The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.

Device Description

The EasyPath RF Introducer Sheath is a sterile, single-use, monopolar endoscopic device intended to be inserted through the working channel of a flexible bronchoscope, with an inner diameter (ID) of 2.8 mm or greater, which provides an extended working channel through which endoscopic tools, such as needles, biopsy forceps, or other endoscopic devices may be introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.

The EasyPath has a flexible shaft with a 2.65 mm OD with braid reinforced tubing and a stylet, to resist kinking during device advancement and articulation. The stylet is used to provide an atraumatic tip and to provide rigidity (i.e., pushability). Removal of the stylet allows for standard 2.0 mm working channel bronchoscopic accessories to be inserted through the lumen of the sheath. The electrode tip of the sheath is visible, as well as the marker bands to provide the user with an indication of movement relative to the bronchoscope. Radiopaque markers are at the distal end of the sheath to aid visualization of the sheath under fluoroscopy, if utilized.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Broncus Medical EasyPath RF Introducer Sheath. It describes the device, its intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as typically seen for AI/software devices. Instead, it lists the types of testing performed to demonstrate that the device meets product specifications and is "safe and effective for its intended clinical use." The "reported device performance" is essentially that the device met the specifications for each test, thereby supporting substantial equivalence.

Acceptance Criteria Category (Type of Testing)	Reported Device Performance (Outcome)
Biocompatibility Testing	Passed (in accordance with ISO 10993-1:2018 for Cytotoxicity, Maximization Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, USP Pyrogen, Phthalates)
Sterilization Validation	Passed (in accordance with ISO 11135:2014 for Ethylene oxide sterilization, achieving a Sterility Assurance Level of 10^-6)
Packaging Verification and Shelf-Life Testing	Passed (in accordance with ISO 11607-1 and ASTM-1980)
Electrical Safety and EMC Safety Testing	Passed (in accordance with IEC 60601-1:2005 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-2:2017, BS EN 60601-2-18:2015)
Bench Performance Testing	Passed (including Packaging Inspection, Dimensional Inspection, Electrical Inspection, Visible Market Band Inspection, Simulated Use testing, Tensile Testing, Ex-vivo RF Application Testing, Corrosion Resistance, Radiopacity Verification, Scope Visualization, Leak Resistance)
In vivo Porcine Lung Thermal Testing	Passed (demonstrated thermal effects in living tissue under simulated use conditions)

2. Sample Size Used for the Test Set and Data Provenance

The document describes various engineering and biological tests, not a clinical study with a "test set" of patient data in the context of AI performance.

Sample Sizes: Not specified for individual bench or in vivo tests. However, typical regulatory submissions for devices like this involve a sufficient number of samples to ensure statistical significance for each test.
Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of this device type. The tests are laboratory-based (bench, in vitro, in vivo animal model) and conducted by the manufacturer or contracted labs as part of the design verification process. The in vivo testing was conducted on porcine lungs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this device type. There is no "ground truth" to be established by human experts in a diagnostic sense for this electrosurgical introducer sheath. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards through the described testing.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of a "test set" requiring adjudication by human readers for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI device or a diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (introducer sheath) with an electrosurgical function, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

Engineering Specifications: The device's physical dimensions, material properties, electrical characteristics, and functional performance must meet predefined design specifications.
Regulatory Standards: Compliance with recognized international and national standards (e.g., ISO, IEC, ASTM) for biocompatibility, sterilization, electrical safety, and packaging.
Bench Test Results: Direct measurement and observation of device performance under controlled laboratory conditions.
In-vivo Animal Model Data: Functional and thermal effects demonstrated in living biological tissue (porcine lung).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for this type of medical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set."

Summary

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January 14, 2021

Broncus Medical, Inc Robin Bush VP, Regulatory Affairs and Quality Assurance 125 Nicholson Lane San Jose, California 95134

Re: K200702

Trade/Device Name: EasyPath RF Introducer Sheath Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, EOQ Dated: December 21, 2020 Received: December 23, 2020

Dear Robin Bush:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200702

Device Name

EasyPath RF Introducer Sheath

Indications for Use (Describe)

