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 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.

AI/ML Overview

The Greiner HOLDEX® Single-Use Holder PP is a disposable plastic holder used for venous blood collection procedures with blood collection devices featuring a female luer port. The submission aims to extend its indication for use.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No failure during use	Performed "without failure" during simulated venous blood draw testing.
No leakage during use	Performed "without leakage" during simulated venous blood draw testing.
Conformity to ISO 594-1	The luer part is made and verified by testing in conformity to ISO 594-1.

2. Sample Size Used for the Test Set and Data Provenance

The test set used 180 blood collection devices with female luer ports. The devices were of common brands legally marketed in the US market. The study appears to be retrospective in the sense that it tested the device with existing, commercially available blood collection devices. The document does not specify if the testing was performed on actual human subjects or simulated laboratory conditions (though "simulated venous blood draw testing" suggests a laboratory setting).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not mention the use of experts to establish ground truth for the test set. The performance data is based on engineering and simulated testing rather than expert clinical assessment of outcomes.

4. Adjudication Method for the Test Set

No adjudication method is mentioned in the document as it does not rely on human assessment of findings. The testing involves observing for failure and leakage.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component. The Greiner HOLDEX is a medical device for blood collection, and its performance is assessed through physical and functional testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable to the Greiner HOLDEX® Single-Use Holder PP. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that its mechanical function is evaluated, but it doesn't involve "human-in-the-loop" performance in the context of an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on objective criteria of mechanical integrity and functionality: absence of failure and absence of leakage during simulated use, and conformity to an international standard (ISO 594-1).

8. The Sample Size for the Training Set

This product is a physical medical device; therefore, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications and quality control, but not a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set for an algorithm, this question is not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Manfred.Abel@gbo.com

Establishment registration number: 8020040

Date prepared: September 16, 2016
1. 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)Regulation Number: 880.5570Regulation name: Needle, hypodermic, single lumenRegulatory Class: IIProduct Code: FMIGeneral Hospital
Secondary Predicate:	Trade Name: Becton Dickinson Brand Multiple Sample Luer Adapter (K991088)Regulation Number: 862.1675Regulation name: tubes, vials, systems, serum separators, blood collectionRegulatory Class: IIProduct Code: JKAClinical Chemistry

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4. DEVICE DESCRIPTION

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 VacuetteHOLDEX Single-useHolder PP	Greiner VacuetteHOLDEX Single-useHolder PP(primary predicate)	BD Vacutainer Luer-LokAccess Device(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-Useholder PP is for use invenous blood collectionprocedures incombination with bloodcollection devices with afemale luer port.	To be used in routinevenipuncture proceduresusing butterfly needlesand/or hypodermic luerneedles.	The VACUTAINER BrandLuer Adapter is a sterile,non-invasive device usedto connect venousaccess devices such asneedles, blood collectionsets, and infusion sets toblood collection tubes.They are also used inconnection with non-needle devices forcollection of blood fromcatheters. TheVACUTAINER BrandLuer Adapter is sold byitself and as a componentof other VACUTAINERBrand devices.
Manufacturer	Greiner Bio-One (GBO)	Greiner Bio-One (GBO)	Becton, Dickinson andcompany (BD)
Sterilizer	Mediscan GmbH	Mediscan GmbH	Not known
Needle Insert	Polypropylene	Polypropylene	Plastic
Sleeve	Does not contain drynatural rubber	Contains natural rubbercompound	Does not contain drynatural 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.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).