Unistik® ShieldLock, Unistik VacuFlip

K223854 · Owen Mumford, Ltd. · JKA · Jun 30, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223854
• Device Name: Unistik® ShieldLock, Unistik VacuFlip
• Applicant: Owen Mumford, Ltd.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly" style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe. Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Device Story

Unistik ShieldLock and Unistik VacuFlip are sterile, single-use blood collection devices. ShieldLock is a winged 'butterfly' set; VacuFlip is a vacuum needle with an integrated safety shield. Used by healthcare professionals in clinical settings for venous blood collection. ShieldLock allows collection into tubes, bottles, or syringes via a female hub. VacuFlip uses a user-activated safety shield to cover the needle post-venipuncture, preventing needlestick injuries. Both devices provide a physical barrier between the user and the needle after activation. The safety features are activated manually by the clinician. These devices facilitate safe blood specimen acquisition, reducing the risk of accidental sharps injury to the healthcare provider.

Clinical Evidence

No clinical testing was performed; substantial equivalence is supported by bench testing and compliance with recognized consensus standards.

Technological Characteristics

Materials: Stainless steel 304, silicone oil, UV-cured adhesive, PVC, polypropylene, isoprene rubber, epoxy resin. Energy: Manual operation. Connectivity: None. Sterilization: Ethylene oxide (SAL 10⁻⁶). Form factor: Butterfly set (ShieldLock) or vacuum needle (VacuFlip) with integrated safety shield. Standards: ISO 7864:2016, ISO 9626:2016, ISO 80369-7:2016, ISO 23908:2011, ISO 10993 series.

Indications for Use

Indicated for trained healthcare professionals performing venipuncture to obtain venous blood specimens from patients into vacuum tubes, blood culture bottles, or syringes. No specific patient population age or gender restrictions; contraindicated for short-term IV infusion.

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 (K212724)
• Vacutainer® Brand Eclipse™ Blood Collection Needle (K982541)

Submission Summary (Full Text)

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June 30, 2023

Owen Mumford Ltd % Patty Cronan Quality Manager Owen Mumford USA Inc. 1755 West Oak Commons Ct. Marietta, Georgia 30062

Re: K223854

Trade/Device Name: Unistik® ShieldLock, Unistik® VacuFlip Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA, FMI Dated: May 30, 2023 Received: June 1, 2023

Dear Patty Cronan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

Porsche Bennett

For David Wolloscheck, Ph.D. Acting 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) K223854

Device Name Unistik® ShieldLock, Unistik® VacuFlip

#### Indications for Use (Describe)

Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly" style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe.

Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY – K223854

### 1. Submitter

| Prepared by: | Owen Mumford Ltd<br>Tel: [phone]<br>Fax: [phone] |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/ Operator<br>Owen Mumford Ltd<br>Brook Hill<br>Woodstock<br>Oxfordshire<br>OX20 1TU<br>United Kingdom<br>Establishment Registration Number: 3003348846 |
| Contact Person: | Darren Mansell<br>Regulatory Affairs Manager<br>Owen Mumford Ltd,<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

#### Date Prepared: 06/30/2023

# 2. Subject Device

| Trade Name: | Unistik® ShieldLock<br>Unistik® VacuFlip |
|--------------------|------------------------------------------|
| Regulation Number: | 21 CFR 862.1675 |
| Common Name: | Blood collection sets |
| Regulation Name: | Blood Specimen Collection Device |
| Regulatory Class: | Class II |
| Product Code(s): | JKA, FPA, FMI |

# 3. Predicate Device(s)

# Predicate Device #1 - 510k number K212724.

| Trade Name: | BD Vacutainer® UltraTouch™ push button blood collection set |
|--------------------|-------------------------------------------------------------|
| Regulation Number: | 21 CFR 862.1675 |
| Common Name: | Blood collection sets |
| Regulation Name: | Blood Specimen Collection Device |
| Regulatory Class: | Class II |
| Product Code: | JKA, FPA |

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#### Predicate Device #2 - 510k number K982541

| Trade Name: | Vacutainer® Brand Eclipse™ Blood Collection Needle |
|--------------------|----------------------------------------------------|
| Regulation Number: | 21 CFR 880.5570 |
| Common Name: | Blood collection needle |
| Regulation Name: | Needle, hypodermic, single lumen |
| Regulatory Class: | Class II |
| Product Code: | FMI |

