(94 days)
Not Found
No
The description focuses on the electrosurgical function and mechanical components of the catheter, with no mention of AI or ML.
Yes
The device is used for electrosurgical procedures to treat soft tissue obstructions, which indicates a therapeutic purpose.
No
The device is an electrosurgical device designed for therapeutic procedures (ablation/cutting of soft tissue), not for diagnosing conditions.
No
The device description explicitly details physical hardware components (catheter, electrode, shaft, plug) and their interaction with other hardware (bronchoscope, electrosurgical unit, patient return electrode). It is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- Device Function: The Empower RF Catheter is an electrosurgical device used directly on soft tissue obstructions within the body (upper airways and tracheobronchial tree) to perform a therapeutic procedure (electrosurgical procedures). It is not used to examine specimens outside the body.
- Intended Use: The intended use clearly states it's for "electrosurgical procedures involving soft tissue obstructions," which is a therapeutic intervention, not a diagnostic test performed on a sample.
Therefore, the Empower RF Catheter falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Empower RF Catheter is a sterile, single-use monopolar endoscopic device intended to be inserted through a flexible bronchoscope or a working channel of a flexible bronchoscope with an inner diameter of 2.0 mm. It has a stainless-steel electrode at the distal end, a flexible catheter shaft comprised of a nitinol wire covered by insulation tubing to prevent kinking and facilitate pushability during bronchoscopic procedures and a standard male banana plug at the proximal end. The banana plug connects to a monopolar connecting cable of a compatible electrosurgical unit. Empower is activated by a footswitch accessory supplied with the electrosurgical unit. Empower is provided in a monopolar configuration and thus, must be used in conjunction with a commercially available compatible patient return electrode to complete the return path for the RF electrical current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue obstructions in the upper airways and tracheobronchial tree.
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)
Performance testing has been completed to demonstrate substantial equivalence of the subject device to the predicate device. Empower was subjected to the following verification and validation tests, as applicable:
- Biocompatibility: Biocompatibility verification was performed for patient contacting components of Empower in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2006.
- Sterilization and Shelf Life Testing: Empower was validated to achieve sterility assurance level of 10 and adopted into a validated E-beam sterilization cycle. Packaging validation was performed. Sterilization validation was performed in accordance with AAMI TIR 33:2005, ISO 11137-1:2006/Amd 2013, ISO 11137-2:2013, and ISO 11137-3:2006.
- Electrical Safety Testing: Electrical safety testing was performed for the applicable components of Empower. The results demonstrated compliance to all applicable requirements of IEC 60601-1:2006, IEC 60601-2-2:2009, and IEC 60601-2-18:2015.
- Performance Bench Testing: The following performance bench tests were performed: Tensile Testing, Packaging Inspection, Dimensional Inspection, Electrical Inspection, Simulated Use testing, Corrosion Resistance, Radiopacity verification, Scope Visualization, Ex-vivo ablation testing.
The results from this testing demonstrates that Empower meets the defined design requirements and supports its safety and effectiveness for its intended use and its substantial equivalence to the predicate device.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 22, 2019
Broncus Medical, Inc Aradhana Dhanabalan Regulatory Affairs Manager 125 Nicholson Lane San Jose, California 95134
Re: K183240
Trade/Device Name: Empower RF Catheter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 19, 2019 Received: February 21, 2019
Dear Aradhana Dhanabalan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David David Krause -S Krause -S Krause -S
Date: 2019.02.22 14:41:28 -05'00' 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) K183240
Device Name Empower RF Catheter
Indications for Use (Describe)
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.
| 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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Broncus Medical, Inc.
125 Nicholson Lane
San Jose, CA 95134 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| PRIMARY CONTACT | Aradhana Dhanabalan
Regulatory Affairs Manager
Broncus Medical, Inc.
Phone: 650-428-1600 Ext.311
Email: adhanabalan@broncus.com |
| SECONDARY CONTACT | Liz Raphael
Senior Regulatory Affairs Manager
Broncus Medical, Inc.
Phone: 408-728-1037
Email: Iraphael@broncus.com |
| DATE PREPARED | February 15, 2019 |
| TRADE NAME | Empower RF Catheter |
| COMMON NAME | Radiofrequency (RF) Catheter |
| CLASSIFICATION NAME | Electrosurgical cutting and coagulation devices and accessories |
| DEVICE CLASSIFICATION | Class II, 21 CFR §878.4400 |
| PRODUCT CODE | GEI |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Empower RF Catheter is a sterile, single-use monopolar endoscopic device intended to be inserted through a flexible bronchoscope or a working channel of a flexible bronchoscope with an inner diameter of 2.0 mm.