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

l. DATE PREPARED

December 11, 2020

ll. 510(k) SUBMITTER

Broncus Medical, Inc. 125 Nicholson Lane San Jose, CA 95134

Robin Bush, VP Regulatory Affairs and Quality Assurance Contact Person: 650-428-1600 x 348

lll. DEVICE

Trade Name of Device:	EasyPath RF Introducer Sheath (Model 10011)
Device Class:	Class II
Classification Name:	Bronchoscope (Flexible and Rigid) and Accessories /
	Electrosurgical cutting and coagulation device and accessories
Regulation Number:	21 CFR 878.4400
Product Code:	GEI (Primary)
	EOQ (Secondary)

IV. PREDICATE DEVICES

Multiple Predicate Device Information:

Primary Predicate Device	Manufacturer	510(k)#	Clearance Date
Empower RF Catheter	Broncus Medical, Inc.	K183240	February 22, 2019
Secondary Predicate Device	Manufacturer	510(k)#	Clearance Date
Archimedes Sheath (current commercial name)[Cleared as LungPoint Tools: LungPoint Sheath and LungPoint Dilation Balloon]	Broncus Medical, Inc.	K131234	October 15, 2013

V. DEVICE DESCRIPTION

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introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.

VI. INDICATIONS FOR USE

VII. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE

The EasyPath RF Introducer Sheath is substantially equivalent to legally marketed predicate devices. The EasyPath RF Introducer Sheath is substantially equivalent in intended use, indications for use, technological characteristics and principles of operation to the Broncus Empower RF Catheter and the Broncus Archimedes Sheath and, cleared by FDA in K183240 and K131234, respectively.

The EasyPath Introducer Sheath is substantially equivalent to multiple predicate devices. The EasyPath RF Introducer Sheath has the same intended use and combines the indications for use, technological features and functions of the Broncus Empower RF Catheter (K183240), as well as the Broncus Archimedes Sheath (K131234; cleared as the LungPoint Tools: LungPoint Sheath, LungPoint Dilation Balloon). These devices are all intended for use during interventional bronchoscopy procedures involving soft tissue in the upper airways and tracheobronchial tree, as determined by the physician performing the bronchoscopy. Similar to the Empower RF Catheter, the EasyPath combines the features of an RF electrode to enable physicians to cut target tissue via RF energy, as well as the features and functions of an introducer sheath with working channel, similar to the cleared Archimedes Sheath. Similar to the predicate devices, the EasyPath is designed to be used with flexible bronchoscopes of 2.8 mm or greater in the upper airways and tracheobronchial tree, allowing introduction of endoscopic tools for use at target sites.

Key technological characteristics of the EasyPath Introducer RF Sheath are compared to the predicate devices in the following table. The table illustrates equivalence of the subject EasyPath RF Introducer Sheath to the primary and secondary predicate devices, Empower (K183240) and Archimedes Sheath (K131234). A discussion regarding any technological differences in the subject device (EasyPath RF Introducer Sheath), when compared to the predicate devices, is provided below the table.

