VACUETTE SAFELINK Holder with male luer lock

K180545 · Greiner Bio-One Na, Inc. · FMI · May 21, 2018 · General Hospital

Device Facts

• Record ID: K180545
• Device Name: VACUETTE SAFELINK Holder with male luer lock
• Applicant: Greiner Bio-One Na, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The VACUETTE SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.

Device Story

VACUETTE SAFELINK Holder is a sterile, single-use, non-invasive blood collection device. It consists of a polypropylene cylinder with a centric male luer lock and an internal stainless steel needle with a synthetic polyisoprene sleeve. The device facilitates blood draw by connecting to female luer port devices and puncturing the cap of a blood collection tube. Used by healthcare professionals in clinical settings. The centric luer lock design allows secure attachment to non-needle devices. The device ensures safe, effective blood collection, maintaining substantial equivalence to existing holders while providing a specific luer configuration.

Clinical Evidence

Bench testing only. Performance testing demonstrated equivalence to the predicate device regarding liquid leakage, fitting strength, pull-out force, stress cracking, air leakage, separation force, unscrewing torque, resistance to overriding, and free hemoglobin levels. Testing conducted in conformity with ISO 80369-7:2016.

Technological Characteristics

Materials: Polypropylene cylinder, stainless steel needle, synthetic polyisoprene sleeve. Design: Centric male luer lock. Sterilization: E-Beam (SAL 10^-6). Standards: ISO 80369-7:2016 for fitting assembly. Single-use, non-invasive.

Indications for Use

Indicated for use in blood collection procedures in combination with devices with a female luer port.

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

• Greiner HOLDEX® Single-use Holder PP (K160532)

Submission Summary (Full Text)

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May 21, 2018

Greiner Bio-One NA Inc. Manfred Abel Quality System & Regulatory Affairs Manager 4238 Capital Drive Monroe, North Carolina 28110

Re: K180545

Trade/Device Name: VACUETTE® SAFELINK Holder with male luer lock Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 26, 2018 Received: March 1, 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.

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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 (OS) regulation (21 CFR Part 820); 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.

Tina Kiang -S

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) K180545

Device Name

VACUETTE SAFELINK Holder with male luer lock

Indications for Use (Describe)

The VACUETTE SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.

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

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### PREMARKET NOTIFICATION 510(K) SUMMARY- K180545

| 1. SUBMITTER<br>Applicant Name: | Greiner Bio-One GmbH.<br>Bad Haller Strasse 32<br>4550 Kremsmuenster,<br>Austria |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Manfred Abel, M.S., MBA<br>Greiner Bio-One NA Inc.<br>4238 Capital Drive<br>Monroe, NC 28110<br>704 261 7823<br>[e-mail] |
| Establishment registration number: | 8020040 |
| Date prepared: | Apr 25, 2018 |
| 2. DEVICE | |
| Trade Name: | VACUETTE® SAFELINK Holder with male luer lock |
| Common name: | Holder |
| Classification: | Name: Needle, hypodermic, single lumen<br>Product Code: FMI<br>Regulation No: 880.5570<br>Class: 2<br>Review Panel: General Hospital |
| 3. PREDICATE DEVICE | |

| Predicate device: | Greiner HOLDEX® Single-use Holder PP (K160532) | |
|-------------------|----------------------------------------------------|----------------------------------------------------------|
| Classification: | Name:<br>Product Code:<br>Regulation No:<br>Class: | Needle, hypodermic, single lumen<br>FMI<br>880.5570<br>2 |

Review Panel:

## 4. DEVICE DESCRIPTION

The VACUETTE® SAFELINK Holder with male luer lock is a sterile, single-use, non-invasive device, which consists of a cylinder made from polypropylene plastic with a centric molded male luer lock at the top. The centric location of the male luer lock is to facilitate the connection to non-needle devices with a female luer port. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate

General Hospital

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blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.

## 5. INDICATION FOR USE

The VACUETTE® SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.

