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510(k) Data Aggregation
(64 days)
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.
The provided document is a 510(k) Pre-market Notification for a medical device called the "PolypVac Microdebrider." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with explicit acceptance criteria related to a specific disease or condition.
Therefore, the document does not contain information about explicit acceptance criteria for disease diagnosis or treatment effectiveness based on a study of the device's performance against ground truth (e.g., sensitivity, specificity, AUC, or other accuracy metrics). Instead, the acceptance criteria are related to the functional performance and safety of the device, and the "study" is a series of non-clinical bench tests comparing it to a predicate device.
Here's the information as requested, adapted to the content provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to Functional Performance/Safety) | Reported Device Performance and Assessment |
|---|---|
| Functional Testing: Device must meet all product specification requirements and function as intended. | The modified PolypVac Microdebrider passed all functional testing and met all product specification requirements, demonstrating equivalent performance to that of the predicate device (K133133). |
| Resection Rate: (Implied: similar or equivalent to predicate device) | Specific rates are not provided, but the device passed functional testing, implying its resection rate is considered adequate and equivalent to the predicate. |
| Simulated Use Testing: (Implied: safe and effective under simulated use conditions) | The device passed simulated use testing, demonstrating equivalent performance to the predicate. |
| Biocompatibility: All contact materials must be evaluated per ISO 10993 and found biocompatible. | The modified PolypVac Microdebrider and the predicate device are biocompatible in accordance with ISO 10993. This was assessed through Cytotoxicity, Sensitization, and Irritation tests. |
| Irrigation: The modified device must meet all fluid flow requirements. | The modified device meets all fluid flow requirements. |
| Packaging: Package must meet ASTM F1980-07 and D4169-14, ensuring sterility and protection. | The modified packaging configuration has passed all packaging validation tests, showing that it equivalently protects the device and maintains sterility. |
| Sterilization: Must achieve a Sterility Assurance Level (SAL) of 10-6. | E-beam radiation with SAL 10-6 (Same as predicate). |
| Technological Characteristics: Changes do not affect the principles of operation or performance, and no additional risks/hazards identified. | User interface modifications (shape optimization, 360° blade rotation, optimized trigger) and physical/dimensional changes (blade diameter, metal tip, vacuum connection, separate filter) were concluded not to affect the principles of operation or performance and introduced no additional risks or hazards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in numerical terms (e.g., number of devices tested or number of trials). The "Test Set" here refers to the units of the PolypVac Microdebrider that underwent non-clinical bench testing.
- Data Provenance: The testing was non-clinical, bench testing. The country of origin for the data generation is not specified, but the applicant, Laurimed LLC, is based in Redwood City, CA, USA. The data is prospective in the sense that new testing was conducted on the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device is a surgical instrument. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against predefined specifications and industry standards (ISO, ASTM).
- Experts: Not applicable in the context of clinical "ground truth" (e.g., disease diagnosis). The tests were conducted by personnel with expertise in engineering, materials science, and sterilization validation. Specific numbers and qualifications of these individuals are not provided in this regulatory document.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus on clinical ground truth (e.g., image interpretation). For bench testing, the results are typically objectively measured against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed or necessary in support of this premarket notification." This type of study is not relevant for a surgical microdebrider seeking 510(k) clearance based on substantial equivalence to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of AI is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the established performance characteristics of the predicate device. This includes functional performance (e.g., resection, fluid flow), material biocompatibility, and packaging integrity.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and comparison to an existing device, not on statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth established for it.
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