SiO2 Coated Syringe 3 mL is a plastic disposable standard 3 mL piston syringe without needle is made of a cyclic olefin polymer (COP) and coated internally with silica glass layers. The layer is deposited by plasma enhanced chemical vapor deposition (PECVD) process.

This is a standard 3 mL single use, disposable syringe without needle.

AI/ML Overview

This document describes the non-clinical testing for the SiO2 Coated Syringe 3 mL to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists numerous tests and standards to which the device conforms. Instead of specific numerical acceptance criteria (which are typically defined within the standards themselves and not fully detailed here), the document generally states "Complies" or describes the test performed and implies compliance by its inclusion in the summary of successful non-clinical testing.

Acceptance Criteria (Standard & Section/Test)	Reported Device Performance
ISO 7886-1: Sterile hypodermic syringes for single use
Section 5, Cleanliness	Complies (Test Performed)
Section 6 & Annex A, Limits for Acidity or Alkalinity	Complies (Test Performed)
Section 7 & Annex A, Limits for Extractable Metals	Complies (Test Performed)
Section 8, Lubricant	Complies (Test Performed)
Section 9, Tolerance on Graduated Capacity	Complies (Test Performed)
Section 10.1, Scale	Complies (Test Performed)
Section 10.2, Numbering of Scale	Complies (Test Performed)
Section 10.3, Overall Length of Scale to Nominal Capacity Line	Complies (Test Performed)
Section 10.4, Position of Scale	Complies (Test Performed)
Section 11.1, Dimensions	Syringe Dimensions (Test Performed)
Section 11.2, Finger Grips	Complies (Test Performed)
Section 12.1, Design	Complies (Test Performed)
Section 12.2, Fit of Piston in Barrel	Complies (Test Performed)
Annex G, Force to Operate	Plunger Withdraw: Fi=2.11 N, Fm=2.39 N; Plunger Deploy: Fi=2.35 N, Fm=0.58 N (Reported values)
Section 12.3, Fiducial Line	Complies (Test Performed)
Section 13.2, Position of Nozzle on End of Barrel	Complies (Test Performed)
Section 13.3, Nozzle Lumen	Complies (Test Performed)
Section 14.1 - Annex C, Dead Space	Complies (Test Performed)
Section 14.2 - Annex D, Liquid Leakage Compression	Complies (Test Performed)
Section 14.2 - Annex B, Air Leakage past Syringe Piston during Aspiration	Complies (Test Performed)
ISO 594 - 1 and -2: Conical fittings with a 6 % (Luer) taper
Section 5.1, Gauging	Complies (Test Performed)
Section 5.2, Liquid Leakage	Complies (Test Performed)
Section 5.3, Air Leakage	Complies (Test Performed)
Section 5.4, Separation Force	Complies (Test Performed)
Section 5.5, Unscrewing Torque	Complies (Test Performed)
Section 5.6, Ease of Assembly	Complies (Test Performed)
Section 5.7, Resistance to Overriding	Complies (Test Performed)
Section 5.8, Stress Cracking	Complies (Test Performed)
Biocompatibility Testing (ISO 10993-1, G95-1)
Cytotoxicity: Elution Test, Serum Supplemented MEM Extract	Materials found to be non-reactive (Test Performed)
Skin Sensitization Test Protocol, Guinea Pig Maximization Test	Materials found to be non-reactive (Test Performed)
Intracutaneous (Intradermal) Reactivity Test	Materials found to be non-reactive (Test Performed)
Systemic Toxicity: Saline and Vegetable Oil Extracts	Materials found to be non-reactive (Test Performed)
Hemolysis Test (NIH Method) Saline Extract	Materials found to be non-reactive (Test Performed)
Extractable and Leachables (ISO 7886-1 coated/uncoated)	Complies (Test Performed)
USP Rabbit Pyrogen Test (Material Mediated)	Complies (Test Performed)
Bacterial Endotoxin-Mediated Pyrogen test (Limulus Amebocyte Lysate Test)	Complies (Test Performed)
Other Non-Clinical Testing
ASTM D4169-14: Performance Testing of Shipping Containers and Systems	Complies (Test Performed)
ASTM F1980-07 (2011): Accelerated Aging of Sterile Barrier Systems	Complies (Test Performed)
Real-time aging (24 months)	Complies (Test Performed)
Oxygen Transmission Rate ("OTR")	Complies (Test Performed)
Container compatibility with certain drug products	Complies (Test Performed)
Mechanical stressor	Complies (Test Performed)
Environmental stressor - freeze-thaw study	Complies (Test Performed)
Ink adhesion and Wipe & Tape Test Report	Complies (Test Performed)
Physical Characteristics Test	Complies (Test Performed)
Syringe Dimensions	ID: 8.62mm, OD: 11.34mm (Reported values)
Plunger Force Test	Fi=2.11 N, Fm=2.39 N, Fi=2.35 N, Fm=0.58 N (Reported values)
FTIR Test method for coating chemistry	Complies (Test Performed)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for each of the non-clinical tests. It lists the tests performed, implying that appropriate sample sizes per the respective standards (ISO, ASTM, etc.) were used. The data provenance is non-clinical bench testing, conducted by or on behalf of SiO2 Medical Products. The document does not specify countries of origin for the data, but it is implied to be from the manufacturer's testing or accredited labs. All data presented appears to be prospective in the sense that it was generated for this specific submission to demonstrate conformance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable to this submission. The tests are non-clinical engineering and biocompatibility tests against established international standards (ISO, ASTM, USP). Ground truth is established by the methods defined in these standards, not by expert consensus on clinical observations. The "experts" in this context would be laboratory technicians and engineers qualified to perform these specific tests according to the standard operating procedures.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical or diagnostic studies involving human interpretation. For non-clinical bench testing, results are typically determined by measurements against predefined acceptance criteria from the relevant standards.

