The CrossCountry™ Transbronchial Access Tool is to be utilized through a flexible endoscope with an extended working channel by physicians who are trained in endoscopic techniques to puncture the tracheobronchial wall and facilitate access of additional endobronchial tools for patients with endobronchial lesions, peripheral lung nodules, or lung masses.

Device Description

The CrossCountry™ transbronchial access tool (CrossCountry Tool) is a flexible endobronchial tool made up of two components: a wire and a catheter. The wire is used inside of the catheter. The product is used through a flexible endoscope with an extended working channel. The CrossCountry tool is designed to puncture a hole in the tracheobronchial wall then, using the catheter to dilate the channel, allows for subsequent endoscopic tool placement. This allows for access to lesions without a bronchus sign (outside the airways). The product is packaged in a Tyvek™ pouch and sterilized with ethylene oxide.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CrossCountry™ Transbronchial Access Tool. It includes information about the device's characteristics, comparison to predicate devices, and performance data from various tests, including an animal study. However, it does not explicitly state acceptance criteria in a quantitative or categorized manner, nor does it provide detailed numerical results for device performance against specific criteria.

Based on the available information, here's an attempt to answer your questions, with significant limitations due to the lack of specific numerical data for acceptance criteria and device performance:

1. A table of acceptance criteria and the reported device performance

The document mentions that an animal study was conducted and that "All of the acceptance criteria were met." However, it does not specify what those criteria were or provide quantitative results for how the device performed against them. Therefore, a table with specific criteria and performance cannot be created from the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "A preclinical study was conducted using the CrossCountry access tool on one side of the lung and a control device on the opposite side of the lung." This implies a sample size of at least one animal, with the device tested on one side and a control on the other. The exact number of animals is not specified beyond "one" for the study description itself, though it could be interpreted as at least one animal was used with the device tested in one lung and a control in the other.
Data Provenance: Not specified. It's an animal study, which is typically prospective in nature. The country of origin of the data is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document discusses an animal study, not a study involving human experts establishing ground truth for imaging or clinical diagnosis. The "ground truth" in this context would likely be based on the physical outcome of the procedure in the animal model (e.g., successful puncture, dilation, and access).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept typically applies to human reader studies where there are disagreements in interpretation. For an animal study evaluating device function, adjudication methods like 2+1 or 3+1 are not relevant. The assessment of study outcomes would likely be performed by the researchers conducting the experiment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not mention an MRMC comparative effectiveness study, nor does it involve AI assistance. The device is a physical tool, not an AI diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument requiring human intervention, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal study, the "ground truth" would be outcomes data related to the device's mechanical function, such as:

Successful puncture of the tracheobronchial wall.
Successful dilation of the created channel.
Ability to facilitate access for additional endobronchial tools.
Absence of significant adverse events or damage in the animal model.

This is inferred from the statement "This study showed the CrossCountry access tool design meets its intended use."

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model that requires a training set. The various verification and validation tests (Biocompatibility, Design, Animal Study) are for device performance and safety, not for training an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2015

Covidien Ilc Deborah Fleetham Regulatory Affairs Manager 161 Cheshire Lane, Suite 100 Plymouth, MN 55441

Re: K142934

Trade/Device Name: CrossCountryTM Transbronchial Access Tool Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOO Dated: May 15, 2015 Received: May 18, 2015

Dear Ms. Fleetham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K142934

Device Name: The CrossCountry™ Transbronchial Access Tool

Indications for Use:

Prescription Use X AND / OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 7 510(k) Summary

The 510(k) Summary for the CrossCountry™ transbronchial access tool is included on the following page.

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510(k) Summary Covidien llc. Traditional 510(k) CrossCountry™ Transbronchial Access Tool

I. Submitter

Covidien llc 161 Cheshire Lane Suite 100 Plymouth, MN 55441 U.S.A.

Contact Person: Deborah Fleetham, Manager Regulatory Affairs Ph: 763-210-4091 Fax: 763-210-4098 Email : deborah.fleetham@covidien.com Date Prepared : June 12, 2015:

II. DEVICE

Trade Name :	CrossCountry™ Transbronchial Access Tool
Common Name:	Endoscopic Tool
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	21 CFR 874.4680
Product code:	EOQ

III. PREDICATE DEVICE(S)

Primary Predicate:	LungPoint Tools (LungPoint Sheath and LungPoint DilationBalloon) K131234
Common Name:	Sheath and Dilation Balloon
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	21 CFR 874.4680
Product code:	EOQ
Secondary Predicate:	Wang Transbronchial Aspiration Needle – K914181
Common Name:	Transbronchial Needle
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	21 CFR 874.4680
Product code:	EOQ

Primary Predicate: LungPoint Tools (LungPoint Sheath and LungPoint Dilation Balloon) - K131234

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Secondary Predicate: Wang Transbronchial Aspiration Needle - K914181

No additional reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The product is packaged in a Tyvek™1 pouch and sterilized with ethylene oxide.