#### 4. Description of The Devices

The Unistik® ShieldLock is a sterile, single use, multi-sample blood collection set for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik Shield Lock is a 'butterfly needle' with wings, the color of the wings is unique for each needle gauge to assist with identification. The Unistik ShieldLock is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

The Unistik® VacuFlip is a sterile, single use, multi-sample blood collection vacuum needle for use by healthcare professionals to obtain venous blood specimens from patients when used in conjunction with blood collection tubes or syringes. The Unistik VacuFlip is a 'vacuum needle' and is designed with a user activated integral sharps injury prevention feature, the safety shield, which can be activated after the needle is removed from the vein to help prevent needlestick injuries. The safety shield features a textured surface to help improve grip during activation. An audible click signals that the safety shield is activated and is locked in place, covering the needle, and preventing reuse. The color of the safety shield is unique for each needle gauge to assist with identification. The Unistik VacuFlip is designed for prescription use only and is to be used only by healthcare professionals for patients who are required to have venous blood specimens collected.

Please see table 5.1 overleaf for a list of all available device models.

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Table 5.1 List of all available device models

| Device<br>Name | Configuration | Variant | Box Qty. | Product<br>Code |
|-----------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------|-----------------|
| | Blood Collection Set with<br>Luer Adapter | 20G Needle, 19mm needle length, 200mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003763A1 |
| | Blood Collection Set without<br>Luer Adapter | 20G Needle, 19mm needle length, 200mm tube and without Luer or<br>vacuum holder. | 100 | P003764A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 20G Needle, 19mm needle length, 200mm tube, with Luer and vacuum<br>holder attached. | 50 | P003765A1 |
| | Blood Collection Set with<br>Luer Adapter | 20G Needle, 19mm needle length, 300mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003766A1 |
| | Blood Collection Set without<br>Luer Adapter | 20G Needle, 19mm needle length, 300mm tube and without Luer or<br>vacuum holder. | 100 | P003767A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 20G Needle, 19mm needle length, 300mm tube, with Luer and vacuum<br>holder attached. | 50 | P003768A1 |
| Unistik<br>ShieldLock | Blood Collection Set with<br>Luer Adapter | 21G Needle, 19mm needle length, 200mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003769A1 |
| | Blood Collection Set without<br>Luer Adapter | 21G Needle, 19mm needle length, 200mm tube and without Luer or<br>vacuum holder. | 100 | P003770A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 21G Needle, 19mm needle length, 200mm tube, with Luer and vacuum<br>holder attached. | 50 | P003771A1 |
| | Blood Collection Set with<br>Luer Adapter | 21G Needle, 19mm needle length, 300mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003772A1 |
| | Blood Collection Set without<br>Luer Adapter | 21G Needle, 19mm needle length, 300mm tube and without Luer or<br>vacuum holder. | 100 | P003773A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 21G Needle, 19mm needle length, 300mm tube, with Luer and vacuum<br>holder attached. | 50 | P003774A1 |
| | Blood Collection Set with<br>Luer Adapter | 22G Needle, 19mm needle length, 200mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003775A1 |
| | Blood Collection Set without<br>Luer Adapter | 22G Needle, 19mm needle length, 200mm tube and without Luer or<br>vacuum holder. | 100 | P003776A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 22G Needle, 19mm needle length, 200mm tube, with Luer and vacuum<br>holder attached. | 50 | P003777A1 |
| | Blood Collection Set with<br>Luer Adapter | 22G Needle, 19mm needle length, 300mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003778A1 |
| Device<br>Name | Configuration | Variant | Box Qty. | Product<br>Code |
