Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

K163073 · Sol-Millennium Medical, Inc. · JKA · May 19, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163073
• Device Name: Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
• Applicant: Sol-Millennium Medical, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

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.

Device Story

Single-use, sterile, winged blood collection needle (butterfly needle) with safety shield; available in 21G, 23G, and 25G. Used by healthcare professionals for blood collection or short-term (up to 2 hours) IV fluid infusion. Device includes stainless steel cannula, PVC wings/tubing, and optional tube holder. Safety mechanism: after use, user pulls back on tubing while holding wings to retract needle into safety shield, locking it to prevent accidental needlesticks during disposal. Benefits include reduced risk of sharps injury to clinicians. Device is supplied in hard or soft tray packs and sterilized via ethylene oxide gas.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by bench testing, including simulated use studies with nurse evaluators, mechanical performance testing (puncture, unlocking, and shield pulling forces), and biocompatibility assessments (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, and thrombosis).

Technological Characteristics

Materials: Stainless steel (SUS 304) cannula, PVC wings/tubing, polypropylene safety shield, ABS female fitting, LDPE needle cap. Sterilization: Ethylene Oxide (ISO 11135-1). Standards: ISO 8536-4 (infusion sets), ISO 7864 (needles), ISO 23908 (sharps protection), ISO 594-2 (luer fittings), ISO 10993-1 (biocompatibility). Form factor: Winged needle with safety shield and optional tube holder. Connectivity: None.

Indications for Use

Indicated for blood collection or short-term infusion (up to 2 hours) of intravenous fluids in patients requiring venipuncture or fluid administration, with consideration given to patient size and appropriateness for the solution being infused.

Regulatory Classification

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.

Predicate Devices

• BD Vacutainer Safety Lok Blood Collection Set (K980414)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|--|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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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) #:

C.

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 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.

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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 Blood<br>Collection Needle<br>(Subject Device) | BD Vacutainer Safety-Lok Blood<br>Collection Set (Predicate Device) | Same, similar<br>or different |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Indication for Use | The Sol-Care Safety<br>Blood Collection<br>Needle (with and<br>without a Pre-attached<br>Tube Holder) is a single<br>use, sterile, winged<br>blood collection needle<br>to be used for blood<br>collection or short-term<br>infusion (up to 2 hours)<br>of intravenous fluids.<br>The device is designed<br>with a safety<br>mechanism to help<br>reduce the risk of<br>needlestick injury. | The Vacutainer Brand Blood<br>Collection Set and Safety-Lok<br>Blood Collection Set is a winged<br>blood collection needle and<br>flexible tubing for venipuncture<br>to collect blood specimen from<br>patients or monitoring blood<br>pressure. The Safety-Lok Blood<br>Collection Set also contains a<br>needle safety shield which<br>minimizes the possibility of a<br>needlesticks if manually<br>activated following blood<br>collection. The Vacutainer<br>Brand Blood Collection Set and<br>Safety-Lok Blood Collection Set<br>is also recommended for use in<br>patients with small veins.<br><br>The Vacutainer Brand Blood<br>Collection Sets and Safety-Lok<br>Blood 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 of<br>fluids and may be used for any<br>patient population with<br>consideration given to patient<br>size, appropriateness for the<br>solution being infused and<br>duration of therapy. | | |
|-------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------|
| Intended use | Blood Collection and<br>Infusion of Intravenous<br>Solutions for up to 2<br>hours | Blood Collection and Infusion of<br>Intravenous Solutions for up to 2 hours | | Same |
| Product design/ component materials | | | | |
| Needle Cap | LDPE (Low Density<br>Polyethylene) | Plastic | | Similar |
| Needle, Butterfly<br>Wings | 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 Collection<br>Needle | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) | | Same |
| Needle Cover | Clear LDPE (Low Density<br>Polyethylene) | 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/o<br>Holder/ materials | Tray Pack | Tray Pack | | Same |
| Method to retract<br>needle | Pull back on tubing until<br>needle is locked within the<br>Safety Shield | Pull back on tubing until<br>needle is locked within the<br>Safety Shield | | Same |
| Method of<br>sterilization | 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
- 2. 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)

- 4. 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.
- 5. 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.