UNION MEDICAL UM-D30 COAGULATOR

K981430 · She Medical, Inc. · GEI · Jun 5, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981430
• Device Name: UNION MEDICAL UM-D30 COAGULATOR
• Applicant: She Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

UM-D30 Coagulator; electrosurgical device for coagulation of open wounds or skin lesions. Used in dermatology, plastic surgery, and general surgery. Operated by qualified physicians. Device applies thermal energy to tissue to close wounds; does not perform cutting. Intended for small surgical procedures. Benefits include controlled hemostasis of minor wounds/lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical coagulator; non-cutting design. Specific materials, energy parameters, and dimensions not disclosed in provided text.

Indications for Use

Indicated for coagulation of open wounds or skin lesions during small surgical procedures in dermatology, plastic surgery, and general surgery. Restricted to use by or on the order of a qualified physician.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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)