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Network Eye Spears and Points: Indicated for all microsurgical ophthalmic procedures for tissue manipulation and management of fluids in the operative field.

Network Wicks and Drains: Indicated for all microsurgical ophthalmic procedures for management of fluids in the operative field.

Network Shields: Indicated for placement on the cornea to moisten the cornea and shield the retina from intense operating light during ophthalmic surgery.

Device Description

Network Eve Spears, Points, Drains, Wicks and Shields are single devices designed for tissue manipulation, fluid management and shielding of light in ophthalmic surgery. Spears and points consist of a triangle of dry Polyvinyl Alcohol (formalized) Sponge (PVA) or Cellulose sponge, either attached to a polypropylene handle for handling or separate to be picked up by forceps. The triangular shape allows the surgeon to carry out pinpoint absorption of liguid. Drains and Wicks are PVA Sponges in various sizes and shapes for wicking of fluid away from the operative field. Shields are circular-shaped PVA Sponges that moisten the cornea and reduce the light intensity on the retina during surgery.

AI/ML Overview

This submission, K130117, focuses on demonstrating substantial equivalence for the Network Eye Spears, Points, Wicks, Drains and Shields to existing predicate devices. It does not contain information about a study with acceptance criteria in the typical sense of measuring device performance against specific targets for diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are based on meeting established safety and performance benchmarks through non-clinical testing, primarily biocompatibility, sterility, and shelf-life, to show equivalence to legally marketed predicates.

Here's a breakdown of the requested information based on the provided text, with many points being "Not Applicable" (N/A) due to the nature of the device and the submission type:

Acceptance Criteria and Device Performance

This submission demonstrates substantial equivalence to predicate devices rather than proving performance against specific numerical acceptance criteria for a novel diagnostic or therapeutic effect. The "acceptance criteria" are the successful completion of non-clinical tests aligning with regulatory standards and showing comparability to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criterion (Generalized)	Reported Device Performance (Network Eye Spears, etc.)
Biocompatibility	Cytotoxicity	Acceptable results per ISO 10993 and Blue Book Memo, G95-1 (for mucosal membrane/compromised surface contact)	Acceptable results for both PVA and Cellulose sponges.
	Sensitization	Acceptable results per ISO 10993 and Blue Book Memo, G95-1	Acceptable results for both PVA and Cellulose sponges.
	Primary Skin Irritation	Acceptable results per ISO 10993 and Blue Book Memo, G95-1	Acceptable results for PVA sponge. (Cellulose supported by long history of safe clinical use).
	Acute Systemic Toxicity	Acceptable results per ISO 10993 and Blue Book Memo, G95-1	Acceptable results for PVA sponge.
	Endotoxin (LAL Test)	Below maximum specification limit of 20 EU/device	NMP PVA Sponge devices are below 20 EU/device. NMP Cellulose Sponge devices are below 20 EU/device.
Sterility	Sterility Assurance	Sterility Assurance Level (SAL) of 10^-6^	Achieved SAL of 10^-6^ via electron beam radiation, validated per ISO 11137-1:2006 and ISO 11137-2:2012 (Method 1). Same method and SAL as predicates K920354, K923922, K990671; same radiation source as K920354, K923922.
Product/Package Stability	Package Integrity	Packaging maintains sterile barrier for defined shelf life.	Testing on accelerated-aged product manufactured, packaged, and sterilized under normal conditions demonstrates packaging provides a sterile barrier for the defined shelf life.
	Product Functionality	Product remains functional for defined shelf life.	Testing on accelerated-aged product manufactured, packaged, and sterilized under normal conditions demonstrates product functionality for the defined shelf life.
Comparison to Predicate	Intended Use	Identical or equivalent to predicate devices.	Indications for use are equivalent to predicate devices.
	Design	Similar or equivalent features and materials to predicate devices.	Design (dry sponge wicking, triangular shape option, shield as physical barrier) and components (PVA and Cellulose sponge materials, polypropylene/plastic handle) are equivalent or identical (K920354 & K923922) to predicate devices.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This submission relies on non-clinical laboratory testing and comparison to predicate devices, not a clinical "test set" of patient data. The sample sizes for biocompatibility, sterility validation, and accelerated aging tests would be determined by relevant ISO standards, but specific numbers are not provided in the summary.
- Data Provenance: Not applicable in the context of patient data. The tests were performed by Network Medical Products, Ltd. as described in the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "ground truth" established by experts for a clinical test set in this submission; the evaluation criteria are defined by recognized standards (ISO 10993, ISO 11137, Blue Book Memo G95-1) for device safety and performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical "test set" requiring adjudication.
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 device is a manual surgical tool (sponges, wicks, shields) and does not involve AI or human readers for interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical tool and does not involve algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical ground truth. The "ground truth" for demonstrating equivalence is based on established regulatory standards and the known safety and performance of already-marketed predicate devices. For biocompatibility, laboratory assay results are the "truth." For sterility, established SAL is the "truth." For materials, the chemical composition and physical properties are the "truth."
The sample size for the training set:
- Not applicable. This submission does not involve a "training set" as it's not an AI/machine learning device. The "training" for the manufacturing process would be part of the quality system, but no specific data points are provided here.
How the ground truth for the training set was established:
- Not applicable.

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