The CoreDx Pulmonary Mini-Forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps can be used with endoscopes for ultrasound guided mini-forcens biopsy (MFB) of submucosal and extramural lesions of the trachcobronchial tree. These for any purpose other than their intended use.

Device Description

The CoreDx Pulmonary Mini-Forceps is a sterile, single use device comprised of jaws at the distal tip, attached to a flexible coil with a spool and a thumb ring handle attached at the proximal end of the device. The two radial jaws are attached to an actuation mechanism and can be opened and closed by sliding the spool handle. The jaws are designed to tear and retain tissues within the jaws. Once the CoreDx Pulmonary Mini-Forceps is positioned at the target area, the radial jaws are opened and a sample of tissue is collected for histological examination. The CoreDx Pulmonary Mini-Forceps are designed to be compatible with scopes that have a working channel with a minimum inner diameter (ID) of 1.2 mm. The CoreDx™ Pulmonary Mini-Forceps is designed for use in the pulmonary system. The proposed device can also be used following an EBUS Transbronchial Needle Aspiration (EBUS-TBNA) procedure to pass through the airway wall and access a lymph node via an EBUS scope.

AI/ML Overview

The provided text describes the 510(k) clearance for the CoreDx™ Pulmonary Mini-Forceps, a medical device used for collecting tissue samples. The majority of the document focuses on regulatory information, device description, indications for use, and a comparison to predicate devices, rather than a detailed study proving the device meets specific performance acceptance criteria.

While the document states that "the performance of the proposed device meets the requirements of its pre-defined acceptance criteria and intended use," it does not provide the specific numerical acceptance criteria for each test or detailed study results. The "Performance Data" section lists the types of tests performed but lacks the quantitative outcomes and the methodology of a study designed to prove the device meets pre-defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document, as it primarily focuses on the regulatory submission and substantial equivalence argument rather than the in-depth results of a clinical or performance study.

Here's an attempt to answer based on the available information and explicitly noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states "the performance of the proposed device meets the requirements of its pre-defined acceptance criteria," but it does not list these criteria or the specific numerical performance results against them.

The types of tests performed (without specific results or criteria) include:

Test Type	Reported Device Performance (Qualitative)	Acceptance Criteria (Not Detailed)
Biocompatibility	Met requirements of ISO 10993: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, USP Rabbit Pyrogen Testing.	Meets ISO 10993 standards and specific tests.
Sterilization	Met requirements of ISO 11135-1 (Ethylene Oxide) and ISO 10993-7 (ETO residuals).	Meets ISO 11135-1 and ISO 10993-7 standards.
Bench Tests	Passability, Pushability, Working Length, Device Reliability, Forceps Operation, Forceps Integrity, Smooth Edges.	Device performed as intended and met pre-defined requirements (details not provided).
Ultrasound Visibility	Confirmed through user feedback assessment in a swine lung model.	Visible under ultrasound.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified for any of the performance tests.
Data Provenance:
- Bench tests suggest laboratory testing.
- Ultrasound visibility was assessed in a "swine lung model," indicating an animal study.
- No human clinical data (retrospective or prospective) is mentioned for performance validation against acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document mentions "user feedback assessment" for ultrasound visibility in a swine model but does not detail the number or qualifications of these users/experts. For other mechanical/biocompatibility tests, ground truth typically comes from lab measurements against standards.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests primarily involve bench testing and an animal model, formal "adjudication" in the sense of human reader consensus for imaging interpretation would not apply.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) study was not performed, nor is it applicable. This device is a mechanical biopsy forceps, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm or AI.

7. The Type of Ground Truth Used

For biocompatibility: Adherence to ISO standards and specific test methods (e.g., cell viability, toxicity assays).
For sterilization: Adherence to ISO standards for ethylene oxide sterilization and residuals.
For bench tests (Passability, Pushability, etc.): Likely engineering specifications and measurements to determine if the device performed within defined parameters (details not provided).
For ultrasound visibility: User feedback assessment in a swine model, implying qualitative or semi-quantitative observation by unquantified "users."

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/machine learning algorithm that requires a "training set."

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

This question is not applicable. The device is not an AI/machine learning algorithm.

In summary, the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to predicate devices through regulatory compliance, material testing, and functional bench testing. It does not contain the detailed quantitative performance study results and methodologies typically expected for an AI/software as a medical device (SaMD) submission. The "acceptance criteria" mentioned are qualitative statements about meeting standards and pre-defined requirements, rather than specific numerical thresholds.

