(214 days)
Not Found
No
The device description and performance metrics focus on mechanical safety features and physical properties, with no mention of AI or ML.
No.
The device is a blood collection system designed to prevent needlestick injuries during venipuncture, not to treat any medical condition.
No
This device is a blood collection needle and holder system, designed for routine venipuncture procedures and needle stick injury prevention. It is not used to diagnose a medical condition.
No
The device description clearly indicates it is a physical device consisting of a tube holder, needle, and safety shield. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for routine venipuncture procedures and blood collection. It focuses on the physical act of drawing blood and protecting against needlestick injuries.
- Device Description: The description details a tube holder and needle with a safety shield. These are instruments used in the process of collecting a sample, not for performing a diagnostic test on the sample itself.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, detect substances, or provide any diagnostic information about the patient's health.
- Performance Studies: The performance studies focus on the mechanical functionality of the device (force, torque, leakage, etc.) and its ability to perform the blood collection procedure safely. They do not involve evaluating the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose diseases or conditions. This device is a tool for collecting the sample, which might then be used in an IVD test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
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
properly trained healthcare professionals, adequately trained healthcare personnel
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® QUICKSHIELD Complete (Plus) is manufactured and verified by testing in conformity with applicable recognized consensus standards like ISO 23908, ISO 7864, and ISO 9626 but not limited to those standards. Simulated use tests were performed for venous blood collection procedure as well as the functionality of the safety mechanism was tested.
The VACUETTE® QUICKSHIELD Complete (Plus) 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 devices.
Key results: Force to remove shield: Pass, Torque to rotate shield: Pass, Torque to screw out needle: Pass, Spin out: Pass, Force to activate safety mechanism: Pass, Force necessary to bend safety shield with needle by 90°: Pass, Puncture force: Pass, Friction force: Pass, Leakage: Pass.
Sterility testing: VACUETTE® QUICKSHIELD Complete (Plus) are sterilized by e-beam irradiation for a final Sterility Assurance Level (SAL) of 10° per ISO 11137-1. Bioburden testing was performed in accordance with ISO 11737-1.
Biocompatibility testing: Performed in accordance with ISO 10993 series and Guidance for industry and Food and Drug Administration Stuff - Use of the International Standard ISO 10993-1. The holder was classified as "surface device with short term contact to intact skin", and the cannula was classified as "external communicating device with short term contact to the blood path." Evaluated biological endpoints: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), Hemocompatibility (ISO 10993-4), Material mediated pyrogenicity (ISO 10993-11), Acute Systemic Toxicity (ISO 10993-11).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility Assurance Level (SAL) of 10°
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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 19, 2024
Greiner Bio-One North America Inc Manfred Abel Regulatory Affairs & Quality Systems Manager 4238 Capital Drive Monroe, North Carolina 28110
Re: K233979
Trade/Device Name: VACUETTE® QUICKSHIELD Complete (Plus) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FMI Dated: June 20, 2024 Received: June 20, 2024
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233979
Device Name VACUETTE® QUICKSHIELD Complete (Plus)
Indications for Use (Describe)
The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the logo for Greiner Bio-One. The logo features a stylized blue wave-like shape above the word "greiner" in a bold, sans-serif font. Below "greiner" is the text "BIO-ONE" in a smaller, sans-serif font.
K233979 - Premarket Notification 510(K) Summary
1. SUBMITTER
| Applicant name: | Greiner Bio-One GmbH.
Bad Haller Strasse 32
4550 Kremsmünster,
Austria |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Manfred Abel
Greiner Bio-One NA Inc.
4238 Capital Drive
Monroe, NC 28110
Phone +1 704 261 7800
manfred.abel@gbo.com |
| Establishment registration number: | 8020040 |
| Date prepared: | July 19, 2024 |
| 2. DEVICE | |
| Trade name: | VACUETTE® QUICKSHIELD Complete (Plus) |
| Common name: | Safety tube holder pre-assembled with the needle |
| Regulation: | 862.1675, Blood Specimen Collection Device |
| Primary classification product code: | JKA – Blood specimen collection device |
| Subsequent classification product code: | FMI – Needle, hypodermic, single lumen |
| Medical device class: | II |
| Review panel: | General Hospital |
| 3. PREDICATE DEVICES | |
| Primary predicate device: | Blood Collection Needle with/without Holder,
Safety Blood Collection Needle with/without Holder,
Luer Access Device-holder with Pre-attached Multiple Sample
Adapter (K200027) |
4. DEVICE DESCRIPTION
Secondary predicate device:
The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.
