(176 days)
The DTS G2 System is indicated for use for coagulation of soft tissue.
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.
The provided 510(k) summary for the DTS G2 System is for a Class II medical device, specifically an electrosurgical cutting and coagulation device. The information provided in the document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against specific acceptance criteria for a diagnostic AI/ML device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI/ML performance, ground truth, expert consensus, and reader studies) are not applicable to this submission.
Here's a breakdown of the available information and why other fields are N/A:
Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Specification | Not explicitly detailed in the provided document | "The results showed the system met specification." |
| Equivalence to Predicate | "Indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent." | "The DTS G2 System is equivalent to the predicate product." |
| Safety and Materials | Materials suitable for use | "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." |
Study Details for this Device
Given the nature of this 510(k) submission (a medical device for tissue coagulation, not an AI/ML diagnostic) and the provided text:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for performance testing.
- Data Provenance: "Product and animal testing was conducted." No country of origin is specified. This was likely prospective bench and animal testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. This is a non-AI device; ground truth for performance was likely based on physical measurements and observations during product and animal testing, not expert interpretation.
-
Adjudication method for the test set: N/A. Not relevant for this type of device testing.
-
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: N/A. This is not an AI/ML diagnostic device requiring a reader study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, not an algorithm. Performance involves the device's physical interaction, not an algorithm's standalone output.
-
The type of ground truth used: For the product and animal testing, the ground truth would have been established through direct observation, physiological measurements, and possibly histological examination in animal models to confirm "coagulation of soft tissue" and device function according to specifications. Pathology data would be relevant for animal testing outcomes.
-
The sample size for the training set: N/A. This device does not use an AI/ML model that requires a training set.
-
How the ground truth for the training set was established: N/A. No training set is applicable.
{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 DriveMenlo Park, CA 94025USATel: 650-326-2656Fax: 650-326-3108 | |
| Contact | Kathy O'Shaughnessy, PhDVP 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
§ 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.