(159 days)
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.
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.
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.
§ 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.