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Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RFIntroducer SheathSubject Device	Primary PredicateEmpower RFCatheter(Empower)K183240	SecondaryPredicateArchimedesSheath(aka LungPointTools/Sheath)K131234	Differences(Justification forEquivalency)
Intended Use	Intended for use ininterventionalbronchoscopyprocedures involvingsoft tissue of theupper airways andtracheobronchialtree.Introduced through aflexiblebronchoscope,facilitates siteaccess, and use ofother endoscopicsurgical devices.	Intended for use ininterventionalbronchoscopyprocedures involvingremoval/cutting(incision,vaporization,ablation, coagulationand hemostasis) ofsoft tissues of theupper airways andtracheobronchialtree.Introduced through aflexiblebronchoscope.	Intended for use ininterventionalbronchoscopyprocedures involvingsoft tissue of thebronchial tree.Introduced through aflexiblebronchoscope,facilitates siteaccess and use ofother endoscopicsurgical devices.	Same intendeduse therefore,equivalent
Indications forUse	The EasyPath RFIntroducer Sheath isa single-use deviceintended to be usedwith flexiblebronchoscopes as aworking channelthrough whichendoscopic toolsmay be introducedto target tissue.It is indicated forelectrosurgicalprocedures involvingcutting andcoagulation of softtissue in the upperairways andtracheobronchialtree.	The Empower RFCatheter is a single-use, electrosurgicaldevice designed tobe used with flexiblebronchoscopes.It is indicated forelectrosurgicalprocedures involvingsoft tissueobstructions in theupper airways andtracheobronchialtree.	The LungPoint Toolsare endoscopic toolsintended to be usedwith LungPointSoftware guidedbronchoscopes.The LungPointSheath is intendedto be used as aworking channelthrough whichendoscopic toolsmay be introducedto targeted tissue ordirectly through theworking channel ofthe bronchoscope.	The EasyPath andEmpower areindicated forelectrosurgicalproceduresinvolving soft tissuein the upperairways andtracheobronchialtree.The EasyPath andArchimedesSheath, areworking channelsthrough whichendoscopic toolsmay be introducedto targeted tissue.Same combinedindications foruse in the sameanatomy;therefore,equivalent.
Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RFIntroducer SheathSubject Device	Primary PredicateEmpower RFCatheter(Empower)K183240	SecondaryPredicateArchimedesSheath(aka LungPointTools/Sheath)K131234	Differences(Justification forEquivalency)
User	Qualified physicians:Interventionalpulmonologists,thoracic surgeons,and pulmonarytechnologists	Qualified physicians:Interventionalpulmonologists,thoracic surgeons,and pulmonarytechnologists	Qualified physicians:Interventionalpulmonologists,thoracic surgeons,and pulmonarytechnologists	Same, therefore,equivalent.
Method ofIntroduction	Flexiblebronchoscope withminimum workingchannel of 2.8mm	Flexiblebronchoscope orminimum workingchannel of 2.0mm	Flexiblebronchoscope with aminimum workingchannel of 2.8mm	Introduced throughflexiblebronchoscopes; theOD diameter ofEasyPath is thesame as theArchimedes Sheathto allow the smallerOD treatmentdevices (such asthe Empower) topass through theSheaths.Similar, therefore,equivalent.
DeliveryApproach	Visual (viabronchoscope);Optional - virtualbronchoscopicnavigation system	Visual (viabronchoscope);Optional - virtualbronchoscopicnavigation system	Visual (viabronchoscope);Optional - virtualbronchoscopicnavigation system	Same, therefore,equivalent.
Target Tissue	Soft tissue in theupper airways andtracheobronchialtree	Soft tissueobstructions in theupper airways andtracheobronchialtree	Soft tissue in theupper airways andtracheobronchialtree	Same, therefore,equivalent.
Tip Type	Blunt atraumatic tip	Ball point (blunt)	Blunt atraumatic tip	Similar atraumatictip shapes;therefore,equivalent.
Catheter OD	2.65 mm	1.8 mm	2.65 mm	Similar to Empowerand Identical toArchimedes; fitthrough a 2.8 mmflexiblebronchoscope.Similar OD;therefore,equivalent.
Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RFIntroducer SheathSubject Device	Primary PredicateEmpower RFCatheter(Empower)K183240	SecondaryPredicateArchimedesSheath(aka LungPointTools/Sheath)K131234	Differences(Justification forEquivalency)
Working Length	900 mm	1445 mm	900 mm	EasyPath andArchimedes havethe same workinglength.The longer workinglength of theEmpower allows itto extend throughthe end of theworking sheaths.Same asArchimedesSheath; less thanEmpower;therefore,equivalent.
RadiopaqueMarkers	Yes	Yes	Yes	Same
Energy Used	Monopolar RFenergy	Monopolar RFenergy	Not applicable	Same
Energy Source	Commerciallyavailable, compatibleelectrosurgical units	Commerciallyavailable, compatibleelectrosurgical units	Not applicable	Same
GeneratorPower Setting	10-75W	7- 50W	Not applicable	Power settingstypically used areless than maximum.Performance testingwas performed atmaximum settings.Similar; therefore,equivalent.
Applied RFTime andGeneratorEffect Setting	Activate until desiredtissue effect isachieved, generally1-3 seconds	Activate until desiredtissue effect isachieved, generally<30 minutes	Not applicable	Adjustable power,effect setting, andtime.Similar toEmpower;therefore,equivalent.
ElectrodeMaterial	Platinum Iridium	Stainless Steel	Not applicable	Similar; therefore,equivalent
Single Use	Yes	Yes	Yes	Same
Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RFIntroducer SheathSubject Device	Primary PredicateEmpower RFCatheter(Empower)K183240	SecondaryPredicateArchimedesSheath(aka LungPointTools/Sheath)K131234	Differences(Justification forEquivalency)
PackagingMaterials	Pouch: Tyvek /polyethylene	Pouch: Tyvek /polyethylene	Pouch: Tyvek /polyethylene	Same
SterilizationMethod	Ethylene Oxide	E-beam	E-beam	StandardsterilizationmethodsSimilar; therefore,equivalent
SterilityAssuranceLevel	$10^{-6}$	$10^{-6}$	$10^{-6}$	Same

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As presented above, the larger OD (outer diameter) of 2.65 mm and a shorter minimum working channel (900 mm) of the EasyPath allows bronchoscopic devices of smaller OD and longer length, such as the Empower Catheter, to be introduced through the EasyPath Sheath and extend through the end of the device to reach distal regions of the tracheobronchial tree. The devices are designed for to be used with a wide range of bronchoscopes with a minimum diameter of 2.8 mm. EasyPath and Archimedes have the same working length.

