(29 days)
No reference devices were used in this submission.
No
The summary describes a modification to an existing ablation antenna, focusing on material changes for increased stiffness and an adhesive for seal strengthening. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation or description. The performance studies focus on mechanical robustness, stability, biocompatibility, and usability of the modified antenna.
Yes
The device is described as an "Ablation System" intended for "coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors," which are therapeutic actions.
No
The device is described as an "Ablation System" intended for "coagulation (ablation) of soft tissue," which signifies a therapeutic function rather than a diagnostic one.
No
The device description clearly details physical components (antenna, cooling jacket, adhesive) and mentions manufacturing processes and material changes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an "Ablation System" and "Percutaneous Antenna." These are instruments used for delivering energy to tissue for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, 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 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 Emprint Ablation System is not intended for use in cardiac procedures.
Product codes
NEY
Device Description
Covidien has modified the Emprint Ablation System's Percutaneous Antenna (Catalog Numbers: CA15L1, CA20L1 and CA30L1). The modified ablation antenna is identical to the device described in K133821, with two exceptions. The antenna's tissue contacting cooling jacket is manufactured from a new, biocompatible material that significantly increases the antenna's stiffness. Additionally, an adhesive has been added at the antenna shaft's proximal joint to strengthen the seal. By making the antenna stiffer, the cooling jacket material change is expected to enhance the antenna's usability; it does not affect the Emprint Ablation System's essential function, performance or underlying principles of operation.
Like its predicate, the modified antenna (Catalog Numbers CA15L2, CA20L2 CA30L2) is provided sterile (EO) and is intended for use with the Emprint Ablation System in health care facilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care facilities
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)
Bench Verification Testing: Verification testing was conducted to (1) demonstrate the modified antenna's continued robustness to mechanical stresses, (2) confirm that the antenna's printed depth markings were not affected by the underlying cooling jacket material change, (3) quantify the stiffness of the antenna's shaft relative to the 510(k) cleared device and, (4) confirm that the change did not impact the system's essential function - the performance of thermal ablations in soft tissue. Some of the verification tests were conducted using the fully-assembled Emprint Percutaneous Antenna, while other tests required only the cooling jacket sub-assembly.
Product Stability Testing: Stability testing was conducted to evaluate the effect of the cooling-jacket material change on the antenna's performance over time. The testing was broad in scope and included mechanical stress testing, cytotoxicity testing and performance testing.
Biocompatibility Testing: Biocompatibility testing of the new fiberglass material and the modified cooling jacket subassembly was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. Additionally, the modified cooling jacket subassembly underwent a full chemical characterization.
Validation Testing: Representative end users participated in a simulated-use validation study. The participants completed a series of tasks designed to be representative of those performed with the antenna during ablation procedures. Objective and subjective test results confirmed that (1) essential and safety-critical tasks were performed with the stiffer antenna in a safe and effective manner, (2) the modified device met usability requirements and, (3) there were no new, use-related risks, associated with the change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, with a focus on the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Covidien LLC Ms. Patti Arndt Principal Regulatory Affairs Specialist 5920 Longbow Drive Boulder, Colorado 80301
Re: K163105
Trade/Device Name: Emprint Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: November 4, 2016 Received: November 7, 2016
Dear Ms. Arndt:
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. 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 of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
EmprintTM Ablation System
Indications for Use (Describe)
The 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 Emprint Ablation System is not intended for use in cardiac procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Transportation Use (64-35B-001 Subpart B) □ On-Site Service Use (64-35B-001 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
l. SUBMITTER
II.
