SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE

K132681 · Sol-Millennium Medical, Inc. · MEG · May 22, 2014 · General Hospital

Device Facts

• Record ID: K132681
• Device Name: SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
• Applicant: Sol-Millennium Medical, Inc.
• Product Code: MEG · General Hospital
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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.

Device Story

Sol-Guard Safety Syringe is a sterile, single-use piston syringe with an integrated, manually activated safety shield. Device is used for delivery of U-100 insulin or Tuberculin. Operation involves standard injection followed by user-actuated extension of the safety shield over the needle; shield is rotated left or right to lock in place, preventing needle re-exposure. Used in clinical or home settings by healthcare providers or patients. Safety shield reduces risk of accidental needle stick injuries during handling and disposal. Device is sterilized via Ethylene Oxide gas.

Clinical Evidence

No clinical data submitted. Safety and effectiveness supported by bench testing, including simulated use study per FDA guidance for sharps injury prevention features, and verification against ISO standards (ISO 7864, 7886, 8537, 10993-1, 23908).

Technological Characteristics

Piston syringe with integrated safety shield. Materials: Silicone oil lubricant. Standards: ISO 8537 (insulin), ISO 7886 (TB), ISO 10993-1 (biocompatibility), ISO 23908 (sharps protection), ISO 9626 (needle tubing). Sterilization: Ethylene Oxide (ISO 11135). Needle gauge: 25-29G. Needle length: 1/2"-1".

Indications for Use

Indicated for delivery of U-100 insulin or Tuberculin in patients requiring such injections. Includes integrated safety shield to prevent accidental needle sticks.

Regulatory Classification

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.

Predicate Devices

• Kendall Monoject Magellan Insulin and TB Safety Syringe (K061492)

Submission Summary (Full Text)

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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

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.

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 Use<br>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.<br><br>For TB Use<br>The 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 Use<br>The 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.<br><br>For TB Use<br>The 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:

1. 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;
- 7. 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"

9. FDA Guidance on the content of premarket notification

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

- 11. 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 [phone] or [phone] 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 [phone] or [phone] 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 [e-mail]

"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

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## 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 [e-mail]

"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)

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