Recommended power settings for the generator vary depending on use. The RF application time for EasyPath is seconds, compared to minutes for Empower RF Catheter. Verification and performance data confirm the time and settings for the devices; these differences do not affect product performance, and do not raise new issues of safety or effectiveness. The instructions for use for EasyPath and Empower include statements to use the lowest power and effect setting to achieve the desired tissue effect.

Sterilization methods used are standard methods of sterilization for medical devices. The same test methods, shelf life, accelerated aging and performance testing were used to confirm the EasyPath RF Introducer Sheath meets specifications at the end of shelf-life. The different sterilization method has no impact on biocompatibility, sterility assurance level or product performance.

The minor differences in dimensional characteristics, such as length and diameter, between the subject and predicate device, does not affect the device's intended use or principles of operation. As such, these differences do not raise additional questions on safety and effectiveness; therefore. the EasyPath RF Introducer Sheath is substantially equivalent to the predicate devices.

VIII. PERFORMANCE DATA

Design verification testing was performed for the EasyPath RF Introducer Sheath to demonstrate that the device meets product specifications and is safe and effective for its intended clinical use. As applicable, design verification testing was performed according to recognized standards. The following testing was provided for the subject 510(k) and supports the substantial equivalence of the EasyPath RF Introducer Sheath to the predicate devices:

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Biocompatibility Testing; in accordance with ISO 10993-1:2018. Biological evaluation of ● medical devices - Part 1: Evaluation and testing within a risk management process
- O Cytotoxicity
- Maximization Sensitization o
- Intracutaneous Irritation o
- Acute Systemic Toxicity O
- USP Pyrogen O
- o Phthalates
Sterilization Validation; in accordance with ISO 11135:2014, Sterilization of health-care ● products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
. Packaging Verification and Shelf-Life Testing; in accordance with ISO 11607-1 and ASTM-1980
Electrical Safety and EMC Safety Testing, in accordance with:
- IEC 60601-1:2005 and A1:2012. Medical electrical equipment Part 1: General O requirements for basic safety and essential performance
- IEC 60601-1-2:2014, General requirements for basic safety and essential o performance - collateral standard: electromagnetic compatibility - rRequirements and tests
- IEC 60601-2-2:2017, Particular requirements for the basic safety and essential O performance of high frequency surgical equipment and high frequency surgical accessories
- BS EN 60601-2-18:2015, Particular requirements for the basic safety and essential O performance of endoscopic equipment
Bench Performance Testing: ●
- Packaging Inspection
- Dimensional Inspection
- -Electrical Inspection
- -Visible Market Band Inspection
- Simulated Use testing
- Tensile Testing
- Ex-vivo RF Application Testing
- Corrosion Resistance
- -Radiopacity Verification
- -Scope Visualization
- Leak Resistance
In vivo Porcine Lung Thermal Testing

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IX. CONCLUSIONS

The EasyPath RF Introducer Sheath share the same intended use, and combined indications for use and technological features as the cleared Empower RF Catheter (K183240) and Archimedes Sheath (K131234). It is substantially equivalent in intended use / indications for use, as well as technological characteristics and principles of operation to the predicate devices. The minor differences in dimensions or characteristics between the subject and the predicate devices do not raise new concerns of safety and effectiveness.

Design verification testing included biocompatibility, sterilization, packaging and shelf life studies, electrical, and thermal safety, as well as performance and in vivo testing. The results of verification and validation demonstrate reasonable assurance of safety and effectiveness.

The data and information provided within this premarket notification demonstrates that EasyPath RF Introducer Sheath is safe and effective for its intended clinical use and does not introduce or raise new questions of safety and effectiveness, The EasyPath RF Introducer Sheath is as safe, as effective and performs as well as the predicate devices, is substantially equivalent to the predicate devices, thereby supporting a determination of substantial equivalence.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.