(189 days)
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.
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.
This FDA 510(k) summary describes the acceptance criteria and study results for two medical devices: Unistik® ShieldLock Blood Collection Set and Unistik® VacuFlip Safety Blood Collection Needle.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Requirement (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Cleanliness (ISO 7864:2016, ISO 9626:2016) | ISO 7864:2016 / ISO 9626:2016 | Meets specification |
| Limits of Acidity or Alkalinity (ISO 7864:2016, ISO 9626:2016) | ISO 7864:2016 / ISO 9626:2016 | Meets specification |
| Limits for Extractable Metals (ISO 7864:2016, ISO 9626:2016) | ISO 7864:2016 / ISO 9626:2016 | Meets specification |
| Tubular Needle Designation Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Color Coding Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Conical Fitting Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Colour of Hub Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Needle Cap Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| General-Needles and Tapered-Needles Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Tolerances on Length Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Freedom from Defects Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Lubricant Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Needle Point Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Needle Retention Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Patency of Lumen Test (ISO 7864:2016) | ISO 7864:2016 | Meets specification |
| Surface Finish and Visual Test (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Cleanliness Test (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Limits for Acidity & Alkalinity Test (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Size Designation Test (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Dimensions Test Record (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Stiffness Test Records (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Resistance of Tubing to Breakage Test Records (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Resistance to Corrosion Test Records (ISO 9626:2016) | ISO 9626:2016 | Meets specification |
| Fluid Leakage Test (ISO 80369-7:2016) | ISO 80369-7:2016 | Meets specification |
| Subatmospheric Pressure Air Leakage (ISO 80369-7:2016) | ISO 80369-7:2016 | Meets specification |
| Stress Cracking Test (ISO 80369-7:2016) | ISO 80369-7:2016 | Meets specification |
| Resistance to separation from axial load (ISO 80369-7:2016) | ISO 80369-7:2016 | Meets specification |
| Safety Feature Testing (ISO 23908:2011) | ISO 23908:2011 | Meets specification |
| Particulate Matter Test (USP 788) | 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 |
| Biocompatibility | ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ASTM F756-2017, ISO 10993-4:2017 | Meets all requirements |
| Sterilization Assurance Level | SAL of 10⁻⁶ (as per ISO 11135-1:2014) | Achieves required SAL of 10⁻⁶ |
| Shelf Life (Sterility maintenance) | 5 years from date of sterilization (as per ISO 11135-1:2014, ISTA 3A (2018), ASTM F88/F88M-15, ASTM F 1929-15, ASTM F1886 / F1886M-16, ISO 10993-7:2008) | Remains sterile for 5 years |
2. Sample size used for the test set and the data provenance
The document explicitly states that "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." The tables show a comprehensive list of bench tests and corresponding ISO/ASTM standards.
- Sample Size for Test Set: The document does not specify the exact sample size for each individual test. It generally states that "samples" were tested. However, the mention of "samples that were accelerated aged to the 5 year shelf life" for Unistik® ShieldLock's shelf life confirmation implies multiple units were subjected to these tests. Given the nature of medical device testing for regulatory submission, these samples would have been representative of the production.
- Data Provenance (Country of Origin and Retrospective/Prospective): The data provenance is not explicitly stated in terms of country of origin. The submitting company, Owen Mumford Ltd, is located in the United Kingdom. The testing appears to be prospective as it's verification testing for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The studies described are bench testing (laboratory-based performance and safety evaluations against recognized industry standards and internal specifications) and biocompatibility testing. These types of studies do not involve human expert interpretation of results to establish a "ground truth" in the way clinical studies or AI diagnostic studies do. The "ground truth" is typically defined by the objective metrics and criteria within the specified standards.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human observers or readers to resolve discrepancies in diagnoses or assessments, which is not the nature of the bench and biocompatibility testing performed here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." These devices are blood collection devices and do not involve AI assistance or diagnostic interpretation by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm (AI) performance study was done. These are physical medical devices (blood collection sets and needles), not AI algorithms.
7. The type of ground truth used
The "ground truth" for the performance criteria is established by the requirements and specifications within the referenced international and national standards (ISO, ASTM, USP), as well as the manufacturer's own validated specifications. For example, for "Fluid Leakage Test," the ground truth is "Meets specification" based on the criteria outlined in ISO 80369-7:2016. For biocompatibility, the ground truth is adherence to the requirements of the ISO 10993 series and FDA guidance.
