(81 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a blood collection holder, with no mention of AI or ML technologies.
No
The device is a holder for blood collection procedures, designed to facilitate blood draw, not to treat or diagnose a disease or condition.
No
The device is a blood collection holder, which is a tool used in the process of collecting blood. It does not perform any diagnostic function itself; rather, it facilitates the collection of samples that may later be used for diagnostic purposes.
No
The device description clearly outlines physical components made of plastic and stainless steel, and the performance studies focus on mechanical properties and leakage, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in blood collection procedures in combination with devices with a female luer port." This describes a device used to facilitate the collection of a biological sample (blood).
- Device Description: The description details a holder with a needle for drawing blood into a collection device. It does not describe a device that performs a test on the collected sample to diagnose a condition or provide information about a physiological state.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical components that are characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for collecting the specimen, not for testing it.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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 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 conducted to demonstrate and support the substantial equivalency claim that the device performs as intended and in an equivalent manner as the predicate device.
Testing included: Liquid Leakage of rubber sleeve and ultrasonic welding area (seaming seal area) including Kickback Testing, Fitting strength between rubber sleeve and needle insert, Pull Out Force Needle, Stress cracking and liquid leakage from fitting assembly under pressure, Air leakage into fitting assembly during aspiration, Separation force of fitting assembly, Unscrewing torque of fitting assembly, Resistance to overriding, Free hemoglobin.
All tests passed, demonstrating equivalence to the predicate device or conformity to ISO 80369-7:2016.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ 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- K180545
| 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: | Apr 25, 2018 |
| 2. DEVICE | |
| Trade Name: | VACUETTE® SAFELINK Holder with male luer lock |
| Common name: | Holder |
| Classification: | Name: Needle, hypodermic, single lumen
Product Code: FMI
Regulation No: 880.5570
Class: 2
Review Panel: General Hospital |
| 3. PREDICATE DEVICE | |
| Predicate device: | Greiner HOLDEX® Single-use Holder PP (K160532) | |
|---|---|---|
| Classification: | Name: | |
| Product Code: | ||
| Regulation No: | ||
| Class: | Needle, hypodermic, single lumen | |
| FMI | ||
| 880.5570 | ||
| 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
4
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
pass/fail |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------|
| Liquid Leakage of rubber sleeve
and ultrasonic welding area
(seaming seal area) including
Kickback Testing | Equivalence to predicate device, internal
specification | pass |
| Fitting strength between rubber
sleeve and needle insert | Equivalence to predicate device, internal
specification | pass |
| Pull Out Force Needle | Equivalence to predicate device, internal
specification | pass |
| Stress cracking and liquid
leakage from fitting assembly
under pressure | Tested in conformity to ISO 80369-7:2016 | pass |
| Air leakage into fitting assembly
during aspiration | Tested in conformity to ISO 80369-7:2016 | pass |
| Separation force of fitting
assembly | Tested in conformity to ISO 80369-7:2016 | pass |
| Unscrewing torque of fitting
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.