Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device descriptions and performance studies focus on mechanical features, safety mechanisms, and standard medical device testing (biocompatibility, sterilization, etc.). There is no mention of AI, ML, image processing, or data-driven performance metrics.

Therapeutic

No
These devices are blood collection sets and needles, used to obtain blood specimens for diagnostic purposes, not for treating or preventing disease.

Diagnostic

No

The device is a blood collection set and needle, used for obtaining blood specimens, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like needles, wings, safety shields, and hubs, indicating it is a hardware medical device used for blood collection. There is no mention of software as a component or function.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
Device Function: The Unistik® ShieldLock and Unistik® VacuFlip are devices used to collect blood specimens from a patient. They are tools for obtaining the sample, not for analyzing the sample itself.
Intended Use: The intended use clearly states they are for "venipuncture to obtain blood specimens" and "for multiple collections of venous blood." This focuses on the collection process.
Device Description: The descriptions detail the physical characteristics and safety features related to the blood collection process (needles, wings, safety shields).
Performance Studies: The performance studies focus on the safety and effectiveness of the device in the collection process (biocompatibility, sterilization, package integrity), not on the accuracy or performance of a diagnostic test.

While the collected blood specimens will likely be used for IVD testing, the devices themselves are classified as blood collection devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

JKA, FPA, FMI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained healthcare professionals / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance data included design verification testing to demonstrate safe and effective operation for both Unistik ShieldLock and Unistik VacuFlip. Bench testing was conducted against defined acceptance criteria and met specifications for cleanliness, limits of acidity or alkalinity, limits for extractable metals, tubular needle designation, color coding, conical fitting, color of hub, needle cap, general-needles and tapered-needles, tolerances on length, freedom from defects, lubricant, needle point, needle retention, patency of lumen, surface finish and visual, stiffness, tubing resistance to breakage, resistance to corrosion, fluid leakage, subatmospheric pressure air leakage, stress cracking, resistance to separation from axial load, safety feature, particulate matter, package integrity testing, and simulated transportation. Biocompatibility testing was performed according to ISO 10993 series and FDA guidance for externally communicating devices with circulating blood contact for limited duration (≤ 24 hours), including tests for in vitro cytotoxicity, irritation and skin sensitization, systemic toxicity, hemolytic properties, and interactions with blood. Sterilization validation using ethylene oxide was performed per ISO 11135-1:2014 to achieve a SAL of 10-6. No clinical testing was performed. All tests met acceptance criteria, demonstrating safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K212724, K982541

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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3

510(k) SUMMARY – K223854

1. Submitter

| Prepared by: | Owen Mumford Ltd
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/ Operator
Owen Mumford Ltd
Brook Hill
Woodstock
Oxfordshire
OX20 1TU
United Kingdom
Establishment Registration Number: 3003348846 |
| Contact Person: | Darren Mansell
Regulatory Affairs Manager
Owen Mumford Ltd,
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466
Email: darren.mansell@owenmumford.com |

Date Prepared: 06/30/2023

2. Subject Device

| Trade Name: | Unistik® ShieldLock
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

4

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.

5

Table 5.1 List of all available device models

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

6

7

8

9

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

The subject device has an
additional two-handed
procedure listed for
activation of the safety
feature, wherein the
tubing can be pulled with
the second hand,
removing the need to
activate the safety feature
with the thumb or finger.

The subject device differs
in that the user is advised
in the IFU to activate the
safety feature until an
audible 'click' is heard,
confirming to the user that
the safety feature has
been activated.

The safety feature of both
devices securely sheaths
the needle behind a layer
of solid plastic which
forms a physical barrier
between the patient/user
and the exposed needle.