5. 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

This section is not applicable. This submission is for a physical medical device (syringe) and does not involve AI, human readers, or diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This submission is for a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests listed is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 594, ISO 10993-1, ASTM D4169-14, ASTM F1980-07). For biocompatibility, this includes outcomes of biological assays (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity). For physical tests, it refers to quantitative measurements (e.g., dimensions, forces, leakage rates) meeting specified ranges or thresholds.

8. The Sample Size for the Training Set

This section is not applicable. This submission is for a physical medical device and does not involve a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable. This submission is for a physical medical device and does not involve a training set for an algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2016

SiO2 Medical Products c/o Mr. Paul Dryden Consultant 350 Enterprise Drive Auburn, Alabama 36830

Re: K153553

Trade/Device Name: SiO2 Coated Syringe 3 mL Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 15, 2016 Received: April 18, 2016

Dear Mr. Dryden:

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.

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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.

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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K153553

Device Name

SiO2 Coated Syringe 3 mL

Indications for Use (Describe)

The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.

Type of Use (Select one or both, as applicable) XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Page 1 of 4 16-May-16

SiO2 Medical Products350 Enterprise DriveAuburn, Alabama 36830	Tel – 334-321-5060Email: randy.crenshaw@sio2med.com
Official Contact:	Randy CrenshawDirector of Quality and Regulatory
Proprietary or Trade Name:	SiO2 Coated Syringe 3 mL
Common/Usual Name:	Syringe, Piston
Classification Name/Code:	FMF - Syringe, Piston21 CFR 880.5860Class II
Device:	SiO2 Coated Syringe 3 mL
Predicate Device:	K110771 – Becton Dickinson – Single Use syringe
Reference Device:	K111091 - Merit Medical Syringe

Device Description:

This is a standard 3 mL single use, disposable syringe without needle.

Indications for Use:

The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.

Contraindications

Do not use this syringe with sesame oil-based drugs.
. Do not use this syringe with non-polar solvents.

Discussion of Substantial Equivalence

Element ofComparison	Subject Device	Becton Dickinson Single Use SyringeK110771
Syringe Type	Piston Syringe - FMF	Piston Syringe - FMF
Intended Use(s)	The SiO2 Coated Syringe 3 mL is intended tobe used to inject fluids into, or withdrawfluids from, the body.	For use by health care professionals forgeneral purpose fluid aspiration/injection.
Length	82.77mm	79.3 – 80.7mm
Barrel diameter	ID: 8.62mmOD: 11.34mm	ID: 8.5 – 8.7mmOD: 10.0 – 10.2mm

Table 1 - Substantial Equivalence Comparative Table

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510(k) Summary Page 2 of 4 16-May-16

Element ofComparison	Subject Device	Becton Dickinson Single Use SyringeK110771
Finger Grip Size andShape	Length: 24.64 – 25.14mmWidth: 14.43 - 14.93mmThickness: 1.85-2.11mm	Length: 24.33 - 24.59mmWidth: 12.57 – 12.83mmThickness: 1.85-2.11mm
Tip type	Centric - male luer lockComplying with ISO 594-1, -2	Centric - male luer lockComplying with ISO 594-1,-2
Volume	3 mL	3 mLPlus various sizes
Barrel marking specs	Complies with ISO 7886-1	Complies with ISO 7886-1
Graduations legibility	Legible	Legible
Lubricant type	Silicone	Silicone
Plunger Operation(Fi and Fm Forces)	Plunger Withdraw:Fi=2.11 N, Fm=2.39 NPlunger Deploy:Fi=2.35 N, Fm=0.58 N	Plunger Withdraw:Fi=1.18 N, Fm=1.48 NPlunger Deploy:Fi=2.21 N, Fm=1.68 N
Barrel transparency	Transparent and Clear	Transparent and Clear
Delivery accuracy	Complies with ISO 7886-1ISO 7886-1	Complies with ISO 7886-1ISO 7886-1
Labeling	ISO 7886-1ISO 15223-121 CFR Part 801	21 CFR Part 801
Sterilization	E-beam Irradiation sterilization 25KGy;achieving 10-6 SAL	Ethylene Oxide or Irradiation sterilization10-6 SAL
Shelf-life andAge testing	12 months empty
Mechanical andenvironmentalstressors	Mechanical forceFreeze / thaw testing
Verification of coatingchemistry	Using FTIR Microscopy Test Method

