Greiner Holdex

K160532 · Greiner Bio-One Na, Inc. · FMI · Nov 3, 2016 · General Hospital

Device Facts

• Record ID: K160532
• Device Name: Greiner Holdex
• Applicant: Greiner Bio-One Na, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Nov 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.

Device Story

Disposable plastic holder for venous blood collection; consists of polypropylene cylinder with off-center male luer; internal stainless steel needle with synthetic polyisoprene sleeve. Used by clinicians to facilitate blood draw by connecting to female luer ports on blood collection devices (e.g., IV catheters). Device punctures cap of blood collection tube to allow blood flow. Single-use; non-invasive. Benefits include secure connection to various luer-access devices, enabling blood collection from catheters or other luer-compatible systems.

Clinical Evidence

Bench testing only. Simulated venous blood draw testing performed using 180 blood collection devices with female luer ports from multiple manufacturers (BD, B. Braun, Smiths Medical). Testing verified performance against ISO 594-1 standards for luer components. No clinical data.

Technological Characteristics

Polypropylene plastic cylinder; stainless steel needle; synthetic polyisoprene sleeve. Luer connection conforms to ISO 594-1. Sterilized via E-Beam. Single-use. No software or electronics.

Indications for Use

Indicated for venous blood collection procedures in combination with blood collection 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

• Vacuette HOLDEX Single-Use Holder PP (K980768)
• Becton Dickinson Brand Multiple Sample Luer Adapter (K991088)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 3, 2016

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

Re: K160532

Trade/Device Name: Greiner Holdex® Single-Use Holder PP Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 28, 2016 Received: November 1, 2016

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 (reporting of medical devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kianq -5

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)

K160532

Device Name Greiner HOLDEX® Single-Use Holder PP

Indications for Use (Describe)

The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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### Premarket notification 510(k) Summary

#### 1. SUBMITTER

#### Applicant Name:

Greiner Bio-One GmbH. Bad Haller Strasse 32 4550 Kremsmuenster, Austria

## Contact person:

Manfred Abel, M.S., MBA Greiner Bio-One NA Inc. 4238 Capital Drive Monroe, NC 28110 704 261 7823 [e-mail]

### Establishment registration number: 8020040

- Date prepared: September 16, 2016
- 2. DEVICE

Greiner HOLDEX® Single-Use Holder PP Trade Name:

Common name: Greiner Holdex

Trade Name: Greiner HOLDEX® Single-Use Holder PP Classification: Regulation Number: 880.5570 Regulation name: Needle, hypodermic, single lumen Regulation Number: 880.5570 Regulatory Class: II Product Code: FMI General Hospital

## 3. PREDICATE DEVICES

| Primary Predicate: | Trade Name: Vacuette HOLDEX Single-Use Holder PP (K980768)<br>Regulation Number: 880.5570<br>Regulation name: Needle, hypodermic, single lumen<br>Regulatory Class: II<br>Product Code: FMI<br>General Hospital |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate: | Trade Name: Becton Dickinson Brand Multiple Sample Luer Adapter (K991088)<br>Regulation Number: 862.1675<br>Regulation name: tubes, vials, systems, serum separators, blood collection<br>Regulatory Class: II<br>Product Code: JKA<br>Clinical Chemistry |

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# 4. DEVICE DESCRIPTION

The Greiner HOLDEX Single-Use Holder PP is a disposable plastic holder, which consists of a cylinder made from polypropylene plastic with an off-center molded male luer at the top. The off-center location of the male luer is to facilitate venipuncture when using luer needles. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.

The purpose of this submission is to obtain premarket clearance in order to market the HOLDEX® Single-Use Holder PP for the extended indication for use.

