No
The device description and performance studies focus on electrical current and tissue interaction, with no mention of AI/ML terms or data processing related to learning or prediction.
Yes
The device is described as being used for soft tissue management in the oral cavity for incision, excision, and coagulation procedures, which are therapeutic interventions.
No
Explanation: The device is described as an AC-powered device for soft tissue management (cutting or removing) and coagulation in the oral cavity. Its intended use is for surgical procedures, not for diagnosing conditions.
No
The device description explicitly 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue." This describes a surgical or therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from a patient outside the body.
- Device Description: The device description clearly states it's an "AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes." It works by passing an electrical current through an electrode tip into the tissue to cut or coagulate. This is a description of an electrosurgical device used for direct tissue manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process that would be performed in vitro (outside the living organism).
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct surgical intervention on the patient.
N/A
Intended Use / Indications for Use
Soft tissue management within the oral cavity to address the indications for incision, excision and in
tination in the states in interessed coftinene Soft ussue management while as a soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
EKZ
Device Description
The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the 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): 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.
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for MACAN Engineering Electro Surgical Products. The word "MACAN" is in a stylized font inside of a black oval. Below the oval, the word "ENGINEERING" is printed in a simple, sans-serif font. Underneath that, the words "Electro Surgical Products" are printed in a similar font.
1564 North Damen Avenue, Chicago, IL 60622
Phone 773-772-2000
Fax 773-772-2003 Toll Free 1-866-MACAN11 1-866-622-2611
Image /page/0/Picture/5 description: The image shows a logo for UL Registered Firm. The logo consists of the letters "UL" inside of a circle. The words "REGISTERED FIRM" are written around the bottom half of the circle. The logo is black and white.
No. A9969 ISO 9001-2000 EN ISO 9001-2000 BS EN ISO 9001-2000
510 (k) Summary
510 (k) Owner: Contact Person:
Preparation Date: Device Classification Name: Device Proprietary Trade Name: Regulation: Product Code: Classification: Owner/Operator: Owner/Operator Number
Rich Garrett ( address as above ) Product Engineer Mickey Albergo ( Address as above ) Business Manager 21 April 2005 Unit, Electrosurgical, and Accessories, Dental Radiosurge MC6A 872.4920 EKZ Class II MACAN Engineering and Manufacturing Co. 1418975
David Fried ( address as above ) Board Chairman
Device Description
The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
| Predicate Substantially Equivalent Devices | |
|---|---|
| K955176 | K950239 |
| Ellman Int'l | Parkell |
| Dento-surge 90FFP | Sensimatic 500SE |
| 872.4920 | 872.4920 |
| EKZ | EKZ |
| Class II | Class II |
Summary conclusion: it is reasonable to conclude that the Radiosurge MC6A device is substantially equivalent to the predicate substantially equivalent listed devices in current distribution in terms of clinical indication, generator electrical characteristics and observed histological effect. It is also reasonable to indication, generative device is substantially equivalent to the cited predicate devices in terms of hand piece, dispersive plate, cables, and electrode tips in form, function, electrical parameters, and naterial including biocompatibility of related engineering thermoplastics and insulation materials.
1
Original Premarket Approval Application for Regio MC6A 21 April, 2005
K050735 page 2 510 (k) Summary
The summary conclusion is based on the following comparisons:
Comparison of the clinical indications given for the Radiosurge MC6A device and the published clinical indications for the predicate Dento-surge device and the predicate Sensimatic 500SE device by examining available published literature.
Comparison of the Radiosurge MC6A device generator function and the predicate Dento-surge device was done on the basis of published specification, laboratory measurements conducted at Macan using a production sample of the Dento-surge device, examination of comparative histological effects in a biologic test medium, and anecdotal clinical comparisons of the Radiosurge device and the predicate device. The Sensimatic 500SE device was not compared for generator function.
Comparison of the physical science related to the respective devices was conducted by reference to relevant scientific literature.
