(188 days)
The HM-930 Electrosurgical unit is to be used in order to cut and coagulate the skin in surgical procedures.
The HM-930 Eletrosurgical unit has been design to provide the broadest possible range of electrosurgical capabilities. This unit provide monopolar cutting and coagulation capabilities for most demanding procedures. This device can be used for multi-purposes and has the capabilities necessary to perform any particular need.
The provided document is a 510(k) premarket notification for the Hill-Med HM-930 Electrosurgical Unit. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with human subjects.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Instead, the document primarily focuses on:
- Device Description: What the HM-930 Electrosurgical Unit does (monopolar cutting and coagulation capabilities).
- Intended Use: To cut and coagulate the skin in surgical procedures.
- Comparison to Predicate Device: How the HM-930 is similar to and differs from the HM-880II Electrosurgical Unit (e.g., RF Output Waveforms, presence of cutting coagulation and bipolar outputs, alarms, digital display). The key difference mentioned is the RF Output Waveform (500 Khz for HM-930 vs. 300 Khz for HM-880II).
- Conclusion of Substantial Equivalence: The manufacturer asserts that the HM-930 is substantially equivalent to the predicate device.
- FDA Response: The FDA's letter confirming substantial equivalence based on the provided information.
To answer your prompt, a clinical study with acceptance criteria would typically involve metrics like safety endpoints (e.g., rates of adverse events, burns) and effectiveness endpoints (e.g., successful tissue cutting/coagulation, hemostasis, healing rates). Such studies are not part of this 510(k) submission, which relies on the established safety and effectiveness of the predicate device.
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Image /page/0/Picture/0 description: This image shows the logo and contact information for HILL-MED Corporation. The logo includes the company name and a stylized graphic. The text indicates that the company is located at 7217 N.W. 46th Street in Miami, Florida, with a zip code of 33166. The phone number is (305) 594-8574, and the fax number is (305) 594-3205. The date MAY 3 0 2000 is also present.
November 4, 1999
FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES Center for Devices and Radiological Health Document Control Center (HFZ-404) 9200 Corporate Boulevard Rockville, MD 20850
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is _ K 99 3991 -
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1 . Submitter Identification.
Jhoana Vasquez Regulatory Affairs HILL-MED, Inc. 7217 N.W. 46th Street Miami, Florida 33166 -
- Name of the Device:
HM-930 Electrosurgical Unit. Common Name: Electrosurgical Unit. Classification Name: Solid State Electro surgical Unit Class: II Classification number: 79HAM, Regulation # 878.4400
- Name of the Device:
-
- Predicate Device Information:
HM-880 Electrosurgical Unit. K961473, Hill-Med Corporation, 7217 N.W. 46th Street, Miami, Florida 33166.
- Predicate Device Information:
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4. Device Description:
The HM-930 Eletrosurgical unit has been design to provide the broadest possible range of electrosurgical capabilities. This unit provide monopolar cutting and coagulation capabilities for most demanding procedures. This device can be used for multi-purposes and has the capabilities necessary to perform any particular need.
5. Intended Use:
The HM-930 Electrosurgical Unit is to be used in order to cut and coagulate the skin in surgical procedures.
6. Comparison to Predicated Device:
The HM-930 Electrosurgical unit is used in exactly same manner as HM-880II Electrosurgical unit, both units are intended to cut and coagulate the skin in surgical procedures.
The HM-930 has an RF Output Waveforms of 500 Khz (=/- 10%) while the HM-880II unit has 300 Khz (+/- 10%), both units have cutting coagulation and bipolar outputs, both units have visuable and audible alarm to advise when patient plates cables are disconnected, both units are real digital output display.
7. Conclusion:
Based upon the aforementioned information, the Hill-Med HM-930 Electrosurgical unit is substantially equivalent and is used in exactly the same manner as Hill-Med HM-880II Electrosurgical unit.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.
Public Health Service
MAY 3 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jhoana Vasquez Regulatory Affairs Hill-Med Corporation 7217 N.W. 46th Street Miami, Florida 33166
K993991 Re:
Trade Name: HM-930 Electrosurgical Unit Regulatory Class: II Product Code: GEI Dated: May 2, 2000 Received: May 4, 2000
Dear Ms. Vasquez:
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 (QS) 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.
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Page 2 - Ms. Jhoana Vasquez
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,
Duna R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Unterem 1993991
Device Name: HM-930 Electrosurgical Unit.
Indications For Use:
The HM-930 Electrosurgical unit is to be used in order to cut and coagulate the skin in surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune R. Lochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_K_99399
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Couuter Use
(Optional Format 1-2-96)
§ 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.