## 5. INDICATION FOR USE

The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.

| | Greiner Vacuette<br>HOLDEX Single-use<br>Holder PP | Greiner Vacuette<br>HOLDEX Single-use<br>Holder PP<br>(primary predicate) | BD Vacutainer Luer-Lok<br>Access Device<br>(secondary predicate) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA status | Under review | K980768 | K991088 |
| Classification | Class II | Class II | Class II |
| Regulation | 880.5570 | 880.5570 | 862.1675 |
| Product Code | FMI | FMI | JKA |
| Intended Use | The HOLDEX Single-Use<br>holder PP is for use in<br>venous blood collection<br>procedures in<br>combination with blood<br>collection devices with a<br>female luer port. | To be used in routine<br>venipuncture procedures<br>using butterfly needles<br>and/or hypodermic luer<br>needles. | The VACUTAINER Brand<br>Luer Adapter is a sterile,<br>non-invasive device used<br>to connect venous<br>access devices such as<br>needles, blood collection<br>sets, and infusion sets to<br>blood collection tubes.<br>They are also used in<br>connection with non-<br>needle devices for<br>collection of blood from<br>catheters. The<br>VACUTAINER Brand<br>Luer Adapter is sold by<br>itself and as a component<br>of other VACUTAINER<br>Brand devices. |
| Manufacturer | Greiner Bio-One (GBO) | Greiner Bio-One (GBO) | Becton, Dickinson and<br>company (BD) |
| Sterilizer | Mediscan GmbH | Mediscan GmbH | Not known |
| Needle Insert | Polypropylene | Polypropylene | Plastic |
| Sleeve | Does not contain dry<br>natural rubber | Contains natural rubber<br>compound | Does not contain dry<br>natural rubber |
| Needle | Stainless Steel | Stainless Steel | Not known |
| Sterilization | E-Beam | E-Beam | Gamma |
| Storage | 4 - 25 C° | 4 - 25 C° | 4 - 25 C° |
| Use | Single use only | Single use only | Single use only |

# 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

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The indications for use of the Greiner HOLDEX under review are similar to the predicate devices. The subiect device and the primary predicate device have been used for the intended use of the primary predicate device according to K980768. The subject device and the primary predicate device are also equivalent in design, performance and materials. The intended use of the subject device for venous blood collection procedures in combination with blood collection devices with a female luer port is considered substantially equivalent to the intended use of the secondary predicate device (K991088) to be used in connection with non-needle devices for collection of blood from catheters.

# 7. PERFORMANCE DATA

Performance testing was done to demonstrate that the Greiner HOLDEX can be used for venous blood collection procedures in combination with blood collection devices with a female luer port. The Greiner HOLDEX is made and verified by testing in conformity to ISO 594-1 for the luer part. In addition, simulated venous blood draw testing was performed on the HOLDEX Single-Use Holder PP using 180 blood collection devices with female luer ports of common brands which are legally marketed on the US market while following the Instructions for Use for the Greiner HOLDEX:

- . 383540 / BD: Nexiva™ Closed IV Catheter System; 18 GA 1.75 IN; 1.3 x 45mm; 4740 ml/hr 79 ml/ min
- 383662 / BD: Nexiva Q-Syte™ Luer Access Split-Septum; 22 GA 1.00 IN; 0.9 x 25mm; 1980 ml/hr, . 33 ml/min
- · 382933 / BD: Insyte Shielded I.V. Catheter; BD Insyte Autoguard BC Winged; 20 GA 1.00 IN; 1.1 x25mm; 63 ml/min
- 4253574-01 / Bbraun: Introcan Safety Winged PUR; 20G x 1" (1.1 x 25mm); 65 ml/min
- 4253540-01 / Bbraun: Introcan Safety Winged PUR; 22G x 1" (0.9 x 25mm); 35 ml/min
- · 4057 / Jelco / Smiths Medical: Jelco® I.V. Catheter Radiopaque (20G, 1", 25 mm, 1.15 mm, 65 ml/min)

## 8. DISCUSSION / CONCLUSION

We compared the performance of the Greiner HOLDEX to the similar indications of use of the predicate devices. The results showed that the Greiner HOLDEX performed without failure and leakage. Based on the device features, principles of operation, technological characteristics and indications for use of the current Greiner HOLDEX we conclude that the subject device performs in a substantially equivalent manner to the predicate devices.