(77 days)
MACAN -Regis MC6A
Not Found
No
The device description and the absence of mentions of AI, ML, or related concepts strongly suggest it is a traditional electrosurgical unit without AI/ML capabilities.
Yes
The device is used for soft tissue management, including incision, excision, and control of bleeding, which directly addresses medical conditions or performs therapy.
No
Explanation: The device description states its intended use is for soft tissue management (incision, excision) and controlling bleeding during surgery, which are therapeutic or surgical functions, not diagnostic ones.
No
The device description clearly states it is an "AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes," indicating it is a hardware device with electrical components and electrodes, not software only.
Based on the provided information, this device 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.
- Device Function: The description clearly states that the device is a dental electrosurgical unit used for "Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue." It uses electrical energy to cut or coagulate tissue directly within the oral cavity.
- No Sample Analysis: There is no mention of the device analyzing any samples taken from the body. Its function is to directly interact with and modify tissue.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.
Product codes
EKZ
Device Description
The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
MACAN -Regis MC6A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.
0
DEC 9 2005
Original Premarket Approval Application for MACAN MC-4A
20 Sept 2005
510(k) SUMMARY
| 510(k) Owner :
Contact person : | Mickey Albergo ( Business Manager)
Rich Garrett ( Product Engineer ) |
|------------------------------------|----------------------------------------------------------------------------------------------------------|
| Business address: | MACAN Engineering and Manufacturing Co.
1564 N. Damen Ave.
Chicago, Ill. 60622
1-(773)-772-2000 |
| Device Classification Name : | Unit, Electrosurgical, and Accessories, Dental |
| Device Proprietary Trade Name : | MACAN model MC-4A Dental Electrosurgical Unit |
| Regulation : | 872.4920 |
| Product Code : | EKZ |
| Classification : | class II |
| Owner/Operator : | MACAN Engineering and Manufacturing Co. |
| Owner/Operator Number : | 1418975 |
Device description : The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
Predicate Substantially Equivalent Device Legally Marketed : MACAN -Regis MC6A
Unit, Electrosurgical, and Accessories, Dental Device Classification Name : 872.4920 Regulation : EKZ Product Code : class II Classification : 510(k) Number : 050735
SUMMARY TABLE OF COMPARISON
| Indications for Use | SAME |
|---|---|
| Electrical Output | SAME RATINGS |
| Electrodes | SAME |
| same manufacturer, same part numbers | |
| Accessories | SAME |
| same manufacturer, same part numbers | |
| Control Functions | SAME |
It is reasonable to conclude, on the basis of the Summary Table of Comparison, that the MACAN model MC-4A dental electrosurgical unit is substantially equivalent to the cited predicate device. Note : the issue of electrode and hand piece material bio-compatibility is addressed within the submission for the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
Public Health Service
DEC 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mickey Albergo Manager Macan Engineering Company 1564 North Damen Avenue Chicago, Illinois 60622
Rc: K052622
Trade/Device Name: MACAN Model MC-4A Dental Electrosurgery Unit Regulation Number: 872.4920 Regulation Name: Dental Electrosurgical Unit and Accessories Regulatory Class: II Product Code: EKZ Dated: September 20, 2005 Received: September 27, 2005
Dear Mr. Albergo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include eenurements 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wr 1), tends of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, ITDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Albergo
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or me rot of any ly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ilouing (= = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), nlease contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overs Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
K052622 510(k) Number (if known):
MACAN model MC-4A dental electrosurgery unit
Device Name:
Indications For Use:
Soft tissue management within the oral cavity to address the indications for incision, excision and
ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
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