(616 days)
Not Found
No
The 510(k) summary describes a standard blood collection needle and a safety blood collection needle. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on standard device functionality and biocompatibility.
No.
The device is a blood collection needle used for diagnostic purposes (collecting blood samples), not for treating a disease or condition.
No
Explanation: The device is a blood collection needle, used for collecting blood samples. This is a tool for sample collection, not for diagnosing a medical condition.
No
The device description clearly describes physical, sterile, single-use needles and associated safety mechanisms and holders, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a blood collection needle. Its sole purpose is to collect the blood sample. It does not perform any analysis or testing on the blood itself.
- Intended Use: The intended use clearly states "for the collection of blood samples into evacuated blood collection tubes." This is a pre-analytical step, not a diagnostic test.
While the collected blood sample will likely be used for IVD testing, the needle itself is a tool for obtaining the sample, not the diagnostic device.
N/A
Intended Use / Indications for Use
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
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
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)
Biocompatibility
In accordance with ISO 10993-1, the Blood Collection Needle is classified as Externally Communicating Device, Blood Path Direct, Limited Contact (, Material Mediated pyrogenicity
- ASTM F756-08, "Standard Practice for Assessment of Haemolytic Properties of Materials
- ISO 10993-4:2002/Amd 1:2006: "Biological evaluation of medical devices Part 4: Selection of tests ● for interactions with blood
- USP, Particulate matter in injections
Sterilization Validation
The sterile Blood Collection Needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 11135:2014, Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices,
- ISO 11138-1: 2017, Sterilization of health care products -- Biological indicators Part 1: General ● requirements.
- ISO 10993-7 :2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
- ISO 11607-1:2009. Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2006. Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11737-1:2018, Sterilization of health care products-Microbiological methods-Part1: Determination of a population of microorganisms on products.
- ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- LAL test was performed according to:
- USP 39th ed. 2016: Bacterial Endotoxins Test
- USP 39th ed. 2016: Transfusion and infusion assemblies and similar medical devices.
- European Pharmacopoeia current edition: 2.6.14 Bacterial Endotoxins.
Performance Testing
The sterile, Blood Collection Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 7864:2016, "Requirements and test methods Sterile hypodermic needles for single use. Requirements and test methods",
- ISO 9626:2016, "Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods"
- ISO 23908:2011, "Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
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
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December 14, 2021
Vacutest Kima Srl Elisa Buggio Regulatory Assistant Via dell'Industria 12 Arzegrande, Padova 35020 Italy
Re: K200932
Trade/Device Name: Blood Collection Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 10, 2021 Received: November 15, 2021
Dear Elisa Buggio:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Gang Peng For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200932
Device Name Blood Collection Needles
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
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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3
K200932 510(k) Summary
| Prepared Date: | December 8, 2021 |
|---|---|
| Applicant: | |
| Company Name: | Vacutest Kima s.r.l |
| Company Address: | Via dell'Industria 12 |
| 35020 Arzegrande (Padova) - Italy | |
| Company Phone: | +39 049 9719511 |
| Company Fax: | +39 049 9719542 |
| Company e-mail | info@vacutestkima.it |
| Official Contact for Correspondence: | Buggio Elisa |
| Phone: | +39 049 9719511 |
| E-mail: | regulatory@kima.it |
DEVICE IDENTIFICATION
| Trade name: | Blood Collection Needles |
|---|---|
| Generic/ Common Name: | Hypodermic needles |
| Classification: | 21 CFR §880.5570 |
| Class II | |
| Classification name: | Hypodermic single lumen needle |
| Product Code: | FMI |
| Panel: | General Hospital |
PREDICATE DEVICE:
BD Vacutainer® Eclipse™ Blood Collection Needle, BECTON DICKINSON VACUTAINER SYSTEMS
4
DEVICE DESCRIPTION
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
| Gauge | Length |
|---|---|
| 18g, 20g, 21g, 22g | 1 ½ "& 1" |
| 20g, 21g, 22g (Needle safety feature) | 1 ½ "& 1" |
INDICATIONS FOR USE
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes. The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Attribute /
Characteristics | Blood Collection Needles
(Submitted Product) | BD Vacutainer®
Eclipse™ Blood
Collection Needle,
(Legally Marketed
Predicate Device) | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 'K" numbers | K200932 | K982541 | |
| CFR Section | 880.5570 | 880.5570 | same |
| Pro-code | FMI | FMI | same |
| Classification name | Hypodermic single lumen needle | Hypodermic single lumen needle | same |
| Intended / Indications for
Use | The Blood Collection Needles are sterile,
single use medical devices specifically
intended to be used by trained healthcare
professionals for the collection of blood
samples into evacuated blood collection
tubes.
The Safety Blood Collection Needles are
sterile, single use medical devices
specifically intended to be used by trained
healthcare professionals for the collection
of blood samples into evacuated blood
collection tubes; they are designed with a
safety mechanism, which can be activated
to cover the needle immediately after
puncture to provide protection from
accidental needle sticks. | The BD Vacutainer® Eclipse™
Blood Collection Needle is a
sterile, multiple sample, single-
use device for blood collection.