V. INDICATION FOR USE

The CrossCountry™ transbronchial access tool is to be utilized through a flexible endoscope with an extended working channel by physicians who are trained in endoscopic techniques to puncture the tracheobronchial wall and facilitate access of additional endobronchial tools for patients with endobronchial lesions, peripheral lung nodules, or lung masses.

VI. SUMMARY OF CHARACTERISTICS COMPARED TO PREDICATE DEVICE

Transbronchial endoscopic techniques are the foundation for the CrossCountry tool and both the primary and secondary predicate. All of these tools are intended to access lung lesions. At a high level, the subject and predicate devices are based on the following technological elements:

. All are introduced endoscopically and used to reach the target lung tissue
Each device is inserted through a channel which can be a bronchoscope or other . working channel.
. All are transient devices intended for short-term introduction through a naturally occurring orifice.
The CrossCountry tool and the Wang Transbronchial Aspiration Needle have . sharp distal ends to puncture the tracheobronchial wall.

See table below for a detailed summary of the characteristics compared to the predicate device.

T Trademark of its respective owner

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Characteristic	CrossCountry Tool	Broncus Medical Inc.Lungpoint Tools(Primary Predicate)K131234	Wang TransbronchialAspiration Needle(Secondary Predicate)K914181
Device Classification	Class II	Class II	Class II
FDA Product Code	EOQ	EOQ	EOQ
Technological Characteristics
Components	Wire and Catheter	LungPoint Sheath andLungPoint Balloon	Transbronchial AspirationNeedle
Single Use	Yes	Yes	Yes
Anatomical Location	Lung	Lung	Lung
Introduction into thebody	Endobronchial	Endobronchial	Endobronchial
Sharp Distal Tip	Yes - Wire	Not known	Yes - Needle
Radiopaque distal end	Yes	Yes	Yes
Dilation Ability	Yes	Yes	No
Dilation Mechanism	Mechanical	Pneumatic	None
Working OuterDiameter	Catheter OD: 2.01mmWire OD: 0.66mm	Sheath - 2.65 mmBalloon: 1 mm(uninflated)4 mm (inflated)	Tip OD: 1.9 mm
Working Length	Catheter: 109.9 cmWire: 116.1 cm	Sheath: 90 cmBalloon: 97.5 cm	130 cm
Tip Diameter	Catheter: Tapers down toslightly larger than thewire - Wire: 0.41mm	Not applicable	22 gauge needle(0.028 in / 0.71mm)
Material
Working OuterMaterial	Polymer – CopolyesterElastomerBraid - 304 StainlessSteel	Not Known	PTFE
Wire TipWire	TitaniumNitinol	Not Known	Stainless Steel

The following technological differences exist between the subject and predicate devices:

The CrossCountry tool dilates using mechanical pressure while the LungPoint . Tools dilate using pneumatic pressure.

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. The CrossCountry tool incorporates a sharp wire tip to puncture the tracheobronchial wall while the LungPoint Tool must rely on a separate device to puncture the wall.
The CrossCountry tool provides access for other endoscopic tools to sample tissue while the Wang transbronchial aspiration needle is able to sample tissue directly.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Data:

Biocompatibility testing was completed in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993 "Biological Evaluation fo Medical Devices Part 1: Evaluation and Testing" May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" as recognized by FDA. The following tests were conducted:

Cytotoxicity
Sensitization ●
. Intracutaneous Reactivity

Design Verification and Validation Testing Data:

Tensile Testing
Shelf Life Testing
Simulated Use Testing ●
Distribution Testing ●
Compatibility Testing ●
. Dimensional Testing

Animal Study Data:

A preclinical study was conducted using the CrossCountry access tool on one side of the lung and a control device on the opposite side of the lung. All of the acceptance criteria were met. This study showed the CrossCountry access tool design meets its intended use.

SUBSTANTIAL EQUIVALENCE CONCLUSION VIII.

Covidien Ilc has demonstrated that the proposed CrossCountry access tool is substantially equivalent to the LungPoint Tools and the Wang Transbronchial Aspiration Needle which are legally marketed for the same intended use. The non-clinical data and the invivo animal study provide adequate justification to demonstrate that the CrossCountry access tool should perform as intended in the specified use condition.

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.