VACUETTE® QUICKSHIELD Complete (K072320)
The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the
5
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needle immediately following venipuncture.
5. INDICATION FOR USE
The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.
The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for singleuse only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Greiner Bio-One NA Inc. believes that the VACUETTE® QUICKSHIELD Complete (Plus) is substantially equivalent in intended use, indications for use, principles of operation, and technological characteristics to the predicate devices. Any differences between VACUETTE® QUICKSHIELD Complete (Plus) and the predicate devices do not raise new types of safety or effectiveness issues, as further discussed below.
| | Candidate Device | Primary
Predicate
Device | Secondary
Predicate
Device | Remark |
|----------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------|
| Name | VACUETTE®
QUICKSHIELD
Complete (Plus) | Blood Collection
Needle with/without
Holder, Safety
Blood Collection
Needle with/without
Holder, Luer
Access Device- | VACUETTE®
QUICKSHIELD
Complete | n/a |
| 510(k) Number | K233979 | K200027 | K072320 | n/a |
| Classification | Class II | Class II | Class II | n/a |
| Regulation | 862.1675 | 862.1675 | 880.5570 | n/a |
| Product Code | Primary product code:
JKA
Subsequent product code:
FMI | Primary product code:
JKA
Subsequent product
code: FMI | FMI | n/a |
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| Indications for Use | The VACUETTE® QUICKSHIELD Complete | The Blood Collection Needle with/without holder | The QUICKSHIELD Complete | Different. S&E evaluated by external and internal performance testing, see further information below. |
|---|---|---|---|---|
| The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions. The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device 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 VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions. | The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Luer access device-holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood. | The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device 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. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions. | Different. S&E evaluated by external and internal performance testing, see further information below. |
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Image /page/7/Picture/1 description: The image shows the logo for Greiner BIO-ONE. The logo features a blue, curved shape above the word "greiner" in a bold, black sans-serif font. Below "greiner" is the text "BIO-ONE" in a smaller, black sans-serif font.
| Manufacturer | Greiner Bio-One (GBO) | Jiangsu Caina
Medical Co., Ltd | Greiner Bio-One (GBO) | n/a |
|----------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Safety
mechanism | Active safety
mechanism. One-hand
activation. | The safety shield is
intended to prevent
needle sticks. Only on
the Safety | Active safety
mechanism. One-
hand activation. | Same |
| | Manual operation for
activation. | Manual | Manual operation
for activation. | |
| Cannula
variants | • Multiple
Sampling Needle
(K973620)
• Visio Plus Needle
(K061483) | Various gages and
length | • Multiple Samling
Needle (K973620)
• Visio Plus Needle
(K061483) | SE |
| Cannula
Gauges | 21G or 22G | 27G, 25G, 23G, 22G,
21G, 20G, 18G | 21G or 22G | SE |
| Cannula
Length | 1" or 1.25" or 1.5" | 1" or 1.25" or 1.5" | 1" or 1.25" or 1.5" | SE |
| Sterile | Yes | Yes | Yes | SE |
| SAL | 10-6 | 10-6 | 10-6 | SE |
| Sterilization | E-Beam Irradiation | ETO | ETO | Different,
evaluation
according to ISO
11137-1 and ISO
11137-2. |
| Non-pyrogenic | Yes | Yes | Yes | SE |
| Materials -
comply
with ISO
10993-1 | Yes | Yes | Yes | SE |
| Use | Single use only | Single use only | Single use only | SE |
| | Materials: | | | |
| Needle Cap | PP | Same | Same | SE |
| Needle | Stainless Steel AISI 304 | Same | Same | SE |
| Rubber sleeve | Rubber Sleeve | Rubber Sleeve | Rubber Sleeve | SE |
| Holder | PP | Same | Same | SE |
| Safety shield | PP | Same | Same | SE |
| | Connection of: | | | |
| Needle and
Holder | Pre-attached | Pre-attached | Pre-attached | SE |
| Holder and
shield | Rotational shield | n/a | Non-rotational shield | Different, S&E
evaluated by
internal test
method |
Comparison of Technological Characteristics
As can be seen in the above table a comparison of the VACUETTE® QUICKSHIELD Complete (Plus) and its features show that both the candidate device and the predicate devices have the same fundamental scientific technological characteristics. The VACUETTE® QUICKSHIELD Complete (Plus) and the predicate devices include the same safety mechanism covering the needle after the blood collection. The used safety mechanisms need to be activated manual activation of the safety mechanism of candidate device as well as the predicate devices the safe and locked position of the safety
8
Premarket Notification VACUETTE®QUICKSHIELD Complete (Plus) Greiner Bio-One
Image /page/8/Picture/1 description: The image shows the logo for Greiner Bio-One. The logo features a blue, curved shape above the word "greiner" in bold, black letters. Below "greiner" is the text "BIO-ONE" in smaller, black letters. The blue curved shape is reminiscent of a stylized wave or swoosh.