Comparison of the respective device hand pieces was conducted by physical examination and electrical measurements for form and function. While substantially equivalent in those respects, it should be noted that while these accessories differ materially, both respective materials each have manufacturer bio-compatibility data available. The Radiosurge device accessory hand piece employs polysulfone material, trade name AMOCO Udel P-1700 #937 ( black ) for which the manufacturer cites FDA 21 CFR 177.1655 and UL E36098 compliance. Thee Sensimatic 500SE was not compared for the hand piece accessory.
Comparison of the respective device dispersive plates was made by physical examination and electrical measurements conduction sample of the predicate Dento-surge device, by examining histological effects in a test media, and by means of the anecdotal clinical comparisons cited. It should be noted that the respective dispersive plates differ in size but provide substantially equivalent clinical function. The Sensimatic 500SE device was not compared for dispersive plate function, except to note that said accessory is dimensionally similar to the Dento-surge device.
Comparison of the respective device accessory electrode tips was made on the basis of equivalence in form, function, clinical application, and material as published by the predicate Dento-surge device manufacturer in terms of interchangeable part numbers ( Ellman Radiosurgery catalog, copyright 1990 ). The colors of the respective insulation materials differ leading to the question of dye bio-compatibility. The Sensimatic 500SE accessory electrodes are materially equivalent to the Radiosurge accessory electrodes and are the same color, hence, it is reasonable to conclude on the basis of existing approvals that the Radiosurge accessory electrodes are substantially equivalent to listed predicate devices on the basis of form, function, intended clinical application, and biocompatibility.
The Radiosurge device has been examined by UL. and complies with standard UL. 60601 as tested to IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2 as an isolated output monopolar electrosurgical generator, and is listed under number 6UA7 bearing the C/US mark. The Dentosurge device was UL listed to standard UL544 under number 483E. The Sensimatic 500SE device is CE marked as compliant with IEC 60601-1-2, but not IEC 60601-1-2, but not IEC 60601-2-2. It is felt that these differences do not represent any disparity in compared clinical application, generator therapeutic electrical currents, or the intended histological effects derived there from.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Public Health Service
MAY 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rich Garrett Product Engineer Macan Engineering Company 1564 North Damen Avenue Chicago, Illinois 60622
Re: K050735
. Trade/Device Name: Radiosurge MC6A Regulation Number: 872.4920 Regulation Name: Dental Electrosurgical Unit and Accessories Regulatory Class: II Product Code: EKZ Dated: May 11, 2005 Received: May 13, 2005
Dear Mr. Garrett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined the device is substantially equivalent (for the relerenced above and nave acternines re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Ameliuments, of to devices that have act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Ocomette , werefore, market the device, subject to the general approval application (11.11).). The general controls provisions of the Act include Controls provisions of the Fist - Fisting 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 II your device is classified (See ass 10) was controls. Existing major regulations affecting (PMA), it may of subject to Sach adata Craneral Regulations, Title 21, Parts 800 to 898. In your device can be found in the South virther announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Garrett
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled on that your device complies with other requirements mean that FDA has made a decemmanen and your winistered by other Federal agencies. of the Act of ally rederal statues and regarments, including, but not limited to: registration You must comply with an the Act 5 requirements (21 CFR Part 801); good manufacturing practices and listing (21 CFR Part 807), laboling (21 CFR Part 820) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 8 requirements as set forth in the quality systems (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) I his letter will anow you to begin marketing your substantial equivalence of your device to a premarket notification. The I DA miding of basicing of 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), If you desire specific advice for your do roo career of the Also, please note the regulation please contact the Office of Comphanes art(210) = 10) = 10 Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binan Promoter (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
Enclosure
4
ﺮ
Indications for Use
510(k) Number (if known):
Device Name: Radiosurge MC6A
Indications For Use:
Soft tissue management within the oral cavity to address the indications for incision, excision and in
tination in the states in interessed coftinene Soft ussue management while as a 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)
Kein Moley for M.S.P
(Civision Sign-Off) Oivision of Anesthesiology, General Hospital, Infection Control, Dental Devices
Pag 1 of __
510(k) Number:_K