VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

K173757 · Greiner Bio-One Na, Inc. · FMI · Apr 19, 2018 · General Hospital

Device Facts

• Record ID: K173757
• Device Name: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
• Applicant: Greiner Bio-One Na, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Device Story

Single-use, sterile, winged needle device for venous blood collection or short-term IV fluid infusion. Features flexible tubing with Luer connector and semi-automatic safety mechanism. Operated by trained healthcare professionals in clinical settings. Safety mechanism activated manually by user; spring-driven motion covers needle immediately post-venipuncture to prevent accidental needlestick injuries. Luer port allows connection to standard accessories like holders or adapters. Device provides physical protection for clinicians; facilitates safe blood draw and fluid delivery.

Clinical Evidence

Bench testing only. Performance verified against ISO 7864, ISO 23908, ISO 9626, ISO 8536-4, and ASTM standards. Biocompatibility confirmed per ISO 10993 series. Sterility validated per ISO 11137-1. All tests passed.

Technological Characteristics

Winged needle (AISI 304 stainless steel) with flexible PVC tubing. Components: PP needle cap, PC protector, PMMA hub, ABS stopper/connector, TPE wing. Semi-passive safety mechanism uses AISI 301 stainless steel spring. Sterilized via irradiation (SAL 10^-6). Complies with ISO 7864, 23908, 9626, 8536-4, 11137-1, 10993, and ASTM F2096/F1929.

Indications for Use

Indicated for venous blood collection and/or short-term intravenous fluid infusion. For use by trained healthcare professionals.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• VACUETTE SAFETY BLOOD COLLECTION SET & SAFETY INFUSION SET (K121908)

Submission Summary (Full Text)

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April 19, 2018

Greiner Bio-One NA Inc Manfred Abel Quality Systems and Regulatory Affairs 4238 Capital Drive Monroe, North Carolina 28110

Re: K173757

Trade/Device Name: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 12, 2018 Received: March 13, 2018

Dear Manfred Abel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173757

Device Name

VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set

Indications for Use (Describe)

The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Type of Use (Select one or both, as applicable)

| <span></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------------------------|
| <span></span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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### SECTION 5. PREMARKET NOTIFICATION 510(K) SUMMARY: K173757

#### 1. SUBMITTER Applicant Name: Greiner Bio-One GmbH. Bad Haller Strasse 32 4550 Kremsmuenster, Austria

- Manfred Abel, M.S., MBA Contact person: Greiner Bio-One NA Inc. 4238 Capital Drive Monroe, NC 28110 704 261 7823 [e-mail]
### Establishment registration number: 8020040

Date prepared: Apr. 17, 2018

- 2. DEVICE
VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set Trade Name:

- Blood Collection Set Common name:
Classification: Needle, hypodermic, single lumen Name: Product Code: FMI Regulation No: 880.5570 Class: ನ Review Panel: General Hospital

### 3. PREDICATE DEVICE

VACUETTE SAFETY BLOOD COLLECTION SET & SAFETY Predicate: INFUSION SET (K121908)

### 4. DEVICE DESCRIPTION

The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a singleuse, sterile, winged needle bonded to flexible tubing with a Luer connector and a semiautomatic release of the safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation ensuring the needle is covered immediately following venipuncture to aid in the protection against accidental needlestick injury. The EVOPROTECT Safety Blood Collection/Infusion Set is individually wrapped, sterile with a luer port. The luer port can be used to connect FDA cleared accessories like luer adapter, holder, etc.

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# 5. INDICATION FOR USE

The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject device and the predicate device have the same fundamental technology, technological characteristics, and intended use.

Based on the device features, principles of operation and technological characteristics, the VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is substantially equivalent to the predicate device.

| | NEW GBO Product<br>VACUETTE®<br>EVOPRTOTECT Safety<br>Blood Collect/ Infusion<br>set | Predicate Device<br>VACUETTE® Safety Blood<br>Collection / Infusion set | Comparison | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| FDA Status | Under review | K121908 | NA | |
| Classification | Class II | Class II | same | |
| Regulation | 880.5570 | 880.5570 | same | |
| Classification<br>Product Code | FMI | FMI | same | |
| Intended Use | The VACUETTE<br>EVOPROTECT Safety<br>Blood Collection/Infusion<br>Set is indicated for<br>venous blood collection<br>and/or the short-term<br>infusion of intravenous<br>fluids. It is to be used by<br>appropriately trained<br>healthcare professionals<br>in accordance with the<br>instructions. | The SAFETY Blood<br>Collection/Infusion Set is a<br>single-use, sterile, winged<br>blood collection needle<br>bonded to a flexible tubing<br>with a luer connector. The<br>Vacuette Safety Blood<br>Collection/Infusion Set is<br>used for blood collection<br>and/or the short-term<br>infusion of intravenous<br>fluids. The winged needle is<br>designed with a safety<br>shield, which can be<br>activated to cover the<br>needle immediately<br>following venipuncture to<br>aid in the protection against<br>accidental needlestick<br>injury. | same | |
| Sterile | yes | yes | same | |
| | NEW GBO Product<br>VACUETTE®<br>EVOPRTOTECT Safety<br>Blood Collect/ Infusion<br>set | Predicate Device<br>VACUETTE® Safety Blood<br>Collection / Infusion set | Comparison | |
| Device Characteristics | | | | |
| Safety<br>mechanism | Semi-passive safety<br>mechanism.<br>One-hand activation. | Active safety mechanism.<br>One-hand activation. | equivalent | |
| | Manual operation for<br>activation (i.e. release).<br>Afterwards spring force<br>driven motion in safe<br>position. | Manual operation for<br>activation (i.e. release).<br>Afterwards manual driven<br>motion in safe position. | equivalent | |
| Cannula<br>Gauges | 21/23/25 | 21/23/25 | same | |
| Cannula Length | 3/4" | 3/4" | same | |
| Sterile | Yes | Yes | same | |
| Storage | 4 - 25 C° | 4 - 36 C° | equivalent | |
| Use | Single use only | Single use only | same | |
| Tubing Lengths | 4"; 7½"; 12" | 4"; 7½"; 12" | same | |
| Materials:<br>All data as detailed and as known: | | | | |
| Needle Cap | PP | PP | same | |
| Needle | Stainless Steel AISI 304 | Stainless Steel AISI 304 | same | |
| Wing | TPE | PVC | equivalent | |
| Protector | PC | PC | same | |
| Hub | PMMA | PMMA | same | |
| Activation<br>spring / manual | Stainless Steel Spring<br>AISI 301 | manual | equivalent | |
| Stopper | ABS | ABS | same | |
| Tubing | PVC with plasticizer | PVC with plasticizer | same | |
| Connector | ABS | ABS | same | |
| Connector Cap | PP | PP | same | |
| Adhesive | UV cured adhesive | Solvent bonding | equivalent | |
| Packaging | Blister | Pouch | equivalent | |

