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.

Summary

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510(k) Summary:

Owner:

Network Medical Products, Ltd. Coronet House, Kearsley Road Ripon, North Yorkshire HG4 2SG, UK

Phone: (44) 01765 609555

Submission contact: Alison March Senior QA/RA Manager Alison.M@networkmedical.co.uk (44) 01765 609555

OCT 2 9 2013

Date prepared: October 27, 2013

Device Common Name: Ophthalmic Sponge

Device Proprietary Name: Network Eye Spears, Points, Wicks and Shields

Classification: Class II

Regulation Number: 886.4790

Product Code: HOZ

Predicate Devices:

Ultracell Medical Technologies, Inc., Ophthalmic Sponges, K920354 Ultracell Medical Technologies, Inc., Surgical Spears, K923922 DeRoyal Industries, Inc., Surgical Eye Spears, K972693 Hurricane Medical, Inc., Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, K990671

Indication for Use:

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

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

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

Description:

Comparison to Predicate Devices:

Network Eye Spears, Points, Drains, Wicks and Shields are equivalent to the predicates in intended use, design, and component materials as tabulated below.

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Comparison to Predicates:

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Characteristics	Network Eye Spears,Points, Wicks, Drainsand ShieldsK130117	Ultracell EyeSpears, Points,Wicks, Drains andShieldsK920354 &K923922	DeRoyal SurgicalEye SpearK972693	Hurricane MedicalSurgical Spears andSponges, CornealLight Shield,Drainage WickK990671
Indications foruse	Eye Spears and Points:Indicated for allmicrosurgicalophthalmic proceduresfor tissue manipulationand management offluids in the operativefield.Wicks and Drains:Indicated for allmicrosurgicalophthalmic proceduresfor management offluids in the operativefield.Shields: Indicated forplacement on thecornea to moisten thecornea and shield theretina from intenseoperating light duringophthalmic surgery.	Fluid control andtissue manipulation ofthe surface of the eyeduring eye surgery.	Used to absorbfluids from theoperative fieldduring ophthalmicand microscopicsurgical procedures.	Used to removeexcess fluid anddebris from thesurgical area orinstrument. Also,placed on the corneato moisten the corneaand protect the retinafrom the intenseoperating light duringophthalmic surgery.
Biocompatibility	Acceptable resultsaccording to FDA BlueBook Memo, G95-1, onuse of ISO 10993-1tests.	Acceptable resultsaccording to FDABlue Book Memo,G95-1, on use of ISO10993-1 tests.	Acceptable resultsaccording to FDABlue Book Memo,G95-1, on use ofISO 10993-1 tests.	Unknown
Principles ofoperation	Dry sponge wickingaction removes fluid;triangular shape optionallows for targetedabsorption whereneeded; sponge shieldis physical barrier forreduction of light.	Dry sponge wickingaction removes fluid;triangular shapeoption allows fortargeted absorptionwhere needed;sponge shield isphysical barrier forreduction of light.	Dry sponge wickingaction removesfluid; triangularshape option allowsfor targetedabsorption whereneeded.	Dry sponge wickingaction removes fluid;triangular shapeoption allows fortargeted absorptionwhere needed;sponge shield isphysical barrier forreduction of light.
Sponge material	Polyvinyl Alcohol(formalized) Spongeand Cellulose Sponges	Polyvinyl Alcohol(formalized) Spongeand CelluloseSponges	Cellulose Sponge	Hydrocellulose, PVASponge, viscose andUS-origin cotton
Handle material,spears	Polypropylene	Polypropylene	High density plastic	Plastic
Sterility	E-Beam Radiation,SAL 106; Sterile BarrierPackaging	E-beam Radiation,SAL 106; SterileBarrier Packaging	Eto, SAL 106;Sterile BarrierPackaging	Gamma Radiation,SAL 106; SterileBarrier Packaging

Non-clinical Testing:

Non-clinical testing for biocompatibility, sterility, and product/package stability was submitted to demonstrate substantial equivalence to the predicate devices, as detailed below. No clinical tests were submitted.