8. The sample size for the training set
This section is not applicable. There is no AI component mentioned in the device description or testing. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set.
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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
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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 (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
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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 LtdTel: +44(0)1993 812021Fax: +44(0)1993 813466 |
|---|---|
| Prepared for: | Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 3003348846 |
| Contact Person: | Darren MansellRegulatory Affairs ManagerOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: darren.mansell@owenmumford.com |
Date Prepared: 06/30/2023
2. Subject Device
| Trade Name: | Unistik® ShieldLockUnistik® 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
| DeviceName | Configuration | Variant | Box Qty. | ProductCode |
|---|---|---|---|---|
| Blood Collection Set withLuer Adapter | 20G Needle, 19mm needle length, 200mm tube and with Luerattached. No vacuum holder. | 100 | P003763A1 | |
| Blood Collection Set withoutLuer Adapter | 20G Needle, 19mm needle length, 200mm tube and without Luer orvacuum holder. | 100 | P003764A1 | |
| Blood Collection Set withPre-Attached Holder | 20G Needle, 19mm needle length, 200mm tube, with Luer and vacuumholder attached. | 50 | P003765A1 | |
| Blood Collection Set withLuer Adapter | 20G Needle, 19mm needle length, 300mm tube and with Luerattached. No vacuum holder. | 100 | P003766A1 | |
| Blood Collection Set withoutLuer Adapter | 20G Needle, 19mm needle length, 300mm tube and without Luer orvacuum holder. | 100 | P003767A1 | |
| Blood Collection Set withPre-Attached Holder | 20G Needle, 19mm needle length, 300mm tube, with Luer and vacuumholder attached. | 50 | P003768A1 | |
| UnistikShieldLock | Blood Collection Set withLuer Adapter | 21G Needle, 19mm needle length, 200mm tube and with Luerattached. No vacuum holder. | 100 | P003769A1 |
| Blood Collection Set withoutLuer Adapter | 21G Needle, 19mm needle length, 200mm tube and without Luer orvacuum holder. | 100 | P003770A1 | |
| Blood Collection Set withPre-Attached Holder | 21G Needle, 19mm needle length, 200mm tube, with Luer and vacuumholder attached. | 50 | P003771A1 | |
| Blood Collection Set withLuer Adapter | 21G Needle, 19mm needle length, 300mm tube and with Luerattached. No vacuum holder. | 100 | P003772A1 | |
| Blood Collection Set withoutLuer Adapter | 21G Needle, 19mm needle length, 300mm tube and without Luer orvacuum holder. | 100 | P003773A1 | |
| Blood Collection Set withPre-Attached Holder | 21G Needle, 19mm needle length, 300mm tube, with Luer and vacuumholder attached. | 50 | P003774A1 | |
| Blood Collection Set withLuer Adapter | 22G Needle, 19mm needle length, 200mm tube and with Luerattached. No vacuum holder. | 100 | P003775A1 | |
| Blood Collection Set withoutLuer Adapter | 22G Needle, 19mm needle length, 200mm tube and without Luer orvacuum holder. | 100 | P003776A1 | |
| Blood Collection Set withPre-Attached Holder | 22G Needle, 19mm needle length, 200mm tube, with Luer and vacuumholder attached. | 50 | P003777A1 | |
| Blood Collection Set withLuer Adapter | 22G Needle, 19mm needle length, 300mm tube and with Luerattached. No vacuum holder. | 100 | P003778A1 | |
| DeviceName | Configuration | Variant | Box Qty. | ProductCode |
| UnistikShieldLock | Blood Collection Set withoutLuer Adapter | 22G Needle, 19mm needle length, 300mm tube and without Luer orvacuum holder. | 100 | P003779A1 |
| Blood Collection Set withPre-Attached Holder | 22G Needle, 19mm needle length, 300mm tube, with Luer and vacuumholder attached. | 50 | P003780A1 | |
| Blood Collection Set withLuer Adapter | 23G Needle, 19mm needle length, 200mm tube and with Luerattached. No vacuum holder. | 100 | P003781A1 | |
| Blood Collection Set withoutLuer Adapter | 23G Needle, 19mm needle length, 200mm tube and without Luer orvacuum holder. | 100 | P003782A1 | |
| Blood Collection Set withPre-Attached Holder | 23G Needle, 19mm needle length, 200mm tube, with Luer and vacuumholder attached. | 50 | P003783A1 | |
| Blood Collection Set withLuer Adapter | 23G Needle, 19mm needle length, 300mm tube and with Luerattached. No vacuum holder. | 100 | P003784A1 | |
