Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (introducer sheath) for delivering RF energy and facilitating access for other tools. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical and electrical properties, not algorithmic performance.

Therapeutic

Yes.
The device is intended for electrosurgical procedures involving cutting and coagulation of soft tissue, which are therapeutic interventions.

Diagnostic

No

The device is an RF Introducer Sheath intended for electrosurgical procedures involving cutting and coagulation of soft tissue, functioning as a working channel for endoscopic tools and delivering RF energy for therapeutic purposes, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, single-use medical device with a flexible shaft, electrode tip, stylet, and radiopaque markers. It also details extensive hardware-related testing (biocompatibility, sterilization, electrical safety, bench performance, in vivo testing). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, the EasyPath RF Introducer Sheath is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states it's for use with flexible bronchoscopes as a working channel and for electrosurgical procedures involving cutting and coagulation of soft tissue in the body (upper airways and tracheobronchial tree). IVD devices are used to examine specimens outside the body to provide information for diagnosis, monitoring, or screening.
Device Description: The description details a physical device inserted into the body for surgical procedures, not a reagent, instrument, or system used to test biological samples.
Anatomical Site: The device is used within the upper airways and tracheobronchial tree, which are internal anatomical sites. IVD devices analyze samples taken from the body.
Performance Studies: The performance studies focus on the physical and electrical performance of the device itself, as well as its interaction with tissue in vivo (porcine lung thermal testing). IVD performance studies would involve evaluating the accuracy and reliability of tests performed on biological samples.

In summary, the EasyPath RF Introducer Sheath is a surgical device used for electrosurgical procedures within the body, not a device used for testing biological samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

GEI, EOQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper airways and tracheobronchial tree

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physicians: Interventional pulmonologists, thoracic surgeons, and pulmonary technologists

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)

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. 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:

Biocompatibility Testing; in accordance with ISO 10993-1:2018. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Tests included Cytotoxicity, Maximization Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, USP Pyrogen, 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 requirements for basic safety and essential performance.
- IEC 60601-1-2:2014, General requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - rRequirements and tests.
- IEC 60601-2-2:2017, Particular requirements for the basic safety and essential 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 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

The results of verification and validation demonstrate reasonable assurance of safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K183240, K131234

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

1

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)

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.

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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Image /page/3/Picture/0 description: The image contains the logo for Broncus Medical. The logo features a stylized, partial yellow circle above the word "BRONCUS" in blue, sans-serif font. The circle appears to be an arc, positioned above and slightly behind the text, giving the logo a modern and clean look.

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

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

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Image /page/4/Picture/0 description: The image contains the logo for Broncus Medical. The logo features a yellow arc above the word "BRONCUS" in blue. The arc starts above the "B" and ends above the "S" in Broncus. The font is sans-serif and the color is a vibrant blue.

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.

VI. INDICATIONS FOR USE

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.

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 RF
Introducer Sheath
Subject Device	Primary Predicate
Empower RF
Catheter
(Empower)
K183240	Secondary
Predicate
Archimedes
Sheath
(aka LungPoint
Tools/Sheath)
K131234	Differences
(Justification for
Equivalency)
Intended Use	Intended for use in
interventional
bronchoscopy
procedures involving
soft tissue of the
upper airways and
tracheobronchial
tree.
Introduced through a
flexible
bronchoscope,
facilitates site
access, and use of
other endoscopic
surgical devices.	Intended for use in
interventional
bronchoscopy
procedures involving
removal/cutting
(incision,
vaporization,
ablation, coagulation
and hemostasis) of
soft tissues of the
upper airways and
tracheobronchial
tree.
Introduced through a
flexible
bronchoscope.	Intended for use in
interventional
bronchoscopy
procedures involving
soft tissue of the
bronchial tree.
Introduced through a
flexible
bronchoscope,
facilitates site
access and use of
other endoscopic
surgical devices.	Same intended
use therefore,
equivalent
Indications for
Use	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.	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 LungPoint Tools
are endoscopic tools
intended to be used
with LungPoint
Software guided
bronchoscopes.
The LungPoint
Sheath is intended
to be used as a
working channel
through which
endoscopic tools
may be introduced
to targeted tissue or
directly through the
working channel of
the bronchoscope.	The EasyPath and
Empower are
indicated for
electrosurgical
procedures
involving soft tissue
in the upper
airways and
tracheobronchial
tree.
The EasyPath and
Archimedes
Sheath, are
working channels
through which
endoscopic tools
may be introduced
to targeted tissue.
Same combined
indications for
use in the same
anatomy;
therefore,
equivalent.
Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RF
Introducer Sheath
Subject Device	Primary Predicate
Empower RF
Catheter
(Empower)
K183240	Secondary
Predicate
Archimedes
Sheath
(aka LungPoint
Tools/Sheath)
K131234	Differences
(Justification for
Equivalency)
User	Qualified physicians:
Interventional
pulmonologists,
thoracic surgeons,
and pulmonary
technologists	Qualified physicians:
Interventional
pulmonologists,
thoracic surgeons,
and pulmonary
technologists	Qualified physicians:
Interventional
pulmonologists,
thoracic surgeons,
and pulmonary
technologists	Same, therefore,
equivalent.
Method of
Introduction	Flexible
bronchoscope with
minimum working
channel of 2.8mm	Flexible
bronchoscope or
minimum working
channel of 2.0mm	Flexible
bronchoscope with a
minimum working
channel of 2.8mm	Introduced through
flexible
bronchoscopes; the
OD diameter of
EasyPath is the
same as the
Archimedes Sheath
to allow the smaller
OD treatment
devices (such as
the Empower) to
pass through the
Sheaths.
Similar, therefore,
equivalent.
Delivery
Approach	Visual (via
bronchoscope);
Optional - virtual
bronchoscopic
navigation system	Visual (via
bronchoscope);
Optional - virtual
bronchoscopic
navigation system	Visual (via
bronchoscope);
Optional - virtual
bronchoscopic
navigation system	Same, therefore,
equivalent.
Target Tissue	Soft tissue in the
upper airways and
tracheobronchial
tree	Soft tissue
obstructions in the
upper airways and
tracheobronchial
tree	Soft tissue in the
upper airways and
tracheobronchial
tree	Same, therefore,
equivalent.
Tip Type	Blunt atraumatic tip	Ball point (blunt)	Blunt atraumatic tip	Similar atraumatic
tip shapes;
therefore,
equivalent.
Catheter OD	2.65 mm	1.8 mm	2.65 mm	Similar to Empower
and Identical to
Archimedes; fit
through a 2.8 mm
flexible
bronchoscope.
Similar OD;
therefore,
equivalent.
Substantial Equivalence Comparison of Key Technological Characteristics
Feature	EasyPath RF
Introducer Sheath
Subject Device	Primary Predicate
Empower RF
Catheter
(Empower)
K183240	Secondary
Predicate
Archimedes
Sheath
(aka LungPoint
Tools/Sheath)
K131234	Differences
(Justification for
Equivalency)
Working Length	900 mm	1445 mm	900 mm	EasyPath and
Archimedes have
the same working
length.

The longer working
length of the
Empower allows it
to extend through
the end of the
working sheaths.

Performance testing
was performed at
maximum settings.

Similar; therefore,
equivalent. |
| Applied RF
Time and
Generator
Effect Setting | Activate until desired
tissue effect is
achieved, generally
1-3 seconds | Activate until desired
tissue effect is
achieved, generally