10

11

12

13

14

| | | | | | impact on safety or
effectiveness |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging | Shelf box - Cardboard
Laminate
Individual Units - Blister
Packed | | Shelf box - Cardboard Laminate
Individual Units - Blister Packed | | Same |
| Components
and Materials | Stainless Steel, Silicone, UV
Curing adhesive, Polyvinyl
Chloride, Acrylonitrile
butadiene styrene, Epoxy
Resin, Isoprene Rubber,
Polypropylene | | Stainless Steel, Silicone, UV
Curing adhesive, Polyvinyl
Chloride, Acrylonitrile butadiene
styrene, Epoxy Resin, Isoprene
Rubber, Polypropylene | | Same - all materials for
subject device are used in
the predicate device. The
additional materials used
in predicate are for
components that are not
included in the subject
device. The subject
device
component/materials
were tested in accordance
to ISO10993 series and
therefore the difference in
components and
materials do not raise new
or different questions of
safety and effectiveness. |
| | Polyolefin, UV Curable Ink,
Acrylic, Isopropyl Alcohol,
Polyethylene | | Needle tube | Stainless
Steel 304 | |
| | | | Lubricate | Silicone oil | |
| | Wing | Polyolefin | Adhesive of
patient-end needle | UV curing
adhesive | |
| | Hub | Polypropylene | Needle
wing | Polyvinyl
Chloride | |
| | Button Ink | UV Curable Ink | Flexible tube | Polyvinyl
Chloride | |
| | Front Barrel | Polypropylene | | | |
| | Rear Barrel | Acrylic | | | |
| | Rear
Barrel
Lubricant | Silicone | Needle hub (male
luer lock
connector) | Acrylonitri
le
butadiene | |
| | Rear Barrel
Lubricant
Diluent | Isopropyl
Alcohol | Connect base
(female luer lock
connector) | Acrylonitri
le
butadiene | |
| | Spring | Stainless Steel
302 | Puncture
needle | Stainless
Steel 304 | |
| | IV
Protector
(Cannula
Protector) | Polyethylene | Adhesive of
puncture needle | Epoxy
Resin | |
| | IV
Cannula/NP
Cannula | Stainless Steel
304 | Rubber sleeve | Isoprene
Rubber | |
| | Tubing | Polyvinyl
Chloride | Needle Cap | Polyviny
l
Chloride | |
| | Cannula
Lubricant | Silicone | | | |
| | Cannula Adhesive | UV cured
adhesive | | | |
| | Hub-Tubing
Adhesive | UV cured
adhesive | | | |
| | Female
Luer
Connectors | Acrylonitrile
Butadiene
Styrene | Safety Sheath | Polypropyl
ene | |
| | Luer Adapter Hub | Polypropylene | | | |
| | NP Sleeve | Synthetic
Isoprene
Rubber | | | |
| | Luer Adhesive | Heat Curing
Epoxy Resin | | | |
| | Luer
Cannula
Lubricant | Medical Grade
Silicone | | | |
| | Luer Cap | Polypropylene | | | |
| | Top Web | Paper | | | |
| | Blister | Polyethylene
terephthalate
— glycol
modified | | | |
| | Pre-attached
holder | Polypropylene | | | |

15

16

VacuFlip and the predicate device
Test/ Characteristic	BD Vacutainer® Eclipse ™
Blood Collection Needle;
(K982541)	Subject Device:
Unistik® VacuFlip	Comparison
Patient Target Group	General use	General use	Same
Indications for Use
Statement	The Vacutainer Brand
ECLIPSE Blood Collection
Needle is a sterile, multiple
sample, single-use device for
blood collection. The needle is
designed with an attached
safety shield, which can be
activated to cover the needle
immediately after venipuncture
to provide protection from
accidental needle sticks.	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.	Both devices are sterile,
multiple sample single
use devices for blood
collection.
Both devices are
indicated for use by
healthcare
professionals.
Both devices feature a
user activated safety
shield that covers the
needle to help protect
against needle stick
injury.
Frequency of Use	As required by healthcare
professional	As required by healthcare
professional	Same
Needle Gauges	20G, 21G, 22G	20G, 21G, 22G	Same
To confirm safety and
effectiveness, the
devices have been
tested to ISO
7864:2016, ISO
9626:2016 and are
confirmed to meet the
required specifications.
Needle length	1 ½ inch	1 inch, 1 ¼ inch, 1 ½ inch	Same
Integral sharps injury
prevention feature?	Yes	Yes	Same
Safety feature
activation method	User activates with thumb after
venipuncture, shield 'pivots'
around the hinge, locking into
place at the needle base and
at the cannula	User activates with thumb after
venipuncture, shield 'pivots'
around the hinge, locking into
place at the needle base and
at the cannula	Same
Test/ Characteristic	BD Vacutainer® Eclipse™
Blood Collection Needle;
(K982541)	Subject Device:
Unistik® VacuFlip	Comparison
Single-use?	Yes	Yes	Same
Sterility	Sterile	Sterile	Same
Sterility
Assurance Level
(SAL) 10-6	Yes	Yes	Same
Sterilization method	Gamma	Ethylene oxide	Different; sterilization
method was validated
per over kill method as
qualified in accordance
with Annex B of ISO
11135-1:2014 and been
verified to the required
SAL of 10-6 ; no effect on
device
safety/effectiveness.
Shelf Life	5 Years	5 Years	Same
Pre-attached blood
tube holder?	Attached holder configuration
available	Attached holder configuration
available	Same
Non-pyrogenic	Yes	Yes	Same
Non-toxic	Yes	Yes	Same
Materials	Compliant with ISO 10993
series	Compliant with ISO 10993
series	Same
Operating principle	Venipuncture performed by
force generated by healthcare
professional	Venipuncture performed by
force generated by healthcare
professional	Same
Packaging	Shelf box - Cardboard
Laminate
Individual Units - Blister
Packed	Shelf box - Cardboard
Laminate
Individual Units - Blister
Packed	Same
Components and
materials	Cannula- stainless steel
Hub- polystyrene
Safety Shield- polypropylene
Rubber Sleeve- synthetic
rubber
Holder (integrated model)-
polypropylene
Lubricant- silicone	Needle tube- Stainless Steel
304
Lubricant - Silicone oil
Adhesive of patient-end needle

