(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a prefilled saline syringe, with no mention of AI or ML.
No
The device is described as a syringe prefilled with saline for flushing indwelling vascular access devices, which is a maintenance activity rather than a therapeutic treatment.
No
The device is a prefilled syringe used for flushing indwelling vascular access devices, which is a therapeutic or maintenance function, not a diagnostic one.
No
The device description clearly states it is a polypropylene syringe prefilled with saline, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "only for the flushing of indwelling vascular access devices." This is a direct therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a prefilled syringe with saline solution for flushing. This aligns with a medical device used for patient care, not for testing samples in vitro.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Product codes (comma separated list FDA assigned to the subject device)
NGT
Device Description
0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device met all the predetermined acceptance criteria for the following performance, packaging, and biocompatibility tests:
- Performance/Design Verification Tests: Tip Cap Removal Torque, Reflux, Tip Cap Leakage, Leakage past Stopper, Breakloose force, Breakout Force, Sustaining Force, Retaining Ring Force, Expelled Volume, NaCl Assay, pH, Iron, Heavy Metals, NaCl solution weight loss, UV Analysis, Bacterial Endotoxin, Sterility, Surface Sterility, Particulate Matter, Appearance and Solution Clarity/Barrel Transparency. All tests passed.
- Primary Package Integrity: No leaks when tested by Vacuum Bubble Leak (ASTM F2096-11), Non-porous, Seal strength and width value as per BD validated force and width measurements respectively, No defects in packaging seals when visually inspected, Clean peel of blister pack with no foreign matter. All tests passed.
- Biocompatibility: Cytotoxicity (Grade ≤ 2), Sensitization (Non-Sensitizer), Irritation (Final Test Sample Score ≤ 1), Acute Systemic Toxicity (No significantly greater biological reaction than the control), Material Mediated Pyrogenicity (No temperature rise ≥ 0.5° C), Hemocompatibility (≤ 5% hemolysis), Genotoxicity (Non-mutagenic), LAL Endotoxin (Below the Endotoxin Limit 0.5 EU/device), Extractable and Leachable Analysis (noted no extractables and leachables identified that indicated significant risk concerns). 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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2023
Becton, Dickinson and Company Samhitha Mohan Sr. Staff Regulatory Affairs Specialist 1 Becton Dr Franklin Lakes, New Jersey 07417
Re: K231161
Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: April 24, 2023 Received: April 24, 2023
Dear Samhitha Mohan:
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
1
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) 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 (OS) 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 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,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231161
Device Name
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
Indications for Use (Describe)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the BD logo, which includes an orange sunburst symbol and the letters "BD" in blue. Below the logo is the text "0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe". The text describes the product as a saline flush syringe containing 0.9% sodium chloride.
| Submitter Name: | Becton, Dickinson and Company | |
|---|---|---|
| Submitter | ||
| Information | Submitter Address: | 1 Becton Dr |
| Franklin Lakes | ||
| NJ 07417 | ||
| Contact Person: | Samhitha Mohan | |
| Sr. Staff Regulatory Affairs | ||
| Specialist | ||
| Email Address: | ||
| Phone Number: | (214)-971-0979 | |
| Fax Number: | (201)-847-5307 | |
| Date of Preparation: | 21 July, 2023 | |
| Trade Name: | 0.9% Sodium Chloride Injection, | |
| USP, BD PosiFlush™ SF Saline | ||
| Flush Syringe | ||
| Subject Device | Common Name: | 0.9% Sodium Chloride Injection |
| Flush Syringe | ||
| Regulation Number: | 21 CFR 880.5200 | |
| Device Class: | Class II | |
| Classification Name: | Saline, Vascular Access Flush | |
| Product Code: | NGT | |
| Classification Panel: | General Hospital | |
| Trade Name: | 0.9% Sodium Chloride Injection, | |
| USP BD PosiFlush™ SF Syringe | ||
| Predicate Device | 510(k) Number: | K153481 |
| Classification Name: | Saline, Vascular Access Flush | |
| Regulation Number: | 21 CFR 880.5200 | |
| Regulatory Class: | Class II | |
| Product Code: | NGT | |
| Classification Panel: | General Hospital |
510(k) Summary (21 CFR §807.92)
4
| Device Description | 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration. |
