(65 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical unit for cutting and coagulating tissue and explicitly states that AI, DNN, or ML are "Not Found".
Yes
The device is used to cut and coagulate skin in surgical procedures, indicating it is intended for the treatment or mitigation of disease.
No
The device is used to cut and coagulate skin in surgical procedures, indicating a therapeutic rather than diagnostic function. It is an electrosurgical unit.
No
The device is described as an "Electrosurgical Unit" with the function to "cut and coagulate (burn) the skin," which inherently involves hardware components to deliver energy for these actions. The summary does not mention any software-only functionality.
Based on the provided information, the UM-150A unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "cut and coagulate (burn) the skin in surgical procedures." This describes a direct surgical intervention on a living patient, not a test performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: It is described as an "Electrosurgical Unit," which is a type of device used for surgical procedures, not for diagnostic testing of samples.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The UM-150A operates directly on the patient's skin during surgery.
N/A
Intended Use / Indications for Use
The UM-150A unit is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
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): 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.
Not Found
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1898 AUG
- Union Medical Engineering Co., Ltd. c/o Ms. Annie Velez President and Director of Regulatory Affairs SHE Medical, Inc. 8930 S.W. 68 Court, #H3 Miami, Florida 33156
K981908 Re: Trade Name: UM-150A Electrosurgical Unit Regulatory Class: II Product Code: GEI Dated: April 21, 1998 Received: June 1, 1998
Dear Ms. Velez:
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.
1
Page 2 - Ms. Annie Velez
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
2
INDICATION FOR USE STATEMENT
K981908 510(k) Number: Not yet available
Device Name: Electrosurgical Units
Device Model: UM-150A
Indications for Use:
The UM-150A unit 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 ﺤﻠﻴ
Over the Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of General Restorative Devices 1981908 510(k) Number _
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