The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.

Device Description

The GenCut™ core biopsy system (GenCut system) is an endobronchial biopsy system that consists of a core biopsy tool, extension tube, locking syringe, and a tissue removal brush. The GenCut system is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system (cleared under 510(k) K092365).

The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration.

The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:

Extension tube .
Locking syringe .
Tissue removal brush ●

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the GenCut™ Core Biopsy System meets them, based on the provided text:

Acceptance Criteria and Device Performance for GenCut™ Core Biopsy System

The document states, "All acceptance criteria were met" for the preclinical study. However, the specific quantitative acceptance criteria or performance metrics are not explicitly defined in the provided text. The document only broadly states that the device was evaluated for its ability to retrieve specimens from lung tissues.

Therefore, the table below reflects what can be inferred rather than explicitly stated quantitative criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Ability to successfully retrieve tissue specimens	All acceptance criteria were met. Device design meets intended use.
Functionality in an endobronchial lung biopsy procedure	All acceptance criteria were met. Device design meets intended use.
Safe operation within intended use	No adverse events or safety concerns mentioned; biocompatibility testing passed.
Compatibility with flexible endoscope/superDimension system	Functionality confirmed during simulated use and animal study.
Biocompatibility	Passed Cytotoxicity, Sensitization, Intracutaneous Study.
Structural Integrity (Tensile, Shelf Life, Packaging, Dimensional)	Passed Tensile Testing, Shelf Life Testing, Packaging and Distribution Testing, Dimensional Testing.

2. Sample Size and Data Provenance

Test Set Sample Size: A "preclinical study was conducted in a porcine model." The exact number of porcine subjects is not specified.
Data Provenance: Prospective (animal study mimicking clinical use). Country of origin is not specified.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Three physicians.
Qualifications of Experts: Two pulmonologists and one thoracic surgeon. Years of experience are not specified.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. It says "All acceptance criteria were met. Therefore, the design of the GenCut system meets the intended use." This implies a consensus or agreement among the experts regarding the successful performance, but the specific process (e.g., 2+1, 3+1) is not detailed.

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

No MRMC comparative effectiveness study was done. The study described is a preclinical animal study evaluating the device's performance, not comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical core biopsy system, not an AI algorithm. Therefore, a standalone (algorithm-only) performance evaluation is not relevant.

7. Type of Ground Truth Used

The ground truth for the animal study was based on the direct observation and assessment of the three expert physicians (two pulmonologists and one thoracic surgeon) during the biopsy procedures in the porcine model. This would likely involve:

Successful specimen retrieval.
Quality of the retrieved specimens (though not explicitly detailed).
Ease of use and functionality of the device.
Absence of complications related to the device.

8. Sample Size for the Training Set

Not applicable. This device is a physical core biopsy system, not an AI or machine learning model that requires a "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth associated with it in that context. The "ground truth" for its performance evaluation (animal study) was established by direct expert observation and assessment.

Summary

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

April 29, 2015

Covidien llc Jenny Jiang Regulatory Affairs Manager 161 Cheshire Lane, Suite 100 Plymouth, MN 55441

Re: K142839

Trade/Device Name: GenCut™ Core Biopsy System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: April 2, 2015 Received: April 3, 2015

Dear Ms. Jiang:

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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Page 2 - Ms. Jiang

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,

Tejashri 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
510(k) Number (if known)	K142839
Device Name	GenCut™ Core Biopsy System
Indications for Use
	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use (Describe)	The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
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)
	CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
	The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)	Page 1 of 1

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510(k) Summary

Covidien llc Traditional 510(k) GenCut™ Core Biopsy System

1. Submitter

510(k) Submitter:

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

Contact Person:

Jenny Jiang Regulatory Affairs Manager Phone: 763-647-5531 Fax: 763-210-4098 Email: jenny.jiang@covidien.com

Date Prepared: 4/28/2015

2. Device

Trade Name :	GenCut™ Core Biopsy System
Common Name:	Core Biopsy System
Model Number:	SDCT01
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR Part 874.4680
Product code:	EOQ

3. Predicate Device

Primary Predicate Device

Device Name :	Wang Transbronchial Aspriation Needle
510(k):	K914181
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR Part 874.4680
Product code:	EOQ
Manufacturer:	ConMed Corporation

Secondary Predicate Device

Device Name :	eXcelon™ Transbronchial Aspiration Needle
510(k):	K040018
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR Part 874.4680
Product code:	EOQ

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Manufacturer: Boston Scientific

4. Device Description

The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:

Extension tube .
Locking syringe .
Tissue removal brush ●

5. Indications for Use

6. Summary of Characteristics Compared to Predicate Devices

Both the subject device and predicate devices have technological principle. All of these tools are advanced into the body through a flexible endoscope or other working channel. Once they reach the target biopsy site, suction is applied through a syringe and a sample is taken from the desired site. Once the sample is obtained, the devices are withdrawn from the body and a sample can be expelled from the tool.

Overall, the subject and predicate devices are all based on the following same technological elements:

Device introduced endoscopically and used to reach the target site

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Device inserted through a flexible endoscope or other working channel .
Use of a distal tip to collect tissues and a syringe to aspirate samples out of the . shaft
. Device intended for short-term introduction and transient use through a naturally occurring orifice

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

Characteristic	GenCut system(Subject Device)K142839	Wang TransbronchialAspiration Needle(Predicate Device)K914181
Device Classification	Class II	Same
FDA Product Code	EOQ	Same
Technological Characteristics
Anatomical Site	Lung	Same
Introduction to TargetTissue	EndobronchialDelivered to targettissue through aworking channel	Same
Specimen SamplingMechanism	Repeated axial motionwith applied suctionthrough a workingchannel	Same
Cell Collection	Aspiration with asyringe	Same
Working OuterDiameter	1.8 mm	1.9 mm
Working Length	106 cm - 115 cm	130 cm
Shaft Marks	Present	No
Tip	Blunted	Sharpened
Retractable DistalEnd	No	Yes
Radiopaque DistalEnd	Yes	Same
Material
Working OuterMaterial	Polymer - CopolyesterElastomerBraid - 304 StainlessSteel	PTFE
Tip Material	Stainless Steel	Same

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

. The GenCut core biopsy tool contains a blunt distal tip with a side-cutting mechanism to facilitate tissue sampling while the primary predicate device features sharp distal tip with an end-cutting mechanism.
The GenCut core biopsy tool has a polymeric shaft with steel braid reinforcement. ● The primary predicate device features a PTFE sheath.

In conclusion, the GenCut™ Core Biopsy System is technologically equivalent to the predicate device.

7. Performance Data

Non-clinical performance testing has been performed on GenCut system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

ISO 10993-1:2009(Corr: 2010) Biological evaluation of medical devices Part 1: . Evaluation and testing
. ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008(Corr:2009) Biological evaluation of medical devices -- Part 7: ● Ethylene oxide sterilization residuals
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
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

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

Biocompatibility Data:

Biocompatibility testing was successfully 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 Study .

Design Verification and Validation Testing Data:

Tensile Testing ●
Shelf Life Testing
Simulated Use Testing ●

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. Packaging and Distribution Testing
. Dimensional Testing

Animal Study Data:

A preclinical study was conducted in a porcine model undergoing an endobronchial lung biopsy procedure. Three physicians including two pulmonologists and one thoracic surgeon conducted the study. All acceptance criteria were met. Therefore, the design of the GenCut system meets the intended use.

8. Substantial Equivalence Discussion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the proposed GenCut system has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.

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.