|---|---|
| Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices. |
| Technological Characteristic-s | The following table provides a comparison between the subject and predicate devices – |
5
| Attribute | Subject Device
(0.9% Sodium
Chloride Injection,
USP BD PosiFlush™
SF Saline Flush
Syringe) | Predicate Device
(0.9% Sodium
Chloride Injection,
USP BD PosiFlush™
SF Syringe) -
K153481 | Compar
-ison |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications
for Use | The 0.9% Sodium
Chloride Injection,
USP, BD PosiFlush™ SF
Saline Flush Syringes
are intended to be
used only for the
flushing of indwelling
vascular access
devices. | The 0.9% Sodium
Chloride Injection, USP,
BD PosiFlush™ SF
Syringes are intended to
be used only for the
flushing of indwelling
vascular access devices. | Similar;
"Saline
Flush" is
added to the
name of the
subject
device |
| Operating
Principle | The tip cap is twisted
off from the barrel and
plunger rod is
depressed to drive the
flow of 0.9% sodium
chloride USP solution
through the indwelling
vascular access
devices. The saline
solution 'cleans out' or
displaces any other
fluid and maintains
patency of the line. | The tip cap is twisted off
from the barrel and
plunger rod is depressed
to drive the flow of
0.9% sodium chloride
USP solution through
the indwelling vascular
access devices. The
saline solution 'cleans
out' or displaces any
other fluid and
maintains patency of the
line. | Identical |
| Syringe
Configuration | 10mL | 10mL | Identical |
| Single
Use? | Yes | Yes | Identical |
| Sterile? | Yes | Yes | Identical |
| Use in
Sterile
Field? | Yes | Yes | Identical |
| Content of
syringe
package | One pre-filled syringe
per pack | One pre-filled syringe
per pack | Identical |
| Device
Components | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Identical |
| Barrel
Material | Polypropylene-
Polyethylene
Random Copolymer | Polypropylene
Homopolymer | Similar;
Subject device
material is
assessed as per
ISO 10993-1 |
| Barrel Lubricant | Silicon
e | Silicone | Identical |
| Plunger Rod
Material | Polypropylene | Polypropylene | Identical |
| Stopper
Material | Styrene-Butadiene
Rubber | Styrene-Butadiene
Rubber | Identical |
| Stopper Lubricant | Silicon
e | Silicone | Identical |
| Tip Cap
Material | Polypropylene-
Polyethylene
Random Copolymer | Polypropylene
Homopolymer | Similar;
Subject device
material is
assessed as per
ISO 10993-1 |
| Tip Cap
Colorant | White | White | Identical |
| Packaging
Configuration | Blister pack Shelf Carton Case Carton | Blister pack Shelf Carton Case Carton | Identical |
| Primary
Packaging
Material | Film on film | Paper on film | Different;
Appropriate
packaging tests
are performed
to ensure
sterile barrier
integrity is
maintained |
| Mode of
Sterilization | Gam
ma | Autoclave | Different |
| SAL | 10-6 | 10-6 | Identical |
| Shelf Life | 1 year | 3 years | Different;
Subject device
shelf life has
been assessed
by appropriate
bench
performance
testing |
| Tip Cap Removal
Torque | Measure the torque
required to remove
the tip cap from the
syringe | Measure the
torque required
to remove the tip
cap from the
syringe | Same as
Predicate |
| Tip Cap Leakage | Measure the
resistance to leakage
in between the Luer
and the tip cap for
pre-filled syringes | Measure the
resistance to
leakage in
between the Luer
and the tip cap
for pre-filled
syringes | Same as
Predicate |
| Breakloose Force | Measure the initial
maximum force
required to move
the plunger
rod/stopper in the
syringe barrel | Measure the initial
maximum force
required to move the
plunger rod/stopper in
the syringe barrel | Same as
Predicate |
| Breakout Force | Measure the
maximum force
required to move the
plunger rod/stopper
in the syringe barrel
a short time after
initially
moving the
plunger
rod/stopper | Measure the
maximum force
required to move
the plunger
rod/stopper in
the syringe barrel
a short time after
initially moving
the plunger
rod/stopper | Same as
Predicate |
| Sustaining Force | Measure the average
force required to
move the plunger
rod/stopper in the
syringe barrel | Measure the
average force
required to move
the plunger
rod/stopper in
the syringe barrel | Same as
Predicate |
| Reflux | Measure the
potential blood
reflux into the
catheter from
PosiFlush™ SF
syringe | Measure the
potential blood
reflux into the
catheter from
PosiFlush™ SF
syringe | Same as
Predicate |
| Retaining Ring
Force | Measure the force
necessary to remove
the plunger rod /
stopper assembly
from
the syringe barrel
after assembly | Measure the force
necessary to remove
the plunger rod /
stopper assembly from
the syringe barrel after
assembly | Same as
Predicate |
| Leakage past
Stopper | Measure the
resistance to leakage
in between
the barrel and
stopper for pre-filled
syringes | Measure the
resistance to leakage
