(74 days)
The DeRoyal Industries Inc., Surgical Eye Spear is indicated for use in ophthalmic or microscopic surgical procedures to absorb fluids from the operative field.
The DeRoyal Industries Inc., Surgical Eye Spear is to be used to absorb fluids from the operative field during ophthalmic and microscopic surgical procedures.
The DeRoyal Industries, Inc., Surgical Eye Spear functions in the same manner as predicate devices in that it is comprised of an absorbent spear attached to a plastic handle.
Device Design/Materials Used Physical Properties: The DeRoyal Industries, Inc., Surgical Eye Spear is made of materials commonly used in predicate devices. The spear is comprised of cellulose and the handle is made of a high density plastic.
The provided 510(k) summary for the DeRoyal Industries, Inc., Surgical Eye Spear primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria. This type of submission relies on comparative data for device characteristics and biocompatibility testing to show safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific quantitative performance metrics in a clinical study. Instead, acceptance is based on demonstrating the device is substantially equivalent to a legally marketed predicate device. The performance is assessed by comparing key characteristics and materials. Biocompatibility tests have acceptance criteria (e.g., "All test results were deemed acceptable"), but specific numerical thresholds are not provided in this summary.
| Characteristic / Test | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance (DeRoyal Surgical Eye Spear) |
|---|---|---|
| Functional Equivalence | Same function as predicate | Functions in the same manner as predicate devices to absorb fluids. |
| Sponge Material | Same as predicate (Cellulose) | Cellulose |
| Handle Material | Same as predicate (High Density Polyethylene) | High Density Polyethylene |
| Shape | Same as predicate (Triangular Sponge Head) | Triangular Sponge Head |
| Sponge Tip Measurements | Approximately same as predicate | 11/16 inch (length), 9/32 inch (width) |
| Plastic Handle Measurements | Approximately same as predicate | 2-3/16 inch (length), .092-.125 inch (diameter) |
| Sizes | Same as predicate (One Size) | One Size |
| Sterility | Sterile, SAL 10⁻⁶, compliant residue levels | Sterile, Ethylene Oxide with SAL of 10⁻⁶, meets proposed maximum residual limits |
| Biocompatibility (Cytotoxicity) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Sensitization) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Intraocular Irritation) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Systemic Injection) | Acceptable per ISO 10993-1 & USP Class VI | Deemed acceptable |
| Biocompatibility (Hemolysis) | Acceptable per ISO 10993-1 | Deemed acceptable |
| Biocompatibility (Intracutaneous Toxicity) | Acceptable Per USP Class VI | Deemed acceptable |
| Biocompatibility (Intracutaneous Implantation) | Acceptable Per USP Class VI | Deemed acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Data was not required for this submission." This means there was no clinical test set for evaluating device performance in a real-world scenario (e.g., on human patients). The "test set" for demonstrating substantial equivalence was effectively the predicate device's specifications and the results of the specified bench-top and in-vitro biocompatibility tests.
- Sample Size for Test Set: Not applicable for clinical performance. For biocompatibility, the number of samples used for each test is not specified, but the tests were performed "to assure the safety and biocompatibility."
- Data Provenance: The biocompatibility tests would have been performed in a laboratory setting (in-vitro and in-vivo animal models for some tests like systemic injection). The country of origin for these lab tests is not specified. The data is retrospective in the sense that it refers to tests performed on the device or its materials, not ongoing clinical observations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical data was required, there was no "ground truth" to establish from expert consensus regarding clinical performance. For the biocompatibility tests, the "ground truth" is established by the validated methodologies and acceptance criteria outlined in the referenced standards (ISO 10993-1, USP Class VI). The experts involved would be the certified laboratory personnel performing and interpreting these tests, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring adjudication of outcomes by experts. The biocompatibility test results would be interpreted against established standards by laboratory staff.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Data was not required for this submission." This type of study would involve human readers (e.g., surgeons) evaluating cases with and without AI assistance, which is outside the scope of this conventional medical device submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This device is a physical surgical tool, not an AI algorithm. Therefore, "algorithm only" performance is not relevant.
7. The Type of Ground Truth Used
The primary "ground truth" used for this submission is:
- Predicate Device Specifications: The established characteristics and performance of the legally marketed predicate device (Ultracell Medical Technologies K923922).
- Biocompatibility Standards: The established scientific and regulatory standards for biocompatibility (ISO 10993-1, USP Class VI) which serve as the "ground truth" for determining if the device materials are safe for biological contact.
8. The Sample Size for the Training Set
Not applicable. This device is a physical, non-software/AI product. There is no "training set" in the context of machine learning or AI. The design and manufacturing process are informed by general engineering principles and existing product knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for one. The "ground truth" for the device's design is the established practice and safety profile of the predicate device and the materials used in current medical devices.
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.