The needle is designed with an
attached safety shield, which
can be activated to cover the
needle immediately after
venipuncture to provide
protection from accidental
needle sticks. | Comment #1
Different: both the subject
and the predicatedevice are
indicated for use in clinical
environments forblood
collection; the subject device
is also offered withoutsafety
mechanism, but this does
not impact the device's
diagnostic/ therapeutic use
or raise new questions of
safety or effectiveness as
compared to the predicate |
| Cannula material | AISI 304 Stainless Steel | AISI 304 Stainless Steel | same |
| Attribute /
Characteristics | Blood Collection Needles
(Submitted Product) | BD Vacutainer®
Eclipse™ Blood
Collection Needle,
(Legally Marketed
Predicate Device) | Comparison |
| Hub material | Polypropylene (PP) | Polystyrene (PS) | Different: both polymers; PP
is commonly used to
Manufacture plastic
laboratory supplies |
| Hub color | color coded ISO 6009 | color coded ISO 6009 | same |
| Rubber sleeve | synthetic Isoprene | synthetic Isoprene | same |
| Cover | rigid cover, polypropylene | rigid cover, polyethylene | same |
| Adhesive | epoxy type adhesive | epoxy type adhesive | same |
| Lubricant | medical grade silicone oils | medical grade silicone oils | same |
| Needle diameter (gauge) | 18G, 20G, 21 G, 22G | 21 G, 22G | Comment #2
Different: The submitted
device is offered in a wider
range of needle options in
comparison to the predicate
device; this does not affect
the operation of the device,
as proved by thenon-clinical
tests performed
on the subject device. |
| Needle length | 1 inch, 1 ½ inch | 1 ¼ inch | Comment #2
Different: The differences in
the needle length between
the subject and the primary
predicate device do not
impact the subject device
performances; there are no
potential issues of safety and
effectiveness for these
differences in the length of the
needle, as proved by the non-
clinical tests performed on
the subject
device |
| Tip configuration | double tipped: the longest portion of the
needle is used to puncture the patient's
vein, the shortest part fits inside the tube
holder | double tipped: the longest
portion of the needle is used to
puncture the patient's vein, the
shortest part fits inside the
tube holder | same |
| Shelf life | 3 years | 5 years | Different: The shorter shelf
life of the subject device
poses no new issues of
safety and effectiveness in
comparison to the longer
shelf life of the
predicate device |
| Attribute /
Characteristics | Blood Collection Needles
(Submitted Product) | BD Vacutainer®
Eclipse™ Blood
Collection Needle,
(Legally Marketed
Predicate Device) | Comparison |
| Primary Packaging | individually packed with a plastic cover
composed by 2 parts sealed with a label or
packed in sealed individual blisters | individually sealed sterile
pouch | Different: Both the packaging
systems used for the subject
devices are validated and the
SAL is 10-6 substantially
equivalent |
| Secondary Packaging | cardboard box | cardboard box | same |
| Sterilization | Ethylene Oxide (EO)
SAL 10-6 | Gamma irradiation
SAL 10-6 | Comment #3
Different: A different
sterilizationmethod is applied
on the subject device in
comparison with the
predicate device, butthe
assurance sterility level is the
same. Thus, no issues of
safety arise. |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | same |
| Functional testing | Testing in compliance with
ISO 7864:2016
ISO 9626:2016
ISO 23908:2011 | ISO 7864:1993
ISO 9626:1991 | Different: the subject device
contains testing for the safety
feature |
| Sharps injury
prevention
feature | Blood Collection Needles
(Submitted Product) | BD Vacutainer®
Eclipse™ Blood
Collection Needle
(Legally Marketed
Predicate Device) | Comparison |
| Material | Plastic (PP) | Plastic (PP) | same |
| Pigments | Transparent Light blue | Transparent pink | Different: Both mechanisms
are made with transparent
plastic that allows the
operator to see the correct
closure of the safety
device |
| Bonding agents | None | None | same |
| Technical description | The safety shield is connected to the
holder. The safety needle cover is
positioned so as not to interfere with
blood collection; it can be rotated to
find a suitable position during the
blood collection.
Activation can be done by the user
with a single-handed technique.
Once activated, the safety device
completely encloses the needle and
cannot be disengaged. | The safety shield is connected to
the needle, in a fixed position
thus it can't be rotated.
Activation can be done by the
user with a single-handed
technique.
Once activated, the shield
completely enclose the needle,
mechanism cannot be
disengaged. | Different:
In the predicate device the
safety shield is connected to
the needle, in a fixed position,
while in the subject device it
is connected to the holder
and it can rotate. This
difference in the design of the
subject device facilitates the
blood collection and does not
affect the safety and
effectiveness of the subject |
| | Length: 53.5 | Length 47.70
Distance from the holder: 11 mm | device, as proved by the
benching tests performed. |
| Principle of
operation | Rotate the light blue safety needle
cover towards the bottom of holder.