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The above table shows that the VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is equivalent to the predicate device. The differences in storage, wing material, activation, adhesive and packaging is equivalent as demonstrated in the performance testing.

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# 7. PERFORMANCE DATA

The VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is manufactured and tested in conformity with a variety of recognized consensus standards. Performance data show that the device performs as intended and in an equivalent manner as the predicate devices.

| Requirement | Acceptance | Results pass/fail |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------|
| Penetration resistance Cap | Penetration resistance >3N for 21G, 23G and 25G. Equivalent to predicate device. | pass |
| Cannula cleanliness | Tested in accordance with to ISO 7864:2014 | pass |
| Cannula radial orientation | Equivalent to predicate device. | pass |
| Cannula puncture & friction force 21G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 23G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 25G | Equivalent to predicate device | pass |
| Cannula bond force 21G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 23G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 25G | Tested in accordance with ISO 7864:2016 | pass |
| Flow rate water 10cm tubing, 21G (extreme: max flow rate over all variants) | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 21G | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30cm tubing, 25G (extreme: min flow rate over all variants) | Equivalence, internal Specification | pass |
| Breaking compressive force cannula before activation | Tested in accordance with ISO 23908:2011 | pass |
| Size designation | Tested in accordance with ISO 9626:2016 | pass |
| Dimensional | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for stiffness | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for breakage | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for corrosion | Tested in accordance with ISO 9626:2016 | pass |
| Requirement | Acceptance | Results<br>pass/fail |
| Activation force safety<br>mechanism | Tested in accordance with ISO<br>23908:2016 | pass |
| Breaking force safety mechanism<br>compression | Tested in accordance with ISO<br>23908:2011 | pass |
| Breaking force safety mechanism<br>tension | Tested in accordance with ISO<br>23908:2011 | pass |
| Bond strength Hub to Stopper | Equivalence,<br>ISO 8536-4:2010 + Amd 1:2013 | pass |
| Bond strength Tubing to Stopper | Equivalence,<br>ISO 8536-4:2010 + Amd 1:2013 | pass |
| Bond strength Tubing to<br>Connector | Equivalence,<br>ISO 8536-4:2010 + Amd 1:2013 | pass |
| Tubing breaking force | Equivalence,<br>ISO 8536-4:2010 + Amd 1:2013 | pass |
| Detaching torque Luer Adapter<br>(LA) to Connector | Equivalent to predicate device | pass |
| Detaching force Luer Adapter to<br>Connector | Equivalent to predicate device | pass |
| Spring characteristic | Equivalent to ISO 23908:2011,<br>simulated use | pass |
| Leakage of product (pressure &<br>vacuum) | Equivalent to predicate device | pass |
| Simulated use | According to intended use and<br>specification | pass |
| Tightness single packaging<br>(Bubble test) | According to ASTM F2096-04 | pass |
| Tightness single packaging (Dye<br>penetration) | According to ASTM F1929-15, ISO<br>11607-2 and EN 868-5 | pass |
| Sealing strength and max.<br>opening force single packaging | According to ISO 11607-1 and EN 868-<br>5 | pass |
| Biocompatibility testing | Testing according to ISO 10993-1 and<br>FDA guidance | pass |
| Sterility testing | Testing according to 11137-1 | pass |

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# Sterility testing

VACUETTE® EVOPROTECT Safety Blood Collection/ Infusion Sets are sterilized by irradiation for a final Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-1 Sterilization of health care products. Bacterial endotoxin testing was performed by according to ANSI/AAMI ST72:2011.

### Biocompatibility testinq

Biocompatibility for the VACUETTE® EVOPROTECT Safety Blood Collection/lnfusion Set was performed in accordance with standards of the ISO 10993 series and others to demonstrate that the subject device meets requirements of the following standards:

- Cytotoxicity (ISO 10993-5, USP 38: 2016) ●
- . Sensitization (ISO 10993-10:2010, ISO 10993-12 2012)
- Irritation (ISO 10993-10) .
- . Acute Systemic Toxicity (ISO 10993-11, USP 39 and ASTM F 750-87)
- Pyrogenicity (USP 39<151>) ●

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- Hemocompatibility (ISO 10993-4, ASTM F756) .
- . Particulate Matter (USP 788)
- Genotoxicity characterization of extractable (ISO 10993-3) .

### 8. CONCLUSION

Results from the performance verification and validation show that the EVOPROTECT Safety Blood Collection/Infusion Set meets established performance criteria and performance is as intended and substantially equivalent to the predicate device.