The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury

Device Description

The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder.

The Sol-Care Safety Blood Collection Needle consists of:

Stainless steel cannula (Intravenous end and Non-patient end of Cannula)
Wings (Color coded according to needles gauge)
Tubing
Female luer adaptor
Intravenous (IV) needle protector (covers the needle before use)

The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.

The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.

The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.

AI/ML Overview

The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder) meets these criteria. Since this is a medical device submission, the "acceptance criteria" are derived from recognized ISO standards and specific internal test protocols, and the "reported device performance" is the successful completion of these tests.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Form/Fit/Functionality	ISO 8536-4:2010 (Infusion Sets)	Met appropriate requirements.
	ISO 7864:1993 (Sterile Hypodermic Needles)	Met appropriate requirements.
	PRJ001_096: Butterfly Needle Chemistry Test	Protocol and Report successfully completed.
	PRJ001_062: Butterfly Needle Appearance and Size Test	Protocol and Report successfully completed.
	PRJ001_060: Butterfly Needle Systematic Flow Test	Protocol and Report successfully completed.
	PRJ001_056: Butterfly Needle Systematic Blocking Test	Protocol and Report successfully completed.
	PRJ001_057: Butterfly Needle Protector Drawing Force Test	Protocol and Report successfully completed.
	PRJ001_054: Butterfly Needle Puncture Force Test	Protocol and Report successfully completed.
	PRJ001_053: Butterfly Needle Unlocking Force Test	Protocol and Report successfully completed.
	PRJ001_052: Butterfly Needle Shield Pulling Force Test	Protocol and Report successfully completed.
	PRJ001_049: Butterfly Needle Rubber Sealing Test	Protocol and Report successfully completed.
Sharps Injury Protection	ISO 23908:2011 (Sharps Protection Features)	Met appropriate requirements.
	Simulated Use Study with Nurse Evaluators	Successfully demonstrated effectiveness.
Packaging & Sterilization	ISO 11607-1:2009+A1:2014 (Packaging for Sterilized Medical Devices)	Met appropriate requirements.
	ISO 11607-2:2006 (Validation for Forming, Sealing, Assembly Processes)	Met appropriate requirements.
	Seal Validation of the Soft Pack	Successfully completed.
	Seal Validation of the Hard Pack	Successfully completed.
	Simulated Transit Test for the Soft Pack	Successfully completed.
	Simulated Transit Test for the Hard Pack	Successfully completed.
	Accelerated Aging (Soft Pack, 0, 1, 2, 3 years)	Product testing at specified time points successfully completed.
	Accelerated Aging (Hard Pack, 0, 1, 2, 3 years)	Product testing at specified time points successfully completed.
	Low Temperature (-20°C) Product Qualification	Successfully completed.
	High Temperature (60°C) Product Qualification	Successfully completed.
	ISO 11135-1:2007 (Ethylene Oxide Sterilization Confirmation and Routine Control)	Device family adopted into existing validated sterilization, complying with AAMI TIR 28. Cycle validated per ISO 11135-1:2014.
Interoperability/Connections	ISO 594-2:1998 (Conical fittings with 6% Luer taper)	Met appropriate requirements.
	PRJ001_059: Butterfly Needle Systematic Leakage Test	Protocol and Report successfully completed.
Biocompatibility	ISO 10993-1:2006 (Biological evaluation of medical devices)	Met appropriate requirements.
	Cytotoxicity	Successfully completed.
	Irritation Test/Intracutaneous Reactivity	Successfully completed.
	Sensitization Study	Successfully completed.
	USP and ISO Systemic Toxicity Studies	Successfully completed.
	Haemolysis test	Successfully completed.
	Thrombosis Testing	Successfully completed.
	Complement Activation C3a and SC5b-9 Assay (GLP)	Successfully completed.
	ASTM Hemolysis Assay Direct Contact and Extract Method (GLP)	Successfully completed.

Important Note: The document consistently states "met the appropriate requirements" or "Protocol and Report successfully completed" for each test, implying that the device successfully passed all established criteria within those tests/standards. The specific quantitative acceptance thresholds are not detailed in this summary document but would be part of the full test reports (e.g., PRJ001_096).

Here's the remaining information based on the provided text:

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test, but a "Simulated Use Study with Nurse Evaluators" was conducted, implying human interaction with the device. For the accelerated aging tests, product testing occurred at "time 0, years 1, 2 and 3," which points to batches of devices being tested.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted by the manufacturer or their contracted laboratories as part of their premarket submission. The regulatory context (FDA 510(k) submission in the USA) implies the data is generated for US regulatory standards. All nonclinical tests are listed, indicating these are internal or contract lab results rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is largely not applicable in the context of this device and report. The "ground truth" for a blood collection needle in this submission is established by adherence to recognized engineering and biocompatibility standards (e.g., ISO, ASTM). Performance is measured against physical, chemical, and biological criteria, not against expert medical interpretations of complex images or patient outcomes in the same way an AI diagnostic device would be.
A "Simulated Use Study with Nurse Evaluators" was conducted, indicating that nurses (experts in using such devices) evaluated the device. However, the number and specific qualifications (beyond "nurse") are not detailed, and their role was likely to assess usability and safety features in a simulated environment, rather than establishing a "ground truth" diagnosis.

