K Number
K153553
Device Name
SiO2 Coated syringe 3 ml
Date Cleared
2016-05-17

(158 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.
Device Description
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.
More Information

No
The device description and performance studies focus on the physical properties and functionality of a standard syringe, with no mention of AI or ML capabilities.

No
The device is a syringe used for injecting or withdrawing fluids, which is a delivery mechanism, not a therapeutic action itself.

No

Explanation: The device is described as a syringe used for injecting or withdrawing fluids, and its testing primarily focuses on mechanical performance and sterility standards. There is no mention of it being used to diagnose conditions or process diagnostic data.

No

The device description clearly states it is a physical syringe made of plastic and coated internally with silica glass layers, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "to inject fluids into, or withdraw fluids from, the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic procedures, not for examining specimens in vitro (outside the body).
  • Device Description: The description details a syringe, a tool for administering or collecting substances from the body. It doesn't mention any components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Providing diagnostic information based on the analysis of specimens
    • Reagents or test kits
    • Calibration or quality control procedures for diagnostic testing

The device is clearly described as a syringe for manual use, which falls under the category of general medical devices used for procedures involving the body directly.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FMF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:
Bench testing was performed to demonstrate that the subject device meets the ISO 7886-1 and other applicable standards.
Tests included:

  • ISO 7886-1- Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use (Sections 5, 6 & Annex A, 7 & Annex A, 8, 9, 10.1, 10.2, 10.3, 10.4, 11.1, 11.2, 12.1, 12.2, Annex G, 12.3, 13.2, 13.3, 14.1 - Annex C, 14.2 - Annex D, 14.2 - Annex B)
  • ISO 594 - 1 and -2 - Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1 and Part 2 (Sections 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8)
  • 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
  • Ink adhesion and Wipe & Tape Test Report
  • Plunger Force Test
  • Physical Characteristics Test
  • Syringe Dimensions
  • Plunger Force Test
  • FTIR Test method for coating chemistry

Biocompatibility testing:

  • 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)

Key results:
The performance testing, design and features, and non-clinical testing demonstrated that the SiO2 Coated Syringe 3 mL is substantially equivalent to the predicate device. The materials in fluid contact were evaluated and found to be non-reactive.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110771

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K111091

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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.

1

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

3

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

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

Device Description:

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.

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 of
Comparison | Subject Device | Becton Dickinson Single Use Syringe
K110771 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Syringe Type | Piston Syringe - FMF | Piston Syringe - FMF |
| Intended Use(s) | The SiO2 Coated Syringe 3 mL is intended to
be used to inject fluids into, or withdraw
fluids from, the body. | For use by health care professionals for
general purpose fluid aspiration/injection. |
| Length | 82.77mm | 79.3 – 80.7mm |
| Barrel diameter | ID: 8.62mm
OD: 11.34mm | ID: 8.5 – 8.7mm
OD: 10.0 – 10.2mm |

Table 1 - Substantial Equivalence Comparative Table

4

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

| Element of
Comparison | Subject Device | Becton Dickinson Single Use Syringe
K110771 |
|----------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Finger Grip Size and
Shape | Length: 24.64 – 25.14mm
Width: 14.43 - 14.93mm
Thickness: 1.85-2.11mm | Length: 24.33 - 24.59mm
Width: 12.57 – 12.83mm
Thickness: 1.85-2.11mm |
| Tip type | Centric - male luer lock
Complying with ISO 594-1, -2 | Centric - male luer lock
Complying with ISO 594-1,-2 |
| Volume | 3 mL | 3 mL
Plus 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 N
Plunger Deploy:
Fi=2.35 N, Fm=0.58 N | Plunger Withdraw:
Fi=1.18 N, Fm=1.48 N
Plunger Deploy:
Fi=2.21 N, Fm=1.68 N |
| Barrel transparency | Transparent and Clear | Transparent and Clear |
| Delivery accuracy | Complies with ISO 7886-1
ISO 7886-1 | Complies with ISO 7886-1
ISO 7886-1 |
| Labeling | ISO 7886-1
ISO 15223-1
21 CFR Part 801 | 21 CFR Part 801 |
| Sterilization | E-beam Irradiation sterilization 25KGy;
achieving 10-6 SAL | Ethylene Oxide or Irradiation sterilization
10-6 SAL |
| Shelf-life and
Age testing | 12 months empty | |
| Mechanical and
environmental
stressors | Mechanical force
Freeze / thaw testing | |
| Verification of coating
chemistry | 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.

5

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 (