(176 days)
No
The description details a manually operated microwave tissue coagulation system with no mention of automated decision-making, image analysis, or adaptive algorithms typically associated with AI/ML.
Yes
The DTS G2 System is indicated for the coagulation of soft tissue, which is a therapeutic action.
No
Explanation: The device is described as being used for coagulation of soft tissue, which is a therapeutic function, not a diagnostic one. It delivers microwave energy to interact with tissue, rather than gathering information about a condition.
No
The device description clearly outlines multiple hardware components including an applicator, external microwave generator, cooling fluid pump, tubing, electric circuits, circuit boards, cooling fans, power supply, integrated vacuum pump, microwave module, and a front panel/control board assembly. 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 device description details a system that delivers microwave energy to soft tissue via an applicator. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived 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 DTS G2 System is indicated for use for coagulation of soft tissue.
Product codes
NEY
Device Description
The DTS G2 System is designed to interact-using a surface contact applicator. The system consists of an applicator; external microwave generator with integrated 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, integrated vacuum pump, 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 distal end has a sterile, disposable applicator head that contacts the patient.
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 and animal testing was conducted to evaluate conformance to product specification and equivalence to predicate devices.
The results showed the system met specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072870 Foundry Newco X Microwave Tissue Coagulation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko82819
510(k) Summary
Page 1 of 2
General Information
| Classification | Class II | MAR 20 2005 |
|---|---|---|
| Trade Name | DTS G2 System | |
| Submitter | Miramar Labs, Inc. | |
| 199 Jefferson Drive | ||
| Menlo Park, CA 94025 | ||
| USA | ||
| Tel: 650-326-2656 | ||
| Fax: 650-326-3108 | ||
| Contact | Kathy O'Shaughnessy, PhD | |
| VP Clinical and Regulatory Affairs |
Intended Use
The DTS G2 System is indicated for use for coagulation of soft tissue.
Predicate Devices
K072870 Foundry Newco X Microwave Tissue Coagulation System
Device Description
The DTS G2 System is designed to interact-using a surface contact applicator. The system consists of an applicator; external microwave generator with integrated 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, integrated vacuum pump, 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 distal end has a sterile, disposable applicator head that contacts the patient.
1
Page 2 of 2
Materials
All materials used in the manufacture of the DTS G2 System are suitable for this use and have been used in numerous previously cleared products.
Testing
Product and animal testing was conducted to evaluate conformance to product specification and equivalence to predicate devices.
The results showed the system met specification.
Summary of Substantial Equivalence
The DTS G2 System is equivalent to the predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Miramar Labs, Inc. % Kathy O'Shaughnessy, PhD VP, Clinical and Regulatory Affairs 199 Jefferson Drive Menlo Park, California 94025
MAR 2 0 2009
Re: K082819
Trade/Device Name: DTS G2 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: February 27, 2009 Received: March 2, 2009
Dear Dr. O'Shaughnessy:
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.
3
Page 2 - Kathy O'Shaughnessy, PhD
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 yours.
fmhi, m.D. for
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6082819
Indications for Use
510(k) Number (if known):
DTS G2 System
Device Name:
Indications for Use:
The DTS G2 System is indicated for use for coagulation of soft tissue.
X
Prescription Use (Per 21 CFR 801 Subpart D) 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)
Nil R P Ogale for mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(
Number K082819