| Blood Collection Set withoutLuer Adapter | 23G Needle, 19mm needle length, 300mm tube and without Luer orvacuum holder. | 100 | P003785A1 | |
| Blood Collection Set withPre-Attached Holder | 23G Needle, 19mm needle length, 300mm tube, with Luer and vacuumholder attached. | 50 | P003786A1 | |
| Blood Collection Set withLuer Adapter | 25G Needle, 19mm needle length, 200mm tube and with Luerattached. No vacuum holder. | 100 | P003787A1 | |
| Blood Collection Set withoutLuer Adapter | 25G Needle, 19mm needle length, 200mm tube and without Luer orvacuum holder. | 100 | P003788A1 | |
| Blood Collection Set withPre-Attached Holder | 25G Needle, 19mm needle length, 200mm tube, with Luer and vacuumholder attached. | 50 | P003789A1 | |
| Blood Collection Set withLuer Adapter | 25G Needle, 19mm needle length, 300mm tube and with Luerattached. No vacuum holder. | 100 | P003790A1 | |
| Blood Collection Set withoutLuer Adapter | 25G Needle, 19mm needle length, 300mm tube and without Luer orvacuum holder. | 100 | P003791A1 | |
| Blood Collection Set withPre-Attached Holder | 25G Needle, 19mm needle length, 300mm tube, with Luer and vacuumholder attached. | 50 | P003792A1 | |
| UnistikVacuFlip | Blood Collection SafetyNeedle with Pre-AttachedHolder | 21G 1-1/4" Needle with Pre-Attached Holder | 50 | P004823A1 |
| Blood Collection SafetyNeedle with Pre-AttachedHolder | 22G 1-1/4" Needle with Pre-Attached Holder | 50 | P004825A1 | |
| DeviceName | Configuration | Variant | Box Qty. | ProductCode |
| UnistikVacuFlip | 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 | |
| DeviceName | Configuration | Variant | Box Qty. | ProductCode |
| UnistikVacuFlip | Blood Collection SafetyNeedle | 20G 1" Needle with Luer | 100 | P003806A1 |
| Blood Collection SafetyNeedle | 21G 1" Needle with Luer | 100 | P003807A1 | |
| Blood Collection SafetyNeedle | 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/Characteristic | Predicate Device:BD Vacutainer®UltraTouch™ Push ButtonBlood Collection Set,K212724 | Subject Device:Unistik® ShieldLock | Comparison |
|---|---|---|---|
| Patient TargetGroup | General use including patientswith difficult vein access (DVA) | General use | Specific reference to DVAhas no effect on devicesafety/effectiveness asDVA is a subset ofgeneral use |
| Indications forUse Statement | Indications for Use (Describe):The BD Vacutainer®UltraTouch™ Push ButtonBlood Collection Set is asterile, multi-sample, single-use fixed winged bloodcollection set intended to beused by trained healthcareprofessionals for venipunctureto obtain blood specimensfrom patients, including thosepatients with difficult veinaccess who may have small,fragile, and/or non-palpableveins, into evacuated bloodcollection tubes and/or bloodculture bottles. When usedwithout the male adapter, thedevice allows the clinician toobtain a blood specimen fromthe female hub with a syringe,if necessary. The device canbe used for short-term, single | Indications for Use (Describe):The Unistik ShieldLock BloodCollection Set is a sterile, multi-sample, single-use 'butterfly' styleblood collection set intended to beused by trained healthcareprofessionals for venipuncture toobtain blood specimens frompatients into blood collectiontubes or blood culture bottles.When used without the maleadapter, the device allows theclinician to obtain a bloodspecimen from the female hubwith a syringe. | Both devices are sterile,multi-sample, single-use'winged' ('butterfly' stylenamed so due to wingfeatures) blood collectionsets.Both devices areindicated for use bytrained healthcareprofessionals forvenipuncture and bloodcollection into bloodcollection tubes and/orblood collection bottles.Both devices areindicated for use withoutthe male adapter to allowa clinician to obtain ablood specimen from thefemale hub with a syringe. |
| infusions with considerationgiven to patient size andappropriateness for thesolution being infused. Thedevice is not to be left in placeand is to remain under thedirect supervision of aclinician. The recommendeduse of the device is to activatethe needle safety feature priorto removal from thevenipuncture site. Theretraction of the intravenous(IV) end of the needle aids inthe prevention of accidentalneedlestick injury. | The predicate device isindicated for use for short-term single IV infusions,the subject device is notindicated for use for shortterm IV infusions, this hasno effect on its safety oreffectiveness as a bloodcollection set; the devicebox and IFU are markedwith the warning: "Thisdevice is not indicated forshort-term infusions". | ||