UV cured adhesive
Needle hub (male luer lock
connector) Polypropylene | Similar - both devices
use Stainless steel,
silicone, polypropylene.
The subject device uses
isoprene rubber which is
a form of synthetic
rubber; the predicate
just lists 'synthetic
rubber'. |
| Test/ Characteristic | BD Vacutainer® Eclipse ™
Blood Collection Needle;
(K982541) | Subject Device:
Unistik® VacuFlip | Comparison |
| | | Connect base (female luer lock connector)- Acrylonitrile butadiene | The subject device lists additionally: UV cured adhesive and Epoxy Resin. |
| | | Puncture needle - Stainless Steel 304 | The devices were functionally tested to confirm efficacy of these materials. |
| | | Adhesive of puncture needle- Epoxy Resin | |
| | | Rubber sleeve- Isoprene Rubber | The patient contact materials were tested as required in accordance with:
ISO 10993-5:2009,
ISO 10993-10:2010,
ISO 10993-11:2017
ASTM F756-2017
ISO 10993-4:2017 |
| | | Needle cap- Polypropylene
Safety sheath- Polypropylene
Needle holder- Polypropylene | All materials were found to meet specification. |

Table 5.3: Comparison of the technical characteristics between the subject device Unistik
VacuFlip and the predicate device

17

18

7. Performance Data

Non-clinical performance data:

Design verification testing has been performed on the Unistik® ShieldLock and Unistik VacuFlip lancets to demonstrate that the devices operate safely and effectively. Testing has been conducted to evaluate the performance of the devices against defined acceptance criteria.

Bench Testing

Performance testing (bench testing) was conducted on the subject devices and the results demonstrate that the subject devices operate safely and effectively as intended.

Test	Requirement	Results
Cleanliness	ISO7864:2016	Meets specification
Limits of Acidity or Alkalinity	ISO7864:2016	Meets specification
Limits for Extractable Metals	ISO7864:2016	Meets specification
Tubular Needle Designation Test	ISO7864:2016	Meets specification
Color Coding Test	ISO7864:2016	Meets specification
Conical Fitting Test	ISO7864:2016	Meets specification
Colour of Hub Test	ISO7864:2016	Meets specification
Needle Cap Test	ISO7864:2016	Meets specification
General-Needles and Tapered-
Needles Test	ISO7864:2016	Meets specification
Tolerances on Length Test	ISO7864:2016	Meets specification
Freedom from Defects Test	ISO7864:2016	Meets specification
Lubricant Test	ISO7864:2016	Meets specification
Needle Point Test	ISO7864:2016	Meets specification
Needle Retention Test	ISO7864:2016	Meets specification
Patency of Lumen Test	ISO7864:2016	Meets specification
Surface Finish and Visual Test	ISO9626:2016	Meets specification
Cleanliness Test	ISO9626:2016	Meets specification
Limits for Acidity & Alkalinity Test	ISO9626:2016	Meets specification
Size Designation Test	ISO9626:2016	Meets specification
Dimensions Test Record	ISO9626:2016	Meets specification
Stiffness Test Records	ISO9626:2016	Meets specification
Test Records for Resistance of
Tubing to Breakage	ISO9626:2016	Meets specification
Test Records for Resistance to
Corrosion	ISO9626:2016	Meets specification
Fluid Leakage Test	ISO80369-7:2016	Meets specification
Subatmospheric Pressure Air
Leakage	ISO80369-7:2016	Meets specification
Stress Cracking Test	ISO80369-7:2016	Meets specification
Resistance to separation from axial
load	ISO80369-7:2016	Meets specification
Safety Feature Testing	ISO 23908:2011	Meets specification
Particulate Matter Test	USP 788	Meets specification
Package Integrity Testing	ASTM F88/F88M-15
ASTM F 1929-15
ASTM F1886 / F1886M-16	Meets specification
Simulated Transportation Test	ISTA 3A (2018)	Meets specification
Test	Requirement	Results
Cleanliness	ISO7864:2016	Meets specification
Limits of Acidity or Alkalinity	ISO7864:2016	Meets specification
Limits for Extractable Metals	ISO7864:2016	Meets specification
Tubular Needle Designation Test	ISO7864:2016	Meets specification
Color Coding Test	ISO7864:2016	Meets specification
Conical Fitting Test	ISO7864:2016	Meets specification
Colour of Hub Test	ISO7864:2016	Meets specification
Needle Cap Test	ISO7864:2016	Meets specification
General-Needles and Tapered-
Needles Test	ISO7864:2016	Meets specification
Tolerances on Length Test	ISO7864:2016	Meets specification
Freedom from Defects Test	ISO7864:2016	Meets specification
Lubricant Test	ISO7864:2016	Meets specification
Needle Point Test	ISO7864:2016	Meets specification
Needle Retention Test	ISO7864:2016	Meets specification
Patency of Lumen Test	ISO7864:2016	Meets specification
Surface Finish and Visual Test	ISO9626:2016	Meets specification
Cleanliness Test	ISO9626:2016	Meets specification
Limits for Acidity & Alkalinity Test	ISO9626:2016	Meets specification
Size Designation Test	ISO9626:2016	Meets specification
Dimensions Test Record	ISO9626:2016	Meets specification
Stiffness Test Records	ISO9626:2016	Meets specification
Test Records for Resistance of
Tubing to Breakage	ISO9626:2016	Meets specification
Test Records for Resistance to
Corrosion	ISO9626:2016	Meets specification
Fluid Leakage Test	ISO80369-7:2016	Meets specification
Subatmospheric Pressure Air
Leakage	ISO80369-7:2016	Meets specification
Stress Cracking Test	ISO80369-7:2016	Meets specification
Resistance to separation from axial
load	ISO80369-7:2016	Meets specification
Safety Feature Testing	ISO 23908:2011	Meets specification
Particulate Matter Test	USP 788	Meets specification
Package Integrity Testing	ASTM F88/F88M-15
ASTM F 1929-15
ASTM F1886 / F1886M-16	Meets specification
Simulated Transportation Test	ISTA 3A (2018)	Meets specification

