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510(k) Data Aggregation
(54 days)
SUNTOUCH EYE SPEAR
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.
SUNTOUCH® Eye Spears are sterilized, single-use devices designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery. The Eye Spears include seven models which share same material. The models are different in size and configuration of plastic handle.
They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets them:
Note: The provided document describes a "Substantially Equivalent" (SE) determination, which focuses on comparing a new device to an existing legally marketed device (predicate device). This is different from a de novo premarket review where novel performance criteria might be established. Therefore, the "acceptance criteria" here largely refer to demonstrating comparable performance to the predicate device and compliance with relevant standards. The "study" is primarily a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5: 2009 (Tests for In Vitro cytotoxicity) | Complied with ISO 10993-5. |
| ISO 10993-10: 2010 (Tests for irritation and skin sensitization) | Complied with ISO 10993-10. |
| Sterility | |
| Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6. (Method: Radiation) |
| USP 35-NF30:2012, Bacterial Endotoxins Test | Test conducted. (Implicitly met, as overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device.") |
| Packaging & Shelf Life | |
| ASTM F88/F88M-09 (Seal Strength of Flexible Barrier Materials) | Test conducted. (Implicitly met, as overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device.") |
| ASTM FI140-07 (Reapproved 2012) (Internal Pressurization Failure Resistance of Unrestrained Packages) | Test conducted. (Implicitly met, as overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device.") |
| ASTM F1929-12 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Test conducted. (Implicitly met, as overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device.") |
| Shelf Life (5 years) | No specific test result stated, but "Shelf Life: 5 years" is listed as a characteristic that matches the predicate. Implicitly, design and materials support this shelf life. |
| Physical/Performance Properties (for fluid absorption and debris removal) | |
| BS EN 13726-1: 2002 (Test methods for primary wound dressings - Part 1: Aspects of absorbency) | Absorbency tested per BS EN 13726-1. (Results are considered "Similar" to predicate in comparison table, and overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device.") |
| USP 35-NF30:2012, Particulate Matter in Ophthalmic Solutions | Microscopic Particle Count tested per USP . (Implicitly met, as overall conclusion states device "met all design specifications as was Substantially Equivalent (SE) to the predicate device." and performance is "Similar" to predicate.) |
| Absorption capacity (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Release of particulates (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Wicking rate (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Pore size (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Dry density (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| pH and formaldehyde residues in aqueous extracts (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Mechanical strength of sponge-handle attachment (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Visual inspection for rough edges (physical property test) | Tested. (Implicitly met, as overall conclusion states device "met all design specifications.") |
| Overall | |
| Substantially Equivalent (SE) to predicate device (K002279) | Determined to be SE to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many eye spears were tested for absorbency, or how many units for sterility). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
Data Provenance: The tests were conducted by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd. located in China. The data would be considered prospective for the purpose of demonstrating the specified characteristics for this device submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of 510(k) submission. "Ground truth" established by experts is typically relevant for studies involving diagnosis, image interpretation, or clinical decision-making. This submission deals with the physical and biological properties of a medical device (eye spear). The acceptance criteria are based on established international and national standards (ISO, ASTM, USP, BS EN) and comparison to a predicate device, rather than expert consensus on a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. As the tests are non-clinical and objective (e.g., measuring absorbency, cytotoxicity), there is no "adjudication method" in the sense of resolving discrepancies between human interpretations of clinical data. The results would be objectively measured and compared against the defined standard or specification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiology interpretation). This 510(k) pertains to a non-diagnostic, single-use medical device (an eye spear) and does not involve AI or human interpretation in its intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical instrument, not a software algorithm or an AI-powered system, so the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this device is the objective measurement against established industry and regulatory standards, and comparison to the characteristics of the predicate device.
- For biocompatibility: Adherence to ISO 10993 standards.
- For physical properties (absorbency, particulate release, etc.): Measurement against specific test methods (e.g., BS EN 13726-1, USP ) and demonstration of comparable performance to the predicate device.
- For sterility: Achieving a defined SAL and passing endotoxin tests.
- For packaging: Passing specified ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or machine learning model, so there is no "training set" in the context of data used for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device, this question is not relevant.
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