(77 days)
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.
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.
The provided document, K052622 for the MACAN MC-4A Dental Electrosurgical Unit, is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical studies with acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.
The document focuses on comparing the MACAN MC-4A to its predicate device, MACAN-Regis MC6A, across several characteristics:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study would. Instead, it presents a "SUMMARY TABLE OF COMPARISON" demonstrating equivalence to a predicate device.
| Characteristic | MACAN MC-4A (New Device) | MACAN-Regis MC6A (Predicate Device) | Statement of Equivalence |
|---|---|---|---|
| Indications for Use | Same | Same | SAME |
| Electrical Output | Same Ratings | Same Ratings | SAME RATINGS |
| Electrodes | Same manufacturer, same part numbers | Same manufacturer, same part numbers | SAME |
| Accessories | Same manufacturer, same part numbers | Same manufacturer, same part numbers | SAME |
| Control Functions | Same | Same | SAME |
2. Sample size used for the test set and the data provenance:
Not applicable. No new clinical test set data was generated for this 510(k) submission. The substantial equivalence argument relies on prior claims and performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth for a test set was not established as no new clinical study was conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a dental electrosurgical unit, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgical unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in the context of a clinical study was established for this submission. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
Not applicable. No new training set for an algorithm was used.
9. How the ground truth for the training set was established:
Not applicable. No training set requiring ground truth establishment was used.
In summary, the K052622 document demonstrates substantial equivalence by highlighting the identical nature of key characteristics between the new device (MACAN MC-4A) and its predicate (MACAN-Regis MC6A). It does not involve new clinical trials or performance studies with acceptance criteria as would be expected for novel devices or AI solutions.
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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. 606221-(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 | SAMEsame manufacturer, same part numbers |
| Accessories | SAMEsame 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.
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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.
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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
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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
Page 1 of __
§ 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.