(14 days)
No
The summary describes a standard electrosurgical generator using RF energy for cutting and coagulation, with no mention of AI or ML features.
Yes
The device is intended for electrosurgical cutting or coagulation of soft tissues in general surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical generator intended for cutting or coagulation of soft tissues, which are therapeutic actions rather than diagnostic ones.
No
The device is described as an electrosurgical generator that uses RF energy and handpieces, indicating it is a hardware device.
Based on the provided information, the SenoRx ES 300 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required." This describes a procedure performed directly on a patient's tissues, not on samples taken from the body.
- Device Description: The device "cuts and coagulates soft tissue" using RF energy. This is a direct surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the SenoRx ES 300 is a surgical device used for direct tissue manipulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.
Product codes
GEI
Device Description
The ES 300 Electrosurgical Generator is designed to cut and coagulate soft tissue. The ES 300 uses radio frequency (RF) energy to perform both cutting and coagulation, using RF handpieces.
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)
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
K030473 1/2
FEB 2 6 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being 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 |
| c. Telephone: | |
| Facsimile: | (949) 362-4800 |
| (949) 362-3519 | |
| d. Contact Person: | Amy Boucly |
| Director, Regulatory Affairs | |
| and Quality Assurance |
e. Date Summary Prepared: January 30, 2003
2. DEVICE IDENTIFICATION
| a. Trade/Proprietary
| Name: | ES 300 Generator |
|---|---|
| b. Classification Name: | Electrosurgical Cutting and |
| Coagulation Device and Accessories | |
| 878.4400 |
IDENTIFICATION OF PREDICATE DEVICES 3.
Force FX Surgitron IEC II
Valleylab, Incorporated, K944602 Ellman International, Inc., K001253, K001407
DESCRIPTION OF THE DEVICE 4.
The ES 300 Electrosurgical Generator is designed to cut and coagulate soft tissue. The ES 300 uses radio frequency (RF) energy to perform both cutting and coagulation, using RF handpieces.
1
K030473 2/2
STATEMENT OF INTENDED USE 5.
The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.
6. COMPARISON WITH PREDICATE DEVICES
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 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 in flight, composed of three curved lines.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Intertek Testing Services Donald J. Sherratt Medical Stream Director 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K030473
Trade/Device Name: SENORX ES 300 Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 7, 2003 Received: February 12, 2003
Dear Mr. Sherratt:
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. Iisting 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
3
Page 2 – Mr. Donald J. Sherratt
(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. 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). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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
SenoRx Inc. Premarket Notification ES 300 Generator
2 . Indications for Use Page
1 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ES 300 Generator
Indications for Use:
The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | ----------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
Miriam C. Provost
(Division Sign-Off) (Division Sign of General, Restorative and Neurological Devices
510(k) Number K030473
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