(121 days)
Not Found
No
The description focuses on the physical components, energy delivery, and cooling system, with no mention of AI or ML for image processing, decision support, or other functions.
Yes
The device is indicated for the ablation (coagulation) of soft tissue, which is a therapeutic intervention.
No
Explanation: The device is described as an ablation system designed for the coagulation of soft tissue, heating it to the point of necrosis. Its function is to treat tissue, not to diagnose conditions or diseases.
No
The device description clearly outlines multiple hardware components including flexible ablation probes, a microwave source, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm. This is not a software-only device.
Based on the provided text, the NEUWAVE™ Flex Microwave Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "ablation (coagulation) of soft tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that delivers microwave energy to heat and destroy tissue within the body. This is an in-vivo (within the living organism) process.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NEUWAVE™ Flex Microwave Ablation System performs a therapeutic action directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.
The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a physician.
Product codes
NEY
Device Description
The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.
The FLEX is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.
Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.
Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.
The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.
A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.
The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.
A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.
The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.
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
facility use and should only be used under the orders of a physician.
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 NEUWAVE Flex Microwave Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including:
- IEC 60601-1:2005 + CORR 1:2006, CORR 2:2007 + Amendment 1:2012 ●
- IEC 60601-2-2:2009
- IEC 60601-2-6:2012
- IEC 60601-1-2:2007/AC:2010
- EN ISO 11607-1:2009
- ISO 10993-1: 2009
The NEUWAVE Flex Microwave Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The NEUWAVE Flex Microwave Ablation System and Accessories has been verified through rigorous testing that, in part, supports the compliance of NEUWAVE Flex Microwave Ablation System and Accessories to the standards listed above.
The system passed all pre-determined acceptance criteria identified in the test plan. Ex-vivo testing in bovine liver and lung and porcine kidney was conducted to produce data for the Instructions for Use and to compare to the predicate devices. Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices.
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100744, K113237, K122217, K130399, K160936
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
NeuWave Medical, Inc. Mr. Dan Kosednar Director of Regulatory Affairs 3529 Anderson Street Madison, Wisconsin 53704
Re: K163118
Trade/Device Name: NEUWAVE Flex Microwave Ablation System and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NEY Dated: February 17, 2017 Received: February 21, 2017
Dear Mr. Kosednar:
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 -S
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
510(k) Number (if known) K163118
Device Name
NEUWAVE Flex Microwave Ablation System and Accessories
Indications for Use (Describe)
The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.
The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a physician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Date: | 03/06/2017 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the |
| NEUWAVE Flex Microwave Ablation System and Accessories | |
| Company: | NeuWave Medical, Inc. |
| 3529 Anderson Street | |
| Madison, WI 53704 | |
| FDA Establishment# | 3008769756 |
| Contact: | Dan Kosednar, Director of Regulatory Affairs |
| P - 608-512-1592 | |
| F - 608-512-1509 | |
| Proprietary: | NEUWAVE Flex Microwave Ablation System and Accessories |
| Common: | System, Ablation, Microwave and Accessories |
| Classification: | Surgical Devices, 73 NEY, 21 CFR 878.4440 |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
Predicate Devices
The NEUWAVE Flex Microwave Ablation System and Accessories is substantially equivalent to the following currently marketed device:
- . Certus 140 2.45 GHz Ablation System and Accessories – Class II – 21CFG878.4400 which has been the subject of a cleared 510(k) with the FDA log number K100744, K113237, K122217, K130399 and K160936.
Indications For Use
The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.
The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.
The system is designed for facility use and should only be used under the orders of a physician.
Device Description
The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.
The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX
FLEX 510(k) Submission Safety Summary Page 1 of 6
4
is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.
Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.
Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.
The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.
A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.
The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.
A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.
The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.
Comparison to Predicate
The FLEX Microwave Ablation System is an evolution of the predicate Certus 140 2.45GHz Ablation System and Accessories. Below is a tabular comparison of the similarities and differences:
5
| Feature/Specification | NEUWAVE Flex Microwave
Ablation System | Predicate Certus 140 Ablation
System and Accessories (K160936) | Comments/impact on
safety and
effectiveness | |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Indication for Use | The NEUWAVE Flex Microwave
Ablation System and Accessories
is indicated for the ablation
(coagulation) of soft tissue.
The NEUWAVE Flex is not
indicated for use in cardiac
procedures. | The NeuWave Medical Certus 140™
2.45 GHz Ablation System and
Accessories are indicated for the
ablation (coagulation) of soft tissue in
percutaneous, open surgical and in
conjunction with laparoscopic surgical
settings.
The Certus 140 is not indicated for use
in cardiac procedures. | The FLEX indications for
use are a subset of the
predicate indications. | |
| Energy Source | 2.45 GHz Frequency Modulated
Source Microwave | 2.45 GHz Frequency Modulated Source
Microwave | No change from
predicate | |
| Power Distribution
Module (PDM) | PDM mounts to the PDM and
Accessories Support Arm and
allows for the connection of a
single (1) FLEX ablation probe. | PDM mounts to the imaging table rail
and allows for the connection of up to
three (3) ablation probes | The PDM concept and
construct is similar to
the predicate. However,
the FLEX system only
supports the use of a
single ablation probe at
a time. | |
| Probe applications | The FLEX ablation probes can be
used in multiple applications,
including percutaneous (via an
introducer), open surgical and
procedures in which the target
tissue is accessed via a lumen or
scope such as an endoscope or
coaxial introducer. | Percutaneous, open surgical and in
conjunction with laparoscopic. | The nature of the
flexible probe enables
the FLEX system to be
used in additional
applications in which the
target tissue is accessed
via a lumen or scope
such as an endoscope or
coaxial introducer. | |
| Probe dimensions | French 6 diameter and 150cm in
length. | CertusLK, CertusLN and CertusPR probes
are 17 gauge and available in 15 and
20cm lengths.
