(46 days)
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No
The summary describes a simple coagulator device that uses heat to close wounds. There is no mention of AI, ML, image processing, or any data-driven decision-making process.
Yes
The device is used to coagulate open wounds or skin lesions in surgical procedures, which is a therapeutic intervention.
No
The device is described as being used to "only coagulate (burn) an open wound or skin lesions" to "close open wounds or lesions." This is a therapeutic action, not a diagnostic one. There is no mention of the device identifying, detecting, or measuring a medical condition.
No
The description clearly states the device is a "Coagulator Device Name: UM-D30" and describes its function as coagulating (burning) tissue, which is a physical action performed by a hardware device, not software alone.
Based on the provided information, the UM-D30 Coagulator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- UM-D30 Function: The description clearly states the UM-D30 Coagulator is used in surgical procedures to coagulate (burn) open wounds or skin lesions. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
Therefore, the UM-D30 Coagulator falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UM-D30 Coagulator is used in small surgical procedures in dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
Product codes
GEI
Device Description
Coagulator Device Name: Coagulator, Device Model: UM-D30. The device coagulates (burns) an open wound or skin lesions and closes open wounds or lesions by coagulating (burning) the skin.
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, in dermatology, plastic surgery and general surgery.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1698 JUN
Union Medical Engineering Company, Limited ·c/o Ms. Annie Velez SHE Medical, Incorporated President & Director of Requlatory Affairs 8930 South West 68th Court #H3 Miami, Florida 33156
K981430 Re: UM-D30 Coaqulator Trade Name: Regulatory Class: II Product Code: GEI Dated: April 15, 1998 Received: April 20, 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 marketéd 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 (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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.
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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".
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Sincerely yours,
ScaleDe
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: K981430
Coagulator Device Name:
Device Model: UM-D30
Indication: for Use:
The UM-D30 Coagulator is used in small surgical procedures in dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.
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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K981430 |
| Prescription Use | OR Over the Counter Use |
|---|---|
| ------------------ | ------------------------- |
(Per 21 CI:R 801.109)