For Insulin Use: The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.
For TB Use: The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.

Device Description

The Sol-Guard Safety Syringe is a sterile, single use, standard hypodermic syringe with an attached Safety Shield to cover the needle. The Sol-Guard Safety Syringe will be labeled as either an Insulin Safety Syringe for U-100 insulin or as a Tuberculin Safety Syringe. The Safety Shield is extended by the user's finger or thumb. To lock the Safety Shield in place, the user turns the Safety Shield either right or left until it locks in place. Once the Safety Shield is locked in place, the Safety Shield can't be pulled back exposing the needle. The Safety Shield on the Sol-Guard Safety Syringc covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Sol-Guard Safety Syringe are sterilized by Ethylene Oxide Gas and I the Dot Gaire Saile Sare pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Sol-Guard Insulin and Tuberculin Safety Syringe, based on the provided text:

Sol-Guard Insulin and Tuberculin Safety Syringe: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding numerical performance results for the device itself. Instead, it states that the device "met the appropriate requirements contained in the following standards." The reported device performance is implicitly that it complies with these standards.

Feature/Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Safety Syringe Functionality	Device ensures the Safety Shield covers the needle after use and guards against accidental needle stick when activated.	Met: "The Safety Shield on the Sol-Guard Safety Syringe covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination."
Material Biocompatibility	Complies with ISO 10993-1.	Met: "ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing"
Terminal Sterilization	Complies with ISO 11135.	Met: "ISO 11135:2007, Medical Apparatus - Epoxy Ethane Sterilization Confirmation and Routine Control"
Packaging for Sterilized Devices	Complies with ISO 11607-1.	Met: "ISO 11607-1.- 1:2006. Packaging for terminally sterilized medical devices"
Sharps Injury Protection	Complies with ISO 23908.	Met: "ISO 23908:2007, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles. introducers for catheters and needles used for blood sampling"
Hypodermic Needles	Complies with ISO 7864.	Met: "ISO 7864:1993. Sterile Hypodermic Needles for Single Use;"
Hypodermic Syringes (General)	Complies with ISO 7886.	Met: "ISO 7886:1993, Sterile Hypodermic Syringes for Single Use" (for TB use)
Insulin Syringes	Complies with ISO 8537.	Met: "ISO 8537:2007, Sterile, Single-Use Syringes, with or without Needle, for Insulin."
Stainless Steel Needle Tubing	Complies with ISO 9626.	Met: "ISO 9626:1991, Stainless Steel Needle Tubing for Manufacture of Medical Devices;"
FDA Guidance (Needles)	Complies with FDA Guidance on hypodermic single lumen needles (April 1993).	Met: "FDA Guidance on the content of premarket notification [510(k)] submissions for hypodermic single lumen needles, April, 1993."
FDA Guidance (Sharps Injury Prevention)	Complies with FDA Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features (August 9, 2005).	Met: "A Simulated Use Study was conducted with the Sol-Guard Safety Syringe per the requirements of the FDA's Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features."
Overall Product Specifications	Meets all product specifications and requirements.	Met: "The device has been tested and found to meet all product specifications and requirements."
Performance over Device Life	Verified through accelerated aging.	Met: "Accelerated aging was used to verify the performance of the product over the life of the device."

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

The document does not explicitly state the specific sample sizes used for the "Simulated Use Study" or for testing adherence to the various ISO standards. It mentions a "Simulated Use Study" but does not detail its methodology, sample size, or data provenance (e.g., country of origin, retrospective or prospective nature). The other tests refer to compliance with standards, which would imply a certain number of units were tested, but these numbers are not provided.

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

This information is not provided. The study mentioned is a "Simulated Use Study," likely evaluating the safety feature, but no details about experts establishing ground truth or their qualifications are given. For general compliance with ISO standards, the "ground truth" is defined by the standard's specifications and test methods, not typically by expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

This information is not provided. There is no mention of an adjudication method for the "Simulated Use Study" or any other tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on substantial equivalence to a predicate device and adherence to safety and performance standards rather than comparing the device's diagnostic or therapeutic effectiveness in a clinical setting with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable as the device is a physical medical device (safety syringe), not an algorithm or AI software. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.

