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The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection.

The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (age > 21 years).

The Pre-B. Seal Lung Biopsy System is a sterile single-use medical device comprised of the following components:

• Prefilled Hydrogel Syringe
• Delivery System 15cm length, 16cm length, 20cm length

The model numbers are:

• Pre-B. Seal Lung Biopsy Plug System 15cm (Model # FG0001)
• Pre-B. Seal Lung Biopsy Plug System 16cm (Model # FG0002)
• Pre-B. Seal Lung Biopsy Plug System 20cm (Model # FG0003)

The Delivery System is comprised of an introducer pre-assembled with a delivery needle, with depth markings on the external surface of the introducer. The delivery needle and introducer are both constructed of stainless steel. A pebax white depth marker ball sits on the introducer and may be used in addition to the markings as a depth indicator. The delivery system is ethylene oxide (EO) sterilized and is patient contacting (≤ 24 hours (includes transient contact).

The prefilled syringe contains a sealant (hydrogel) which acts as an absorbable lung biopsy plug. The hydrogel plug consists of gelatin, saline and hyaluronic acid. The plug is provided in ready to use configuration within a prefilled hydrogel syringe. The hydrogel is biodegradable.

The prefilled hydrogel is steam sterilized. The hydrogel is patient contact (> 30 days (i.e., permanent)) The syringe is indirect patient contacting.

These components have been designed for use during a CT-guided transthoracic lung biopsy procedure. The syringe is attached to the delivery system and then purged using a standard hypodermic purging technique outside of the patient. The distance from the skin to the pleura surface is measured using CT imaging, and using this information, the device is advanced to the intended deployment location within the lung under CT guidance. The hydrogel plug is deployed via the prefilled syringe below the surface of the lung through the delivery system. The hydrogel plug creates a seal around the delivery system through which a biopsy is conducted. When the biopsy is complete, the delivery system is withdrawn, and the hydrogel plug remains in place to fill the void and marks the biopsy needle entry site for visualization during surgical resection. The hydrogel plug is biodegradable and resorbs over approximately 49 days.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a GLP animal study that demonstrates the Pre-B Seal Lung Biopsy Plug System meets these criteria. Since the device is a physical medical device (lung biopsy plug) and not an AI/Software as a Medical Device (SaMD), several of the requested questions related to AI (e.g., number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Selio Medical Limited Pre-B Seal Lung Biopsy Plug System are largely derived from the requirements specified in the Special Controls (21 CFR 878.4755) for absorbable lung biopsy plugs and demonstrated through comparative testing with the predicate device (Bio-Seal Lung Biopsy Tract Plug System, DEN090007).

