(133 days)
Not Found
No
The device description explicitly states that the generator is composed of analog and digital circuits with no software or firmware, and there are no mentions of AI, DNN, or ML in the provided text.
Yes
Explanation: The device is intended for "coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors," which is a direct therapeutic intervention.
No
Explanation: The device is an ablation system designed to coagulate soft tissue, including tumors, and does not provide diagnostic information.
No
The device description clearly outlines multiple hardware components including a generator, antenna, cable, and pump, and explicitly states the generator has no software or firmware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors." This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is a microwave-based system that delivers energy to ablate tissue. This is an interventional device used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Covidien Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.
Product codes
NEY
Device Description
The Emprint™ Ablation System is a microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The Emprint™ Ablation Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation Generator provides for user setting of ablation time and ablation power (5 to 100W). With an optional temperature probe, the Emprint™ Ablation Generator can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature. The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient. The Emprint™ Ablation System consists of the following components: Emprint™ Ablation Generator (2450 MHz), Emprint™ Ablation Antenna (sterile, single use), Emprint™ Ablation Reusable Cable, and Emprint™ Ablation Pump. The system also includes the following optional components: Emprint™ Ablation Cart (with Isolation Transformer), Remote Temperature Probe (sterile, single-use), and Footswitch. The system must be used with a standard IV bag of sterile normal saline (not provided with the system).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver tumors
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)
The performance of the proposed device was characterized using the same methods used for one of the predicate devices. Coagulations were conducted on several ex vivo and in vivo tissue types at various power and duration settings. The shapes of the coagulation zones created were analyzed and compared to that of the predicate. Bench testing also included verification of dimensional characteristics, surface temperatures, and skin penetration. The system adheres to the applicable IEC 60601 standards.
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.
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/1 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with three white rectangles inside. The rectangles are stacked vertically, with the top and bottom rectangles being smaller than the middle one.
510(k) Summary
APR 2 8 2014
Date: April 28, 2014
510(k) Submitter/Holder
Covidien IIc 15 Hampshire Street Mansfield, MA 02048
Contact
Heather V. Nigro Senior Director, Global Regulatory Affairs Telephone: 508-452-1936 Fax: 508-452-1941 Email: heather.nigro@covidien.com
Name of Device
Trade Name: Emprint™ Ablation System Microwave ablation system and accessories Common Name: Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II, NEY).
Purpose of Submission
The purpose of this submission is to gain clearance for a new microwave ablation system.
Predicate Devices
Emprint™ Ablation System described in this substantially equivalent to the following commercially available predicate devices:
| Trade Name: | Valleylab Microwave Ablation Generator |
|---|---|
| Device Common Name: | Microwave ablation system and accessories |
| 510(k) Number: | K072687 |
| Manufacturer: | Covidien llc |
| Trade Name: | Certus 140 2.45 GHz Ablation System and Accessories |
| Device Common Name: | Microwave ablation system and accessories |
| 510(k) Number: | K113237 |
System Description
The Emprint™ Ablation System is a microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna.
The Emprint™ Ablation Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation Generator provides for user setting of ablation time and ablation power (5 to 100W). With an optional temperature probe, the Emprint™
1
Ablation Generator can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature.
The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. No saline is in contact with the patient.
The Emprint™ Ablation System consists of the following components: Emprint™ Ablation Generator (2450 MHz), Emprint™ Ablation Antenna (sterile, single use), Emprint™ Ablation Reusable Cable, and Emprint™ Ablation Pump. The system also includes the following optional components: Emprint™ Ablation Cart (with Isolation Transformer), Remote Temperature Probe (sterile, single-use), and Footswitch.
The system must be used with a standard IV bag of sterile normal saline (not provided with the system).
Intended Use
The Covidien Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.
The Covidien Emprint™ Ablation System is not intended for use in cardiac procedures.
Technological Characteristics
The Emprint™ Ablation System operates at 2.450 MHz and is capable of operating up to 100 Watts. The user has the ability to select the desired power and time limits. The substantial equivalence of the Emprint™ Ablation System to the predicates is shown by similarity in intended use, indications for use, materials, and performance.
Performance Data
The performance of the proposed device was characterized using the same methods used for one of the predicate devices. Coagulations were conducted on several ex vivo and in vivo tissue types at various power and duration settings. The shapes of the coagulation zones created were analyzed and compared to that of the predicate. Bench testing also included verification of dimensional characteristics, surface temperatures, and skin penetration.
The system adheres to the applicable IEC 60601 standards.
Sterilization
The Emprint™ Ablation Generator, the Reusable Cable, the Pump, and the Cart are not provided sterile and are not used in the sterile field. These four components are reusable, and their cleaning instructions are provided in the instructions for use.
Sterilization validation was performed on the packaged Ablation Antenna and the Remote Temperature Probe according to the requirements of ISO 11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The sterility assurance level for the devices is 10-6.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or flowing elements.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2014
Covidien LLC Ms. Heather Nigro Senior Director, Global Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K133821
Trade/Device Name: Emprint Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Microwave Ablation System And Accessories Regulatory Class: Class II Product Code: NEY Dated: March 27, 2014 Received: March 28, 2014
Dear Ms. Nigro:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Heather Nigro
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ |