The Captura® Disposable Bronchoscope Biopsy Forceps (subject device) represents modifications made to the Disposable Bronchoscope Biopsy Forceps (predicate device) currently cleared to market via 510K K923847 by Wilson-Cook Medical, Inc. The Captura® Disposable Bronchoscope Biopsy Forceps consist of a spool handle, coated coilspring catheter, drive cable, forceps cups and forceps housing.

The bronchoscope biopsy forceps is used by passing the device through a prepositioned endoscope to the targeted location. The forceps cups are attached on one end of the coilspring sheath with the spool handle attached to the opposite end. The handle is actuated by moving the spool forward to open the forceps cups and backward to close. The Captura® Bronchoscope Biopsy Forceps have a surgical rim edge around the circumference of the cups and the cups are fenestrated. The cups are opened and pressed against the biopsy site. When the cups are closed, they are pulled away from the biopsy site, pinching off the top surface, obtaining a tissue biopsy.

AI/ML Overview

This document is a 510(k) premarket notification for the Captura® Bronchoscope Biopsy Forceps, a medical device. It does not describe a study involving machine learning, AI, or software, but rather a traditional medical device equivalency assessment. Therefore, most of the questions about acceptance criteria, AI performance, ground truth, and training sets are not applicable.

Here's the information that can be extracted from the provided text, aligning with the spirit of your request where possible:

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

Since this is a submission for a physical medical device, there isn't a direct "performance metric" like accuracy or precision as would be found in an AI/ML study. Instead, the "performance" relates to demonstrating the device functions comparably to a predicate device and adheres to safety and functional standards.

Acceptance Criteria (Demonstrated Through Testing)	Reported Device Performance (as stated in submission)
Functionality (Shelf Life Testing)	Subject device performs as intended
Durability / Mechanical Integrity (Flex and Fracture Design Verification)	Subject device performs as intended
Biopsy Efficacy (Force to Biopsy)	Subject device performs comparably to the predicate device
Packaging Integrity (Burst Testing, Dye Leak Testing)	Packaging maintains integrity and device sterility
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Material-mediated Pyrogenicity)	Biocompatibility performed in accordance with FDA Guidance (ISO 10993-1)
Substantial Equivalence to Predicate Device	Maintained intended use, key operating mechanics, and technological characteristics.

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

The document does not specify general "sample sizes" in terms of patient data or clinical images, as this is not an AI/ML study. Instead, testing involves physical exemplars of the device. The text states:

Sample Size: Not specified for individual tests. Testing would typically involve multiple units of the device for each test (e.g., several devices for flex and fracture, multiple packaged units for burst/dye leak tests).
Data Provenance: The testing was conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. This is a medical device manufacturer based in Winston-Salem, North Carolina, USA. The data is from in-house design verification and validation testing, which is prospective for the purpose of demonstrating substantial equivalence.

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. This is a submission for a physical medical device. "Ground truth" in this context refers to engineering specifications, validated test methods, and compliance with standards, not expert medical opinion on diagnostic images or data.

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

Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 are typically used for interpreting ambiguous cases or establishing ground truth in clinical or imaging studies involving human readers, which is not relevant here.

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

Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. There is no algorithm or AI component to this physical biopsy forceps device.

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

The "ground truth" for this medical device's performance is established by:

Engineering Specifications: The design and manufacturing specifications of the device.
Validated Test Methods: Adherence to established scientific and engineering principles for testing functionality, durability, and safety.
Regulatory Standards: Compliance with FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility).
Predicate Device Performance: The cleared performance of the previously marketed predicate device (Disposable Bronchoscope Biopsy Forceps, K923847) serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for this physical medical device.

Summary

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February 21, 2018

Wilson-Cook Medical Inc. Ashley Howard Regulatory Affairs Specialist I 4900 Bethania Station Road Winstom-Salem, North Carolina 27105

Re: K163377

Trade/Device Name: Captura® Bronchoscope Biopsy Forceps Regulation Number: 21 CFR 874.5680 Regulation Name: Bronchoscope (Fixed and Rigid) and Accessories Regulatory Class: Class II Product Code: EOO Dated: January 16, 2018 Received: January 22, 2018

Dear Ashley Howard:

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.

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163377

Device Name

Captura® Bronchoscope Biopsy Forceps

Indications for Use (Describe)

This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary

Name:	Wilson-Cook Medical, Inc. / Cook Endoscopy
Address:	4900 Bethania Station RoadWinston-Salem, North Carolina 27105
Phone:	(336) 744-0157 ext. 6174
Contact:	Ashley Howard, Specialist I - Regulatory Affair
Date:	February 15, 2018
Trade Name:	Captura® Bronchoscope Biopsy Forceps
Common Name:	Bronchoscope Biopsy Forceps
Classification Name:	Bronchoscope (flexible or rigid) and accessories21 CFR §874.4680, EOQ, Class II
Predicate Device:	Disposable Bronchoscope Biopsy Forceps,K923847, cleared November 18, 1992

Indications for Use

This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.

Device Description

Substantial Equivalence

Changes were made to the predicate Disposable Bronchoscope Biopsy Forceps cleared to market via K923847. These changes include: a material formulation change for the forceps components, a catheter material change, elimination of a spiked forceps cup option and updated handle design.

These changes to the subject device were made in an effort to improve the strength of the components, improve passage through the endoscope and to facilitate process improvements for components.

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The subject device operates in the same manner as the predicate device after these changes. Design verification and design validation testing demonstrated substantial equivalence of the device.

The modified Captura® Disposable Bronchoscope Biopsy Forceps (subject device) is substantially equivalent to the predicate with respect to the intended use, key operating mechanics and technological characteristics.

Summary of Non-Clinical Testing

The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.

Shelf Life Testing .
- o Functional Testing
Design Validation/Verification Testing .
- o Flex and Fracture Design Verification
- o Force to Biopsy
Packaging Validation ●
- Burst Testing O
- Dye Leak Testing o

Summary of Biocompatibility Testing

Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process." The following tests were performed:

. Cytotoxicity
. Sensitization
Irritation ●
. Acute toxicity
Material-mediated Pyrogenicity ●

Conclusion

We believe that the subject device is substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. The nonclinical data support the substantial equivalence of the subject device and the performance testing, verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use. The non-clinical data demonstrates that the subject device performs comparably to the predicate device that is currently marketed for the same intended use.

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.