in between the barrel
and stopper for pre-
filled syringes | Same as
Predicate |
| Expelled Volume | Measure the volume
of saline solution | Measure the volume
of saline solution
expelled from the
syringe | Same as
Predicate |
| Sterility | To verify 10-6
Sterility Assurance
Level (SAL) on all
surface (fluid path
and external surface)
of syringe, fluid path
and inside
surface of primary
packaging | To verify 10-6
Sterility Assurance
Level (SAL) on all
surface (fluid path
and external
surface) of syringe,
fluid path and inside
surface of primary
packaging | Same as
Predicate |
| NaCl Solution
Stability | Following tests to
comply with 0.9%
NaCI Injection USP
Monograph – NaCl
Assay, pH,
Endotoxin,
Particulate Matter,
Iron, Heavy metals,
UV/Vis | Following tests to
comply with 0.9%
NaCl Injection USP
Monograph – NaCl
Assay, pH,
Endotoxin,
Particulate Matter,
Iron, Heavy metals,
UV/Vis | Same as
Predicate |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same as
Predicate |
| Sensitization | Non-Sensitizer | Non-Sensitizer | Same as
Predicate |
| Irritation or
Intracutaneous
Activity | Non-irritant | Non-irritant | Same as
Predicate |
| Acute Systemic
Toxicity | No acute systemic
toxicity | No acute systemic
toxicity | Same as
Predicate |
| Material Mediated
Pyrogenicity | Not a material
mediated-pyrogen | Not a material
mediated-pyrogen | Same as
Predicate |
| Hemocompatibility | Non-hemolytic | Non-hemolytic | Same as
Predicate |
| Genotoxicity | Non-genotoxic | Non-genotoxic | Same as
Predicate |
| LAL Endotoxin | Below the Endotoxin
Limit 0.5 EU/device | Below the Endotoxin
Limit 0.5 EU/device | Same as
Predicate |
| Extractable and
Leachable
Analysis | Extractable and
leachable substances
showed
toxicologically
acceptable levels. | Extractable and
leachable substances
showed
toxicologically
acceptable levels. | Under the
condition of the
chemical
characterization
testing, there
were no
extractables
and leachables
identified that
indicated
significant risk
concerns |
6
7
8
9
10
Discussion:
The subject device and predicate device are different with respect to the following items:
-
- "Saline Flush" is added to the name of the subject device
-
- The mode of sterilization was changed from autoclave (predicate) to gamma irradiation (subject). The gamma sterilized test samples were evaluated for performance, packaging integrity and biocompatibility.
-
- The barrel and tip cap resin of both subject and predicate device is polypropylene. However, the subject device polypropylene has small amount of polyethylene which ensures compatibility with gamma sterilization process. Appropriate performance tests and biocompatibility tests were performed to ensure safety and effectiveness.
-
- The blister pack was changed from paper on film to film on film material. This change ensures compatibility with gamma sterilization process. Package integrity tests were performed to evaluate the material change.
-
- The shelf life of the subject device is lowered to 1 year. Stability tests were performed to support 1 year shelf life of the subject device.
The different technological characteristics between the subject and predicate device are evaluated in bench performance testing, packaging integrity and biocompatibility tests demonstrating that there are no new or different questions of safety and effectiveness.
BD has performed the following performance tests in accordance with 21 CFR §820.30 to demonstrate that the Non-Clinical PosiFlush™ SF Syringe performs equivalent to the predicate Testing devices. The following tests were performed on the subject device to an internal specification or a Standard:
11
| Test | Purpose | Acceptance
Criteria | Result | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|
| | Performance/Design Verification Tests | | | |
| Tip Cap
Removal
Torque | Measure the torque required to
remove the tip cap from the
syringe | Tip Cap can be
twisted off as per
BD validated force | Pass | |
| Reflux | Measure the potential blood reflux
into the catheter from PosiFlush™
SF syringe | Reflux greater than
BD validated
internal value | Pass | |
| Tip Cap
Leakage | Evaluate the resistance to leakage
between the barrel Luer and the
tip cap for pre-filled syringes | No evidence of Tip
Cap leakge | Pass | |
| Leakage past
Stopper | Evaluate the resistance to leakage
between the barrel and stopper
ribs | No leakage of
solution past the
stopper ribs | Pass | |
| Breakloose
force | Measure the initial maximum
force required to move the
plunger rod/stopper in the syringe
barrel | | Pass | |
| Breakout
Force | Measure the maximum force
required to move the plunger
rod/stopper in the syringe barrel a
short time after initially moving
the plunger rod/stopper | Force to move
plunger rod/stopper
is less than the BD
validated force | Pass | |
| Sustaining
Force | Measure the average force
