The Sol-Care Safety Hypodermic Needle is used in conjunction with a standard syringe. This device is used for aspiration and administration of medication.

The Sol-Care Safety Hypodermic Needle safety mechanism covers the needle after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

Device Description

The Sol-Care Safety Needle is a sterile, single use, standard hypodermic needle with a shield to enclose the needle after use. The device is available in 18 to 30 gauge and in lengths from 3/8" to 1-1/2". In addition, the needle tip is available in a regular bevel.

The Sol-Care Safety Needle has a shield that covers the needle point after use. In the activated position, the needle shield guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Sol-Care Safety Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister 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 the study information for the Sol-Care Safety Needle, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Met)	Reported Device Performance
ISO 7864:1993, Sterile Hypodermic Needles for Single Use	Met appropriate requirements
ISO 594-2:1998, Conical Fittings with a 6% (Luer) Taper	Met appropriate requirements
ISO 9626:1991, Stainless Steel Needle Tubing for Medical Devices	Met appropriate requirements
ISO 14971:2009, Medical Devices, Application of Risk Analysis	Met appropriate requirements
ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization	Met appropriate requirements
ISO 11607-1, 1:2006, Packaging for Terminally Sterilized Medical Devices	Met appropriate requirements
ISO 10993-1:2006, Biological Evaluation of Medical Devices Part 1	Met appropriate requirements
ISO 23908:2007, Sharps Injury Protection Requirements and Test Methods	Met appropriate requirements
FDA Guidance on Premarket Notification [510(k)] for Hypodermic Needles (1993)	Met appropriate requirements
Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features (2005)	Met appropriate requirements
All Product Specifications and Requirements	Device met all product specifications and requirements
Performance over Life of Device (Accelerated Aging)	Verified performance over the life of the device
Safety and Effectiveness for Intended Use (Simulated Use Study)	Concluded to be safe and effective for intended use

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

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the Simulated Use Study. It only states that a "Simulated Use Study was conducted."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications for the Simulated Use Study.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set in the Simulated Use Study.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as described in the provided summary. The study mentioned is a "Simulated Use Study" for the device itself, not a comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study, as typically understood for algorithms, was not conducted as this device is a physical medical device (a safety needle), not an AI algorithm. The "Simulated Use Study" evaluates the device's physical safety mechanism.

7. Type of Ground Truth Used

For the "Simulated Use Study," the type of ground truth would be based on the objective criteria of sharps injury prevention and proper function of the safety mechanism as defined by the relevant standards (e.g., ISO 23908:2007). It isn't explicitly stated as expert consensus, pathology, or outcomes data in the traditional sense, but rather adherence to performance standards and avoidance of accidental needle sticks in a simulated environment.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is a physical device, and the evaluation relies on adherence to engineering and safety standards, rather than machine learning training data.

9. How Ground Truth for the Training Set Was Established

Since this is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The "ground truth" for the device's design and performance is established through adherence to recognized international and FDA standards for medical devices and safety features. The "Simulated Use Study" would verify that the device performs as intended in accordance with these established standards.

Summary

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

K123684

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

MAY 0 8 2013

Summary of Safety and Effectiveness for the Safety Needle

Date Prepared: January 31, 2013

Submitter Information A.

Sol-Millennium Medical, Inc. 5415 Sugarloaf Parkway. Suite 2203 Lawrenceville, GA 30043

Phone Number: Fax Number:

949-433-3058 760-295-4381

Trade Name:

Sol-Care Safety Needle

B. Device Information

Trade/Proprietary Name:

Common name of device:

Classification Name:

Product Code:

Regulatory Class:

Classification Number:

Reason for 510(k):

Needle, Hypodermic, Single Lumen

80 EMI

Hypodermic Needle

880.5570

Significant modification of device previously found equivalent (Expanded intended use to include the addition of a safety feature)

j Predicate Device: BD Eclipse Hypodermic Needle Predicate 510(k) #: K010188 Predicate product code: FMI
16-2

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

D. Device Description

E. Statement of Indications for Use
The Sol-Care Hypodermic Needle is used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

The Sol-Care Hypodermic Needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

E. Comparison of Required Technological Characteristics:

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-Care Safety Needle and the BD Eclipse Needles. This included:

1. Label Review
  :,
a. Both devices were similar in design, function and intended use.
b. Both devices were labeled as EO Sterilized, non pyrogenic,

non toxic, single use, latex free and with a five year shelf life.

1. Intended Use Comparison
- a. The intended use for both devices is the same.
1. Material Comparison
- a. Both devices are fabricated from the same materials.

16-3

{2}------------------------------------------------

1. Physical, mechanical and biological specifications
- a. A comparison of physical, mechanical and biological specifications showed that the Sol-Care Safety Needles are substantially equivalent to the predicate device.
G. Summary and Conclusion of Nonclinical and Clinical Tests:

The Sol-Care Safety Needles met the appropriate requirements contained in the following standards:

1. ISO 7864:1993, Sterile Hypodermic Needles for Single Use;
1. ISO 594-2:1998, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment;
1. ISO.9626:1991, Stainless Steel Needle Tubing for Manufacture of Medical Devices;
1. ISO 14971:2009, Medical Devices, Application of Risk Analysis
ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization న. Confirmation and Routine Control
11607-1,-1:2006, Packaging for terminally sterilized medical devices 6.
ISO 10993-1:2006, Biological evaluation of medical devices Part 1: 7. Evaluation and testing
1. 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"

FDA Guidance on the content of premarket notification ರಿ. [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.y

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

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-Care Safety Necdle. The conclusion of the study showed that the Sol-Care Safety-Needle is safe and effective for its intended use.

11-5

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.

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

May 8, 2013

Mr. Jim Barley Director of Regulatory Affairs/Quality Assurance Sol-Millennium Medical 5415 Sugarloaf Pkwy Suite 2203 Lawrenceville, GA 30043

Re: K123684

Trade/Device Name: Sol-Care Safety Needle Regulation Number: 21 CFR 880,5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 31, 2013 Received: February 21, 2013

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.

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

Page 2 - Mr. Barley

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/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,

Image /page/5/Picture/8 description: The image contains a handwritten inscription that appears to say "for with our wits". The text is stylized and somewhat difficult to read due to the cursive handwriting and overlapping strokes. The inscription is surrounded by some geometric shapes.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications For Use

K125684 510(k) Number (if known):

Device Name: Sol-Care Safety Needle

Indications For Use:

The Sol-Care Safety Hypodermic Needle is used in conjunction with a standard syringe. This device is used for aspiration and administration of medication.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Richard C. Chapman 2013.05.07 12:31:53 -04'00' Sivision Sign-Off) ·vision of Anesthesiology, General Hospital iection Control, Dental Devices Page 1 of ﻒ ﺇ K12360 510(k) Number:

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).