(94 days)
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 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.
The provided text describes a 510(k) premarket notification for the "Empower RF Catheter," an electrosurgical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the "EC 2.7 Endoscopic Cutter (K120909)," through comparative analysis and performance testing.
It is important to note that this document does not describe a study involving an AI-based device or a multi-reader, multi-case (MRMC) study. Therefore, several of the requested sections related to AI performance, sample sizes for AI training/testing, ground truth establishment for AI, expert qualifications, and human reader performance improvement with AI assistance cannot be extracted from this text.
The acceptance criteria and performance data provided are for a medical device (an RF catheter), demonstrating its safety and effectiveness through well-established engineering and biological testing standards, rather than clinical efficacy studies or AI performance metrics.
Here's an analysis of the provided text based on the request, focusing on the information that is present:
Device: Empower RF Catheter (Electrosurgical Device)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a quantitative table format suitable for a direct "acceptance criteria vs. reported performance" comparison. Instead, it describes various tests performed to ensure the device meets design requirements and standards. The "performance data" section lists the types of tests conducted, implying that the device "meets" the requirements of these tests.
Therefore, a direct table of acceptance criteria and reported device performance as typically seen for AI device metrics (e.g., sensitivity, specificity thresholds) cannot be constructed from this document. The performance is demonstrated by compliance with the referenced standards and successful completion of the listed tests.
| Acceptance Criterion (Implied by Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility | Compliant with ISO 10993-1, -5, -10, -11 |
| Sterility Assurance Level (SAL) | Achieved SAL of 10^-6 via validated E-beam sterilization |
| Packaging Integrity | Maintained package integrity, sterility, and labeling |
| Electrical Safety | Compliant with IEC 60601-1, -2-2, -2-18 |
| Tensile Strength | (Performed) - Result implied as satisfactory |
| Dimensional Accuracy | (Performed and noted minor differences from predicate) - Result implied as satisfactory |
| Electrical Integrity | (Performed) - Result implied as satisfactory |
| Simulated Use | (Performed) - Result implied as satisfactory |
| Corrosion Resistance | (Performed) - Result implied as satisfactory |
| Radiopacity | (Verified) - Result implied as satisfactory |
| Scope Visualization | (Performed) - Result implied as satisfactory |
| Ex-vivo ablation | (Performed) - Result implied as satisfactory |
Note: The document only states that these tests were "performed" and that the results "demonstrate that Empower meets the defined design requirements and supports its safety and effectiveness." Specific quantitative results for each test (e.g., exact tensile strength values, specific electrical leakage currents) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document describes engineering and biological performance testing for a physical medical device, not a data-driven AI model. Therefore, the concept of a "test set" in the context of AI models (e.g., a set of medical images) does not apply here.
- Sample Size for Testing: The document does not specify exact sample sizes for each type of bench or biological test (e.g., how many catheters were subjected to tensile testing, or how many biological samples were used for biocompatibility). This information is typically found in detailed test protocols, not summary documents.
- Data Provenance: Not applicable in the context of a medical device's physical and biological performance testing. The "data" are generated from laboratory and bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is not an AI model requiring experts to establish ground truth for image interpretation or diagnosis. The "ground truth" for a physical device's performance is established by scientific and engineering standards and validated test methods.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of human interpretation or AI output requiring adjudication. Performance is measured against engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document pertains to regulatory clearance for a physical medical device, not a diagnostic AI system or a system requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical electrosurgical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing of the Empower RF Catheter, the "ground truth" is based on:
- Compliance with recognized international and national standards: e.g., ISO 10993 series for biocompatibility, AAMI TIR 33, ISO 11137 series for sterilization, IEC 60601 series for electrical safety.
- Established engineering principles and test methodologies: For bench tests like tensile testing, dimensional inspection, corrosion resistance, and ex-vivo ablation.
- Defined design requirements: The document states that testing demonstrated the device "meets the defined design requirements."
8. The Sample Size for the Training Set
Not applicable. This is not an AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device.