The subject device is viewed as substantially equivalent to the predicate device because:

Indications for Use – The proposed indications for use are similar, in that they are to be used to inject fluids into, or withdraw fluids from, the body, also referred to as general purpose fluid aspiration/injection.

Discussion - The indications for use are similar for the subject device and the predicate -K110771 – BD single use syringe.

Technology – The basic design of the subject device is similar as the subject device complies with ISO 7886-1.

Discussion - The basic technology of a plunger style syringe is identical to the predicate. The technology of applying a glass coating to the inside of the barrel is different than the predicate but we have demonstrated that its performance is equivalent and complies with ISO 7886-1 as does the predicate - K110771 - BD Single Use Syringe. The difference in technology has been evaluated and do not raise any new questions related to risk, safety, or effectiveness.

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510(k) Summary Page 3 of 4 16-May-16

Materials – The materials in fluid contact have been evaluated in accordance to the suggestions of ISO 7886-1 and ISO 10993-1 and G95-1 which consider the patient contact as Externally communicating, Circulating blood with Limited duration (<24 hours).

We evaluated the subject device utilizing the following tests:

Cytotoxicity: Elution Test, Serum Supplemented MEM Extract ●
Skin Sensitization Test Protocol, Guinea Pig Maximization Test ●
Intracutaneous (Intradermal) Reactivity Test
Systemic Toxicity: Saline and Vegetable Oil Extracts
. Hemolysis Test (NIH Method) Saline Extract
Extractable and Leachables as described in ISO 7886-1 coated / uncoated .
. USP Rabbit Pyrogen Test (Material Mediated)
. Bacterial Endotoxin-Mediated Pyrogen test (Limulus Amebocyte Lysate Test)

Discussion - We performed the applicable testing for biocompatibility and the materials were found to be non-reactive. We have made reference to the Merit Medical Syringe K111091 which has similar indications for use and the barrel is made of Cyclo-olefin polymer. We included this reference device to support that the Cyclo-olefin polymer is not a new material for use in syringes.

Non-clinical Testing

We performed bench testing to demonstrate that the subject device meets the ISO 7886-1 and other applicable standards. Testing included:

Standard and Tests Performed
ISO 7886-1- Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
Section 5, Cleanliness
Section 6 & Annex A, Limits for Acidity or Alkalinity
Section 7 & Annex A, Limits for Extractable Metals
Section 8, Lubricant
Section 9, Tolerance on Graduated Capacity
Section 10.1, Scale
Section 10.2, Numbering of Scale
Section 10.3, Overall Length of Scale to Nominal Capacity Line
Section 10.4, Position of Scale
Section 11.1, Dimensions
Section 11.2, Finger Grips
Section 12.1, Design
Section 12.2, Fit of Piston in Barrel
Annex G, Force to Operate
Section 12.3, Fiducial Line
Section 13.2, Position of Nozzle on End of Barrel
Section 13.3, Nozzle Lumen
Section 14.1 - Annex C, Dead Space
Section 14.2 - Annex D, Liquid Leakage Compression
Section 14.2 - Annex B, Air Leakage past Syringe Piston during Aspiration
ISO 594 - 1 and -2 - Conical fittings with a 6 % (Luer) taper for syringes, needles and certain othermedical equipment -- Part 1 and Part 2
Section 5.1, Gauging
Section 5.2, Liquid Leakage

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510(k) Summary Page 4 of 4 16-May-16

Section 5.3, Air Leakage
Section 5.4, Separation Force
Section 5.5, Unscrewing Torque
Section 5.6, Ease of Assembly
Section 5.7, Resistance to Overriding
Section 5.8, Stress Cracking
ASTM D4169-14; Standard Practice for Performance Testing of Shipping Containers and Systems
Manual handling – drop test and second Drop Sequence
Vehicle stacking
Loose Load Vibration
Vehicle Vibration
Concentrated Impact

ASTM F1980-07 (2011); Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices
Real-time aging 24 months ●
Oxygen Transmission Rate ("OTR") ●
Container compatibility with certain drug products ●
Mechanical stressor
Environmental stressor - freeze-thaw study Summary
. Ink adhesion and Wipe & Tape Test Report
. Plunger Force Test
. Physical Characteristics Test
. Syringe Dimensions
Plunger Force Test .
. FTIR Test method for coating chemistry

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the SiO2 Coated Syringe 3 mL and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).