4
[Broncus Medical, Inc.- EMPOWER RF Catheter- Traditional 510(k)]
It has a stainless-steel electrode at the distal end, a flexible catheter shaft comprised of a nitinol wire covered by insulation tubing to prevent kinking and facilitate pushability during bronchoscopic procedures and a standard male banana plug at the proximal end.
The banana plug connects to a monopolar connecting cable of a compatible electrosurgical unit. Empower is activated by a footswitch accessory supplied with the electrosurgical unit. Empower is provided in a monopolar configuration and thus, must be used in conjunction with a commercially available compatible patient return electrode to complete the return path for the RF electrical current.
INTENDED USE
The Empower RF Catheter is intended to be inserted through the working channel of a flexible bronchoscope and utilized in electrosurgical procedures involving removal/cutting of soft tissues (incision, vaporization, ablation, coagulation and hemostasis).
INDICATION FOR USE
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.
SUBSTANTIAL EQUIVALENCE TO
Empower is substantially equivalent to the legally marketed predicate device, the EC 2.7 Endoscopic Cutter (K120909). The subject device has the same intended use, indications for use and substantially the same technological characteristics.
The comparison table below, Table 1, presents side by side comparisons between both the devices. The table illustrates equivalence of the subject Empower RF Catheter to the predicate EC 2.7 Endoscopic Cutter.
| Device Name→
Device
Characteristics ↓ | Empower RF Catheter
(Subject Device) | EC 2.7 Endoscopic Cutter
(K120909)
(Predicate Device) | Differences |
|---------------------------------------------|-----------------------------------------|-------------------------------------------------------------|-------------|
| Device Classification | Class II | Class II | Same |
| Code of Federal
Regulations | 878.4400 | 878.4400 | Same |
| Prescription or OTC | Prescription | Prescription | Same |
| Device Type | Sterile, Single-Use | Sterile, Single-Use | Same |
| Table 1: Comparison of Kev Characteristics of Subject Device to the Predicate Device | |||||
|---|---|---|---|---|---|
5
| Device Name→
Device
Characteristics ↓ | Empower RF Catheter
(Subject Device) | EC 2.7 Endoscopic Cutter
(K120909)
(Predicate Device) | Differences |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | The Empower RF
Catheter is intended to
be inserted through the
working channel of a
flexible bronchoscope
and utilized in
electrosurgical
procedures involving
removal/cutting of soft
tissues (incision,
vaporization, ablation,
coagulation and
hemostasis). | The EC 2.7 Endoscopic
Cutter is intended to be
inserted through the
working channel of a
flexible bronchoscope
having an instrument
channel diameter of 2.8 mm
minimum, a working length
of 600 mm, activated by a
foot-switch connected to a
qualified electrosurgical
generator, and utilized in
electrosurgical procedures
involving removal/cutting
of soft tissues (excision,
incision, vaporization,
ablation) while also
providing electrosurgical
coagulation and hemostasis. | Same |
| Indications for use | The Empower RF
Catheter is a single-use,
electrosurgical device
designed to be used
with flexible
bronchoscopes. It is
indicated for
electrosurgical
procedures involving
soft tissue obstructions
in the upper airways
and tracheobronchial
tree. | The EC 2.7 Endoscopic
Cutter is a single use
electrosurgical instrument
designed to be used with
flexible bronchoscopes and
qualified electrosurgical
units. It is indicated for
cutting of soft tissue
obstructions in upper
airways and
tracheobronchial tree, and
provision of electrosurgical
hemostasis during such
procedures. | Same |
| Target Tissue | Soft Tissue obstructions
in the upper airways
and tracheobronchial
tree. | Soft Tissue obstructions in
the upper airways and
tracheobronchial tree. | Same |
| Access Method | Flexible Bronchoscope
with minimum working
channel of 2.0 mm | Flexible Bronchoscope with
minimum working channel
of 2.8 mm | Different,
discussion below |
| Energy Used | Monopolar RF | Monopolar RF | Same |
| Device Name→
Device
Characteristics ↓ | Empower RF Catheter
(Subject Device) | EC 2.7 Endoscopic Cutter
(K120909)
(Predicate Device) | Differences |
| Energy Source | Compatible
Electrosurgical
Generators | Compatible Electrosurgical
Generators | Same |
| Operating Principle | Uses heat delivered via
a distal tip electrode to
facilitate treatment
through thermal
necrosis | Uses heat delivered via a
distal tip electrode to
facilitate treatment through
thermal necrosis | Same |
| Operating Mode | Monopolar
configuration requires
