The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.

Device Description

The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use (disposable) devices. The devices are packaged in a tyvek pouch, which is packaged into a carton box. The Radial Jawns 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle, The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length. To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jav. The dual pull wire design allows the javs to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

AI/ML Overview

This 510(k) pertains to a medical device, specifically the Radial Jaw™ 4 Pulmonary Biopsy Forceps, not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, biocompatibility, sterilization, and various bench tests.

Here's an analysis based on the provided document, addressing the relevant points and noting where AI/ML specific criteria do not apply:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Cytotoxicity	Pass	Passed
	Sensitization	Pass	Passed
	Intracutaneous Reactivity	Pass	Passed
Sterilization	E-Beam Sterilization	Sterility Assurance Level 10⁻⁶	Met requirements; Validated
Bench Testing	Jaw Volume	Met design specifications	Acceptable
	Jaw Opening	Met design specifications	Acceptable
	Jaw Alignment & Engagement	Met design specifications	Acceptable
	Multi-Loop & Retroflex	Met design specifications	Acceptable
	Passability Force	Met design specifications	Acceptable
	Device Throw	Met design specifications	Acceptable
	Pivoting Head	Met design specifications	Acceptable
	Forceps Length for Working Channel	Met design specifications	Acceptable
	Forceps Operation after High Load	Met design specifications	Acceptable
	Forceps Integrity During Extreme Loading	Met design specifications	Acceptable
	Separation of Coil from Clevis	Met design specifications	Acceptable
	Separation of Sheath from Handle	Met design specifications	Acceptable
	Split Handle Design - Handle Separation	Met design specifications	Acceptable
	Split Handle Design - Spool Separation	Met design specifications	Acceptable
	Device Robustness	Met design specifications	Acceptable
	Endoscope Compatibility	Met design specifications	Acceptable
	Smooth Edges	Met design specifications	Acceptable
	Distal End Protector	Met design specifications	Acceptable
Overall	Substantial Equivalence to Predicates	Demonstrated equivalency	Achieved (FDA determination)

Notes on Acceptance Criteria: The document implies that the acceptance criteria for the bench tests were specific design specifications, which the device "met." For biocompatibility, "passed" indicates meeting the requirements of the standards. For sterilization, achieving a Sterility Assurance Level (SAL) of 10⁻⁶ is the standard criterion.

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

Test Set (for performance evaluation): The document does not specify exact sample sizes for each bench test conducted on the device. It states "In-vitro testing has been performed on the finished Radial Jaw™ 4 Pulmonary Biopsy Forceps device" and "bench tests were conducted on the RJ4 Pulmonary Biopsy Forceps." It's common for medical device bench testing to involve a representative number of units to ensure consistency and reliability, but specific counts are not provided here.
Data Provenance: The testing appears to be internal "in-vitro" and "bench tests," conducted by the manufacturer, Boston Scientific Corporation. There is no mention of data from external sources, different countries, or retrospective/prospective clinical data for performance assessment in this 510(k) submission, as it relies on substantial equivalence through design and bench testing.

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

Not Applicable (N/A) / Not provided: For a physical medical device undergoing bench and biocompatibility testing, "ground truth" as typically defined for AI/ML algorithms by expert consensus is not relevant. The "truth" is established by adherence to engineering specifications, recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization), and functional performance measured against predefined criteria. The experts involved would be qualified engineers, material scientists, and microbiologists conducting the tests and evaluating the results against established standards. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation of data is required to establish ground truth or resolve discrepancies, particularly for AI/ML outputs. Since this 510(k) references bench testing and compliance with standards for a physical device, an adjudication method in this sense is not relevant. The pass/fail criteria for each test are typically objective and determined by predefined laboratory protocols and specifications.

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: An MRMC comparative effectiveness study is not relevant here. This is a submission for a physical medical device (biopsy forceps), not an AI-powered diagnostic or assistive technology. No human readers or AI assistance are involved in the function or evaluation of the device as described in this summary.

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

Not Applicable: This is not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is inherently "standalone" in that it performs its function (collecting tissue) without computational human-in-the-loop assistance.

7. The type of ground truth used

Engineering Specifications, International Standards, and Functional Performance: For this device, the "ground truth" or reference for evaluating its performance is based on:
- Design Specifications: Quantitative and qualitative requirements defined by Boston Scientific for the device's physical and functional characteristics (e.g., jaw volume, jaw opening, alignment, forces, robustness, etc.).
- International Standards: Adherence to established standards for biocompatibility (EN ISO 10993-1: 2009) and sterilization (EN ISO 11137-1:2006 and EN ISO 11137-2:2006).
- Predicate Device Characteristics: Comparison to the known characteristics and performance of the legally marketed predicate devices (Radial Jaw™ II and Radial Jaw™ 3 Pulmonary Biopsy Forceps) to demonstrate substantial equivalence.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device that requires a training set. The device is manufactured according to a design, and then tested for compliance.