Remove the transparent needle cover.
Perform blood collection according to
safety procedures. Immediately after
the blood collection, activate the safety
device with a thumb. The safety device
is close to holder so that the single hand
technique activation could be done
simply sliding the thumb along the wall
of the holder. Closing operation ends
after hearing a click and with the visual
check of locking of needle. | Gently position pink safety shield
straight back toward the holder.
Twist and pull colored needle cap
straight off. Holding the barrel of
the holder, perform venipuncture
per your facility's procedure.
Immediately
after removing
needle from vein, position thumb
squarely on pink safety shield
thumb pad and push pink safety
shield forward to cover needle.
An audible click may be heard.
Lock shield into place and inspect.
Do not attempt to engage safety
shield by pressing against a hard
surface. | Different:
Both devices can be activated
with a single hand technique
and cannot be disengaged.
Both devices are in a position
so as not to interfere with
blood collection. In the
submitted product the safety
device can be rotated to find
a suitable position to perform
the venipuncture. |
| Activation Method | Activate the safety device with a thumb
simply sliding the thumb along the wall
of the holder. Closing operation ends
after hearing a click and with the visual
check of locking of needle. | Position thumb squarely on pink
safety shield thumb pad and push
pink safety shield forward to
cover needle. An audible click
may be heard. Lock shield into
place and inspect. | Different:
The safety mechanism is
activated in both the devices
by pushing it with the thumb.
The activation method of the
submitted device allows the
operator to close the safety
device keeping the holder in
the same position during all
blood collection procedure. |
5
6
7
Predicate Device Comparison Chart - sharps injury prevention feature
8
SUBSTANTIAL EQUIVALENCE DISCUSSION:
Comment #1
The Blood Collection Needles are same or similar in intended use, materials and design to the predicate device (K982541). Both the subject and the predicate device are in clinical environments for blood collection. Both the devices have the same principle of operation, same overall design, including use of a holder; the same method of use and very limited duration of contact (≤ 3 min.) with patient's blood; the same cannula material, similar geometry and gauge.
Both the subject and the predicate device are provided with or without a preassembled holder.
The subject device is also offered without safety mechanism, but this does not impact the device's diagnostic/therapeutic use or raise new questions of safety or effectiveness as compared to the predicate. As for the safety mechanism, the subject device is substantially equivalent to the predicate device in materials, design and principle of operation of the sharps injury prevention feature; the slight differences do not affect the safety and effectiveness of the safety shield of the subject device, as proved by the benching tests performed.
Comment #2
The subject device is available in sizes 18g-22g inch x 1 ½ & 1 inch lengths, the predicate device is available in sizes 21g-22g x 1 ¼ inch. Venous flow through the inner diameter of the cannula into attached blood collection tubes is the technological principle for both the subject and predicate device. The subject and predicate device are based on the same or similar technological elements and are made with the same materials, largely used for the same type of medical devices already on the market.
The minor differences in gauge and length of the devices do not impact the safety and effectiveness of the subject device. The performance data (design verification testing) demonstrate that the subject device is as safe and effective as the cited predicates. Thus, the Blood Collection Needles are substantially equivalent to the proposed predicate device.
Comment #3
There are minor differences in sterilization method and shelf life. Sterilization validation, shelf-life and package integrity testing demonstrate that the subject device maintains its sterility and performance through its expiration. These differences do not raise any new types of safety or effectiveness questions.
DISCUSSION OF NON-CLINICAL TESTS
Biocompatibility
In accordance with ISO 10993-1, the Blood Collection Needle is classified as Externally Communicating Device, Blood Path Direct, Limited Contact (, Material Mediated pyrogenicity
- . ASTM F756-08, "Standard Practice for Assessment of Haemolytic Properties of Materials
- ISO 10993-4:2002/Amd 1:2006: "Biological evaluation of medical devices Part 4: Selection of tests ● for interactions with blood
- . USP, Particulate matter in injections
9
Sterilization Validation
The sterile Blood Collection Needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 11135:2014, Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices,
- ISO 11138-1: 2017, Sterilization of health care products -- Biological indicators Part 1: General ● requirements.
- ISO 10993-7 :2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
- . ISO 11607-1:2009. Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2006. Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes
- . ISO 11737-1:2018, Sterilization of health care products-Microbiological methods-Part1: Determination of a population of microorganisms on products.
- . ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- . LAL test was performed according to:
- USP 39th ed. 2016: Bacterial Endotoxins Test
- USP 39th ed. 2016: Transfusion and infusion assemblies and similar medical devices.
- European Pharmacopoeia current edition: 2.6.14 Bacterial Endotoxins.
Performance Testing
The sterile, Blood Collection Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 7864:2016, "Requirements and test methods Sterile hypodermic needles for single use. Requirements and test methods",
- ISO 9626:2016, "Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods"
- . ISO 23908:2011, "Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
CONCLUSION:
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Blood Collection Needle is substantially equivalent to the BD Vacutainer Blood Collection Needle.