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.

AI/ML Overview

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, <85> 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, <789> Particulate Matter in Ophthalmic Solutions	Microscopic Particle Count tested per USP <789>. (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 <789>) 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.

Summary

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510(k) Summary

ﺎﺭ ﮨﮯ

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

K132796 The assigned 510(k) Number: _

Date of Submission: 08/20/2013 1.

OCT 3 0 2013

Sponsor Identification 2.
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China.

Establishment Registration Number: 3007735241

Contact Person: Wei Lu Position: Development Engineer Tel: 86 752 530201 3 Fax: 86 752 5302020 Email: wlu@foryougroup.com

Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 . Email: info@mid-link.net

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1. Proposed Device Identification
  Proposed Device Name: SUNTOUCH® Eye Spear Proposed Device Model: ES1001A-P, ES1001A-P, ES1002A-B, ES1002A-P, ES1002A-P, ES1002B, ES1003B

Proposed Device Common Name: Eye Spear

Regulatory Information: Classification Name: Sponge, Ophthalmic; Classification: II; Product Code: HOZ; Regulation Number: 886.4790; Review Panel: Ophthalmic;

Intended Use Statement: The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.

1. Predicate Device Identification
  510(k) Number: K002279 Product Name: ML Eye Spear Manufacturer: Med-Logics, Inc
Device Description 6.
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.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin 3-2

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sensitization.

ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.

ASTM FI140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.

ASTM F1929-12, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.

BS EN 13726-1: 2002, Test methods for primary wound dressings -Part 1: Aspects of absorbency USP 35-NF30:2012, <85> Bacterial Endotoxins Test.

USP 35-NF30:2012, < 789> Particulate Matter in Ophthalmic Solutions

And following physical properties tests were conducted: absorption capacity, release of particulates, wicking rate. pore size, dry density, pH and formaldehyde residues in aqueous extracts, mechanical strength of sponge-handle attachment, and visual inspection for rough edges. The test results demonstrated that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

Substantially Equivalent (SE) Conclusion 8.

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device(s)
Product Code	HOZ	Same
Regulation Number	21 CFR 886.4790	Same
Intended Use	The Eye Spears are designed to absorb fluids andremove debris from the operative field orinstruments during ophthalmic surgery.	Same
Configuration	Expansive sponge and plastic handle	Same
Performance	Absorbency tested per BS EN 13726-1Microscopic Particle Count tested per USP <789>	Similar
Material	Expansive sponge: PVA	Same
	Handle: PP	Same
Biocompatibility	Comply with ISO 10993-5 and ISO 10993-10.	Same
Single Use	Yes	Same
Sterilization	Method: RadiationSAL: 10-6	Same
Shelf Life	5 years	Same
Label and Labeling	Meet FDA's Requirements	Same

Table 3-1 Comparison of Technology Characteristics

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The proposed device, SUNTOUCH® Eye Spear, is determined to be Substantially Equivalent (SE) to the predicate device(s), ML Eye Spear (K002279), in respect of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.

October 30, 2013

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

Huizhou Foryou Medical Devices Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. BOX 120-119. Shanghai, 200120, China

Re: K132796 Trade/Device Name: Suntouch® Eye Spear Regulation Number: 21 CFR 886.4790 Regulation Name: Sponge, Ophthalmic Regulatory Class: Class II Product Code: HOZ Dated: August 28, 2013 Received: September 6, 2013

Dear Ms. Hong:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability 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 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.

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Page 2 - Ms. Diana Hong

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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic. 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: K132796

Device Name: Device Name: SUNTOUCH® Eye Spear

Indications for Use:

The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.

Prescription Use_ × (part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

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

Concurrence of Center of Devices and Radiological Health (CDRH)

Leonid Livshitz-S
2013:10:24
'00'04-09:17:34

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

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.