(90 days)
The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.
The provided FDA 510(k) clearance letter pertains to a new version of a physical medical device (surgical clips), not an AI/Software as a Medical Device (SaMD).
Therefore, the document does not contain any of the information requested in points 2-9, as these points are specific to the evaluation and validation of AI/SaMD products, which involve concepts like:
- Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC): This is relevant for diagnostic or predictive AI systems.
- Sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details: These are critical components of validating AI model performance to ensure its accuracy, robustness, and generalizability.
Since the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are physical devices, their acceptance criteria and proof of efficacy are based on benchtop non-clinical performance testing and biocompatibility assessments, which are detailed in the "Performance Data" section (Section J) of the 510(k) summary.
Here's how to interpret the provided document in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document lists the following non-clinical performance tests and biocompatibility assessments that were conducted. While explicit "acceptance criteria" are not numerically stated in this summary for each test (as they typically would be in a full test report), the statement "in order to ensure the device performed equivalently to the predicate" implies that the new device's performance in these tests met established safety and efficacy standards, likely mirroring or demonstrating similar performance to the predicate device.
| Acceptance Criteria (Implied) / Performance Test Category | Reported Device Performance (Summary) |
|---|---|
| Non-clinical performance testing: | Conducted following product sterilization, environmental conditioning, simulated distribution, and accelerated aging. The device ensured "performed equivalently to the predicate." |
| - Clip Latching | Met performance standards. |
| - Clip Resistance to Leakage | Met performance standards. |
| - Clip Removal | Met performance standards. |
| Biocompatibility Endpoints (per ISO 10993-1): | All assessed endpoints met standards. |
| - Cytotoxicity (ISO 10993-5) | Assessed and met. |
| - Sensitization (ISO 10993-10) | Assessed and met. |
| - Intracutaneous Reactivity (ISO 10993-10) | Assessed and met. |
| - Systemic toxicity (acute) (ISO 10993-11) | Assessed and met. |
| - Subchronic toxicity (subacute) (ISO 10993-11) | Assessed and met. |
| - Implantation (ISO 10993-6) | Assessed and met. |
| - Material Mediated Pyrogenicity (ISO 10993-11) | Assessed and met. |
| - Chronic Toxicity (ISO 10993-11) | Assessed and met. |
| - Genotoxicity (ISO 10993-3) | Assessed and met. |
| - Carcinogenicity (ISO 10993-3) | Assessed and met. |
| - Chemical Characterization (ISO 10993-18) | Assessed and met. |
For the remaining points (2-9), the information is not applicable to a physical device like surgical clips.
- 2. Sample sized used for the test set and the data provenance: Not applicable to physical clips. Testing involves benchtop models or animal studies for implantation, not human data sets.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for physical clips is established through engineering and biological testing standards, not expert annotation of data.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for AI/SaMD to compare human performance with and without AI assistance.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept applies to AI algorithms.
- 7. The type of ground truth used: For physical devices, ground truth for efficacy and safety is established through validated test methods (e.g., mechanical strength testing, leak resistance, biocompatibility standards, often with reference to predicate devices).
- 8. The sample size for the training set: Not applicable. This relates to AI model development.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the testing performed for a physical medical device (surgical clips) to demonstrate its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility rather than AI/software performance metrics.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.