CertusSR probe is 13 gauge and
available only in a 25cm length.
CertuSurgGT has a 17 gauge cannula
and is only available in one length. | The FLEX system uses a
flexible ablation probe
instead of the metal
cannula-based
percutaneous probes of
the predicate. | |
| Feature/Specification | NEUWAVE Flex Microwave
Ablation System | Predicate Certus 140 Ablation
System and Accessories (K160936) | Comments/impact on
safety and
effectiveness | K163118 |
| Generator Output
Power | The FLEX system allows an output
of 40W – 100W. The user controls
the power setting on the user
interface and can adjust in 5
Watts increments. | CertusLK, CertusLN and CertusSR Probes
are limited to 140W for a single probe,
95W if 2 probes are selected and 65W
if 3 probes are selected.
CertusPR Probes Maximum of 65W per
probe regardless of the number of
probes when used in Ablation Mode.
In Surgical Mode, the maximum power
for CertusPR probes is 95W if one or
two probes are used and 65W if three
probes are used. | The power levels
available on the FLEX are
a subset of the power
levels on the predicate. | |
| | | For the CertuSurgGT, the maximum
power is 110W for a single probe, 95W
if two probes are used and 65W if 3
probes are used. | | |
| Antenna Design | Coaxial Antenna Flex probe | Triaxial Antenna for CertusLK, CertusLN
and Certus SR
Modified Triaxial Antenna for CertusPR
and CertuSurgGT | The FLEX probe antenna
was designed to produce
an ablation zone
substantially equivalent
to the predicate CertusPR
probe but within a
flexible probe shaft.
Testing in ex-vivo liver,
lung and kidney tissue
confirm that the FLEX
probes produce
ablations that are
substantially equivalent
to the predicate probes. | |
| Cooling Mechanism | CO2 cooling using the Joule-
Thompson effect of high pressure
CO2 gas | CO2 cooling using the Joule-Thompson
effect of high pressure CO2 gas | The same CO2 cooling
method is employed to
keep the non-active
portions of the probe at
acceptable
temperatures. | |
| Tissu-Loc Feature | No Tissu-Loc feature | Tissu-Loc feature | The predicate employs a
Tissu-Loc feature to
adhere the probe to
tissue prior to delivering
microwave energy. This
feature is not available
on the FLEX system. | |
| Feature/Specification | NEUWAVE Flex Microwave
Ablation System | Predicate Certus 140 Ablation
System and Accessories (K160936) | Comments/impact on
safety and
effectiveness | |
| Sterilization/Packaging | | | | |
| Probe Sterilization Method | Ethylene Oxide | Ethylene Oxide | This aspect of
system/probe design has
not been modified from
the predicate device. | |
| Probe Packaging | Thermoformed plastic tray with
Tyvek Lid, with E-flute outer box. | Thermoformed plastic tray with Tyvek
Lid, with E-flute outer box. | The packaging used on
the FLEX probes uses the
same tray and lid as the
predicate. | |
| Monitored
Parameters | | | | |
| Elapsed Time
Probe Temperature
Coolant Level
Power in Watts
Coolant Pressure | Yes | Yes | This aspect of
system/probe design has
not been modified from
the predicate device. | |
| Alarms | The following parameters are
monitored and will cause the FLEX
system to stop delivering power if
values are unacceptable:
Gas Coolant Level
Generator Temperature
Probe Temperature
Reflected Power Level
Probe Communication
Probe Authentication | The following parameters are
monitored and will cause the Certus
140 to stop delivering power if values
are unacceptable:
Gas Coolant Level
Generator Temperature
Probe Temperature
Reflected Power Level
Probe Communication
Probe Authentication | This aspect of
system/probe design has
not been modified from
the predicate device. | |
6
7
Performance Data
The NEUWAVE Flex Microwave Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including:
- IEC 60601-1:2005 + CORR 1:2006, CORR 2:2007 + Amendment 1:2012 ●
- IEC 60601-2-2:2009
- IEC 60601-2-6:2012
- . IEC 60601-1-2:2007/AC:2010
- EN ISO 11607-1:2009
- ISO 10993-1: 2009
The NEUWAVE Flex Microwave Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The NEUWAVE Flex Microwave Ablation System and Accessories has been verified through rigorous testing that, in part, supports the compliance of NEUWAVE Flex Microwave Ablation System and Accessories to the standards listed above.
The system passed all pre-determined acceptance criteria identified in the test plan. Ex-vivo testing in bovine liver and lung and porcine kidney was conducted to produce data for the Instructions for Use and to compare to the predicate devices. Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices.
FLEX 510(k) Submission Safety Summary Page 5 of 6
8
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.