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 and therefore no ground truth established for a training set. The 'ground truth' pertinent to this submission relates to the validation of the device's design, manufacturing, and safety against established engineering principles and regulatory standards.

Summary

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K102336

SECTION 6 510(k) SUMMARY

Submitter

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939

Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: January 5, 2011

2. Proposed 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

3. Predicate Device:

Boston Scientific Radial Jaw"11 Pulmonary Biopsy Forceps (K895415) Boston Scientific Radial Jawan 3 Pulmonary Biopsy Forceps (K895415)

4. Proposed Device Description:

The Radial Jaw"15 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use (disposable) devices. The devices are packaged in a tyvek pouch, which is packaged into a carton box. The Radial Jawns 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle, The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length.

To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jav. The dual pull wire design allows the javs to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

5. Intended Use/ Indications for Use:

These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic evaluation. These forceps should not be used for any purpose other than their intended function.

JAN 2 4 2011

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6. Technological Characteristics:

The technological characteristics of the proposed Radial Jaw"™ 4 Pulmonary Biopsy Forceps are similar to the predicate Radial Jaw-Thi Pulmonary Biopsy Forceps (K895415) and the Radial Jawan 3 Pulmonary Biopsy Forceps (K895415).

The proposed device has the same intended use and requires the same technique for obtaining biopsy samples as the predicate devices.

The RJ4 Pulmonary Standard Capacity Biopsy Forceps working length and endoscope working channel compatibility specifications are identical to the RJ3 Pulmonary Standard Capacity Biopsy Forceps. The RJ4 Pulmonary Large Capacity Biopsy Forceps working length and endoscope working channel compatibility specifications are identical to the RJ3 Pulmonary Large Capacity Biopsy Forceps.

The materials of the proposed RJ4 Pulmonary device are similar to the predicate RJ3 Pulmonary Biopsy Forceps.

7. Performance Data:

In-vitro testing has been performed on the finished Radial Jaw™ 4 Pulmonary Biopsy Forceps device and the proposed device met the required specifications for the completed tests.

The proposed RJ4 Pulmonary Biopsy Forceps were evaluated in accordance with EN ISO 10993-1: 2009. The following biocompatibility tests were performed on the biopsy forceps: Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

The RJ4 Pulmonary Biopsy Forceps are E-Beam sterilized. The RJ4 Pulmonary Biopsy Forceps were adopted into the sterilization validation of the master product RJ4 Large Capacity. The sterilization was performed in accordance with EN ISO 11137-1:2006 and EN ISO 11137-2:2006. The validation method was VDmax25. The sterility assurance level is 10°. The RJ4 Pulmonary Biopsy Forceps are not labeled as non-pyrogenic.

The following bench tests were conducted on the RJ4 Pulmonary Biopsy Forceps: Jav Volume, Jaw Opening, Jaw Alignment and Engagement, Multi-Loop and Retroflex, Passability Force, Device Throw, Pivoting Head, Forceps Length for the Working Channel Portion of the Device, Forceps Operation after High Load, Forceps Integrity During Extreme Loading, Separation of Coil from Clevis, Separation of Sheath from Handle, Split Handle Design-Handle Separation, Split Handle Design- Spool Separation, Device Robustness, Endoscope Compatibility, Smooth Edges, and Distal End Protector.

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8. Conclusion:

All biocompatibility tests conducted on the RJ4 Pulmonary Biopsy Forceps passed. Therefore, the RJ4 Pulmonary Biopsy Forceps are considered biocompatible for their intended use.

The RJ4 Pulmonary Biopsy Forceps met the requirements of the sterilization validation. Therefore, the RJ4 Pulmonary Biopsy Forceps are validated for E-Beam sterilization.

All device bench testing results were acceptable. The data demonstrate that the RJ4 Pulmonary Biopsy Forceps sufficiently met the design specifications and are suitable for the intended use.

Boston Scientific Corporation has demonstrated that the proposed Radial Jawns 4 Pulmonary Biopsy Forceps are substantially equivalent to Boston Scientific Corporation's currently marketed Radial Jaw M Pulmonary Biopsy Forceps (K895415) and Radial Jaw™ 3 Pulmonary Biopsy Forceps (K895415),

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

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

Boston Scientific Corporation c/o Ms. Ashley Pyle Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

JAN 2 4 201

Re: K102336

Trade/Device Name: Radial Jaw™ 4 Pulmonary Biopsy Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: BWH Dated: January 5, 2011 Received: January 6, 2011

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. Insting 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. Ashley Pyle

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Rutherford

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): To Be Determined K102336

Device Name: Radial Jaw 4 Pulmonary Biopsy Forceps

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rudy CRNP
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102336

000014

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.