Table 5.4 List of tests performed on Unistik® ShieldLock

19

20

21

Table 5.5 List of tests performed on Unistik® VacuFlip

22

The subject devices comply with the acceptance criteria established based on the specifications of the devices. All additional performance tests met the acceptance criteria.

The results from these tests demonstrate that the Unistik® ShieldLock and Unistik VacuFlip are safe and effective when used as intended.

Biocompatibility:

In accordance with ISO 10993-1:2018, the Unistik® ShieldLock and Unistik VacuFlip devices are classified as shown in Table 5.6 below.

Category	Externally communicating device
Contact	Circulating blood
Contact duration	A (Limited; ≤ 24 hours)

Table 5.6 - ISO 10993-1:2018 classification of Unistik® SheildLock & VacuFlip

Based on available information and biocompatibility reports available for the device and its components, Owen Mumford concludes that the device meets all requirements according to ISO 10993 and FDA guidance when used as intended.

The following Biocompatibility standards were used when assessing the biocompatibility of the subject devices:

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ASTM F756-2017 Standard Practice for Assessment of Hemolytic Properties of Materials. ISO 10993-4:2017 Biological Evaluation of Medical Devices Part 4: Selection of tests for

23

interactions with blood

Sterilization:

The Unistik® ShieldLock Blood Collection Set & Unistik VacuFlip Blood Collection Needle are supplied to the user in a sterile state and remain sterile for 5 years from the date of sterilization. The devices are single-use and are not intended to be reprocessed and re-used. The Unistik® ShieldLock Blood Collection Set & Unistik VacuFlip Blood Collection Needle are sterilized by ethylene oxide sterilization in Accordance with ISO 11135-1:2014. The sterilization cycle below was validated per over kill method as qualified in accordance with Annex B of ISO 11135-1:2014 - "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E. Single batch release".

The following standards were used to assess the sterility and shelf life of the device:

ISO 11135-1:2014 - "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices -Amendment 1: Revision of Annex E, Single batch release"

ISO 10993-7:2008 - Biological evaluation of medical devices

Simulated Transportation Test: ISTA 3A (2018)

ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials (Sterility) ASTM F 1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration

ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

8. Clinical Testing

No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device

9. Conclusion

It can be concluded that the differences between the subject devices. Unistik® ShieldLock Blood Collection set and Unistik® VacuFlip and predicate devices do not raise any new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate devices, BD Vacutainer® UltraTouch™ Push Button Blood Collection Set, cleared under K212724 and BD Vacutainer® Eclipse™ Blood Collection Needle, cleared under K982541.