Table 1: Acceptance Criteria and Reported Device Performance

• Description & Principles of Operation
• Device Design
• Performance Testing (Bench)
• Usability Testing
• GLP Animal Study.
  Conclusion: Device design and materials are appropriate for and consistent with the intended use. |
  | SC(2): Performance testing demonstrates deployment as indicated in labeling, including with indicated introducer needles, and demonstrates expansion/resorption in a clinically relevant environment. | Demonstrated through:
• Performance Testing (Bench - Injection Force, Component Compatibility, Insertion/Withdrawal Force, Simulated Use, etc.)
• Usability Testing
• GLP Animal Study (plug visibility, deployment accuracy, expansion/resorption characteristics, compatibility with biopsy device).
• Instructions for Use.
  Conclusion: The device successfully deploys, and its expansion/resorption characteristics are acceptable and visually confirmed in animal model. |
  | SC(3): In vivo evaluation demonstrates performance characteristics, including ability of plug to not prematurely resorb or migrate, and the rate of pneumothorax. | Demonstrated through:
• GLP Animal Study.
  Conclusion: "The data from this study demonstrated that the performance characteristics, including the ability of the plug to not prematurely resorb or migrate, of the Pre-B. Seal Lung Biopsy Plug System were acceptable. The rate and severity of pneumothorax was less than the predicate device." |
  | SC(4): Sterility testing demonstrates sterility and effects of sterilization process on physical characteristics of plug. | Demonstrated through:
• Sterilization Validation studies (EO for delivery system per ISO 11135:2014, Steam for hydrogel per ISO 17665:2024), achieving SAL of 10-6.
• Effects on physical characteristics shown via Performance Testing (Bench), Usability Testing, GLP Animal Study.
  Conclusion: Device is sterile, and sterilization methods do not adversely affect physical characteristics. |
  | SC(5): Shelf-life testing demonstrates shelf-life of device including physical characteristics of plug. | Demonstrated through:
• Shelf-life testing performed.
  Conclusion: Shelf-life testing was successfully completed, demonstrating acceptable shelf-life and physical characteristics. |
  | SC(6): Device demonstrated to be biocompatible. | Demonstrated through:
• Biocompatibility Testing per ISO 10993-1:2018.
  Conclusion: "Test Results Passed. The results... demonstrates that the proposed device is biocompatible." |
  | SC(7): Labeling includes detailed summary of complications, warnings, and identification of compatible introducer needles. | Demonstrated through:
• Review of Instructions For Use (IFU).
  Conclusion: Labeling meets these requirements. |
  | Overall Substantial Equivalence to Predicate | Demonstrated through:
• Extensive side-by-side comparison (Table 1 in 510(k) Summary) showing similar intended use, indications for use, device class, product code, target population, anatomical site, ability to determine depth, environment of use, absorbable nature, sealing function, plug retention at site, and marking function.
• Differences in components (pre-filled vs. dehydrated hydrogel) and deployment procedure were addressed with supporting data (bench, animal, usability, biocompatibility) to show no new questions of safety/effectiveness.
• Different resorption time compared to predicate (49 days vs. 20 months) was deemed acceptable based on GLP animal study.
• Different hydrogel and delivery system materials were supported by biocompatibility testing.
• Sterilization methods (steam for hydrogel vs. EO for predicate) were validated.
  Conclusion: The proposed device is as safe, effective, and performs as well as the predicate device. |

Study Details for Device Performance

The core study proving the device meets the acceptance criteria is the GLP (Good Laboratory Practice) Animal Study, complemented by various non-clinical bench testing.

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Animal Study): A swine model was used. The exact number of animals or specific 'sample size' for the test set is not explicitly stated in numerical terms (e.g., "n=X animals") within this document. The document states a comparison was done between the proposed device and the predicate device in the swine model.
   • Data Provenance: The study was a prospective animal study, conducted in a GLP (Good Laboratory Practice) environment. The country of origin is not specified, but GLP implies a standardized, regulated conduct of non-clinical safety studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable (N/A): This refers to Human Factors/AI studies. For a physical device like a biopsy plug, the "ground truth" for performance (e.g., pneumothorax rate, migration, resorption) is established by direct observation, measurement, and pathological analysis in the animal model by trained veterinarians, pathologists, and study scientists in a GLP setting, not through expert consensus on images.

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

   • N/A: Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from human reader interpretations (e.g., in radiological studies). In an animal study, endpoints are typically objectively measured and evaluated by the study team, often including pathological assessment. Discrepancies would be resolved through standard GLP study procedures and internal review processes, not specifically these reader adjudication models.

4. 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, N/A: This is not an AI/SaMD study, but a physical medical device. Therefore, MRMC studies are not relevant for proving the performance of the Pre-B Seal Lung Biopsy Plug System. The comparison was the proposed physical device vs. the predicate physical device in an animal model.

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

   • No, N/A: This pertains to AI performance. The device is a physical product designed for human interaction and use during a medical procedure.

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

   • For the GLP Animal Study, the ground truth for device performance and safety endpoints (e.g., device visibility, deployment accuracy, expansion/resorption characteristics, incidence of pneumothorax, hydrogel plug migration, degradation, embolization, biocompatibility: local and systemic effects, overall animal health) was established through:
     • Direct observation and measurement during the procedure.
     • Imaging (CT guidance for visibility, positioning, deployment).
     • Pathological assessment (for degradation/resorption, local effects, embolization, etc.) by qualified personnel (e.g., veterinary pathologists).
     • Outcomes data based on the animal's health and post-procedure observations.

7. The sample size for the training set:

   • N/A: This term applies to machine learning or AI models. This is a physical device developed through traditional engineering design and testing, not by training an AI model.

8. How the ground truth for the training set was established:

   • N/A: As above, this is for AI models. The design of the Pre-B Seal Lung Biopsy Plug System was based on engineering principles, material science, and testing against pre-defined specifications and regulatory requirements, not a training set.

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