "cut and coagulate soft tissue." This is a direct surgical action.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The SenoRx ES-2000 is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The SenoRx ES-2000 Electrosurgical Generator und Shape Select Electrosurgical Scalpel and their accessories are intended for ger eral procedures where electrosurgical cutting or coagulation of soft tissues is required.
The SenoRx ES-2000 electrosurgical generator and accessories are intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. It is not intended for use on the skin or where electrosurgery is contraindicated.
Product codes
GEI
Device Description
The ES-2000 Electrosurgical Generator and Shape Select Electrosurgical Scalpel are designed to cut and coagulate soft tissue. The ES-2000 uses radio frequency (RF) energy to perform both cutting and coagulation, using SenoRx compatible disposable handpieces.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K944602, K001253, K001407, K790187
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
SenoRx Inc. Premarket Notification ES-2000 Generator System and Shape Select Electrosurgical Scalpel
K012799 SEP - 4 2001
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary and effectiveness information is be ng submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| Aliso Viejo | |
| CA 92556 | |
| c. Telephone: | |
| Facsimile: | (949) 662-4800 |
| (949) 662-3519 |
Amy Boucly d. Contact Person: Director, Regulatory Affairs And Cuality Assurance
- August 30, 2001 e. Date Summary Prepared:
DEVICE IDENTIFICATION 2.
- ES-20 10 Generator System and Shape Trade/Proprietary Name: 8. Select Electrosurgical Scalpel
- Electrosurgical Cutting and b. Classification Name: Coagulation Devices and Accessories 878-44:00
IDENTIFICATION OF PREDICATE DEVICES 3.
Force FX Surgitron IEC II
Bovie Hand Control
Valleylab, Incorporated, K944602 Ellmar: International, Inc., K001253, K001407 Sybror Corporation, K790187
DESCRIPTION OF THE DEVICE 4.
The ES-2000 Electrosurgical Generator and Shape Select Electrosurgical Scalpel are designed to cut and coagulate soft tissue. The ES-2000 uses radio frequency (RF) energy to perform both cutting and coagulation, using SenoRx compatible disposable handpieces.
SI
1
STATEMENT OF INTENDED USE 5.
The SenoRx ES-2000 Electrosurgical Generator und Shape Select Electrosurgical Scalpel and their accessories are intended for ger eral procedures where electrosurgical cutting or coagulation of soft tissues is required
COMPARISON WITH PREDICATE DEVIC ES ર.
The intended use, design, construction, material and nominal specifications are comparable to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
SEP = 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SenoRx, Inc. c/o Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K012799
Trade/Device Name: ES-2000 Generator System and Shape Select™ Scalpel Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: July 31, 2001 Received: August 21, 2001
Dear Mr. Sherratt:
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 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). 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 requirements, 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. Donald James Sherratt
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 nouticate 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 11 you desire specially and in vitro diagnostic devices), please contact the Office of Compliance at additionally 59. Additionally, for questions on the promotion and advertising of your device, (301) 594-4639. Traditions of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR 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 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Susan Welke, MD,
for
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
FDA Indications for Use Page 2
KO12799 510(k) number (if known): ___
ES-2000 Generator System and Shape Select™ Scalpel Device Name:
Indications for Use:
The SenoRx ES-2000 electrosurgical generator and accessories are intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. It is not intended for use on the skin or where electrosurgery is contraindicated.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
Over-The-Counter Use
2
SR. MD.
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012799