(129 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a blood collection/infusion set, with no mention of AI or ML capabilities.
No
The device is used for blood collection and short-term infusion, which are diagnostic or supportive procedures, not therapeutic interventions.
No
Explanation: The device is indicated for blood collection and short-term infusion of intravenous fluids, not for diagnosing a condition or disease. It is a blood collection and infusion set with a safety mechanism.
No
The device description clearly outlines a physical medical device (winged needle, tubing, Luer connector, safety mechanism) and the performance studies focus on physical characteristics and functionality, not software performance.
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 and/or the short-term infusion of intravenous fluids." This describes a device used for collecting a sample from the body or administering a substance into the body.
- Device Description: The description details a "winged needle bonded to flexible tubing with a Luer connector and a semi-automatic release of the safety mechanism." This is a physical device used for accessing a vein.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze a sample in vitro (outside the body) to provide diagnostic information about a patient's health. IVDs are typically reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
This device is a medical device used for sample collection and fluid administration, but it does not perform an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a semiautomatic release of the safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation ensuring the needle is covered immediately following venipuncture to aid in the protection against accidental needlestick injury. The EVOPROTECT Safety Blood Collection/Infusion Set is individually wrapped, sterile with a luer port. The luer port can be used to connect FDA cleared accessories like luer adapter, holder, etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
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)
The VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is manufactured and tested in conformity with a variety of recognized consensus standards. Performance data show that the device performs as intended and in an equivalent manner as the predicate devices. Testing was performed according to various ISO and ASTM standards covering: Penetration resistance, Cannula cleanliness, Cannula radial orientation, Cannula puncture & friction force, Cannula bond force, Flow rate water, Breaking compressive force cannula before activation, Size designation, Dimensional, Resistance for stiffness, Resistance for breakage, Resistance for corrosion, Activation force safety mechanism, Breaking force safety mechanism compression, Breaking force safety mechanism tension, Bond strength Hub to Stopper, Bond strength Tubing to Stopper, Bond strength Tubing to Connector, Tubing breaking force, Detaching torque Luer Adapter (LA) to Connector, Detaching force Luer Adapter to Connector, Spring characteristic, Leakage of product (pressure & vacuum), Simulated use, Tightness single packaging (Bubble test), Tightness single packaging (Dye penetration), Sealing strength and max. opening force single packaging, Biocompatibility testing, and Sterility testing. All tests passed.
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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written in a sans-serif font.
April 19, 2018
Greiner Bio-One NA Inc Manfred Abel Quality Systems and Regulatory Affairs 4238 Capital Drive Monroe, North Carolina 28110
Re: K173757
Trade/Device Name: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 12, 2018 Received: March 13, 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.
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 (QS) regulation (21 CFR Part 820);
1
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,
Geeta K. Pamidimukkala -S
for 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) K173757
Device Name
VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set
Indications for Use (Describe)
The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
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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SECTION 5. PREMARKET NOTIFICATION 510(K) SUMMARY: K173757
1. SUBMITTER Applicant Name: Greiner Bio-One GmbH. Bad Haller Strasse 32 4550 Kremsmuenster, Austria
- Manfred Abel, M.S., MBA Contact person: 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. 17, 2018
-
- DEVICE
VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set Trade Name:
- DEVICE
-
Blood Collection Set Common name:
Classification: Needle, hypodermic, single lumen Name: Product Code: FMI Regulation No: 880.5570 Class: ನ Review Panel: General Hospital
3. PREDICATE DEVICE
VACUETTE SAFETY BLOOD COLLECTION SET & SAFETY Predicate: INFUSION SET (K121908)
4. DEVICE DESCRIPTION
The VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set is a singleuse, sterile, winged needle bonded to flexible tubing with a Luer connector and a semiautomatic release of the safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation ensuring the needle is covered immediately following venipuncture to aid in the protection against accidental needlestick injury. The EVOPROTECT Safety Blood Collection/Infusion Set is individually wrapped, sterile with a luer port. The luer port can be used to connect FDA cleared accessories like luer adapter, holder, etc.