| Used for shortterm IV infusion | Yes | No | Short term IV infusion isnot being indicated forUnistik ShieldLock, thishas no effect on its safetyor effectiveness as ablood collection set; thedevice box and IFU aremarked with the warning:"This device is notindicated for short-terminfusions". |
| Frequency ofUse | As required by healthcareprofessional | As required by healthcareprofessional | Same |
| Needle Gauges | 21G, 23G, 25G | 20G, 21G, 22G, 23G, 25G | Additional gauges of 20Gand 22G. 22G is withinthe range of the predicate,so no effect onsafety/effectiveness.Some patients mayrequire a different gaugelancet to achieve therequired blood flow.Therefore, the addition ofthe 20G needle variantrepresents a slightlylarger outer diameterneedle than seen in thepredicate. 20G needlesare widely used inhealthcare and selectedas necessary by thehealthcare professional tomeet patient needs. Thereis no additional risk oreffect on safety andeffectiveness associatedwith differential needle |
| gauges, and these do notaffect depth ofpenetration.To confirm safety andeffectiveness, the deviceshave been tested to ISO7864:2016, ISO9626:2016 and are | |||
| confirmed to meet therequired specifications. | |||
| Needle length | 3/4 inch | 3/4 Inch | Same |
| Tube lengths | 178mm, 305mm | 200mm, 300mm | Subject device lengthsare similar to thepredicate, and within therange of the predicate, sono effect onsafety/effectiveness. |
| Pre-attachedblood tubeholder? | Available with or without pre-attached "BD Vacutainer OneUse Holder" | Available with or without pre-attached Unistik Holder | Same |
| Both devices are availablewith or without pre-attached holder, and bothdevices have holdersavailable to purchaseseparately. | |||
| Luer LockAdapter | Yes | Yes | Same |
| Integral sharpsinjury preventionfeature? | Yes | Yes | Both have a sharps injuryprotection feature,differences discussed inthis table below. |
| Sharps injurypreventionsafety featureoperatingprinciple? | Safety feature is designed tobe activated while needle isstill in the patient's vein.Gauze pad is placed acrossthe venipuncture site, coveringthe front barrel. While theneedle is still in the vein, thedevice body is grasped withthe thumb and middle finger.The push button is activatedwith the tip of the index fingercausing the needle to retractinto the device body. | Safety feature is activated afterthe needle is removed from thepatient's vein.One-handed procedure: Hold theend of the safety shield with yourthumb and index finger and usethe remaining fingers to hold thetubing securely in the palm ofyour hands. Push the safetyshield towards the needle until anaudible click is heard.Two-handed procedure: Hold theend of the safety shield with yourthumb and index finger in onehand, with the other hand, pull the | Both devices have asafety feature that can beactivated by one handusing the thumb/index |
| finger.The predicate devicesafety feature is activatedwhile still in the patientvein, whereas the subjectdevice safety feature isactivated once removedfrom the patient vein. Thesubject device safetyfeature can however beactivated immediatelyafter removal from the | |||
| tubing backwards until an audibleclick is heard. | patient vein, resulting invery limited time with anexposed needle, reducingthe risk of needle stickinjury.The subject device has anadditional two-handedprocedure listed foractivation of the safetyfeature, wherein thetubing can be pulled withthe second hand,removing the need toactivate the safety featurewith the thumb or finger.The subject device differsin that the user is advisedin the IFU to activate thesafety feature until anaudible 'click' is heard,confirming to the user thatthe safety feature hasbeen activated.The safety feature of bothdevices securely sheathsthe needle behind a layerof solid plastic whichforms a physical barrierbetween the patient/userand the exposed needle.Safety feature testing wasconducted in line with ISO23908:2011 to confirmsafety and effectivenessof the subject device; thiswas conducted onsamples that wereaccelerated aged to the 5year shelf life. | ||
