(211 days)
Not Found
No
The device description and performance studies focus on the physical components, chemical properties (saline, IPA), and mechanical functions of a pre-filled syringe with an integrated disinfection unit. There is no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is intended for disinfection and flushing of vascular access devices, not for treating a disease or condition.
No
The device is intended for disinfection and flushing of vascular access devices, not for diagnosing any medical condition.
No
The device description clearly indicates it is a physical product consisting of a pre-filled syringe, saline solution, and an integrated disinfection unit with housing and foam containing isopropyl alcohol. It is a hardware device with a chemical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs." This describes a device used on a medical device (the VAD and its access device) and for a therapeutic/maintenance purpose (flushing), not for the in vitro examination of specimens derived from the human body.
- Device Description: The description details a pre-filled syringe with saline and an integrated disinfection unit containing isopropyl alcohol. This aligns with a device used for cleaning and flushing, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status, diagnose conditions, or monitor treatment. This device's function is entirely external to the body and related to the maintenance of a medical device.
N/A
Intended Use / Indications for Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
Product codes
OTI
Device Description
BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. 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)
Performance/Design Verification Tests:
Container Closure Integrity: Evaluate sterile barrier system for the syringe. Acceptance Criteria: No dye within the syringe. Result: Pass.
Leakage Test: Evaluate sterile barrier system for the syringe. Acceptance Criteria: No leakage from the syringe. Result: Pass.
Torque Removal Test: Evaluate tip cap removal. Acceptance Criteria: Tip Cap can be twisted off as per BD validated force. Result: Pass.
Sterile Fluid Path: Evaluate the syringe's fluid path sterility. Acceptance Criteria: SAL: 10-6. Result: Pass.
Axial Pull Force: Evaluate the potential separation of Tip Cap from Disinfecting Unit (DU). Acceptance Criteria: DU cannot be pulled off per BD validated force. Result: Pass.
Torque: Evaluate the potential separation of Tip Cap from Disinfecting Unit (DU). Acceptance Criteria: DU cannot be twisted off as per BD validated force. Result: Pass.
Particulate Ingress: Evaluate per USP . Acceptance Criteria: USP . Result: Pass.
Antimicrobial Efficacy: Evaluate disinfection efficacy of the DU. Acceptance Criteria: ≥ 4-log reduction. Result: Pass.
70% IPA Concentration: Evaluate IPA concentration over shelf life for the DU. Acceptance Criteria: 70±7%. Result: Pass.
Foam Rotation: Evaluate foam rotation during use. Acceptance Criteria: Foam should not rotate >90 degrees within the DU housing during use. Result: Pass.
Foam Retention: Evaluate foam retention before and during use. Acceptance Criteria: Foam must be retained within the DU. Result: Pass.
Foam Retention (after use): Evaluate foam retention after use. Acceptance Criteria: Foam must be retained within DU after scrubbing. Result: Pass.
Foam Durability: Evaluate foam for evidence of ripped or ragged material and debris or particulate. Acceptance Criteria: No ripped or ragged material and debris or particulate. Result: Pass.
Foam Compressibility and Wetness: Evaluate foam for wetness and compressibility. Acceptance Criteria: Foam must be wet and compressible. Result: Pass.
70% IPA Ingress: Evaluate IPA ingress that may enter the patient IV line. Acceptance Criteria: Maximum dose of 2 mg IPA/kg body mass/day per US EPA. Result: Pass.
Package integrity of DU: Evaluate sterile barrier system of the DU. Acceptance Criteria: Bubble Leak as per ASTM F2096, Seal Width ≥ 0.58 mm, No delamination, Peel Force shall be within: USL: ≤ 12.9 N, LSL: ≥ 3.69 N, Microbial properties as per ISO 11607-1:2019. Result: Pass.
Biocompatibility:
Cytotoxicity: ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Acceptance Criteria: Grade ≤ 2. Result: Pass.
Sensitization: ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Acceptance Criteria: Non-Sensitizer. Result: Pass.
Irritation or Intracutaneous Activity: ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Acceptance Criteria: Final Test Sample Score ≤ 1. Result: Pass.
Acute Systemic Toxicity: ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity. Acceptance Criteria: No significantly greater biological reaction than the control. Result: Pass.
Material Mediated Pyrogenicity: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. Acceptance Criteria: No temperature rise ≥ 0.5° C. Result: Pass.
Hemocompatibility: 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. Acceptance Criteria: ≤ 5% hemolysis. Result: Pass.
LAL Endotoxin: USP 43-NF38 Medical Devices - Bacterial Endotoxin. Acceptance Criteria: Below the Endotoxin Limit 20 EU/device. Result: Pass.
