(198 days)
HI-880DG Plus Electrocoagulator unit is to be used in order to cut and coagulate (burn) the skin in and during minor and general surgery.
HM-880DG Plus Electrocoagulator
The provided document is a 510(k) clearance letter from the FDA for a device called "HM-880DG Plus Electrocoagulator." This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The information provided is purely administrative, confirming the device's clearance for marketing based on substantial equivalence. Therefore, I cannot fulfill your request for a table of acceptance criteria and study details using only the provided text. This type of information is typically found in the 510(k) submission itself, or in a separate clinical or performance study report, not in the FDA's clearance letter.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 4 1998
Mr. Ernesto Ackerman President and Chief Executive Officer Hill-Med Corporation 7217 North West 46th Street Miami, Florida 33166
Re: K981781 Trade Name: HM-880DG Plus Electrocoagulator Regulatory Class: II Product Code: GEI Dated: September 17, 1998 Received: September 21, 1998
Dear Mr. Ackerman:
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 (OS) 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 - Mr. Ernesto Ackerman
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}------------------------------------------------
510(k) Number (if known): K981781
HM-880DG Plus Electronagulator Device Name:
HI-880DG Plus Electrocoagulator unit is to be used in order to cut Indications For Use: Hil-800M Phis Electrocoagurator and surgical procedures such as
and coagulate (burn) the skin in and currers' and coagurate (burn) the timery and general surgery.
Federal Law restricts the use of this device by or on the order of qualified physician only.
(PLEASE DO NOT WRITE BELOW THES LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K961701
Prescription Use
(Per 21 CFR 801.109)
ાર
Over-Tive-Counter Use
(Optional Formal 1-7-96)
§ 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.