7. Type of Ground Truth Used

For the various ISO and FDA guidance documents, the "ground truth" is defined by the specifications and test methods outlined within those standards and guidance documents. For example, the ground truth for "hub/needle bond strength" is achieving the strength specified in ISO 8537 (Insulin) & ISO 7886 (TB). The "Simulated Use Study" would have an implied ground truth related to the successful activation and prevention of needle sticks as per the FDA Guidance for Sharps Injury Prevention, but the specific metrics used to define this "ground truth" are not detailed.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This information is not applicable, as there is no "training set" for this physical medical device.

Summary

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K132681 510(k) Summary (As required by 21 CFR 807.92(a))

Summary of Safety and Effectiveness for the Sol-Guard Insulin and Tuberculin Safety Syringe

Date Prepared: August 26, 2013

Submitter Information A.
Sol-Millennium Medical. Inc. 5415 Sugarloaf Parkway Suite 2203 Lawrenceville, GA 30043 Phone Number:

· Trade Name:

B. Device Information

Trade/Proprietary Name:

Common name of device: Classification Name: Product Code: Regulatory Class: Classification Number: Reason for 510(k):

949-433-3058

Sol-Guard Insulin and Tuberculin Safety Syringes

Sol-Guard Insulin and Tuberculin Safety Syringes Piston syringe with safety feature Piston syringe 80 MEG l I 880.5860 New device

C. Predicate Device: Kendall Monoject Magellan Insulin and TB Safety Syringe

Predicate 510(k) #: Predicate product code:

K061492 MEG

D. Device Description

pg 221 of 257

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The Safety Shield on the Sol-Guard Safety Syringc covers the needle point after use. In the activated position, the Safety Shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Sol-Guard Safety Syringe are sterilized by Ethylene Oxide Gas and I the Dot Gaire Saile Sare pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.

Statement of Indications for Use E. For Insulin Use

The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin.

The Sol-Guard Insulin Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.

For TB Use

The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin.

The Sol-Guard TB Safety Syringe Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.

Comparison of Required Technological Characteristics: F.

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-Guard Insulin and TB Safety Syringe and the Kendall Monoject Insulin and TB Safety Syringes. The following comparison chart shows that the subject device and the predicate device are substantially equivalent:

Pg 222 of 257

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Feature	Sol-Guard Insulin and TB Safety Syringes	Kendall Monoject Insulin and TB Safety Syringe
Syringe type	Piston syringe with Safety Shield	Piston syringe with Safety Shield
Intended Use	For Insulin UseThe Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 Insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.For TB UseThe Sol-Guard Insulin Safety Syringe is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.	For Insulin UseThe device is intended for the delivery of U-100 Insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.For TB UseThe device is intended for the delivery of Tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle sticks.
Principal of operation	The Sol-Guard Safety Syringe is a standard syringe with a shield. The shield can be extended to cover the needle for transport. In addition, once the injection is given, the shield is extended and rotated left or right and locked in place for disposal. The shield is designed to reduce needle stick injuries.	The Kendall Monject Safety Syringe is a standard syringe with a shield. The shield can be extended to cover the needle for transport. In addition, once the injection is given, the shield is extended and rotated left or right and locked in place for disposal. The shield is designed to reduce needle stick injuries.
Specific drug use	Insulin and Tuberculin	Insulin and Tuberculin
Needle
Needle Length	1/2" – 1"	5/16"-5/8"
Needle Gauge	25 – 29	25 – 30
Nozzle type	Needle Hub	Needle Hub
Tip Configuration	15 degree regular point	15 degree regular point
Hub/needle bond strength	ISO 8537(Insulin) & ISO 7886 (TB)	ISO 8537(Insulin) & ISO 7886 (TB)
Barrel
Barrel marking specs	ISO 8537(Insulin) & ISO 7886 (TB)	ISO 8537(Insulin) & ISO 7886 (TB)
Graduations legibility	ISO 8537(Insulin) & ISO 7886 (TB)	ISO 8537(Insulin) & ISO 7886 (TB)
Barrel transparency	Clear	Clear
Lubricant composition	Silicone Oil	Silicone Oil
Lubricant amount cm2	ISO 8537(Insulin) & ISO 7886 (TB)	ISO 8537(Insulin) & ISO 7886 (TB)
Syringe requirements
Delivery accuracy	ISO 8537(Insulin) & ISO 7886 (TB)	ISO 8537(Insulin) & ISO 7886 (TB)
Packaging	Blister Pack	Blister Pack
Sterilization	ETO	ETO
Biocompatibility	ISO 10993-1	ISO 10993-1
Labeling	21 CFR Part 801	21 CFR Part 801