mechanism is reached by the Quickshield-needle-cover. The used materials for all products are the same or at least comparable and the differences do not have an influence on the safety and effectiveness of the candidate device. The candidate device and the predicate devices are provided sterile and single use only.
Comparison of Intended Use
The above comparison table shows the indications for use of the candidate device as well as predicate devices. The indications are comparable in their content so that all products are intended to be used for venous blood collection.
7. PERFORMANCE DATA
The VACUETTE® QUICKSHIELD Complete (Plus) is manufactured and verified by testing in conformity with applicable recognized consensus standards like ISO 23908, ISO 7864, and ISO 9626 but not limited to those standards. Simulated use tests were performed for venous blood collection procedure as well as the functionality of the safety mechanism was tested.
The VACUETTE® QUICKSHIELD Complete (Plus) 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 devices.
| Requirement | Outcome
(Pass or fail) |
|----------------------------------------------------------|---------------------------|
| Force to remove shield | Pass |
| Torque to rotate shield | Pass |
| Torque to screw out needle | Pass |
| Spin out | Pass |
| Force to activate safety mechanism | Pass |
| Force necessary to bend safety shield with needle by 90° | Pass |
| Puncture force | Pass |
| Friction force | Pass |
| Leakage | Pass |
Sterility testing:
VACUETTE® QUICKSHIELD Complete (Plus) are sterilized by e-beam irradiation for a final Sterility Assurance Level (SAL) of 10° per ISO 11137-1 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Bioburden testing for determination of verification dose and subsequently the processing dose was performed in accordance with ISO 11737-1 - Sterilization of medical devices - microbiological methods - Part 1: Determination of a population of microorganisms on products.
Biocompatibility testing:
Biocompatibility for the VACUETTE® QUICKSHIELD Complete (Plus) was performed in accordance with the standards of the ISO 10993 series and under consideration of the Guidance for industry and Food and Drug Administration Stuff - Use of the International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (Attachment A: Table A. 1 Endooints to be addressed in a biological risk assessment). The holder was classified as "surface device with short term contact to intact skin", and the cannula was classified as "external communicating device with short term contact to the blood path." Based on the classification the following biological endpoints were evaluated, and it was demonstrated that the candidate device meets the following standards:
9
Premarket Notification VACUETTE®QUICKSHIELD Complete (Plus) Greiner Bio-One
Image /page/9/Picture/1 description: The image shows the logo for Greiner Bio-One. The logo features the word "greiner" in a bold, sans-serif font, with the letters in black. Above the word "greiner" is a blue, curved shape that resembles a stylized "G". Below the word "greiner" is the text "BIO-ONE" in a smaller, sans-serif font, also in black.
- Cytotoxicity (ISO 10993-5) ●
- . Sensitization (ISO 10993-10)
- . Irritation (ISO 10993-23)
- Hemocompatibility (ISO 10993-4) .
- Material mediated pyrogenicity (ISO 10993-11) ●
- Acute Systemic Toxicity (ISO 10993-11) .
8. CONCLUSION
The test results and the comparison table above show the VACUETTE® QUICKSHIELD Complete (Plus) is substantially equivalent to its predicate devices with respect to intended use, technological and performance characteristics and does not raise new safety or effectiveness concerns.