Extractable and Leachable Analysis: ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of materials. Result: Toxicological Risk Assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Antimicrobial Efficacy: ≥ 4-log reduction
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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July 16, 2022
Becton, Dickinson and Company Samhitha Mohan Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K213955
Trade/Device Name: BD PosiFlush SafeScrub Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: OTI Dated: June 29, 2022 Received: July 1, 2022
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
1
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) 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 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 Oian, M.D., Ph.D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213955
Device Name BD PosiFlush™ SafeScrub
Indications for Use (Describe)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
| 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
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BD PosiFlush™ SafeScrub - K213955
510(k) Summary (21 CFR §807.92)
| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Fax Number:
510(k) Number:
Date of Preparation: | Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes
NJ 07417
Samhitha Mohan
Staff Regulatory Affairs Specialist
Samhitha.Mohan@bd.com
(214) 971-0979
(201) 847-5307
K213955
July 15, 2022 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Device Class:
Classification Name:
Classification Product
Code:
Classification Panel: | BD PosiFlush™ SafeScrub
Pre-filled Saline Syringe with Disinfection Unit
21 CFR 880.5200
Class II
Saline, Vascular Access Flush
QTI
General Hospital |
| Primary
Predicate Device | Trade Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SP
Syringe |
| | 510(k) Number:
Classification Name:
Regulation Number:
Regulatory Class:
Product Code:
Classification Panel: | K161552
Saline, Vascular Access Flush
21 CFR 880.5200
Class II
NGT
General Hospital |
| Predicate Device | Trade Name:
510(k) Number:
Classification Name:
Regulation Number:
Regulatory Class:
Product Code:
Classification Panel: | SiteScrub IPA Device
K112791
Pad, Alcohol, Device Disinfectant
Unclassified
Unclassified
LKB
General Hospital |
| Device
Description | BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated
Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP)
solution with a tip cap that is modified at the distal end to accommodate DU. The DU has
high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low
density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized
by moist heat and the DU is sterilized by gamma irradiation. The subject device is
available only in 10mL syringe configuration. | |
| Indications for
Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush
syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner
for needleless access devices attached to indwelling vascular access devices (VADs) and
flushing of these VADs. | |
| Technological
Characteristic-
s | | The following table provides a comparison between the subject and predicate devices – |
4
5
| Attribute | Subject Device
(BD PosiFlush™
SafeScrub) | Primary Predicate
Device (0.9% Sodium
Chloride Injection, USP
BD PosiFlush™ SP
Syringe) – K161552 | Predicate Device
(SiteScrub IPA
Device) –
K112791 | Comparison |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for
Use | The 0.9% Sodium
Chloride Injection,
USP, BD PosiFlush™
SafeScrub prefilled
flush syringe with an
integrated disinfection
unit is intended to be
used as a disinfection
cleaner for needleless
access devices
attached to indwelling
vascular access
devices (VADs) and
flushing of these
VADs. | The 0.9% Sodium Chloride
Injection, USP, BD
PosiFlush™ SP Syringe is
intended to be used only
for the flushing of
indwelling vascular access
devices. Catalog Number
306547 10 mL BD
PosiFlush™ SP Syringes
are generally compatible
for use with syringe
pumps. | The Site-Scrub IPA
Device is intended
for use on
injection ports and
female Luer hubs
as a disinfecting
cleaner. | The intended use of
the subject device is
created by combining
the intended use of
both the predicates.
The subject device's
intended use does not
include pump
compatible statement
since PosiFlush™
SafeScrub is not
intended to be used
with pumps.
