(251 days)
No additional reference devices were used in this submission.
No
The summary describes a mechanical tool for accessing lung lesions and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to create access to lesions, not to treat them directly. It facilitates the use of other endobronchial tools for therapy or diagnosis, but is not therapeutic itself.
No
This device is designed to create access for subsequent tools to reach lesions outside the airways. Its primary function is interventional (to facilitate access for therapy or further diagnostic sampling), not to diagnose conditions itself.
No
The device description clearly states it is a flexible endobronchial tool made up of a wire and a catheter, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CrossCountry™ Transbronchial Access Tool is a surgical tool used directly within the body to create access to lung lesions. It facilitates a procedure, it doesn't analyze a sample taken from the body.
- Intended Use: The intended use clearly describes a procedure performed in vivo (within the living organism), not an analysis of a sample in vitro (in a lab setting).
The device description and intended use clearly indicate it's a tool for a surgical/interventional procedure, not for laboratory testing of biological samples.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
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™1 pouch and sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lung, tracheobronchial wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians who are trained in endoscopic techniques / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No additional reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
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:
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.
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)
Page 1 of
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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 Dilation
Balloon) 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
5
Secondary Predicate: Wang Transbronchial Aspiration Needle - K914181
No additional reference devices were used in this submission.
IV. 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™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
6
| Characteristic | CrossCountry Tool | Broncus Medical Inc.
Lungpoint Tools
(Primary Predicate)
K131234 | Wang Transbronchial
Aspiration 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 and
LungPoint Balloon | Transbronchial Aspiration
Needle |
| Single Use | Yes | Yes | Yes |
| Anatomical Location | Lung | Lung | Lung |
| Introduction into the
body | 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 Outer
Diameter | Catheter OD: 2.01mm
Wire OD: 0.66mm | Sheath - 2.65 mm
Balloon: 1 mm
(uninflated)
4 mm (inflated) | Tip OD: 1.9 mm |
| Working Length | Catheter: 109.9 cm
Wire: 116.1 cm | Sheath: 90 cm
Balloon: 97.5 cm | 130 cm |
| Tip Diameter | Catheter: Tapers down to
slightly larger than the
wire - Wire: 0.41mm | Not applicable | 22 gauge needle
(0.028 in / 0.71mm) |
| Material | | | |
| Working Outer
Material | Polymer – Copolyester
Elastomer
Braid - 304 Stainless
Steel | Not Known | PTFE |
| Wire Tip
Wire | Titanium
Nitinol | 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.