SOL-GUARD Safety Pull Button Collection Set

K213718 · Sol-Millennium Medical, Inc. · JKA · Aug 30, 2022 · Clinical Chemistry

Device Facts

• Record ID: K213718
• Device Name: SOL-GUARD Safety Pull Button Collection Set
• Applicant: Sol-Millennium Medical, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Device Story

Sterile, single-use, winged blood collection set; 21G, 23G, or 25G needle; flexible tubing; female Luer connector. Used for venipuncture blood sampling or short-term (≤2 hours) IV infusion. Clinician-operated. Features spring-loaded needle retraction mechanism; activated by pulling a button on the butterfly body; needle retracts into clear plastic safety tube post-use to prevent needlestick injuries. Output is blood specimen or IV fluid delivery. Benefits include reduced risk of accidental needlestick injury during disposal.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including performance testing (ISO 7864, ISO 8536-4, ISO 80369-7/20, ISO 23908), biocompatibility (cytotoxicity, sensitization, reactivity, pyrogenicity, systemic toxicity, hemocompatibility), particulate matter (USP <788>), sterility/shelf-life (ASTM F1980-16), and simulated shipping (ISTA 3A).

Technological Characteristics

Materials: Stainless steel needle/spring, PC/LDPE/PVC/PP components. Energy: Mechanical spring-retraction. Connectivity: None. Sterilization: Ethylene Oxide (ISO 11135). Dimensions: 178mm/305mm tubing, 0.75" needle length. Standards: ISO 7864, 6009, 8536-4, 9626, 80369-7/20, 20696, 23908.

Indications for Use

Indicated for venipuncture to obtain blood specimens in patients; may be used for short-term (up to 2 hours) single infusions of IV fluids when used without male Luer adapter. Not for long-term indwelling use; must remain under direct clinician supervision.

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® UltraTouch™ Push Button Blood Collection Set (K153309)

Submission Summary (Full Text)

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August 30, 2022

Sol-Millennium Medical, Inc. PJ Pasia Director, Regulatory Affair 315 Shawnee North Drive Suite 100. Suwanee, Georgia 30024

#### Re: K213718

Trade/Device Name: SOL-GUARD Safety Pull Button Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: August 1, 2022 Received: August 2, 2022

#### Dear PJ Pasia:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213718

#### Device Name

SOL-GUARD™ Safety Pull-Button Blood Collection Set

#### Indications for Use (Describe)

The SOL-GUARD™ Safety Pull-Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens . When used without the male Luer adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal the venipuncture site.

The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

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

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# K213718. 510(k) Summary

August 30, 2022 Date Prepared:

#### Submitter Information A.

Sol-Millennium Medical, Inc. 315 Shawnee North Drive, Suite 100 Suwanee, GA 30024 Contact Person: PJ Pasia Phone Number: 847-363-1264

#### B. Device Information

| Trade/Proprietary Name: | SOL-GUARD™ Safety Pull-Button Blood<br>Collection Set |
|-------------------------|--------------------------------------------------------------|
| Common name of device: | Tubes, Vials, Systems, Serum Separators,<br>Blood Collection |
| Product Code: | JKA, FPA |
| Regulatory Class: | II |
| Regulation Number: | 862.1675 |
| Regulation Name: | Blood Specimen Collection Device |
| Review Panel | Clinical Chemistry |

#### C. Predicate Device

| K153309 | BD Vacutainer® UltraTouch™ Push | |
|---------|---------------------------------|--|
| | Button Blood Collection Set | |

#### D. Device Description

SOL-GUARD™ Safety Pull-Button Blood Collection Set, is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.

The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.

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The SOL-GUARD™ Safety Pull-Button Blood Collection Set is comprised of 3 different configurations as shown below.

| Model Name | Attachments |
|--------------------------------------------------------------------------------|-------------------------------------------------------------|
| SOL-GUARD™ Safety Pull-Button Blood Collection Set<br>with Pre-attached Holder | Provided with pre-assembled<br>Luer adapter and Tube holder |
| SOL-GUARD™ Safety Pull-Button Blood Collection Set<br>with Luer Adapter | Provided with Luer adapter only |
| SOL-GUARD™ Safety Pull-Button IV Infusion Set | No attachment provided |