Additionally, subject
device's intended use
refers to injection
ports and female Luer
hubs as needleless
access devices. |
| Operating
Principle | Same as predicates | The pre-filled USP 0.9%
saline syringe flushes
indwelling vascular access
devices | 70% IPA solution
i.e., antimicrobial
agent and active
mechanical friction
from the foam aids
in disinfection | Identical |
| Disinfectio
-n Time | Same as predicate | N/A | Twist back and
forth for at least 8
repetitions, for a
minimum of 10
seconds | Identical |
| Target
microorga
nisms
for in vitro
antimicrob
-ial
efficacy | • Staphylococcus
aureus
• Staphylococcus
epidermidis
• Escherichia coli
• Pseudomonas
aeruginosa
• Candida albicans
• Candida glabrata
• Acinetobacter
baumannii | N/A | • Staphylococcus
aureus
• Staphylococcus
epidermidis
• Escherichia coli
• Pseudomonas
aeruginosa
• Candida albicans
• Candida
parapsilosis | Identical except
for Acinetobacter
baumannii, Candida
glabrata and Candida
parapsilosis. In
vitro antimicrobial
efficacy testing
was performed for
all the
microorganisms |
| Syringe
Configura-
tion | 10mL only | 3mL, 5mL and 10mL | N/A | Subject device does
not include 3 and 5mL
syringe configurations |
| Device
Compone-
nts | • Barrel
• 0.9% NaCl solution
• Plunger Rod
• Modified Tip Cap
• Stopper Lubricant
• Stopper
• Modified Housing
• Foam
• 70% IPA solution | • Barrel
• 0.9% NaCl solution
• Plunger Rod
• Tip Cap
• Stopper Lubricant
• Stopper | • Housing
• Foam
• 70% IPA
solution | All the components are
identical in design with
the exception of tip
cap and housing. The
distal end of tip cap
and DU housing are
modified to snap fit
with each other to
form PosiFlush™
SafeScrub |
| Barrel
Material | Same as predicate | Polypropylene | N/A | Identical |
| Plunger
Rod
Material | Same as predicate | Polypropylene | N/A | Identical |
| Stopper
Material | Same as predicate | Styrenebutadiene rubber | N/A | Identical |
| Stopper
Lubricant
Material | Same as predicate | Silicone | N/A | Identical |
| Tip Cap
Material | Same as predicate | Polypropylene w/
White Colorant | N/A | Identical |
| DU
Housing
Material | Same as predicate
w/white colorant | N/A | High Density
Polyethylene
(HDPE) w/blue
colorant | HDPE material in DU is
identical to SiteScrub's
housing material. The
subject device's DU
has white colorant to
match with the color of
the tip cap. Colorant
differences are
assessed as per
ISO 10993-1 |
| Foam
Material | Same as predicate | N/A | Low Density
Polyethylene
(LDPE) | Identical |
| Foam
Base
Colorant | Same as predicate | N/A | Copper
phthalocyanine
blue | Identical |
| Packaging
Configurat
ion | Same as predicates | • Flow wrap
• Shelf Carton
• Case Carton | Top Foil | Identical with the
exception of top foil
material. Appropriate
packaging tests are
performed to ensure
top foil maintains
sterile barrier to the
DU |
| Sterilizatio
-n Mode | Same as predicates | Moist heat | Gamma | Identical |
| SAL | Same as predicates | 10-6 (Sterile Fluid Path) | 10-6 (Sterile Fluid
Path) | Identical |
| Shelf Life | 0.5 years | 3 years | 9 months | Subject device shelf
life has been assessed
by appropriate bench
performance testing |
6
7
8
Discussion:
The subject device and predicate devices are different with respect to the following items:
-
- The intended use of the subject device is identical to the predicates with the exception of pump compatibility statement since PosiFlush™ SafeScrub is not intended to be used with infusion pumps. The subject device refers to injection ports and female Luer hubs as needleless access devices. Needleless access devices include needlefree connector, Y-sites, and stopcocks.
-
- PosiFlush™ SafeScrub is created by combining the predicate devices (K161552 and K112791). The distal end of tip cap of PosiFlush SP syringe (K161552) and the housing of SiteScrub IPA Device (K112791) are dimensionally modified to integrate such that they remain attached to each other at all times. This integration/interface is evaluated by torque rotation and axial pull force tests throughout the shelf life.
NOTE: The modified SiteScrub IPA Device in PosiFlush™ SafeScrub is referred as Disinfection Unit (DU).
9
-
- The microorganisms targeted by DU in the in vitro antimicrobial efficacy test were chosen based on the current literature search for microorqanisms that cause catheter related bloodstream infection.
-
- The material of top foil which creates a seal on the DU housing has been updated from the SiteScrub IPA Device to comply with ISO 11607-1:2019 and for vendor consolidation purposes. Similar to the predicate device, the new top foil material also ensures that it retains sterile barrier integrity and accordingly packaging tests such as vacuum bubble leak test, peel force test, seal width, visual inspection, and porosity tests are performed.
-
- Since the colorant of DU housing is changed from blue to white, appropriate biocompatibility tests are performed as per ISO 10993-1 to ensure the safe use of PosiFlush™ SafeScrub. The biocompatibility tests performed on the DU are identified below. The colorant was changed from blue to white to match with the color of tip cap.
-
- The subject device is also evaluated throughout its shelf life by bench performance testing to ensure that the device meets the predetermined acceptance criteria.