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1. Biocompatibility

PVA:

Biocompatibility tests recommended in ISO 10993 with the additional tests recommended in Blue Book Memo, G95-1, for evaluation of devices in contact with mucosal membranes or breached or compromised surfaces for a limited duration, were submitted for PVA Sponge and results found to be acceptable; Cytoloxicity, Sensitization, Primary Skin Irritation, Acute Systemic Toxicity, Limulus Amebocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP PVA Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Polyvinyl Alcohol (formalized) Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicate devices).

Cellulose:

Biocompatibility tests submitted for NMP Cellulose Sponge devices, together with the long history of safe clinical use of cellulose sponge, support the conclusion that NMP Cellulose Sponge devices do not produce adverse local or systemic effects when in limited duration contact with mucosal membranes or breached or compromised surfaces: Cytoloxicity, Sensitization. Limulus Amebocyte Lysate (LAL, Gel Clot Method) testing to measure post-sterilization endotoxin demonstrates that NMP Cellulose Sponge devices are below the maximum specification limit of 20 EU/device. These biocompatibility tests demonstrate that NMP Cellulose Sponge devices are as safe as the predicate devices in that they are biocompatible for the intended use (as are the predicates).

2. Sterility

Network ophthalmic sponge products will be sterlized with electron beam radiation to an SAL of 10". In accordance with the requirements of ISO 11137-1:2006 and ISO 11137-2:2012, a Method 1 sterilization validation supports the SAL of 10°. These submitted results demonstrate that NMP Ophthalmic Sponge devices are as safe as the predicate devices in that they are sterlized by the same method (radiation) and to the same sterility assurance (10) as predicate devices K920354, K923922 and K990671; and in the case of predicates K920354 & the same radiation source (electron beam).

3. Product/Package Stability (Shelf Life)

Package integrity and product functionality testing performed on accelerated-aged product; manufactured, packaged and sterilized under normal production conditions: demonstrates that NMP Ophthalmic Sponge devices are functional for the defined shelf life of the product packaging provides a sterile barrier for the defined shelf life of the product. The shelf life testing submitted demonstrates that NMP Ophthalmic Sponge devices are as effective and perform as well as the predicate devices in that they are maintained as functional and in sterile condition by the sterile barrier packaging (as are the predicates).

Conclusion:

Network Eye Spears, Points, Wicks and Shields are equivalent to the predicates in intended use, design, and component materials, and are identical in raw material and components to predicate devices K920354 &K923922. Non-clinical testing demonstrates that manufacturing processes undertaken by NMP produce substantially equivalent devices that are as safe, as effective, and perform as well as the predicates as follows:

Biocompatibility tests demonstrate that NMP Ophthalmic Sponge devices are as . safe as the predicate devices in that they are biocompatible for the intended use (as are the predicates).
. NMP Ophthalmic Sponge devices are as safe as the predicate devices in that they are sterilized by the same method (radiation) and to the same sterility assurance (108) as predicate devices K920354, K923922 and K990671; and in the case of predicates K920354 &K923922, by the same radiation source (electron beam).
. Shelf life testing submitted demonstrates NMP Ophthalmic Sponge devices are as effective and perform as well as the predicate devices in that they are maintained as functional and sterile by the sterile barrier packaging (as are the predicates).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

October 29, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Network Medical Products, Ltd % Ms. Alison March Senior QA/RA Manager Coronet House, Kearslev Road Ripon, North Yorkshire HG4 2SG, United Kingdom

Re: K130117

Trade/Device Name: Network Eye Spears. Points. Drains, Wicks and Shield Regulation Number: 21 CFR 886.4790 Regulation Name: Sponge, Ophthalmic Regulatory Class: Class II Product Code: HOZ Dated: September 17, 2013 Received: September 17, 2013

Dear Ms. March:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract. Iiability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Alison March

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -S

· for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K130117

Device Name: Network Eye Spears, Points, Wicks, Drains and Shields

Indications for Use:

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.

Prescription Use X (part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

)ア

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) :

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid.Livshitz

S
2013:10.23
'00'04-14:24:33

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K130117

page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.