#### E. Indications for Use

| Characteristic | Subject Device<br>SOL-GUARD™ Safety Pull-Button<br>Blood Collection Set<br>K213718 | Predicate Device<br>BD Vacutainer UltraTouch Push<br>Button Blood Collection Set<br>K153309 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The SOL-GUARD™ Safety Pull-<br>Button Blood Collection Set is a<br>sterile, multi-sample, single-use fixed<br>winged blood collection set intended<br>for venipuncture to obtain blood<br>specimens from patients. When used<br>without the male Luer adapter, the<br>device allows the clinician to obtain<br>blood sampling to the female hub<br>with a syringe, if necessary, or can be<br>used for short-term (up to 2 hours),<br>single infusions with consideration<br>given to patient size and<br>appropriateness for the solution being<br>infused. The device is not to be left in<br>place and remain under the direct<br>supervision of a clinician.<br>The recommended use of the device<br>is to activate the needle safety feature<br>prior to removal the venipuncture<br>site.<br>The retraction of the intravenous (IV)<br>end of the needle aids in the<br>prevention of accidental needlesticks<br>injury. | The BD Vacutainer UltraTouch Push<br>Button Blood Collection Set is a<br>sterile, multi-sample, single-use<br>fixed winged blood collection set<br>intended for venipuncture to obtain<br>blood specimens from patients.<br>When used without the male luer<br>adapter, the device allows the<br>clinician to obtain blood sampling to<br>the female hub with a syringe, if<br>necessary, or can be used for short-<br>term, single infusions with<br>consideration given to patient size<br>and appropriateness for the solution<br>being infused. The device is not to<br>be left in place and remain under the<br>direct supervision of a clinician.<br>The recommended use of the device<br>is to activate the needle safety<br>feature prior to removal from the<br>venipuncture site.<br>The retraction of the intravenous<br>(IV) end of the needle aids in the<br>prevention of accidental needlestick<br>injury. |
| Prescription<br>Only or Over<br>the Counter | Prescription Only | Prescription Only |

There is minor difference to the Indications for Use Statement between the predicate and the subject device. The duration of usage in the Indication for Use statement, "up to 2

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hours" versus "short term" is not an actual difference. The predicate device's maximum time for infusion is also up to 2 hours, according to predicate's IFU, except not stated in their Indication for Use statement. Specifying the duration of use provides clarity and does not affect safety or effectiveness or raise different questions of safety and effectiveness.

#### F. Comparison of Technological Characteristics

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the SOL-GUARD™ Safety Pull-button Blood Collection Set and the BD Vacutainer® UltraTouch Push Button Blood Collection Set. The following comparison chart and discussions show that the subject device and the predicate device are substantially equivalent.

| Specification | Subject Device | Predicate Device | Comments |
|---------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------|
| | SOL-GUARD Safety<br>Pull-Button Blood<br>Collection Set<br>K213718 | BD Vacutainer<br>Ultratech Push Button<br>Blood Collection Set<br>K153309 | (Same or Different) |
| Indicated for infusion | Yes | Yes | Same |
| Single use | Yes | Yes | Same |
| Activation of safety mechanism | Pull Button | Push Button | Different /See comment #1 |
| Components: | | | |
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | Same |
| Needle Diameter ID | Thin Wall | Ultra-Thin Wall | Different /See comment #2 |
| Tubing Length | 7" and 12" | 7" and 12" | Same |
| Needle Length | 0.75" | 0.75" | Same |
| Needle Point | 3-bevel | 5-bevel | Different /See comment #3 |
| Performance: | | | |
| Sterilization Method | Ethylene Oxide | Gamma | Different /See comment #4 |
| Sterility Assurance Level (SAL) | 10-6 | 10-6 | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Shelf life | 3 years | 2 years | Different /See comment #5 |
| Materials: | | | |
| Needle | Stainless Steel | Stainless Steel | Different /See comment #6 |
| Needle/Hub Glue | Epoxy Glue | UV cure adhesive | |
| Spring | Stainless Steel | Stainless Steel | |

SIDE BY SIDE COMPARISON TABLE

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| Specification | Subject Device<br>SOL-GUARD Safety<br>Pull-Button Blood<br>Collection Set<br>K213718 | Predicate Device<br>BD Vacutainer<br>Ultratech Push Button<br>Blood Collection Set<br>K153309 | Comments<br>(Same or Different) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Needle Hub | Low Density<br>Polyethylene | Polypropylene | |
| Sliding Button | Polycarbonate | Polypropylene | |
| Needle Protector | Low Density<br>Polyethylene | Polyethylene | |
| Wings | Polyvinyl Chloride | Polyolefin | |
| Housing A | Polycarbonate | Polypropylene | |
| Housing B | Polycarbonate | Acrylic | |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride | |
| Female Luer Lock<br>Connector | Polyvinyl Chloride | Acrylonitrile-butadiene-<br>styrene | |
| Luer Adapter | Luer Adapter Hub:<br>Polypropylene<br>Needle Cap: Low<br>Density Polyethylene<br>Needle: Stainless Steel<br>Rubber Sleeve:<br>Polyisoprene Rubber | Luer Adapter hub:<br>Polypropylene<br>Needle Cap: Polypropylene<br>Needle: Stainless Steel<br>Rubber Sleeve: Synthetic<br>Isoprene Rubber | |
| Holder | Polypropylene | unknown | |

