(88 days)
The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.
The MTA surgical applicator is inserted into soft tissue and coagulates a volume of tissue surrounding the active The MTA Suglicator tip. Temperature probes are included in the applicator kits to determine the temperature at area of the applicator up. Temperature probos are included in the applicator is to be used with the MTA Sulis™ V the penpher you the obegalate manually set at the desired power levels by the operator.
This document describes the Microsulis Tissue Ablation (MTA) System and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria. Therefore, directly answering the request with a table of acceptance criteria and device performance, and details of a clinical study, is not possible from the provided text.
However, I can extract the relevant information from the document that pertains to its clearance and the types of performance data that were considered.
General Information on Device Clearance:
The Microsulis Tissue Ablation System (K052919) received FDA clearance (JAN 13 2006) as a Class II device for the intraoperative coagulation of soft tissue. This clearance was based on demonstrating "substantial equivalence" to existing legally marketed predicate devices, not on meeting specific, pre-defined clinical acceptance criteria in a comparative outcome study.
The primary forms of "performance data" mentioned are related to engineering and safety standards, rather than direct clinical efficacy metrics against specific acceptance thresholds.
Information derived from the provided text:
1. A table of (implied) acceptance criteria and the reported device performance:
Since this is a 510(k) clearance based on substantial equivalence, there isn't a table of clinical acceptance criteria in the traditional sense, or reported device performance against those criteria. Instead, the "acceptance criteria" are compliance with established engineering, safety, and biocompatibility standards, and the "performance" is the demonstration of meeting these standards and functioning as intended.
| (Implied) Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Medical Electrical Equipment Safety (EN 60601-1) | "The MTA System complies with the following standards: EN 60601-1:2003 Medical Electrical Equipment. Part 1: General requirements for safety" |
| Electromagnetic Compatibility (EN 60601-1-2) | "Meets EN 60601-1-2, EN55011, & IEC60601-1-2.2001" |
| Biocompatibility (ISO 10993) | "Biocompatibility ISO 10993, Biological Evaluation of Medical Devices" |
| Sterility Validation (EN550, ISO 11135) | "Sterilization validation requirements of EN550 and ISO 11135" |
| Shelf Life Distribution Validation (ASTM D4169) | "Shelf Life Distribution Validation Per ASTM D4169, Seal Strength Evaluation per ASTM F88" |
| Package Distribution Simulation (ISTA 2A, ASTM D4169) | "Package Distribution Simulation Per ISTA (International Safe Transit Association) Procedure 2A 2004, Package Distribution Simulation per ASTM D4169" |
| Material Suitability | "Patient contact materials used... are suitable for this use and have been used in numerous previously cleared products." |
| Functionality | "Performance testing was undertaken to ensure that the MTA System functions as intended and meets design specifications." |
| Substantial Equivalence | "The MTA System is equivalent to the predicate products. The indications for use, basic overall function, methods of operation, technological characteristics, and safety and effectiveness are substantially equivalent." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The clearance is based on engineering and bench testing, and substantial equivalence, not a clinical test set with human subjects. Thus, there's no "sample size for a test set" or associated data provenance in the clinical sense.
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. This device received 510(k) clearance based on engineering tests and substantial equivalence. There was no clinical ground truth established by experts for a test set described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication is described.
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 an ablation system, not an AI-assisted diagnostic tool. No MRMC study is mentioned or relevant to this type of device clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an ablation system requiring human operation, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance aspects, the "ground truth" would be the specifications and requirements defined by the referenced standards (e.g., proper electrical current output, successful sterilization, material compatibility, and overall functionality as designed). For the regulatory ground truth, it was the demonstration of substantial equivalence to predicate devices, meaning its characteristics were sufficiently similar in terms of safety and effectiveness.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
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510(k) Summary of Safety and Effectiveness
JAN 1 3 2006
| General Information | |
|---|---|
| Classification | Class II |
| Trade Name | Microsulis Tissue Ablation (MTA) System is comprised ofo MTA Sulis™ V Generatoro Applicator and Temperature probes |
| Submitter | Microsulis Americas, Inc.275 Wyman Street, Suite 12Waltham, MA 024511-781-547-7710 |
| Contact | Timothy Y CowartExecutive Vice President, Chief Regulatory Officer |
Intended Use
intended Use
The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.