| Unistik<br>ShieldLock | Blood Collection Set without<br>Luer Adapter | 22G Needle, 19mm needle length, 300mm tube and without Luer or<br>vacuum holder. | 100 | P003779A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 22G Needle, 19mm needle length, 300mm tube, with Luer and vacuum<br>holder attached. | 50 | P003780A1 |
| | Blood Collection Set with<br>Luer Adapter | 23G Needle, 19mm needle length, 200mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003781A1 |
| | Blood Collection Set without<br>Luer Adapter | 23G Needle, 19mm needle length, 200mm tube and without Luer or<br>vacuum holder. | 100 | P003782A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 23G Needle, 19mm needle length, 200mm tube, with Luer and vacuum<br>holder attached. | 50 | P003783A1 |
| | Blood Collection Set with<br>Luer Adapter | 23G Needle, 19mm needle length, 300mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003784A1 |
| | Blood Collection Set without<br>Luer Adapter | 23G Needle, 19mm needle length, 300mm tube and without Luer or<br>vacuum holder. | 100 | P003785A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 23G Needle, 19mm needle length, 300mm tube, with Luer and vacuum<br>holder attached. | 50 | P003786A1 |
| | Blood Collection Set with<br>Luer Adapter | 25G Needle, 19mm needle length, 200mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003787A1 |
| | Blood Collection Set without<br>Luer Adapter | 25G Needle, 19mm needle length, 200mm tube and without Luer or<br>vacuum holder. | 100 | P003788A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 25G Needle, 19mm needle length, 200mm tube, with Luer and vacuum<br>holder attached. | 50 | P003789A1 |
| | Blood Collection Set with<br>Luer Adapter | 25G Needle, 19mm needle length, 300mm tube and with Luer<br>attached. No vacuum holder. | 100 | P003790A1 |
| | Blood Collection Set without<br>Luer Adapter | 25G Needle, 19mm needle length, 300mm tube and without Luer or<br>vacuum holder. | 100 | P003791A1 |
| | Blood Collection Set with<br>Pre-Attached Holder | 25G Needle, 19mm needle length, 300mm tube, with Luer and vacuum<br>holder attached. | 50 | P003792A1 |
| Unistik<br>VacuFlip | Blood Collection Safety<br>Needle with Pre-Attached<br>Holder | 21G 1-1/4" Needle with Pre-Attached Holder | 50 | P004823A1 |
| | Blood Collection Safety<br>Needle with Pre-Attached<br>Holder | 22G 1-1/4" Needle with Pre-Attached Holder | 50 | P004825A1 |
| Device<br>Name | Configuration | Variant | Box Qty. | Product<br>Code |
| Unistik<br>VacuFlip | Blood Collection Safety Needle with Pre-Attached Holder | 21G 1-1/2" Needle with Pre-Attached Holder | 50 | P004824A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 22G 1-1/2" Needle with Pre-Attached Holder | 50 | P004826A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 21G 1" Needle with Pre-Attached Holder | 50 | P003793A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 22G 1" Needle with Pre-Attached Holder | 50 | P003794A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 20G 1-1/4" Needle with Pre-Attached Holder | 50 | P003795A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 20G 1-1/2" Needle with Pre-Attached Holder | 50 | P003796A1 |
| | Blood Collection Safety Needle with Pre-Attached Holder | 20G 1" Needle with Pre-Attached Holder | 50 | P003797A1 |
| | Blood Collection Safety Needle | 21G 1-1/4" Needle with Luer | 100 | P004819A1 |
| | Blood Collection Safety Needle | 22G 1-1/4" Needle with Luer | 100 | P004821A1 |
| | Blood Collection Safety Needle | 21G 1-1/2" Needle with Luer | 100 | P004820A1 |
| | Blood Collection Safety Needle | 22G 1-1/2" Needle with Luer | 100 | P004822A1 |
| | Blood Collection Safety Needle | 20G 1-1/4" Needle with Luer | 100 | P003798A1 |
| | Blood Collection Safety Needle | 20G 1-1/2" Needle with Luer | 100 | P003805A1 |
| Device<br>Name | Configuration | Variant | Box Qty. | Product<br>Code |
| Unistik<br>VacuFlip | Blood Collection Safety<br>Needle | 20G 1" Needle with Luer | 100 | P003806A1 |
| | Blood Collection Safety<br>Needle | 21G 1" Needle with Luer | 100 | P003807A1 |
| | Blood Collection Safety<br>Needle | 22G 1" Needle with Luer | 100 | P003808A1 |

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#### 5. Indications for Use

Unistik® ShieldLock: The Unistik ShieldLock Blood Collection Set is a sterile, multi-sample, single-use "butterfly' style blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens into blood collection tubes or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe.