Summary

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March 8, 2019

Boston Scientific Corporation Elena Nieves Fellow, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K183085

Trade/Device Name: CoreDx™ Pulmonary Mini-Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: February 5, 2019 Received: February 6, 2018

Dear Elena Nieves:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

James J. Lee -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) K183085

Device Name CoreDx Pulmonary Mini-Forceps

Indications for Use (Describe)

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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510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Elena Nieves Fellow Regulatory Affairs Specialist Tel: 508-683-4347 Fax: 508-683-5939 Date Prepared: November 5, 2018

2. Proposed Device:

Trade Name:	CoreDx™ Pulmonary Mini-Forceps
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	874.4680
Product Code:	EOQ
Classification:	Class II

3. Predicate Device:

Trade Name:	Expect TM Pulmonary Endobronchial Ultrasound TransbronchialAspiration Needle
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	874.4680
Product Code:	EOQ
Classification:	Class II
510(k) Clearance Number:	K163248

4. Reference Device:

Trade Name:	Radial Jaw™ 4 Pulmonary Biopsy Forceps
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	874.4680
Product Code:	BWH
Classification:	Class II
510(k) Clearance Number:	K121186

5. Device Description:

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use in the pulmonary system. The proposed device can also be used following an EBUS Transbronchial Needle Aspiration (EBUS-TBNA) procedure to pass through the airway wall and access a lymph node via an EBUS scope.

6. Indications for Use:

The CoreDx Pulmonary Mini-Forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps can be used with endobronchial ultrasound endoscopes for ultrasound guided mini-forceps biopsy (MFB) of submucosal and extramural lesions of the tracheobronchial tree. These forceps should not be used for any purpose other than their intended use.

7. Technological Characteristics:

The proposed CoreDx Pulmonary Mini-Forceps has different technological characteristics compared to the primary predicate Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248). However, both the proposed and primary predicate device can pass through the scope to the target position. In addition, the materials of the distal section of the proposed and primary predicate are echogenic for visibility under ultrasound.

The proposed CoreDx Pulmonary Mini-Forceps has the same indications for use as the primary predicate Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248) and reference device Radial Jaw™ 4 Pulmonary Biopsy Forceps (K121186). However, the proposed device's working length is 130cm which is longer than the predicate devices in order to access the lung periphery. The proposed CoreDx will also be compatible with currently available digital and ultrasound bronchoscopes. In addition, the proposed device is designed to be compatible with scopes that have a working channel with a minimum inner diameter (ID) of 1.2 mm. Therefore, the dimensions of the proposed device better suit the airway anatomy to ensure market needs are adequality addressed, as the proposed CoreDx Pulmonary Mini-Forceps can be used in the lung periphery.

The proposed CoreDx Pulmonary Mini-Forceps and the primary predicate Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle are intended to be used to obtain tissue samples from the lymph node (one sample acquired and removed in each pass) through the EBUS-TBNA needle puncture hole within and adjacent to the major lumens of the airway that can be identified and targeted using the ultrasound bronchoscope. The proposed CoreDx will follow the same track through the scope and puncture hole as that of the EBUS-TBNA needle. Both the CoreDx and the Expect Pulmonary can reach lesions that require extension beyond the bronchial wall. Extension bevond the bronchial wall may be required in order to access lymph nodes or anatomies such as the lung that a physician is interested in obtaining a biopsy sample. Accessing the lung may be intentional and is considered a standard EBUS-TBNA procedure.

When the proposed CoreDx™ Pulmonary Mini-Forceps is compared to the primary predicate Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle, both devices have technological characteristics which include catheter based

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technology with actuating handles that slightly differ as the proposed includes a handle with a thumb ring while the primary predicate includes a handle with a base. Both the proposed and primary device serve the same function and are intended to be used to obtain tissue samples from the lymph node (one sample acquired and removed in each pass) through the EBUS-TBNA needle puncture hole within and adjacent to the major lumens of the airway that can be identified and targeted using the ultrasound bronchoscope. The difference is that the proposed CoreDx has jaws to obtain tissue samples while the primary predict Expect has a needle to obtain tissue samples, therefore, both devices serve the same function of taking tissue samples.

When the proposed CoreDx is compared to the reference device Radial Jaw™ 4 Pulmonary Biopsy Forceps, the technological characteristics are similar as both devices have a catheter base and the same technology of actuating the handle, opening and closing the jaw. The only technological difference is the length of the proposed device which is longer and was evaluated through bench testing (i.e. Working Length).

8. Performance Data:

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing". Testing that was performed include Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and USP Rabbit Pyrogen Testing; ISO 11135-1 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".

The following bench tests were performed on the CoreDx Pulmonary Mini-Forceps: Passability; Pushability; Working Length: Device Reliability; Forceps Operation; Forceps Integrity; and Smooth Edges.

In addition, the proposed device was evaluated for visibility under ultrasound after a standard EBUS-TBNA procedure in a swine lung model which was confirmed through user feedback assessment.

The non-clinical testing that was performed and submitted demonstrated that the proposed CoreDx Pulmonary Mini-Forceps is substantially equivalent to the primary predicate and reference devices as the performance of the proposed device meets the requirements of its pre-defined acceptance criteria and intended use.

9. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed CoreDx Pulmonary Mini-Forceps is substantially equivalent to the currently cleared Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248) as the performance of the proposed device meets the requirements of its pre-defined acceptance criteria and 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.