Predicate Devices
| • Tyco/Radionics Cool-TipTM RF System | K984552 |
|---|---|
| • Vivant Medical VivaWaveTM Microwave System | K011676 |
| • Vivant VivaThermTM Temperature Measurement System | K031556 |
| • Vivant VivaTip Microwave Ablation Probe and Accessories | K032702 |
Device Description
Device Describution
The MTA surgical applicator is inserted into soft tissue and coagulates a volume of tissue surrounding the active The MTA Suglicator tip. Temperature probes are included in the applicator kits to determine the temperature at area of the applicator up. Temperature probos are included in the applicator is to be used with the MTA Sulis™ V the penpher you the obegalate manually set at the desired power levels by the operator.
Materials
illiatient contact materials used in the manufacture of the MTA System are suitable for this use and have been used in numerous previously cleared products.
Performance Data
Performance testing was undertaken to ensure that the MTA System functions as intended and meets design Penomance lessing was andonente to oneans that the device is substantially equivalent to the specifications. Junicient add were safety and effectiveness criteria. In addition, the testing aloromonitorial problem complies with the following standards.
- that the MTA Cyclem Somple 1:2003 Medical Electrical Equipment. Part 1: General . requirements for safety .
- Tequirements for Salety
Electromagnetic compatibility Meets EN 60601-1-2, EN55011, & IEC60601-1-2.2001 . - Biocompatibility ISO 10993, Biological Evaluation of Medical Devices .
- Sterility Sterilization validation requirements of EN550 and ISO 11135 .
- Stelf Life Distribution Vallation Per ASTM D4169, Seal Strength Evaluation per ASTM F88 .
- Oncir Life Dictional Safe Transit Association (ISTA) Procedure 2A 2004, Package . Distribution Simulation per ASTM D4169
Summary of Substantial Equivalence
Summary of Substantial Equivaler
The MTA System is equivalent to the predicate products. The indications for use, basic overall function, methods The MTA System is equivalient to the productions in the microsulis believes that the MTA system is substantially equivalent to existing legally marketed devices.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
JAN 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy Y. Cowart, Esq., P.E. Executive Vice President of Regulatory Affairs Chief Regulatory Officer Microsulis Americas, Inc. 275 Wyman Street, Ste. 12 Waltham, Massachusetts 02451
Re: K052919
Trade/Device Name: Microsulis Tissue Ablation (MTA) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: December 12, 2005 Received: December 14, 2005
Dear Mr. Cowart:
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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Mr. Cowart
Federal agencies. You must comply with all the Act's requirements, including, but not rcueral agencies: "Fourmals: compy" (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation mandiacturing practice requiredble, 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 11ns letter will and if you to organ - The FDA finding of substantial equivalence of your J rotty promation nowleted 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 If you desire openite the Office of Compliance at (240) 276-0115. Also, please note the oo 1), prease other . "Misbranding by reference to premarket notification" (21CFR Part 16 guildion onlined, "Min other general information on your responsibilities under the 807.97). Tod may obtain only general 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/dsma/dsmamain.html.
Sincerely yours,
Mark Volpe
Mark Melkerson Acting Director Division of General, Restorative and Neurological 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:
Indications For Use:
.
Microsulis Tissue Ablation System and Accessories
The Microsulis Tissue Ablation (MTA) System is indicated The Microsullo Hoose ative coagulation of soft tissue.
Prescription Use પછડ (21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use _ No (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)
2
Page 1 of _ 1 __
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number K052919
§ 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.