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

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

| | VACUETTE® SAFELINK Holder | Greiner HOLDEX Single-use |
|---------------------------|-----------------------------------------|-----------------------------------|
| | with male luer lock | Holder PP (predicate device) |
| FDA status | Under review | K160532 |
| Classification | Class II | Class II |
| Regulation | 880.5570 | 880.5570 |
| Product Code | FMI | FMI |
| Intended Use | The VACUETTE® SAFELINK Holder | The HOLDEX® Single-Use Holder |
| | with male luer lock is for use in blood | PP is for use in venous blood |
| | collection procedures in combination | collection procedures in |
| | with devices with a female luer port. | combination with blood collection |
| | | devices with a female luer port. |
| Manufacturer | Greiner Bio-One (GBO) | Greiner Bio-One (GBO) |
| Sterilizer | Mediscan GmbH | Mediscan GmbH |
| Needle Insert | Polypropylene | Polypropylene |
| Sleeve | Synthetic Polyisoprene Compound. | Synthetic Polyisoprene |
| | Does not contain dry natural rubber | Compound. Does not contain dry |
| | | natural rubber |
| Needle | Stainless Steel | Stainless Steel |
| Luer | Centric male luer lock | Eccentric male slip luer |
| Individual packaging | OPP Flat film (Width 120 mm, | OPP Flat film (Width 120 mm, |
| (blister) | Thickness 25 µm) | Thickness 25 µm) |
| Inner Carton (containing | Carton (181x181x171 mm), Sort: | Carton (181x181x171 mm), Sort: |
| 100 Blisters) | T20E with E-Flute | T20E with E-Flute |
| Outer Carton (containing | Carton (380x380x360 mm), Sort: | Carton (380x380x360 mm), Sort: |
| 8 inner cartons) | SO53/2 with C-Flute | SO53/2 with C-Flute |
| Sterilization | E-Beam | E-Beam |
| Sterility Assurance Level | 10-6 | 10-6 |
| Storage | 4 - 25 C° | 4 - 25 C° |
| Shelf life | 36 months | 36 months |
| Use | Single use only | Single use only |

The indications of use of the VACUETTE® SAFELINK Holder with male luer lock under review are substantially equivalent to the predicate device. The used materials for all components, all packaging levels, and the production and sterilization processes of the device under review are the same as for the predicate device. The only difference is that the design under review has a centric male luer lock, which as benchmark testing indicates, is equivalent to the predicate device and does not raise new question for safety and effectiveness.

Based on the device features, principles of operation and technological characteristics, the VACUETTE® SAFELINK with male luer lock is substantially equivalent to the predicate device.

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## 7. PERFORMANCE DATA

The VACUETTE® SAFELINK with male luer lock is manufactured and tested in conformity with internal specifications and recognized consensus standards. Performance testing was conducted to demonstrate and support our substantial equivalency claim that the device performs as intended and in an equivalent manner as the predicate device.

| Requirement | Acceptance | Results<br>pass/fail |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------|
| Liquid Leakage of rubber sleeve<br>and ultrasonic welding area<br>(seaming seal area) including<br>Kickback Testing | Equivalence to predicate device, internal<br>specification | pass |
| Fitting strength between rubber<br>sleeve and needle insert | Equivalence to predicate device, internal<br>specification | pass |
| Pull Out Force Needle | Equivalence to predicate device, internal<br>specification | pass |
| Stress cracking and liquid<br>leakage from fitting assembly<br>under pressure | Tested in conformity to ISO 80369-7:2016 | pass |
| Air leakage into fitting assembly<br>during aspiration | Tested in conformity to ISO 80369-7:2016 | pass |
| Separation force of fitting<br>assembly | Tested in conformity to ISO 80369-7:2016 | pass |
| Unscrewing torque of fitting<br>assembly | Tested in conformity to ISO 80369-7:2016 | pass |
| Resistance to overriding | Tested in conformity to ISO 80369-7:2016 | pass |
| Free hemoglobin | Benchmark testing | pass |

## 8. CONCLUSION

Results from the design verification show that the VACUETTE® SAFELINK holder with male luer lock meets established performance criteria and performance is as intended and substantially equivalent to the predicate device.