(10 days)
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No
The summary describes a standard electrosurgical generator and makes no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for cutting or coagulation of soft tissues during surgical procedures, not for treating a disease or disorder.
No
Explanation: The "Intended Use / Indications for Use" states that the device is an electrosurgical generator intended for "cutting or coagulation of soft tissues." This describes a therapeutic or surgical function, not a diagnostic one. Diagnostic devices are used to identify or characterize diseases or conditions.
No
The device is described as an "electrosurgical generator," which is a hardware device that produces electrical current for surgical procedures. The description does not mention any software component as the primary or sole function.
Based on the provided information, the SenoRx ES 3000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgical cutting or coagulation of soft tissues" during "general surgical procedures." This describes a device used directly on a patient's tissues in vivo (within the living body).
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) taken from the body to provide information about a person's health. They are used outside the body.
The SenoRx ES 3000 operates directly on the patient's tissues during surgery, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
The SenoRx ES 3000 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
ES 3000 Electrosurgical Generator System
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissues
Indicated Patient Age Range
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Intended User / Care Setting
general surgical procedures
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amy Boucly SenoRx . Inc. Director, Regulatory Affairs and Quality Assurance 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K052857
Trade/Device Name: ES 3000 Electrosurgical Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005
Dear Ms. Boucly:
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, 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 (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 (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.
1
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely vours,
Barbara Boucher
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
| 510(k) Number (if known) | K052857 |
|---|---|
| Device Name | ES 3000 Electrosurgical Generator System |
| Indications for Use | The SenoRx ES 3000 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. |
Prescription Use__X__ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bonellino
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052657