(129 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set:
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report for novel technologies. Therefore, some of the requested information (like MRMC studies, specific sample sizes for all tests, or detailed expert qualifications) is not typically found in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Penetration resistance Cap | >3N for 21G, 23G, and 25G. Equivalent to predicate device. | pass |
| Cannula cleanliness | Tested in accordance with 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) | 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) | 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 |
| 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 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Particulate Matter, Genotoxicity) | pass |
| Sterility testing | Testing according to 11137-1 (SAL of 10-6), Bacterial endotoxin testing (ANSI/AAMI ST72:2011) | pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test or the "test set" in the context often used for AI/algorithm performance. The studies performed are primarily bench and biocompatibility tests for medical devices.
- Sample Size: Not explicitly detailed for each test. The document mentions adherence to specific ISO and ASTM standards, which would dictate appropriate sample sizes for those tests. For example, biocompatibility studies would involve a certain number of samples for each test (e.g., cytotoxicity, sensitization, etc.).
- Data Provenance: The studies are laboratory and bench tests conducted to international (ISO, ASTM) and national (USP, ANSI/AAMI, FDA guidance) standards. It does not involve patient data or human clinical trials in the way an AI algorithm might be evaluated. Therefore, there's no country of origin of data in the typical sense, nor is it a retrospective or prospective clinical study. These are product performance verification and validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The "ground truth" for these types of mechanical, chemical, and biological performance tests is established by adherence to recognized international and national standards (e.g., ISO 7864 for cannula cleanliness, ISO 10993 for biocompatibility). There isn't an "expert consensus" in the sense of clinicians reviewing images or patient outcomes. The "experts" would be the metrology and biological testing technicians and scientists performing the tests according to the specified standard operating procedures and trained in those specific methods.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews where there might be disagreement or a need for a definitive "ground truth" established by multiple human evaluators (e.g., in radiology image reading). For the enumerated engineering and material science tests, the results are typically quantitative measurements or qualitative observations that either meet or do not meet predefined criteria according to the standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms where human interpretation is involved. The VACUETTE EVOPROTECT is a physical medical device (blood collection/infusion set), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone AI algorithm performance study was not done. This device is not an AI algorithm. Its performance is evaluated through physical, mechanical, and biological testing as listed in the table.
7. The Type of Ground Truth Used
The "ground truth" used for this device's performance evaluation is based on:
- Adherence to Recognized Consensus Standards: Many tests refer to specific ISO or ASTM standards (e.g., ISO 7864:2014 for cannula cleanliness, ISO 23908:2011 for breaking compressive force, ISO 10993-1 for biocompatibility). These standards define the test methods and often the criteria for acceptable performance.
- Equivalence to Predicate Device: For several parameters (e.g., penetration resistance, cannula radial orientation, flow rate, detaching torque/force, leakage, spring characteristic), the acceptance criterion is "Equivalent to predicate device." This means the new device performed comparably to a previously cleared, legally marketed device that has demonstrated safety and effectiveness.
- Internal Specification: For some flow rate tests, "internal Specification" is cited, meaning the manufacturer has defined its own performance targets based on the intended use and established engineering principles.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing of a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of an AI algorithm for this device.
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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);
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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
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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.
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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 ProductVACUETTE®EVOPRTOTECT SafetyBlood Collect/ Infusionset | Predicate DeviceVACUETTE® Safety BloodCollection / Infusion set | Comparison | ||
|---|---|---|---|---|
| FDA Status | Under review | K121908 | NA | |
| Classification | Class II | Class II | same | |
| Regulation | 880.5570 | 880.5570 | same | |
| ClassificationProduct Code | FMI | FMI | same | |
| Intended Use | The VACUETTEEVOPROTECT SafetyBlood Collection/InfusionSet is indicated forvenous blood collectionand/or the short-terminfusion of intravenousfluids. It is to be used byappropriately trainedhealthcare professionalsin accordance with theinstructions. | The SAFETY BloodCollection/Infusion Set is asingle-use, sterile, wingedblood collection needlebonded to a flexible tubingwith a luer connector. TheVacuette Safety BloodCollection/Infusion Set isused for blood collectionand/or the short-terminfusion of intravenousfluids. The winged needle isdesigned with a safetyshield, which can beactivated to cover theneedle immediatelyfollowing venipuncture toaid in the protection againstaccidental needlestickinjury. | same | |
| Sterile | yes | yes | same | |
| NEW GBO ProductVACUETTE®EVOPRTOTECT SafetyBlood Collect/ Infusionset | Predicate DeviceVACUETTE® Safety BloodCollection / Infusion set | Comparison | ||
| Device Characteristics | ||||
| Safetymechanism | Semi-passive safetymechanism.One-hand activation. | Active safety mechanism.One-hand activation. | equivalent | |
| Manual operation foractivation (i.e. release).Afterwards spring forcedriven motion in safeposition. | Manual operation foractivation (i.e. release).Afterwards manual drivenmotion in safe position. | equivalent | ||
| CannulaGauges | 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 | |
| Activationspring / manual | Stainless Steel SpringAISI 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 | Resultspass/fail |
| Activation force safetymechanism | Tested in accordance with ISO23908:2016 | pass |
| Breaking force safety mechanismcompression | Tested in accordance with ISO23908:2011 | pass |
| Breaking force safety mechanismtension | Tested in accordance with ISO23908:2011 | 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 toConnector | 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 toConnector | 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 andspecification | pass |
| Tightness single packaging(Bubble test) | According to ASTM F2096-04 | pass |
| Tightness single packaging (Dyepenetration) | According to ASTM F1929-15, ISO11607-2 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 andFDA guidance | pass |
| Sterility testing | Testing according to 11137-1 | pass |
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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<151>) ●
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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.
§ 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).