4. Adjudication method for the test set

Not applicable in the context of this submission. Adjudication methods like 2+1 or 3+1 panels are typically used to establish a definitive "ground truth" when interpreting subjective data (e.g., medical images). This submission focuses on objective engineering, material, and biological performance criteria against established standards, where the test results themselves constitute the "ground truth" of performance.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (blood collection needle), not an AI diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for performance is based on fulfilling the requirements of International Standards (ISO, ASTM) and internal validated test protocols. This includes:
- Engineering specifications (e.g., flow rate, puncture force, needle dimensions).
- Material properties (e.g., chemical compatibility, strength).
- Safety features physical performance (e.g., pulling force for shield activation, locking mechanism).
- Sterility assurance levels.
- Biocompatibility testing results (e.g., cytotoxicity, hemolysis).
- Packaging integrity (e.g., seal strength, transit simulation).
The Simulated Use Study with Nurse Evaluators provides practical "ground truth" for usability and effective activation of the safety mechanism by intended users.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an algorithm is involved.

Summary

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

May 19, 2017

Sol-Millennium Medical, Inc. Mr. James Barley Regulatory Affairs Director 1735 North Brown Road, Suite 120 Lawrenceville, Georgia 30043

Re: K163073

Trade/Device Name: Sol-Care Safety Blood Collection Needle (with and without Preattached Tube Holder) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA Dated: April 10, 2017 Received: April 18, 2017

Dear Mr. James 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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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 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/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 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,
Tina Kiang -

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

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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Name, Title, Office	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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Indications for Use

510(k) Number (if known) K163073

Device Name

Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder)

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)

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

510(k) Summary

(As required by 21 CFR 807.92(a))

510(k) Number K163073

Date Prepared: April 10, 2017

A. Submitter Information
Sol-Millennium Medical, Inc. 1735 North Brown Road Suite 120 Lawrenceville, GA 30043 Contact Person: Phone Number:

Common name of device:

Classification Name:

Product Code:

Regulatory Class:

Reason for 510(k):

Predicate Device:

Predicate 510(k) #:

Classification Number:

B. Device Information Trade/Proprietary Name:
404-973-2200 Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder)

Winged Collection Set, Small Vein Set

Blood Specimen Collection Device

JKA, FPA II 862.1675

James Barley

New device

BD Vacutainer Safety Lok Blood Collection Set

March 3, 1998

K980414

Predicate product code:

JKA

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

D. Device Description

The Sol-Care Safety Blood Collection Needle consists of:

Stainless steel cannula (Intravenous end and Non-patient end of Cannula) -
Wings (Color coded according to needles gauge) -
-Tubing
-Female luer adaptor
-Intravenous (IV) needle protector (covers the needle before use)

The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

E. Statement of Indications for Use

Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder)

The Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder) is a single use, sterile, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury.

F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-Care Safety Blood Collection Needle and BD Vacutainer Safety Lok Blood Collection Set. The following comparison chart shows that the subject device and the predicate device are substantially equivalent:

Feature	Sol-Care Safety BloodCollection Needle(Subject Device)	BD Vacutainer Safety-Lok BloodCollection Set (Predicate Device)	Same, similaror different
Indication for Use	The Sol-Care SafetyBlood CollectionNeedle (with andwithout a Pre-attachedTube Holder) is a singleuse, sterile, wingedblood collection needleto be used for bloodcollection or short-terminfusion (up to 2 hours)of intravenous fluids.The device is designedwith a safetymechanism to helpreduce the risk ofneedlestick injury.	The Vacutainer Brand BloodCollection Set and Safety-LokBlood Collection Set is a wingedblood collection needle andflexible tubing for venipunctureto collect blood specimen frompatients or monitoring bloodpressure. The Safety-Lok BloodCollection Set also contains aneedle safety shield whichminimizes the possibility of aneedlesticks if manuallyactivated following bloodcollection. The VacutainerBrand Blood Collection Set andSafety-Lok Blood Collection Setis also recommended for use inpatients with small veins.The Vacutainer Brand BloodCollection Sets and Safety-LokBlood is also indicated for the	Similar