4
5. INDICATION FOR USE
The VACUETTE EVOPROTECT Safety Blood Collection/Infusion Set is indicated for venous blood collection and/or the short-term infusion of intravenous fluids. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The subject device and the predicate device have the same fundamental technology, technological characteristics, and intended use.
Based on the device features, principles of operation and technological characteristics, the VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is substantially equivalent to the predicate device.
| | NEW GBO Product
VACUETTE®
EVOPRTOTECT Safety
Blood Collect/ Infusion
set | Predicate Device
VACUETTE® Safety Blood
Collection / Infusion set | Comparison | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|
| FDA Status | Under review | K121908 | NA | |
| Classification | Class II | Class II | same | |
| Regulation | 880.5570 | 880.5570 | same | |
| Classification
Product Code | FMI | FMI | same | |
| Intended Use | The VACUETTE
EVOPROTECT Safety
Blood Collection/Infusion
Set is indicated for
venous blood collection
and/or the short-term
infusion of intravenous
fluids. It is to be used by
appropriately trained
healthcare professionals
in accordance with the
instructions. | The SAFETY Blood
Collection/Infusion Set is a
single-use, sterile, winged
blood collection needle
bonded to a flexible tubing
with a luer connector. The
Vacuette Safety Blood
Collection/Infusion Set is
used for blood collection
and/or the short-term
infusion of intravenous
fluids. The winged needle is
designed with a safety
shield, which can be
activated to cover the
needle immediately
following venipuncture to
aid in the protection against
accidental needlestick
injury. | same | |
| Sterile | yes | yes | same | |
| | NEW GBO Product
VACUETTE®
EVOPRTOTECT Safety
Blood Collect/ Infusion
set | Predicate Device
VACUETTE® Safety Blood
Collection / Infusion set | Comparison | |
| Device Characteristics | | | | |
| Safety
mechanism | Semi-passive safety
mechanism.
One-hand activation. | Active safety mechanism.
One-hand activation. | equivalent | |
| | Manual operation for
activation (i.e. release).
Afterwards spring force
driven motion in safe
position. | Manual operation for
activation (i.e. release).
Afterwards manual driven
motion in safe position. | equivalent | |
| Cannula
Gauges | 21/23/25 | 21/23/25 | same | |
| Cannula Length | 3/4" | 3/4" | same | |
| Sterile | Yes | Yes | same | |
| Storage | 4 - 25 C° | 4 - 36 C° | equivalent | |
| Use | Single use only | Single use only | same | |
| Tubing Lengths | 4"; 7½"; 12" | 4"; 7½"; 12" | same | |
| Materials:
All data as detailed and as known: | | | | |
| Needle Cap | PP | PP | same | |
| Needle | Stainless Steel AISI 304 | Stainless Steel AISI 304 | same | |
| Wing | TPE | PVC | equivalent | |
| Protector | PC | PC | same | |
| Hub | PMMA | PMMA | same | |
| Activation
spring / manual | Stainless Steel Spring
AISI 301 | manual | equivalent | |
| Stopper | ABS | ABS | same | |
| Tubing | PVC with plasticizer | PVC with plasticizer | same | |
| Connector | ABS | ABS | same | |
| Connector Cap | PP | PP | same | |
| Adhesive | UV cured adhesive | Solvent bonding | equivalent | |
| Packaging | Blister | Pouch | equivalent | |
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The above table shows that the VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is equivalent to the predicate device. The differences in storage, wing material, activation, adhesive and packaging is equivalent as demonstrated in the performance testing.
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7. PERFORMANCE DATA
The VACUETTE® EVOPROTECT Safety Blood Collection/Infusion Set is manufactured and tested in conformity with a variety of recognized consensus standards. Performance data show that the device performs as intended and in an equivalent manner as the predicate devices.