| Single-use? | Yes | Yes | Same |
| Sterility | Sterile | Sterile | Same |
| SterilityAssurance Level(SAL) 10-6 | Yes | Yes | Same |
| Sterilizationmethod | Gamma | Ethylene oxide | Different; sterilizationmethod was validated perover kill method asqualified in accordancewith Annex B of ISO11135-1:2014 and beenverified to the requiredSAL of 10⁻⁶; no effect ondevicesafety/effectiveness. |
| Shelf Life | 2 Years | 5 Years | Different; the subjectdevice has a shelf life of 5years.To confirm the safety andeffectiveness of thesubject device, sampleswere sterilized,accelerated aged to 5years and then tested inaccordance with thefollowing standards:ISO7864:2016ISO9626-2016 |
| Non-pyrogenic | Yes | Yes | Same |
| Non-toxic | Yes | Yes | Same |
| Materials | Compliant with ISO 10993series | Compliant with ISO 10993 series | Same |
| Operatingprinciple | Venipuncture performed byforce generated by healthcareprofessional | Venipuncture performed by forcegenerated by healthcareprofessional | Same |
| Needle Material | Stainless steel cannula | Stainless steel cannula | Same |
| Needle Point | 5 bevel | 3 bevel | Different, both representindustry standard, no |
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| impact on safety oreffectiveness | |||||
|---|---|---|---|---|---|
| Packaging | Shelf box - CardboardLaminateIndividual Units - BlisterPacked | Shelf box - Cardboard LaminateIndividual Units - Blister Packed | Same | ||
| Componentsand Materials | Stainless Steel, Silicone, UVCuring adhesive, PolyvinylChloride, Acrylonitrilebutadiene styrene, EpoxyResin, Isoprene Rubber,Polypropylene | Stainless Steel, Silicone, UVCuring adhesive, PolyvinylChloride, Acrylonitrile butadienestyrene, Epoxy Resin, IsopreneRubber, Polypropylene | Same - all materials forsubject device are used inthe predicate device. Theadditional materials usedin predicate are forcomponents that are notincluded in the subjectdevice. The subjectdevicecomponent/materialswere tested in accordanceto ISO10993 series andtherefore the difference incomponents andmaterials do not raise newor different questions ofsafety and effectiveness. | ||
| Polyolefin, UV Curable Ink,Acrylic, Isopropyl Alcohol,Polyethylene | Needle tube | StainlessSteel 304 | |||
| Lubricate | Silicone oil | ||||
| Wing | Polyolefin | Adhesive ofpatient-end needle | UV curingadhesive | ||
| Hub | Polypropylene | Needlewing | PolyvinylChloride | ||
| Button Ink | UV Curable Ink | Flexible tube | PolyvinylChloride | ||
| Front Barrel | Polypropylene | ||||
| Rear Barrel | Acrylic | ||||
| RearBarrelLubricant | Silicone | Needle hub (maleluer lockconnector) | Acrylonitrilebutadiene | ||
| Rear BarrelLubricantDiluent | IsopropylAlcohol | Connect base(female luer lockconnector) | Acrylonitrilebutadiene | ||
| Spring | Stainless Steel302 | Punctureneedle | StainlessSteel 304 | ||
| IVProtector(CannulaProtector) | Polyethylene | Adhesive ofpuncture needle | EpoxyResin | ||
| IVCannula/NPCannula | Stainless Steel304 | Rubber sleeve | IsopreneRubber | ||
| Tubing | PolyvinylChloride | Needle Cap | PolyvinylChloride | ||
| CannulaLubricant | Silicone | ||||
| Cannula Adhesive | UV curedadhesive | ||||
| Hub-TubingAdhesive | UV curedadhesive | ||||
| FemaleLuerConnectors | AcrylonitrileButadieneStyrene | Safety Sheath | Polypropylene | ||
| Luer Adapter Hub | Polypropylene | ||||
| NP Sleeve | SyntheticIsopreneRubber | ||||
| Luer Adhesive | Heat CuringEpoxy Resin | ||||
| LuerCannulaLubricant | Medical GradeSilicone | ||||
| Luer Cap | Polypropylene | ||||
| Top Web | Paper | ||||
| Blister | Polyethyleneterephthalate— glycolmodified | ||||
| Pre-attachedholder | Polypropylene |
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| 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 UseStatement | The Vacutainer BrandECLIPSE Blood CollectionNeedle is a sterile, multiplesample, single-use device forblood collection. The needle isdesigned with an attachedsafety shield, which can beactivated to cover the needleimmediately after venipunctureto provide protection fromaccidental needle sticks. | Unistik VacuFlip: The UniStikVacuFlip Safety BloodCollection Needle is intendedto be used by healthcareprofessionals with vacuumblood collection tubes formultiple collections of venousblood. The safety shield isintended to aid in theprotection against accidentalneedle stick injury. | Both devices are sterile,multiple sample singleuse devices for bloodcollection.Both devices areindicated for use byhealthcareprofessionals.Both devices feature auser activated safetyshield that covers theneedle to help protectagainst needle stickinjury. |
