(97 days)
The Microwave Tissue Coagulation System (MTCS) is intended for coagulation of soft tissue.
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.
The provided text does not contain detailed acceptance criteria for the Microwave Tissue Coagulation System (MTCS) or a dedicated study report proving its compliance to specific performance metrics. It primarily focuses on the device's description, intended use, and substantial equivalence to predicate devices for 510(k) clearance.
However, based on the limited information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to product specification | "The results showed the system met specification." |
- Inference: The "product specification" would likely include parameters related to the microwave generator's output power, frequency, safety controls, the applicator's ability to deliver energy, and the overall system's functional integrity. Without the actual specifications, the specific criteria are unknown.
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 states, "Product testing was conducted to evaluate conformance to product specification." It does not provide details on:
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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. The testing described is "product testing" to evaluate conformance to specifications, not a clinical study involving experts establishing ground truth for diagnostic or therapeutic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is typically used in clinical studies with human readers or experts reviewing cases, which is not described here.
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
No. The document describes a medical device for tissue coagulation, not an AI-powered diagnostic or assistive tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (Microwave Tissue Coagulation System), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "product testing" mentioned, the "ground truth" would be the engineering and performance specifications defined by the manufacturer. The device was tested to ensure it met these predetermined physical and functional requirements.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The "training" for such a device would likely refer to manufacturing processes and quality control, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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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.
【JAN 1 4 2008
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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
§ 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.