| Requirement | Acceptance | Results pass/fail |
|---|---|---|
| Penetration resistance Cap | Penetration resistance >3N for 21G, 23G and 25G. Equivalent to predicate device. | pass |
| Cannula cleanliness | Tested in accordance with to ISO 7864:2014 | pass |
| Cannula radial orientation | Equivalent to predicate device. | pass |
| Cannula puncture & friction force 21G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 23G | Equivalent to predicate device | pass |
| Cannula puncture & friction force 25G | Equivalent to predicate device | pass |
| Cannula bond force 21G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 23G | Tested in accordance with ISO 7864:2016 | pass |
| Cannula bond force 25G | Tested in accordance with ISO 7864:2016 | pass |
| Flow rate water 10cm tubing, 21G (extreme: max flow rate over all variants) | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 21G | Equivalence, internal Specification | pass |
| Flow rate water 19 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30 cm tubing, 23G | Equivalence, internal Specification | pass |
| Flow rate water 30cm tubing, 25G (extreme: min flow rate over all variants) | Equivalence, internal Specification | pass |
| Breaking compressive force cannula before activation | Tested in accordance with ISO 23908:2011 | pass |
| Size designation | Tested in accordance with ISO 9626:2016 | pass |
| Dimensional | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for stiffness | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for breakage | Tested in accordance with ISO 9626:2016 | pass |
| Resistance for corrosion | Tested in accordance with ISO 9626:2016 | pass |
| Requirement | Acceptance | Results |
| pass/fail | ||
| Activation force safety | ||
| mechanism | Tested in accordance with ISO | |
| 23908:2016 | pass | |
| Breaking force safety mechanism | ||
| compression | Tested in accordance with ISO | |
| 23908:2011 | pass | |
| Breaking force safety mechanism | ||
| tension | Tested in accordance with ISO | |
| 23908:2011 | pass | |
| Bond strength Hub to Stopper | Equivalence, | |
| ISO 8536-4:2010 + Amd 1:2013 | pass | |
| Bond strength Tubing to Stopper | Equivalence, | |
| ISO 8536-4:2010 + Amd 1:2013 | pass | |
| Bond strength Tubing to | ||
| Connector | Equivalence, | |
| ISO 8536-4:2010 + Amd 1:2013 | pass | |
| Tubing breaking force | Equivalence, | |
| ISO 8536-4:2010 + Amd 1:2013 | pass | |
| Detaching torque Luer Adapter | ||
| (LA) to Connector | Equivalent to predicate device | pass |
| Detaching force Luer Adapter to | ||
| Connector | Equivalent to predicate device | pass |
| Spring characteristic | Equivalent to ISO 23908:2011, | |
| simulated use | pass | |
| Leakage of product (pressure & | ||
| vacuum) | Equivalent to predicate device | pass |
| Simulated use | According to intended use and | |
| specification | pass | |
| Tightness single packaging | ||
| (Bubble test) | According to ASTM F2096-04 | pass |
| Tightness single packaging (Dye | ||
| penetration) | According to ASTM F1929-15, ISO | |
| 11607-2 and EN 868-5 | pass | |
| Sealing strength and max. | ||
| opening force single packaging | According to ISO 11607-1 and EN 868- | |
| 5 | pass | |
| Biocompatibility testing | Testing according to ISO 10993-1 and | |
| FDA guidance | pass | |
| Sterility testing | Testing according to 11137-1 | pass |
7
Sterility testing
VACUETTE® EVOPROTECT Safety Blood Collection/ Infusion Sets are sterilized by irradiation for a final Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-1 Sterilization of health care products. Bacterial endotoxin testing was performed by according to ANSI/AAMI ST72:2011.
Biocompatibility testinq
Biocompatibility for the VACUETTE® EVOPROTECT Safety Blood Collection/lnfusion Set was performed in accordance with standards of the ISO 10993 series and others to demonstrate that the subject device meets requirements of the following standards:
- Cytotoxicity (ISO 10993-5, USP 38: 2016) ●
- . Sensitization (ISO 10993-10:2010, ISO 10993-12 2012)
- Irritation (ISO 10993-10) .
- . Acute Systemic Toxicity (ISO 10993-11, USP 39 and ASTM F 750-87)
- Pyrogenicity (USP 39) ●
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- Hemocompatibility (ISO 10993-4, ASTM F756) .
- . Particulate Matter (USP 788)
- Genotoxicity characterization of extractable (ISO 10993-3) .
8. CONCLUSION
Results from the performance verification and validation show that the EVOPROTECT Safety Blood Collection/Infusion Set meets established performance criteria and performance is as intended and substantially equivalent to the predicate device.