patient return electrode | Monopolar configuration
requires patient return
electrode | Same |
| Device Components | Active electrode,
catheter shaft, electrical
connector | Active electrode, catheter
shaft, electrical connector. | Same |
| Active Electrode | Stainless steel tip | Similar biocompatible
electrode materials | Similar
biocompatible
materials; hence
equivalent |
| Catheter Shaft | Flexible shaft,
polymeric materials | Flexible shaft, polymeric
materials | Similar
biocompatible
materials; hence
equivalent |
| Electrical Connector | Banana Plug | Electrical adaptor | Similar electrical
port; hence
equivalent |
| Catheter Outer
Diameter (OD) | 1.8 mm | 2.68 mm | Different,
discussion below |
| Working Length | 1445 mm (minimum) | 750 mm | Different,
discussion below |
| Sterilization | E-Beam (SAL=10-6) | Ethylene Oxide (SAL=10-6) | Similar Sterility
Assurance Level;
hence equivalent |
[Broncus Medical, Inc.- EMPOWER RF Catheter- Traditional 510(k)]
6
[Broncus Medical, Inc.- EMPOWER RF Catheter-Traditional 510(k)]
A smaller OD (outer diameter) and a longer minimum working channel allows Empower to be used with a wide range of bronchoscopes and the longer working length allows greater flexibility and convenience during equipment setup and scope access. Since the difference between the subject and predicate device include minor differences in dimensional characteristics such as lengths and diameters, it does not alter the device's intended use or principle of operation. As such, these differences do not raise additional questions on safety and effectiveness, and therefore Empower RF Catheter is considered substantially equivalent to the predicate.
7
PERFORMANCE DATA
Performance testing has been completed to demonstrate substantial equivalence of the subject device to the predicate device. Empower was subjected to the following verification and validation tests, as applicable:
Biocompatibility
Biocompatibility verification was performed for patient contacting components of Empower in accordance with:
- -ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process
- -ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for In vitro cytotoxicity
- -ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
- -ISO 10993-11:2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
Sterilization and Shelf Life Testing
Empower was validated to achieve sterility assurance level of 10 and adopted into a validated Ebeam sterilization cycle. Packaging validation was performed to ensure that the device maintains package integrity, sterility and labeling requirements.
Sterilization validation was performed in accordance with:
- -AAMI TIR 33:2005 Sterilization of Health Care Products-Radiation- Substantiation of a selected sterilization dose - Method VDmax
- -ISO 11137-1:2006/Amd 2013 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- -ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- -ISO 11137-3:2006 Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
Electrical Safety Testing
Electrical safety testing was performed for the applicable components of Empower. The results demonstrated compliance to all applicable requirements of the below standards:
- -IEC 60601-1:2006 General requirements for basic safety and essential performance
- -IEC 60601-2-2:2009 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- -IEC 60601-2-18:2015 Particular requirements for the basic safety and essential performance of endoscopic equipment
8
Performance Bench Testing
The following performance bench tests were performed:
- -Tensile Testing
- Packaging Inspection -
- -Dimensional Inspection
- -Electrical Inspection
- -Simulated Use testing
- -Corrosion Resistance
- Radiopacity verification -
- -Scope Visualization
- Ex-vivo ablation testing -
Biocompatibility testing, sterilization and shelf life testing, electrical safety testing, and performance bench testing were performed on Empower. The results from this testing demonstrates that Empower meets the defined design requirements and supports its safety and effectiveness for its intended use and its substantial equivalence to the predicate device.
CONCLUSION
The Empower RF Catheter and the predicate device share intended use, indications for use, and performance characteristics. The minor differences in dimensional characteristics between the subject and the predicate device do not raise any new concerns of safety and effectiveness. Furthermore, the results of verification and validation demonstrate reasonable assurance of safety and effectiveness.
The data and information presented within this 510(k) premarket notification supports a determination of substantial equivalence to the predicate device, and market clearance of the Empower RF Catheter.