Covidien IIc 5920 Longbow Dr. Boulder, CO 80301
| Contact Person: | Patti Arndt
Principal Regulatory Affairs Specialist
Phone: 303-581-6668
FAX: 303-530-6313 |
|------------------------------|----------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | November 2, 2016 |
| | DEVICE |
| Device Trade Name: | Emprint™ Ablation System |
| Device Common Name: | Microwave Ablation System |
| Classification Name: | System, Ablation, Microwave and Accessories |
| Regulatory Class: | II |
NEY
III. PREDICATE DEVICE
Product Code:
Emprint™ Ablation System with Thermosphere™ Technology, K133821
Modification to System Accessory: Emprint™ Percutaneous Antenna with Thermosphere™ Technology: Catalog Nos.CA15L1 (Short), CA20L1 (Standard), CA30L1 (Long)
The device modification is not the subject of a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Covidien has modified the Emprint Ablation System's Percutaneous Antenna (Catalog Numbers: CA15L1, CA20L1 and CA30L1). The modified ablation antenna is identical to the device described in K133821, with two exceptions. The antenna's tissue contacting cooling jacket is manufactured from a new, biocompatible material that significantly increases the antenna's stiffness. Additionally, an adhesive has been added at the antenna shaft's proximal joint to strengthen the seal. By making the antenna stiffer, the cooling jacket material change is expected to enhance the antenna's usability; it does not affect the Emprint Ablation System's essential function, performance or underlying principles of operation.
4
Like its predicate, the modified antenna (Catalog Numbers CA15L2, CA20L2 CA30L2) is provided sterile (EO) and is intended for use with the Emprint Ablation System in health care facilities.
V. INDICATIONS FOR USE
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic and intraoperative coaqulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.
The Emprint Ablation System is not intended for use in cardiac procedures.
Indications for the use of the Emprint System and modified Percutaneous Antenna are identical to the predicate device.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The Emprint Ablation System's current percutaneous antenna (predicate device) and the modified ablation antenna share the same underlying technology. Both devices are used to deliver microwave energy to soft tissue in a highly-controlled way. Signal frequency, power and exposure time are controlled by the system's 2450 MHz generator. The design of the radiating portion of the accessory and continuous cooling of the accessory during the ablation procedure determines the shape (near-spherical) and size of the resulting ablations. The modification to the antenna's cooling jacket (the component that forms the antenna's outer structure) changes the stiffness of the antenna's shaft only.
VII. PERFORMANCE DATA
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Bench Verification Testing
Verification testing was conducted to (1) demonstrate the modified antenna's continued robustness to mechanical stresses, (2) confirm that the antenna's printed depth markings were not affected by the underlying cooling jacket material change, (3) quantify the stiffness of the antenna's shaft relative to the 510(k) cleared device and, (4) confirm that the change did not impact the system's essential function - the performance of thermal ablations in soft tissue. Some of the verification tests were conducted using the fully-assembled Emprint Percutaneous Antenna, while other tests required only the cooling jacket sub-assembly.
Product Stability Testing
Stability testing was conducted to evaluate the effect of the cooling-jacket material change on the antenna's performance over time. The testing was broad in scope and included mechanical stress testing, cytotoxicity testing and performance testing.
5
Biocompatibility Testing
Biocompatibility testing of the new fiberglass material and the modified cooling jacket subassembly was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. Additionally, the modified cooling jacket subassembly underwent a full chemical characterization.
Validation Testing
Representative end users participated in a simulated-use validation study. The participants completed a series of tasks designed to be representative of those performed with the antenna during ablation procedures. Objective and subjective test results confirmed that (1) essential and safety-critical tasks were performed with the stiffer antenna in a safe and effective manner, (2) the modified device met usability requirements and, (3) there were no new, use-related risks, associated with the change.
CONCLUSIONS VIII.
The modified Emprint Percutaneous Antenna is identical to the predicate device, with the exception of an improved seal and a material change that serves to increase the antenna's stiffness. The subject and predicate devices share intended use, technological characteristics, and meet identical performance requirements. The results of comprehensive verification and validation testing raised no new questions of safety or effectiveness and confirmed the usability enhancement. The Emprint Ablation System's Percutaneous Antenna (subject device) and the modified Percutaneous Ablation Antenna (predicate device) are substantially equivalent.