SIDE BY SIDE COMPARISON TABLE

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

	Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)	intravenous administration offluids and may be used for anypatient population withconsideration given to patientsize, appropriateness for thesolution being infused andduration of therapy.
Intended use	Blood Collection andInfusion of IntravenousSolutions for up to 2hours	Blood Collection and Infusion ofIntravenous Solutions for up to 2 hours	Same
Product design/ component materials
Needle Cap	LDPE (Low DensityPolyethylene)	Plastic	Similar
Needle, ButterflyWings	PVC	PVC	Same
Safety Shield	Polypropylene	Polypropylene	Same
Tubing	PVC	PVC	Same
Female Fitting	ABS	ABS	Same
Male Fitting	White Polypropylene	White Polypropylene	Same
Blood CollectionNeedle	Stainless Steel (SUS 304)	Stainless Steel (SUS 304)	Same
Needle Cover	Clear LDPE (Low DensityPolyethylene)	Plastic	Similar
Needle gauges	21G, 23G and 25G	21G, 23G and 25G	Same
Needle Length	3/4"	3/4"	Same
Needle Bevel	60 degree	60 degree	Same
Tubing length	7" and 12"	12"	Same
Packaging design w/oHolder/ materials	Tray Pack	Tray Pack	Same
Method to retractneedle	Pull back on tubing untilneedle is locked within theSafety Shield	Pull back on tubing untilneedle is locked within theSafety Shield	Same
Method ofsterilization	EO	EO	Same
Shelf life	3 year	3 year	Same

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

Summary and Conclusion of Nonclinical Tests: G.
The Sol-Care Safety Blood Collection Needle (with and without a pre-attached Tube Holder) met the appropriate requirements contained in the following standards:
1. ISO 8536-4:2010, Infusion Equipment for Medical Use Part 4: Infusion Sets For Single Use, Gravity Feed and ISO 7864:1993, Sterile Hypodermic Needles for Single Use;
- PRJ001_096, Butterfly Needle Chemistry Test Protocol and Report ●
- . PRJ001 062, Butterfly Needle Appearance and Size Test Protocol and Report
- PRJ001 060, Butterfly Needle Systematic Flow Test Protocol and Report .
- . PRJ001 056, Butterfly Needle Systematic Blocking Test Protocol and Report
- PRJ001_057, Butterfly Needle Protector Drawing Force Test Protocol and Report
- . PRJ001_054, Butterfly Needle Puncture Force Test Protocol and Report
- PRJ001 053, Butterfly Needle Unlocking Force Test Protocol and Report ●
- PRJ001 052, Butterfly Needle Shield Pulling Force Test Protocol and ● Report
- . PRJ001 049, Butterfly Needle Rubber Sealing Test Protocol and Report
1. ISO 23908:2011, Sharps Injury Protection Requirements and Test Methods - Sharps Protection Features for Single-Use Hypodermic Needles, Introducers For Catheters And Needles Used for Blood Sampling.
- . Simulated Use Study with Nurse Evaluators
ISO 11607-1.-1:2009+A1:2014. Packaging for terminally sterilized medical 3. Devices and ISO 11607-2:2006, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes.
- Seal Validation of the Soft Pack ●
- Seal Validation of the Hard Pack ●
- Simulated Transit Test for the Soft Pack ●
- . Simulated Transit Test for the Hard Pack
- . Accelerated Aging of the Soft Pack and Product Testing at time 0, years 1, 2 and 3
- Accelerated Aging of the Hard Pack and Product Testing at time 0, years ● 1.2 and 3
- Low Temperature (-20°C) Product Qualification
- High Temperature (60°C) Product Qualification ●

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Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)

1. ISO 11135-1:2007, Medical Apparatus Epoxy Ethane Sterilization Confirmation and Routine Control
- The Sol-Care Safety Blood Collection Device family was adopted into an existing validated sterilization. This adoption complies with AAMI TIR 28: . Product Adoption and Process Equivalency for Ethylene Oxide Sterilization. The cycle was validated according to the requirements of ISO 11135-1: 2014, Medical devices – Validation and Routine Control of Ethylene Oxide Sterilization.
1. ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
- . PRJ001_059, Butterfly Needle Systematic Leakage Test Protocol and Report
ISO 10993-1:2006, Biological evaluation of medical devices Part 1: 6. Evaluation and testing
- Cytotoxicity, ●
- Irritation Test/Intracutaneous Reactivity ●
- Sensitization Study, ●
- USP and ISO Systemic Toxicity Studies ●
- Haemolysis test
- Thrombosis Testing
- . Complement Activation C3a and SC5b-9 Asay with Sponsor-Supplied Comparison Articie (GLP)
- ASTM Hemolysis Assay Direct Contact and Extract Method (GLP) ●
H. Discussion of Clinical Tests:

None submitted

I. Conclusions Demonstrating Substantial Equivalence through Performance Testing:
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 Sol-Care Safety Blood Collection Needle (with and without pre-attached Tube Holder) are substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.