(251 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a blood collection holder and do not mention any computational or analytical capabilities.
No
The device is described as a blood collection accessory and its function is to facilitate blood draw, not to treat a condition.
No
The device is described as a "Single-Use Holder" for "venous blood collection procedures," indicating it is a tool for obtaining samples, not for analyzing or diagnosing conditions. Its function is to facilitate blood draw, which is a preliminary step to diagnostic testing, but not a diagnostic test in itself.
No
The device description clearly states it is a disposable plastic holder with a stainless steel needle, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "venous blood collection procedures." This describes a process of obtaining a biological sample, not analyzing it.
- Device Description: The description details a holder for blood collection, including a luer adapter and a needle. This is a tool for sample collection, not for performing a diagnostic test on the sample.
- No Mention of Diagnostic Testing: The document does not mention any analysis of the collected blood, any reagents used for testing, or any diagnostic purpose for the device itself.
- Performance Studies: The performance studies focus on the functionality of the holder in collecting blood (leakage, failure) and its compatibility with other collection devices. They do not involve any diagnostic performance metrics.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) to collect the specimen.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
The results showed that the Greiner HOLDEX performed without failure and leakage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
-
- 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: 880.5570
Regulation name: Needle, hypodermic, single lumen
Regulatory Class: II
Product Code: FMI
General Hospital |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate: | Trade Name: Becton Dickinson Brand Multiple Sample Luer Adapter (K991088)
Regulation Number: 862.1675
Regulation name: tubes, vials, systems, serum separators, blood collection
Regulatory Class: II
Product Code: JKA
Clinical Chemistry |
4
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
HOLDEX Single-use
Holder PP | Greiner Vacuette
HOLDEX Single-use
Holder PP
(primary predicate) | BD Vacutainer Luer-Lok
Access 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-Use
holder PP is for use in
venous blood collection
procedures in
combination with blood
collection devices with a
female luer port. | To be used in routine
venipuncture procedures
using butterfly needles
and/or hypodermic luer
needles. | The VACUTAINER Brand
Luer Adapter is a sterile,
non-invasive device used
to connect venous
access devices such as
needles, blood collection
sets, and infusion sets to
blood collection tubes.
They are also used in
connection with non-
needle devices for
collection of blood from
catheters. The
VACUTAINER Brand
Luer Adapter is sold by
itself and as a component
of other VACUTAINER
Brand devices. |
| Manufacturer | Greiner Bio-One (GBO) | Greiner Bio-One (GBO) | Becton, Dickinson and
company (BD) |
| Sterilizer | Mediscan GmbH | Mediscan GmbH | Not known |
| Needle Insert | Polypropylene | Polypropylene | Plastic |
| Sleeve | Does not contain dry
natural rubber | Contains natural rubber
compound | Does not contain dry
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
5
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.