required to move the plunger
rod/stopper in the syringe barrel | | Pass | |
| Retaining
Ring Force | Measure the force necessary to
remove the plunger rod/stopper
assembly from the syringe barrel
after assembly | Force to move
plunger rod/stopper
is greater than the
BD validated force | Pass | |
| Expelled
Volume | Measure the volume of saline
solution expelled from the syringe | USP43-NF38
Container
Content for
Injections | Pass | |
| NaCl Assay | Measure the NaCl concentration
saline solution in syringe samples | 0.9% NaCl Injection
USP Monograph | Pass | |
| pH | Measure the pH of saline solution
in syringe samples | 0.9% NaCl Injection
USP Monograph and
USP43-NF38
pH | Pass | |
| Iron | Measure the amount of iron in
saline solution | 0.9% NaCl Injection
USP Monograph and | Pass | |
| | | USP43-NF38
Iron | | |
| Heavy
Metals | Measure the heavy metals such as
Cadmium, Arsenic, Cobalt,
Vanadium, Copper, Lead, Nickel,
Lithium, Antimony and Mercury in
saline solution | USP43-NF38
Elemental Impurities
- Limits | Pass | |
| NaCl solution
weight loss | Measure the weight loss of saline
solution in pre-filled saline
syringes | USP43-NF38
Containers
Performance Testing | Pass | |
| UV Analysis | Measure the UV absorbance
between 220-360 nm for pre-filled
saline syringes |
Bacterial Endotoxins
Test | Pass | |
| Sterility | To verify 10-6 SAL in the fluid
path. | Sterile; No growth | Pass | |
| Surface
Sterility | To verify 10-6 SAL on all surface of
syringe and inside surface of
primary packaging | in media | Pass | |
| Particulate
Matter | Measure the number of
particulates in saline pre-filled
syringes | USP43-NF38
Particular Matter in
Injections | Pass | |
| Appearance
and Solution
Clarity/
Barrel
Transparency | Examine the appearance, solution
clarity and barrel transparency in
pre-filled saline syringes | Solution and
components are
clear | Pass | |
| Primary
Package
Integrity | Evaluates the sterile barrier
system of the pre-filled syringe
throughout shelf life | No leaks when
tested by Vacuum
Bubble Leak (ASTM
F2096-11) | Pass | |
| | | Non-porous
Seal strength and
width value as per
BD validated force
and width
measurements
respectively | Pass | |
| | | No defects in
packaging seals
when visually
inspected | Pass | |
| | | Clean peel of blister
pack with no foreign
matter | Pass | |
| | | Biocompatibility | | |
| Cytotoxicity | ISO 10993-5:2009
Biological evaluation of medical
devices - Part 5: Tests for in vitro
cytotoxicity | Grade ≤ 2 | Pass | |
| Sensitization | ISO 10993-10:2021
Biological Evaluation of Medical
Devices - Part 10: Tests for Skin
Sensitization | Non-Sensitizer | Pass | |
| Irritation | ISO 10993-23:2021
Biological Evaluation of Medical
Devices - Part 23: Tests for
Irritation | Final Test Sample
Score ≤ 1 | Pass | |
| Acute
Systemic
Toxicity | ISO 10993-11:2017
Biological evaluation of medical
devices — Part 11: Tests for
systemic toxicity | No significantly
greater biological
reaction than the
control | Pass | |
| Material
Mediated
Pyrogenicity | ISO 10993-11:2017
Biological evaluation of medical
devices — Part 11: Tests for
systemic toxicity
USP43-NF38 Pyrogen Test
(USP Rabbit Test) | No temperature rise
≥ 0.5° C | Pass | |
| Hemocompat
-ibility | ISO 10993-4:2017 Biological
evaluation of medical devices Part
4: Selection of tests for
interactions with blood
ASTM F756-17 Standard Practice
for Assessment of Hemolytic
Properties of Materials | ≤ 5% hemolysis | Pass | |
| Genotoxicity | ISO 10993-3: 2014 Biological
evaluation of medical devices –
Part 3: Tests for genotoxicity,
carcinogenicity and reproductive
toxicity | Non-mutagenic | Pass | |
| LAL
Endotoxin | USP 43-NF38 Medical
Devices – Bacterial Endotoxin | Below the Endotoxin
Limit 0.5 EU/device | Pass | |
| | USP43-NF38 Bacterial
Endotoxins Test
ANSI AAMI ST72:2019 Bacterial
endotoxins - Test methods,
routine monitoring, and
alternatives to batch testing | | | |
| Extractable
and
Leachable
Analysis | ISO 10993-18: 2020 Biological
evaluation of medical devices -
Part 18: Chemical characterization
of materials
ISO 10993-17: 2002 Biological
evaluation of medical devices -
Part 17: Establishment of
allowable limits for leachable
substances | N/A | See
Note
1
below | |
12
13
14
Note 1: Under the condition of the chemical characterization testing, there were no extractables and leachables identified that indicated significant risk concerns
The subject device met all the predetermined acceptance criteria for the above listed performance, packaging, and biocompatibility tests.
| Clinical Testing | Not applicable. |
|---|---|
| Conclusion | The conclusions drawn from the nonclinical tests demonstrate that |
| the BD PosiFlush™ SF is as safe, as effective, and performs as well | |
| as or better than the legally marketed predicate device cleared | |
| under K153481. |