(81 days)
The device is a neurosurgical pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable. The Delicot product line is made from lyocell, a manmade fiber derived from cellulose, better known under the brand name of Tencel - a type of rayon; it is supplied in various lengths and widths and has been marketed since 1990. The Delicot product line is one of three rayon-based sponges. The Delicot sponges are manufactured using Dupont Style 8623 consisting of 100% lyocell. Dupont has discontinued the manufacture of Style 8623. Dupont Style 8471 consisting of 58% polyester and 42% lyocell is our proposed replacement.
The provided text is a 510(k) summary for a medical device (Delicot Neurosurgical Sponge) seeking substantial equivalence to a predicate device. It does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic AI device or a device with measurable performance metrics would. Instead, the submission focuses on demonstrating equivalence through material and process changes.
Therefore, many of the requested categories are not applicable to this type of submission.
Here's an analysis based on the provided text:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria:
The core "acceptance criteria" in this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device. The study to prove this involves comparing the modified device (using a new material) to the predicate device across various aspects.
The specific "acceptance criteria" are implied by the points of comparison for substantial equivalence:
- Same indications for use and intended use.
- Same principle of operation.
- Same basic design.
- Equivalent materials.
- Same shelf life.
- Packaged and sterilized using the same materials and processes.
The study conducted to prove this focused on Biocompatibility Testing and Comparability Testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (from submission) |
|---|---|
| Biocompatibility: Lack of toxicity | "The results of the study demonstrate the lack of toxicity of the device and its biocompatibility for use as a neurosurgical sponge." (Cytotoxicity testing completed per ISO-10993 and GLP regulations) |
| Comparability (Existing vs. Modified Sponge): | "American Surgical Company conducted comparability testing on the existing Delicot sponge and the Delicot sponge with the replacement material." (Specific performance metrics or results of this comparability testing are not detailed in the provided summary, beyond the conclusion of substantial equivalence). The overarching conclusion is that the modified device "is substantially equivalent to the predicate device." |
| Indications for Use: Same as predicate | "have the same indications for use and intended use" |
| Principle of Operation: Same as predicate | "use the same principle of operation" |
| Basic Design: Same as predicate | "incorporate the same basic design" |
| Materials: Equivalent to predicate | "incorporate equivalent materials" (change from 100% lyocell to 58% polyester and 42% lyocell, supported by biocompatibility and comparability testing) |
| Shelf Life: Same as predicate | "have the same shelf life" |
| Packaging & Sterilization: Same as predicate | "are packaged and sterilized using the same materials and processes" |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document does not specify the sample size for the biocompatibility testing or the comparability testing.
- Data Provenance: Not explicitly stated, but typically, such testing is conducted in a laboratory setting, either internally or at a contract research organization. The biocompatibility testing was conducted "in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58." This implies a systematic, controlled study. It is prospective for the device under review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This is not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists reading images). Biocompatibility and comparability testing relies on objective laboratory assays and measurements.
4. Adjudication Method for the Test Set:
- Not applicable. There is no human interpretation or adjudication described for these materials and biocompatibility tests.
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:
- Not applicable. This is a submission for a physical medical device (surgical sponge), not an AI/diagnostic software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Biocompatibility: The "ground truth" is defined by established international standards (ISO-10993) and regulatory guidelines (FDA's Blue Book Guidance G95-1) for evaluating biological response and toxicity. The test results (e.g., cell viability in cytotoxicity assays) are compared against these predetermined thresholds for what constitutes a safe response.
- Comparability: The "ground truth" for evaluating the "equivalence" of the new material for mechanical or functional properties (which are not detailed in this summary but would be part of a comparability study) would be the performance characteristics of the predicate device. The new device's performance would need to fall within an acceptable range of the predicate's performance.
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This is not a machine learning or AI device.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).