### Discussions of Differences in Technological Characteristics

### Comment 1: Activation of safety mechanism

For the subject device, to activate the safety mechanism, the button on the body of the butterfly is pulled back, while the predicate device requires to push the button. Both (pull and push) actions allow the release of the internal spring that withdraws the needle from the patient's arm into the safety tube of the blood collection device. Both bench testing (Forces for Activation, Simulated "in-Vein" Needle Retraction, Simulated Jammed Retraction, and Safety Shield Unlocking Resistance) and Simulated Usability Study demonstrated that the "Pull" motion can activate the safety mechanism and provide the same protection for needlestick injury as the predicate device. This difference does not affect safety or effectiveness or raise different questions of safety and effectiveness.

### Comment 2: Needle Diameter Wall

Although the predicate has an Ultra-Thin wall, its original version was a thin-walled needle covered under K030573 (predicate of BD Vacutainer UltraTouch Push Button Blood Collection Set). The difference in needle wall thickness does not raise any questions of safety and effectiveness.

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### Comment 3: Needle Point

Although the predicate has a 5-bevel needle point, its original version was a 3-bevel needle point covered under K030573 (predicate of BD Vacutainer UltraTouch Push Button Blood Collection Set). The difference in bevel type does not raise any questions of safety and effectiveness.

### Comment 4: Sterilization Method

The sterilization validation per ISO 11135 shows that the subject device can reach the same sterilization assurance level as predicate device and there is no impact to safety and effectiveness caused by using Ethylene Oxide sterilization.

#### Comment 5: Shelf life

The real time and accelerated shelf-life testing per ASTM F1980-16 were conducted on subject device, demonstrating no safety and effectiveness were impacted by the prolonged shelf life.

### Comment 6: Materials

The biocompatibility per ISO 10993 and performance testing showed that differences in materials of construction do not raise any questions of safety or effectiveness.

#### G. Performance Testing

The SOL-GUARD Safety Pull-Button Blood Collection Set described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

- . ISO 7864:2016: Sterile hypodermic needles for single use - Requirements and test methods
- ISO 6009:2016: Hypodermic needles for single use - Colour coding for identification
- ISO 8536-4:2019: Infusion equipment for medical use Part 4: Infusion sets for ● single use, gravity feed
- ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical ● devices - Requirements and test methods
- . ISO 80369-7:2021: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015: Small-bore connectors for liguids and gases in healthcare . applications - Part 20: Common test methods
- ISO 20696:2018: Sterile urethral catheters for single use
- 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

### Biocompatibility

In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (<24 hours). The following testing were conducted:

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- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity ●
- Pyrogenicity
- Acute systemic toxicity ●
- Hemocompatibility

### Particulate Matter

Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.

### Sterility, Pyrogen, Shelf-life, Bacterial Endotoxin, and Shipping

The subject device is intended to be sterilized with Ethylene Oxide procedures validated per ISO 11135. The subject device met applicable acceptance criteria for EO and ECH residuals per ISO 10993-7 and pyrogenicity per USP <151>. The following additional tests were conducted:

- Sterile Barrier Packaging testing (Peeling force per ASTM F88/F88M, Clean Peel per ISO 11607-1, and ASTM F1929 for Dye Penetration Test).
- 3-year shelf-life test per ASTM F1980-16 Standard Guide for Accelerated Aging ● of Sterile Barrier Systems for Medical Devices.
- Bacterial Endotoxin testing per European pharmacopoeia 10.2.6.14.
- Simulated Shipping per ISTA 3A Packaged-Product for Parcel Delivery System ● Shipments 70kg (150lb) or Less.

In addition, bacterial endotoxin testing is conducted on every lot during manufacturing to meet pyrogen limit specification 20EU/device.

#### H. Conclusion

The differences between the subject and the predicate devices do not raise any new or different questions of safety and effectiveness. Based on the information provided in this submission, the subject devices, have been determined to be substantially equivalent to the predicate device, BD Vacutainer® UltraTouch™ Push Button Blood Collection Set.