The different technological characteristics between the subject and predicate device are evaluated in bench performance testing, in vitro antimicrobial efficacy, packaging integrity, and biocompatibility tests demonstrating that the different technological characteristics do not raise any new or different questions of safety and effectiveness.
| Test | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| Performance/Design Verification Tests | ||||
| Container | ||||
| Closure | ||||
| Integrity | Evaluate sterile barrier system | |||
| for the syringe | No dye within the | |||
| syringe | Pass | |||
| Leakage Test | Evaluate sterile barrier system | |||
| for the syringe | No leakage from the | |||
| syringe | Pass | |||
| Torque | ||||
| Removal | ||||
| Test | Evaluate tip cap removal | Tip Cap can be twisted | ||
| off as per BD validated | ||||
| force | Pass | |||
| Sterile Fluid | ||||
| Path | Evaluate the syringe's fluid path | |||
| sterility | SAL: 10-6 | Pass | ||
| Axial Pull | ||||
| Force | Evaluate the potential separation | DU cannot be pulled off | ||
| per BD validated force | Pass | |||
| Torque | of Tip Cap from Disinfecting Unit | |||
| (DU) | DU cannot be twisted off | |||
| as per BD validated | ||||
| force | Pass | |||
| Particulate | ||||
| Ingress | Evaluate per USP | USP | Pass | |
| Antimicrobial | ||||
| Efficacy | Evaluate disinfection efficacy of | |||
| the DU | ≥ 4-log reduction | Pass | ||
| 70% IPA | ||||
| Concentrat- | ||||
| ion | Evaluate IPA concentration over | |||
| shelf life for the DU | 70±7% | Pass | ||
| Foam | ||||
| Rotation | Evaluate foam rotation during | |||
| use | Foam should not rotate |
90 degrees within the
DU housing during use | Pass | |
| Foam | Evaluate foam retention before
and during use | Foam must be retained
within the DU | Pass | |
| Retention | Evaluate foam retention after use | Foam must be retained
within DU after
scrubbing | Pass | |
| Foam
Durability | Evaluate foam for evidence of
ripped or ragged material and
debris or particulate | No ripped or ragged
material and debris or
particulate | Pass | |
| Foam
Compressibili | Evaluate foam for wetness and
compressibility | Foam must be wet and
compressible | Pass | |
| | ty and
Wetness | | | |
| | 70% IPA
Ingress | Evaluate IPA ingress that may
enter the patient IV line | Maximum dose of 2 mg
IPA/kg body mass/day
per US EPA | Pass |
| | Package
integrity of
DU | Evaluate sterile barrier system of
the DU | Bubble Leak as per
ASTM F2096 | Pass |
| | | | Seal Width $\geq$ 0.58 mm | Pass |
| | | | No delamination | Pass |
| | | | Peel Force shall be
within:
USL: $\leq$ 12.9 N
LSL: $\geq$ 3.69 N | Pass |
| | | | Microbial properties as
per ISO 11607-1:2019 | Pass |
| | Biocompatibility | | | |
| | Cytotoxicity | ISO 10993-5:2009
Biological evaluation of medical
devices - Part 5: Tests for in vitro
cytotoxicity | Grade $\leq$ 2 | Pass |
| | Sensitization | ISO 10993-10:2010
Biological evaluation of medical
devices - Part 10: Tests for
irritation and skin sensitization | Non-Sensitizer | Pass |
| Irritation or
Intracutaneo
us Activity | ISO 10993-10:2010
Biological evaluation of medical
devices - Part 10: Tests for
irritation and skin sensitization | Final Test Sample Score
$\le$ 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 | No temperature rise $\ge$
0.5° C | Pass | |
| Hemocompat
ibility | ISO 10993-4:2017 Biological
evaluation of medical devices
Part 4: Selection of tests for
interactions with blood | $\le$ 5% hemolysis | Pass | |
| | ASTM F756-17 Standard Practice
for Assessment of Hemolytic
Properties of Materials | | | |
| LAL
Endotoxin | USP 43-NF38 Medical
Devices - Bacterial Endotoxin | Below the Endotoxin
Limit 20 EU/device | Pass | |
| Extractable
and
Leachable
Analysis | ISO 10993-18:2020 Biological
evaluation of medical devices -
Part 18: Chemical
characterization of materials | N/A | Toxicolo-
gical Risk
Assessm-
ent | |
10
11
12
The 2 main components of BD PosiFlush™ SafeScrub are sterilized as follows:
-
- Pre-filled saline syringe with modified syringe tip cap is sterilized by moist heat
13
| Clinical Testing | Not applicable. |
|---|---|
| Conclusion | The BD PosiFlush™ SafeScrub is as safe and as effective and performs as well as or better than the legally marketed devices, 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe and SiteScrub IPA Device. |
| 2. DU is sterilized by gamma irradiation | |
| The subject device met all the predetermined acceptance criteria for the above listed performance tests. |