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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
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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
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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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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 LaneSan Jose, CA 95134 |
|---|---|
| PRIMARY CONTACT | Aradhana DhanabalanRegulatory Affairs ManagerBroncus Medical, Inc.Phone: 650-428-1600 Ext.311Email: adhanabalan@broncus.com |
| SECONDARY CONTACT | Liz RaphaelSenior Regulatory Affairs ManagerBroncus Medical, Inc.Phone: 408-728-1037Email: 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.
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[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→DeviceCharacteristics ↓ | Empower RF Catheter(Subject Device) | EC 2.7 Endoscopic Cutter(K120909)(Predicate Device) | Differences |
|---|---|---|---|
| Device Classification | Class II | Class II | Same |
| Code of FederalRegulations | 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 | |||||
|---|---|---|---|---|---|
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| Device Name→DeviceCharacteristics ↓ | Empower RF Catheter(Subject Device) | EC 2.7 Endoscopic Cutter(K120909)(Predicate Device) | Differences |
|---|---|---|---|
| Intended Use | The Empower RFCatheter is intended tobe inserted through theworking channel of aflexible bronchoscopeand utilized inelectrosurgicalprocedures involvingremoval/cutting of softtissues (incision,vaporization, ablation,coagulation andhemostasis). | The EC 2.7 EndoscopicCutter is intended to beinserted through theworking channel of aflexible bronchoscopehaving an instrumentchannel diameter of 2.8 mmminimum, a working lengthof 600 mm, activated by afoot-switch connected to aqualified electrosurgicalgenerator, and utilized inelectrosurgical proceduresinvolving removal/cuttingof soft tissues (excision,incision, vaporization,ablation) while alsoproviding electrosurgicalcoagulation and hemostasis. | Same |
| Indications for use | The Empower RFCatheter is a single-use,electrosurgical devicedesigned to be usedwith flexiblebronchoscopes. It isindicated forelectrosurgicalprocedures involvingsoft tissue obstructionsin the upper airwaysand tracheobronchialtree. | The EC 2.7 EndoscopicCutter is a single useelectrosurgical instrumentdesigned to be used withflexible bronchoscopes andqualified electrosurgicalunits. It is indicated forcutting of soft tissueobstructions in upperairways andtracheobronchial tree, andprovision of electrosurgicalhemostasis during suchprocedures. | Same |
| Target Tissue | Soft Tissue obstructionsin the upper airwaysand tracheobronchialtree. | Soft Tissue obstructions inthe upper airways andtracheobronchial tree. | Same |
| Access Method | Flexible Bronchoscopewith minimum workingchannel of 2.0 mm | Flexible Bronchoscope withminimum working channelof 2.8 mm | Different,discussion below |
| Energy Used | Monopolar RF | Monopolar RF | Same |
| Device Name→DeviceCharacteristics ↓ | Empower RF Catheter(Subject Device) | EC 2.7 Endoscopic Cutter(K120909)(Predicate Device) | Differences |
| Energy Source | CompatibleElectrosurgicalGenerators | Compatible ElectrosurgicalGenerators | Same |
| Operating Principle | Uses heat delivered viaa distal tip electrode tofacilitate treatmentthrough thermalnecrosis | Uses heat delivered via adistal tip electrode tofacilitate treatment throughthermal necrosis | Same |
| Operating Mode | Monopolarconfiguration requirespatient return electrode | Monopolar configurationrequires patient returnelectrode | Same |
| Device Components | Active electrode,catheter shaft, electricalconnector | Active electrode, cathetershaft, electrical connector. | Same |
| Active Electrode | Stainless steel tip | Similar biocompatibleelectrode materials | Similarbiocompatiblematerials; henceequivalent |
| Catheter Shaft | Flexible shaft,polymeric materials | Flexible shaft, polymericmaterials | Similarbiocompatiblematerials; henceequivalent |
| Electrical Connector | Banana Plug | Electrical adaptor | Similar electricalport; henceequivalent |
| Catheter OuterDiameter (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 SterilityAssurance Level;hence equivalent |
[Broncus Medical, Inc.- EMPOWER RF Catheter- Traditional 510(k)]
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[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.
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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
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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.
§ 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.