(198 days)
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Not Found
No
The summary describes a standard electrocoagulator and lacks any mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
The device is used for cutting and coagulating (burning) the skin during surgery, which are therapeutic actions.
No
The device is described as an electrocoagulator unit used to "cut and coagulate (burn) the skin," which are therapeutic functions, not diagnostic ones.
No
The device is described as an "Electrocoagulator unit," which is a hardware device used for cutting and coagulating tissue. The description does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate (burn) the skin in and during minor and general surgery." This describes a surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The description clearly indicates a device used for a surgical intervention on the patient's skin, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
HM-880DG Plus Electrocoagulator unit is to be used in order to cut and coagulate (burn) the skin in minor and general surgery.
Product codes
GEI
Device Description
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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 / minor 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
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
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)
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Over-Tive-Counter Use
(Optional Formal 1-7-96)