Unistik® VacuFlip: The Unistik VacuFlip Safety Blood Collection Needle is intended to be used by healthcare professionals with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

#### 6. Technological Characteristics

The technical characteristics for the subject device and the predicate devices are shown below in Tables 5.2 and 5.3.

| Table 5.2: Comparison of the technical characteristics between the subject device Unistik | | |
|-------------------------------------------------------------------------------------------|--|--|
| ShieldLock and the predicate device | | |

| Test/<br>Characteristic | Predicate Device:<br>BD Vacutainer®<br>UltraTouch™ Push Button<br>Blood Collection Set,<br>K212724 | Subject Device:<br>Unistik® ShieldLock | Comparison |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Target<br>Group | General use including patients<br>with difficult vein access (DVA) | General use | Specific reference to DVA<br>has no effect on device<br>safety/effectiveness as<br>DVA is a subset of<br>general use |
| Indications for<br>Use Statement | Indications for Use (Describe):<br>The BD Vacutainer®<br>UltraTouch™ Push Button<br>Blood Collection Set is a<br>sterile, multi-sample, single-<br>use fixed winged blood<br>collection set intended to be<br>used by trained healthcare<br>professionals for venipuncture<br>to obtain blood specimens<br>from patients, including those<br>patients with difficult vein<br>access who may have small,<br>fragile, and/or non-palpable<br>veins, into evacuated blood<br>collection tubes and/or blood<br>culture bottles. When used<br>without the male adapter, the<br>device allows the clinician to<br>obtain a blood specimen from<br>the female hub with a syringe,<br>if necessary. The device can<br>be used for short-term, single | Indications for Use (Describe):<br>The Unistik ShieldLock Blood<br>Collection Set is a sterile, multi-<br>sample, single-use 'butterfly' style<br>blood collection set intended to be<br>used by trained healthcare<br>professionals for venipuncture to<br>obtain blood specimens from<br>patients into blood collection<br>tubes or blood culture bottles.<br>When used without the male<br>adapter, the device allows the<br>clinician to obtain a blood<br>specimen from the female hub<br>with a syringe. | Both devices are sterile,<br>multi-sample, single-use<br>'winged' ('butterfly' style<br>named so due to wing<br>features) blood collection<br>sets.<br>Both devices are<br>indicated for use by<br>trained healthcare<br>professionals for<br>venipuncture and blood<br>collection into blood<br>collection tubes and/or<br>blood collection bottles.<br>Both devices are<br>indicated for use without<br>the male adapter to allow<br>a clinician to obtain a<br>blood specimen from the<br>female hub with a syringe. |
| | infusions with consideration<br>given to patient size and<br>appropriateness for the<br>solution being infused. The<br>device is not to be left in place<br>and is to remain under the<br>direct supervision of a<br>clinician. The recommended<br>use of the device is to activate<br>the needle safety feature prior<br>to removal from the<br>venipuncture site. The<br>retraction of the intravenous<br>(IV) end of the needle aids in<br>the prevention of accidental<br>needlestick injury. | | The predicate device is<br>indicated for use for short-<br>term single IV infusions,<br>the subject device is not<br>indicated for use for short<br>term IV infusions, this has<br>no effect on its safety or<br>effectiveness as a blood<br>collection set; the device<br>box and IFU are marked<br>with the warning: "This<br>device is not indicated for<br>short-term infusions". |
| Used for short<br>term IV infusion | Yes | No | Short term IV infusion is<br>not being indicated for<br>Unistik ShieldLock, this<br>has no effect on its safety<br>or effectiveness as a<br>blood collection set; the<br>device box and IFU are<br>marked with the warning:<br>"This device is not<br>indicated for short-term<br>infusions". |
| Frequency of<br>Use | As required by healthcare<br>professional | As required by healthcare<br>professional | Same |
