(63 days)
Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue. Soft tissue management while as a soft tissue.
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.
This document is a 510(k) Summary for the MACAN Radiosurge MC6A device, an electrosurgical unit used for soft tissue management in the oral cavity. It details the device's description, compares it to predicate devices to establish substantial equivalence, and includes the FDA's clearance letter.
Here's the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" can be inferred as being substantially equivalent in clinical indication, generator electrical characteristics, observed histological effect, and physical components.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Comparison Findings for Radiosurge MC6A) |
|---|---|
| Clinical Indications: Substantially equivalent to predicate Dento-surge and Sensimatic 500SE. | Clinical Indications: Found substantially equivalent by examining published literature. |
| Generator Electrical Characteristics: Substantially equivalent to predicate Dento-surge. | Generator Electrical Characteristics: Compared through published specifications, laboratory measurements (against Dento-surge), examination of comparative histological effects in a biologic test medium, and anecdotal clinical comparisons (against Dento-surge). Sensimatic 500SE was not compared for generator function. |
| Observed Histological Effect: Substantially equivalent to predicate Dento-surge. | Observed Histological Effect: Examined in a biologic test medium and through anecdotal clinical comparisons. |
| Handpiece: Substantially equivalent in form, function, electrical parameters, and material. | Handpiece: Compared by physical examination and electrical measurements. Differences in material were noted, but both materials have manufacturer biocompatibility data. Sensimatic 500SE was not compared for the handpiece accessory. |
| Dispersive Plate: Substantially equivalent in clinical function. | Dispersive Plate: Compared by physical examination, electrical measurements (against Dento-surge), examination of histological effects in a test media, and anecdotal clinical comparisons. Differences in size were noted but deemed to provide substantially equivalent clinical function. Sensimatic 500SE was not compared for dispersive plate function (except for dimensional similarity). |
| Accessory Electrode Tips: Substantially equivalent in form, function, clinical application, and material (including biocompatibility). | Accessory Electrode Tips: Compared based on equivalence in form, function, clinical application, and material, referencing manufacturer's published interchangeable part numbers (Ellman Radiosurgery catalog, 1990). Different insulation material colors were addressed by concluding biocompatibility based on existing approvals for the Sensimatic 500SE electrodes (which are materially equivalent and the same color). |
| Safety and Electrical Standards Compliance: Meets relevant IEC and UL standards. | Safety and Electrical Standards Compliance: Examined by UL and complies with UL 60601, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2 as an isolated output monopolar electrosurgical generator. Listed under number 6UA7 bearing the C/US mark. Differences in predicate device UL listings (UL544 for Dento-surge, CE marked for Sensimatic 500SE with some IEC differences) were stated not to represent disparity in clinical application or therapeutic effects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a "test set" in the traditional sense of a patient cohort or a distinct dataset with a sample size for an effectiveness study. The evaluation primarily relies on comparison with existing predicate devices and their published specifications, as well as laboratory testing and anecdotal clinical observations.
- Sample Size: Not applicable in the context of a prospective clinical trial or a structured test set with a defined sample size.
- Data Provenance:
- Published Literature: Used for clinical indications of predicate devices.
- Laboratory Measurements at Macan: Conducted at Macan Engineering (Chicago, IL, USA) using a production sample of the Dento-surge device.
- Biologic Test Medium: Used for examining comparative histological effects. The specific nature or location of this test is not detailed.
- Anecdotal Clinical Comparisons: Performed for both generator function and dispersive plates. The source or design of these "anecdotal" comparisons is not specified, but they imply observational data.
- Physical Examination and Electrical Measurements: Conducted on predicate device components at Macan Engineering.
- Ellman Radiosurgery Catalog (1990): Used for predicate electrode tip information.
- Manufacturer Biocompatibility Data: Referenced for polysulfone material in the Radiosurge handpiece.
- UL Certification: Conducted by UL (Underwriters Laboratories).
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)
This document does not describe a process of establishing "ground truth" through expert consensus for a specific test set. The validation approach is based on demonstrating substantial equivalence to already legally marketed devices. Therefore, it does not mention a number of experts or their qualifications in this context. The "truth" is established by comparing to devices whose safety and effectiveness have already been accepted by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no explicit "test set" requiring adjudication by multiple experts. The evaluation was a comparison against predicate devices through various technical and literature-based assessments.
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 is not an AI/software device and no MRMC study was conducted or described. The device is a physical electrosurgical unit.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. The evaluation focuses on the standalone performance of the electrosurgical unit and its components compared to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, the concept of "ground truth" for a new evaluation is not directly applied in the way it might be for a diagnostic device. Instead, the "truth" or benchmark is derived from:
- Established Performance of Predicate Devices: The FDA-cleared Dento-surge 90FFP and Sensimatic 500SE, whose safety and effectiveness are already accepted.
- Published Specifications and Literature: Regarding predicate device performance and clinical indications.
- Laboratory Measurements: Direct testing of the Radiosurge MC6A against a predicate device (Dento-surge).
- Histological Effects in a Biologic Test Medium: Used to compare tissue responses. This could be considered a form of "ground truth" for tissue interaction.
- Anecdotal Clinical Comparisons: Relying on informal clinical observations.
- Manufacturer Biocompatibility Data: For materials used.
- Compliance with Recognized Standards: UL and IEC electrical safety standards.
8. The sample size for the training set
Not applicable. This is a medical device submission based on substantial equivalence to predicate devices, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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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
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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.
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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.
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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.
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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
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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
§ 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.