| Frequency of Use | As required by healthcareprofessional | As required by healthcareprofessional | Same |
| Needle Gauges | 20G, 21G, 22G | 20G, 21G, 22G | SameTo confirm safety andeffectiveness, thedevices have beentested to ISO7864:2016, ISO9626:2016 and areconfirmed to meet therequired specifications. |
| Needle length | 1 ½ inch | 1 inch, 1 ¼ inch, 1 ½ inch | Same |
| Integral sharps injuryprevention feature? | Yes | Yes | Same |
| Safety featureactivation method | User activates with thumb aftervenipuncture, shield 'pivots'around the hinge, locking intoplace at the needle base andat the cannula | User activates with thumb aftervenipuncture, shield 'pivots'around the hinge, locking intoplace at the needle base andat 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 |
| SterilityAssurance Level(SAL) 10-6 | Yes | Yes | Same |
| Sterilization method | Gamma | Ethylene oxide | Different; sterilizationmethod was validatedper over kill method asqualified in accordancewith Annex B of ISO11135-1:2014 and beenverified to the requiredSAL of 10-6 ; no effect ondevicesafety/effectiveness. |
| Shelf Life | 5 Years | 5 Years | Same |
| Pre-attached bloodtube holder? | Attached holder configurationavailable | Attached holder configurationavailable | Same |
| Non-pyrogenic | Yes | Yes | Same |
| Non-toxic | Yes | Yes | Same |
| Materials | Compliant with ISO 10993series | Compliant with ISO 10993series | Same |
| Operating principle | Venipuncture performed byforce generated by healthcareprofessional | Venipuncture performed byforce generated by healthcareprofessional | Same |
| Packaging | Shelf box - CardboardLaminateIndividual Units - BlisterPacked | Shelf box - CardboardLaminateIndividual Units - BlisterPacked | Same |
| Components andmaterials | Cannula- stainless steelHub- polystyreneSafety Shield- polypropyleneRubber Sleeve- syntheticrubberHolder (integrated model)-polypropyleneLubricant- silicone | Needle tube- Stainless Steel304Lubricant - Silicone oilAdhesive of patient-end needle- UV cured adhesiveNeedle hub (male luer lockconnector) Polypropylene | Similar - both devicesuse Stainless steel,silicone, polypropylene.The subject device usesisoprene rubber which isa form of syntheticrubber; the predicatejust lists 'syntheticrubber'. |
| 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 10993-11:2017ASTM F756-2017ISO 10993-4:2017 | ||
| Needle cap- PolypropyleneSafety sheath- PolypropyleneNeedle 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
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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 ofTubing to Breakage | ISO9626:2016 | Meets specification |
| Test Records for Resistance toCorrosion | ISO9626:2016 | Meets specification |
| Fluid Leakage Test | ISO80369-7:2016 | Meets specification |
| Subatmospheric Pressure AirLeakage | ISO80369-7:2016 | Meets specification |
| Stress Cracking Test | ISO80369-7:2016 | Meets specification |
| Resistance to separation from axialload | 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-15ASTM F 1929-15ASTM 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 ofTubing to Breakage | ISO9626:2016 | Meets specification |
| Test Records for Resistance toCorrosion | ISO9626:2016 | Meets specification |
| Fluid Leakage Test | ISO80369-7:2016 | Meets specification |
| Subatmospheric Pressure AirLeakage | ISO80369-7:2016 | Meets specification |
| Stress Cracking Test | ISO80369-7:2016 | Meets specification |
| Resistance to separation from axialload | 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-15ASTM F 1929-15ASTM F1886 / F1886M-16 | Meets specification |
| Simulated Transportation Test | ISTA 3A (2018) | Meets specification |
Table 5.4 List of tests performed on Unistik® ShieldLock
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Table 5.5 List of tests performed on Unistik® VacuFlip
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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
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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.
§ 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.