The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries.

Device Description

The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is a sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is also designed to aid in the prevention of needle stick injuries. The retractable piston syringe is a plastic disposable syringe made of the following components: Barrel, Plunger, Stopper, Cannula, Locking Ring, Needle Cap, O-Ring, Protective Cap. After use, the health care professional firmly pushes the plunger past the zero line to engage the safety mechanism. Once the safety mechanism is engaged, pulling back the plunger causes the needle to be retracted into the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and the plunger are discarded into a sharps container. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle are sterilized by Ethylene Oxide and supplied sterile in a blister pack or tray pack.

AI/ML Overview

The provided document is for a medical device called "0.5ml Sol-Care™ Ret retractable Safety Syringes" and primarily focuses on its substantial equivalence to a predicate device for FDA clearance. Therefore, the information requested about acceptance criteria and study details related to performance metrics like sensitivity, specificity, or AI assistance is not typically found in this type of submission for a physical medical device.

However, I can extract information regarding performance in terms of meeting established standards for the device. The document explicitly states that the device met the requirements of several ISO standards.

Here's the closest representation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard Reference)	Reported Device Performance
ISO 7886:1993, Sterile Hypodermic Syringes for Single Use	Met the appropriate requirements (implies compliance with all specifications within the standard, e.g., sterility, fluid tightness, material properties, plunger operation, scale markings, etc. specific to single-use hypodermic syringes).
ISO 7886-4:2006, Sterile Hypodermic Syringes for Single Use Syringes with re-use prevention feature	Met the appropriate requirements (implies compliance with additional specifications for safety features preventing re-use, likely related to the retraction mechanism and its function).
ISO 11607-1,-1:2006, Packaging for terminally sterilized medical devices	Met the appropriate requirements (implies compliance with standards for maintaining sterility of the packaged device, integrity, and labeling).
ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization Confirmation and Routine Control	Met the appropriate requirements (implies successful sterilization using Ethylene Oxide and confirmation of its effectiveness).
ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing	Met the appropriate requirements (implies successful completion of biocompatibility tests such as Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Hemolysis tests without adverse reactions).
ISO 9626:1991, Stainless Steel needle tubing for the manufacture of medical devices	Met the appropriate requirements (implies the needle tubing conforms to the specified properties for stainless steel medical device needles).
All product specifications and requirements	The device has been tested and found to meet all product specifications and requirements.

Regarding the other points, the document states or implies the following limitations:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify sample sizes for each test in the ISO standards, nor the country of origin or whether the studies were retrospective or prospective. It only generically states that tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of device performance tests (e.g., sterility, material strength, retraction mechanism function), a "ground truth" established by experts in the clinical or diagnostic sense is not relevant. The ground truth is defined by the objective pass/fail criteria of the engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests against ISO standards typically involve objective measurements or pass/fail observations, not subjective adjudication methods.
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: Not applicable. This is a physical medical device (safety syringe), not an AI/software-based diagnostic or imaging device. There are no "human readers" or "AI assistance" involved in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as detailed above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly referred to is the objective criteria and methodologies defined within the cited ISO standards for device performance and safety (e.g., successful retraction, material biocompatibility limits, sterility assurance levels).
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details a regulatory submission for a physical medical device. Its "acceptance criteria" and "study" revolve around demonstrating compliance with established international standards for the design, manufacturing, and biological safety of such devices, rather than clinical performance metrics of an AI or diagnostic tool.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

August 19, 2016

Sol-Millennium Medical, Inc. Jim Barley Director Of RA/OA 1735 North Brown Road, Suite 120 Lawrenceville, Georgia 30043

Re: K162030

Trade/Device Name: 0.5ml Sol-Care™ Retractable Safety Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: July 14, 2016 Received: July 22, 2016

Dear Jim Barley:

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 devicerelated 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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

510(k) Number (if known)

K162030

Device Name

0.5ml Sol-CareTM Retractable Safety Syringes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	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 required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

{3}------------------------------------------------

Sol-Millennium Medical

	Special 510(k) Summary
	(As required by 21 CFR 807.92(a))
	Date Prepared: August 16, 2016
A.	Submitter Information
	Sol-Millennium Medical, Inc.1735 North Brown RoadSuite 120Lawrenceville, GA 30043Phone Number:	404-973-2200
	Trade Name:	0.5ml Sol-Care™ Retractable Safety Syringes
B.	Device InformationTrade/Proprietary Name:Common name of device:Regulation Name:Product Code:Regulatory Class:Regulation Number:Reason for 510(k):	0.5ml Sol-Care™ Retractable Safety SyringesPiston Syringe with Safety FeaturePiston SyringeMEGII880.5860Special 510(k) Device Modification to add 0.5mlSol-Care™ Retractable Safety Syringe
C.	Predicate Device:	1, 3, 5, 10 and 20ml Sol-Care™ Retractable SafetSyringeSyringes received marketing clearance onSeptember 4, 2009 under 510(k) # K092430.
	Predicate product code:	MEG

D. Device Description
The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is a sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is also designed to aid in the prevention of needle stick injuries.