Pg. 223 of 29

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Summary and Conclusion of Nonclinical and Clinical Tests: G.

The Sol-Guard Insulin and Tuberculin Safety Syringes met the appropriate requirements contained in the following standards:

ISO 7864:1993. Sterile Hypodermic Needles for Single Use;

ISO 7886:1993, Sterile Hypodermic Syringes for Single Use 2.

ISO 8537:2007, Sterile, Single-Use Syringes, with or without Needle, や for Insulin.

11607-1.- 1:2006. Packaging for terminally sterilized medical devices 4.

ISO 11135:2007, Medical Apparatus - Epoxy Ethane Sterilization ง Confirmation and Routine Control

ISO 9626:1991, Stainless Steel Needle Tubing for Manufacture 6. of Medical Devices;
1. ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing
ISO 23908:2007, Sharps injury protection Requirements and test 8. methods - Sharps protection features for single-use hypodermic needles. introducers for catheters and needles used for blood sampling"

FDA Guidance on the content of premarket notification

[510(k)] submissions for hypodermic single lumen needles, April, 1993.

1. Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features. Document Issued on: August 9, 2005
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. Accelerated aging was used to verify the performance of the product over the life of the device.

Instructions for Use detail how to use the devices and the conditions of use. Product labeling clearly shows that the device is for single patient use only.

A Simulated Use Study was conducted with the Sol-Guard Safety Syringe per the requirements of the FDA's Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features.

After review of the Risk Analysis, all verification and validation test data and reports, the conclusion of the Design Review Committee was that the Sol-Guard Safety Syringe is safe and effective for its intended use and is as safe and effective as the predicate device.

Pg 224 of 259

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Public Health Service

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

May 22, 2014

Sol-Millennium Medical, Incorporated Mr. Jim Barley Director of Regulatory Affairs and Quality Assurance 5415 Sugarloaf Parkway, Suite 2203 Lawrenceville, GA30043

Re: K132681

Trade/Device Name: Sol-Guard Insulin Safety Syringe and Tuberculin Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 21, 2014 Received: April 28, 2014

Dear Mr. 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.

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Page 2 - Mr. Brackett

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132681

Device Name

Sol-Guard Tuberculin (TB) Safety Syringe

Indications for Use (Describe)

The Sol-Guard Tuberculin (TB) Safety Syringe is intended for the delivery of Tuberculin.

The Sol-Guard TB Safety Syringe Safety Sleeve covers the needle when activated position, the Safety Shield guards against accidental needle stick.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CHARLES CONTRACTOR CONSTITUTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR A CAST Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/14 description: The image shows a logo with the letters FDA. The letters are blocky and stylized. The logo is black and white.

Digitally signed by Richard C. Chapman -S Date: 2014.05.22 12:51:35 -04'00'

This section applies only to requirements of the Papenwork 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, gether and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other assess 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 FDA 3881 (1/14)

ar Scripts (30)) 443 €740 P

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132681

Device Name

Sol-Guard Insulin Safery Syringe

Indications for Use (Describe)

The Sol-Guard Insulin Safety Syringe is intended for the delivery of U-100 insulin.

The Sol-Guard Insulin Safety Syringe Safety Sleeve covers the necivated. In the activated position, the Safety Shield guards against accidental needle stick.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

STATUS CARDER FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR A Castella Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.05.23 09:06:36 -04'00'

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

DO NOT SEND YOUR CORPLETED 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 deta 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 FDA 3881 (1/14)

Page 1 of 1

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).