(88 days)
Not Found
No
The device description and performance studies focus on standard medical device functionalities and regulatory compliance, with no mention of AI or ML. The power levels are manually set by the operator.
Yes
The device is used for the intraoperative coagulation of soft tissue, which is a therapeutic intervention.
No
The device is described as an ablation system for intraoperative coagulation of soft tissue, not for detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly outlines hardware components (surgical applicator, temperature probes, generator) and performance testing related to hardware standards (electrical safety, electromagnetic compatibility, biocompatibility, sterility, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intraoperative coagulation of soft tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "surgical applicator" inserted into soft tissue to coagulate it. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition. The temperature probes are used to monitor the ablation process, not to diagnose a disease.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Microsulis Tissue Ablation (MTA) System and accessories are for use in the intraoperative coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intraoperative
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)
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
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.
K984552, K011676, K031556, K032702
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the text "Ko52919" in a handwritten style. The text is written in black ink on a white background. The numbers are slightly larger than the letters, and the text is slightly slanted to the right.
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 of |
| o MTA Sulis™ V Generator | |
| o Applicator and Temperature probes | |
| Submitter | Microsulis Americas, Inc. |
| 275 Wyman Street, Suite 12 | |
| Waltham, MA 02451 | |
| 1-781-547-7710 | |
| Contact | Timothy Y Cowart |
| Executive 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.
1
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
2
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
3
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