(97 days)
Not Found
No
The description focuses on manual operation, electrical circuits, and microwave energy delivery, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for coagulation of soft tissue, which is a therapeutic intervention.
No
The device is described as a Microwave Tissue Coagulation System intended for the coagulation of soft tissue, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists multiple hardware components including an applicator, external microwave generator, vacuum pump, and cooling fluid pump and tubing. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that delivers microwave energy to tissue via an applicator. This is consistent with a therapeutic device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to treat tissue directly.
N/A
Intended Use / Indications for Use
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
NEY
Device Description
The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator.
The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.
The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.
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
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)
Product testing was conducted to evaluate conformance to product specification.
The results showed the system met specification.
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.
K011676, K052919, K984552, K021368, K003978
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.
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510(k) Summary
General Information
Class II
Microwave Tissue Coagulation System (MTCS) Trade Name
Submitter
Classification
Foundry Newco X, Inc. 199 Jefferson Drive Menlo Park, CA 94045 USA Tel: 650-326-2656 Fax: 650-326-3108
Contact
Steven Kim Chief Technology Officer
Intended Use
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
Predicate Devices
| K011676 | VivaWave Microwave Ablation System |
|---|---|
| K052919 | Microsulis MTA System |
| K984552 | Radionics Cool-Tip RF System |
| K021368 | Medela Vacuum Pump Model 30 |
| K003978 | AFX Microwave Generator |
Device Description
The Microwave Tissue Coagulation System (MTCS) is designed to coagulate soft tissue using a surface contact applicator. The system consists of an applicator, external microwave generator, vacuum pump, and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator.
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The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.
The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator.
Materials
All materials used in the manufacture of the MTCS are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification.
The results showed the system met specification.
Summary of Substantial Equivalence
The MTCS is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.
Public Health Service
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Foundry Newco X, Inc. % Mr. Steven Kim Chief Technology Officer 199 Jefferson Drive Menlo Park, California 94025
Re: K072870
Trade/Device Name: Microwave Tissue Coagulation System (MTCS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: December 19, 2007 Received: December 20, 2007
Dear Mr. Kim:
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 Federal agencies. You must comply 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 requirements as 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.
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Page 2 - Mr. Steven Kim
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Mulhern
Mark N. Melkerson 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
Device Name:
Microwave Tissue Coagulation System (MTCS)
510(k) Number (if known):
Indications for Use:
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
X OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Off Bigges Forn Lation (ODE) Division of General, Restorative,
and Neurological Devices
12072870 510(k) Number_________________________________________________________________________________________________________________________________________________________________ Page 1 of 1