{4}------------------------------------------------

The retractable piston syringe is a plastic disposable syringe made of the following components:

1. Barrel - The barrel has a scale showing the capacity of the syringe as well as the company brand name with the "Do Not Reuse" symbol.
1. Plunger - Once the plunger is fully depressed, it engages the needle assembly. As the plunger is retracted, the needle assembly is retracted into the barrel. Once the plunger is fully retracted and locked into place, the plunger is snapped off leaving the needle inside the barrel of the syringe.
1. Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger.
Cannula The cannula/needle penetrates the patient's skin to 4. inject/withdraw fluid from the body.
1. Locking Ring - A plastic insert at the top of the barrel. After the injection, the health care professional retracts the plunger with the needle into the barrel. Once the plunger is fully retracted, the plunger is locked onto position at the bottom of the barrel. This safety mechanism ensures the needle cannot be pushed back
1. Needle Cap - The Cap is used to cover and protect the tip of the cannula/needle from being damaged.
1. O-Ring – The O-Ring minimizes the risk of leakage around the adapter
1. Protective Cap - The Protective Cap prevents pre-engagement of the safety mechanism. Only provided with products packaged in a ten pack.

After use, the health care professional firmly pushes the plunger past the zero line to engage the safety mechanism. Once the safety mechanism is engaged, pulling back the plunger causes the needle to be retracted into the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and the plunger are discarded into a sharps container.

The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle are sterilized by Ethylene Oxide and supplied sterile in a blister pack or tray pack. One hundred syringes are packaged in a chipboard box. Each blister pack/tray pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

{5}------------------------------------------------

Sol-Millennium Medical

E. Statement of Indications for Use

The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries.

F. Comparison of Required Technological Characteristics
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle and the cited predicate device. The following comparison chart shows the subject device and the predicate device are substantially equivalent:

0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle versus 1, 3, 5, 10 and 20ml Sol-Care™ Retractable Safety Syringe

ELEMENT OFCOMPARISON	0.5ml Sol-Care™Retractable Safety Syringe	1, 3, 5, 10, 20ml Sol-Care™Retractable Safety Syringe(Predicate Device – 510(k)#K092430)	ComparisonSummary
Intended Use(s)	The 0.5ml Sol-Care™Retractable Safety Syringewith Fixed Needle is used toinject fluids into, orwithdraw fluids from, thebody. In addition, the 0.5mlSol-Care™ RetractableSafety Syringe with FixedNeedle is designed to aid inthe prevention of needlestick injuries.	The Sol-Care™ RetractableSafety Syringe is used toinject fluids into, orwithdraw fluids from, thebody. In addition, the Sol-Care™ Retractable SafetySyringe is designed to aid inthe prevention of needlestick injuries.	Identical
Principle ofOperation	After use, the plunger isfully retracted into the barrelproviding protection againstneedle sticks, rendering thedevice unusable.	After use, the plunger isfully retracted into the barrelproviding protection againstneedle sticks, rendering thedevice unusable.	Identical
Syringe Type	Piston	Piston	Identical

Side by Side Comparison Table

{6}------------------------------------------------

Tip Type	Fixed Needle	Fixed needle and Luer Lock	Similar
Volume	0.5ml	1, 3, 5, 10, and 20 ml	Similar
BarrelTransparency	Clear	Clear	Identical
Biocompatibility	Cytotoxicity Sensitization Study IrritationTest/IntracutaneousReactivity USP and ISOSystemic ToxicityStudies Haemolysis test	Cytotoxicity Sensitization Study IrritationTest/IntracutaneousReactivity USP and ISOSystemic ToxicityStudies Haemolysis test	Identical
Sterilization	ETO	ETO	Identical
Materials	Plunger, Barrel, Cap -PolypropyleneStopper - SantopreneThermoplastic ElastomerNeedle - Stainless steel	Plunger, Barrel, Cap -PolypropyleneStopper - SantopreneThermoplastic ElastomerNeedle- Stainless steel	Identical
Labeling	Per 21 CFR 801	Per 21 CFR 801	Identical

G. Summary and Conclusion of Nonclinical and Clinical Tests:

The 0.5ml Sol-Care™ Retractable Safety Syringe met the appropriate requirements contained in the following standards:

1. ISO 7886:1993, Sterile Hypodermic Syringes for Single Use
1. ISO 7886-4:2006, Sterile Hypodermic Syringes for Single Use Syringes with re-use prevention feature
1. ISO 11607-1,-1:2006, Packaging for terminally sterilized medical devices
1. ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization
Confirmation and Routine Control

ISO 10993-1:2006, Biological evaluation of medical devices Part 1:

Evaluation and testing

ISO 9626:1991, Stainless Steel needle tubing for the manufacture of medical devices

{7}------------------------------------------------

H. Discussion of Clinical Tests:
None submitted.

I. Conclusions Demonstrating Safety, Effectiveness and Performance:

The device has been tested and found to meet all product specifications and requirements. Product labeling clearly shows that the device is for single use only. After review of the Risk Analysis, all verification and validation test data and reports, the conclusion of the Design Review Committee was that the 0.5ml Sol-Care™ Retractable Safety Syringe 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).