(65 days)
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Not Found
No
The summary describes a standard electrosurgical unit for cutting and coagulating tissue and contains no mention of AI or ML terms or concepts.
Yes
The device is used to cut and coagulate skin in surgical procedures, which are therapeutic interventions.
No
The device is described as cutting and coagulating (burning) the skin in surgical procedures, which are therapeutic actions, not diagnostic.
No
The device description explicitly states "Electrosurgical Units, Device Model: ESU-10 / ESU-15", which are hardware devices used for cutting and coagulating tissue. The summary does not mention any software component as the primary or sole function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the ESU-10 / ESU-15, is used to directly cut and coagulate tissue on the body during surgical procedures.
- The intended use clearly describes a surgical tool. The description "to be used in order to cut and coagulate (burn) the skin in surgical procedures" is characteristic of an electrosurgical unit, which is a surgical device, not an IVD.
Therefore, based on the provided information, the ESU-10 / ESU-15 is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
Product codes
GEI
Device Description
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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
skin
Indicated Patient Age Range
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Intended User / Care Setting
qualified physician
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1998
Ms. Annie Velez ·Magna Advanced Technologies, Inc. 7200 N.W. Seventh Street Miami, Florida 33126
K981416 Trade Name: Magnatek Electrosurgical Unit Models, ESU-10, ESU-15 Regulatory Class: II Product Code: GEI Dated: April 14,1998 Received: April 20, 1998
Dear Ms. Velez
Re:
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 (OS) 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.
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.
1
Page 2 - Ms. Annie Velez
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
2
INDICATION FOR USE STATEMENT
510(k) Number:
Not yet available 5981/4/6
Device Name: Electrosurgical Units
Device Model: ESU-10 / ESU-15
Indications for Use:
The ESU-10 / ESU-15 units is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
Federal Law restricts the use of this device by or on the order of a qualified physician only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use
to oeez
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number