| Needle Gauges | 21G, 23G, 25G | 20G, 21G, 22G, 23G, 25G | Additional gauges of 20G<br>and 22G. 22G is within<br>the range of the predicate,<br>so no effect on<br>safety/effectiveness.<br>Some patients may<br>require a different gauge<br>lancet to achieve the<br>required blood flow.<br>Therefore, the addition of<br>the 20G needle variant<br>represents a slightly<br>larger outer diameter<br>needle than seen in the<br>predicate. 20G needles<br>are widely used in<br>healthcare and selected<br>as necessary by the<br>healthcare professional to<br>meet patient needs. There<br>is no additional risk or<br>effect on safety and<br>effectiveness associated<br>with differential needle |
| | | | |
| | | | gauges, and these do not<br>affect depth of<br>penetration.<br>To confirm safety and<br>effectiveness, the devices<br>have been tested to ISO<br>7864:2016, ISO<br>9626:2016 and are |
| | | | confirmed to meet the<br>required specifications. |
| Needle length | 3/4 inch | 3/4 Inch | Same |
| Tube lengths | 178mm, 305mm | 200mm, 300mm | Subject device lengths<br>are similar to the<br>predicate, and within the<br>range of the predicate, so<br>no effect on<br>safety/effectiveness. |
| Pre-attached<br>blood tube<br>holder? | Available with or without pre-<br>attached "BD Vacutainer One<br>Use Holder" | Available with or without pre-<br>attached Unistik Holder | Same |
| | | | Both devices are available<br>with or without pre-<br>attached holder, and both<br>devices have holders<br>available to purchase<br>separately. |
| Luer Lock<br>Adapter | Yes | Yes | Same |
| Integral sharps<br>injury prevention<br>feature? | Yes | Yes | Both have a sharps injury<br>protection feature,<br>differences discussed in<br>this table below. |
| | | | |
| Sharps injury<br>prevention<br>safety feature<br>operating<br>principle? | Safety feature is designed to<br>be activated while needle is<br>still in the patient's vein.<br>Gauze pad is placed across<br>the venipuncture site, covering<br>the front barrel. While the<br>needle is still in the vein, the<br>device body is grasped with<br>the thumb and middle finger.<br>The push button is activated<br>with the tip of the index finger<br>causing the needle to retract<br>into the device body. | Safety feature is activated after<br>the needle is removed from the<br>patient's vein.<br>One-handed procedure: Hold the<br>end of the safety shield with your<br>thumb and index finger and use<br>the remaining fingers to hold the<br>tubing securely in the palm of<br>your hands. Push the safety<br>shield towards the needle until an<br>audible click is heard.<br>Two-handed procedure: Hold the<br>end of the safety shield with your<br>thumb and index finger in one<br>hand, with the other hand, pull the | Both devices have a<br>safety feature that can be<br>activated by one hand<br>using the thumb/index |
| | | | finger.<br>The predicate device<br>safety feature is activated<br>while still in the patient<br>vein, whereas the subject<br>device safety feature is<br>activated once removed<br>from the patient vein. The<br>subject device safety<br>feature can however be<br>activated immediately<br>after removal from the |
| | | tubing backwards until an audible<br>click is heard. | patient vein, resulting in<br>very limited time with an<br>exposed needle, reducing<br>the risk of needle stick<br>injury.<br><br>The subject device has an<br>additional two-handed<br>procedure listed for<br>activation of the safety<br>feature, wherein the<br>tubing can be pulled with<br>the second hand,<br>removing the need to<br>activate the safety feature<br>with the thumb or finger.<br><br>The subject device differs<br>in that the user is advised<br>in the IFU to activate the<br>safety feature until an<br>audible 'click' is heard,<br>confirming to the user that<br>the safety feature has<br>been activated.<br><br>The safety feature of both<br>devices securely sheaths<br>the needle behind a layer<br>of solid plastic which<br>forms a physical barrier<br>between the patient/user<br>and the exposed needle.<br><br>Safety feature testing was<br>conducted in line with ISO<br>23908:2011 to confirm<br>safety and effectiveness<br>of the subject device; this<br>was conducted on<br>samples that were<br>accelerated aged to the 5<br>year shelf life. |
| Single-use? | Yes | Yes | Same |
| Sterility | Sterile | Sterile | Same |
| Sterility<br>Assurance Level<br>(SAL) 10-6 | Yes | Yes | Same…