(88 days)
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.
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.
This document pertains to the 510(k) premarket notification for the "0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe," a medical device, not an AI/ML-driven device or an imaging system. Therefore, the questions regarding AI/ML performance metrics, expert consensus for ground truth, MRMC studies, or training/test set details are not applicable to this submission.
This submission focuses on demonstrating substantial equivalence to a predicate device (K153481) through bench performance testing, packaging integrity, and biocompatibility tests. The "acceptance criteria" here refer to the specifications for these non-clinical tests, rather than diagnostic performance metrics of an AI model.
Here's the information extracted that aligns with the request, re-interpreting "acceptance criteria" and "study" in the context of this device's submission:
1. Table of Acceptance Criteria and Reported Device Performance
| 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 leakage | 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 | Force to move plunger rod/stopper is less than the BD validated force | 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 | Force to move plunger rod/stopper is less than the BD validated force | 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 <697>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 <791> pH | Pass |
| Iron | Measure the amount of iron in saline solution | 0.9% NaCl Injection USP Monograph and USP43-NF38 <241> Iron | Pass |
| Heavy Metals | Measure the heavy metals such as Cadmium, Arsenic, Cobalt, Vanadium, Copper, Lead, Nickel, Lithium, Antimony and Mercury in saline solution | USP43-NF38 <232> Elemental Impurities - Limits | Pass |
| NaCl solution weight loss | Measure the weight loss of saline solution in pre-filled saline syringes | USP43-NF38 <671> Containers Performance Testing | Pass |
| UV Analysis | Measure the UV absorbance between 220-360 nm for pre-filled saline syringes | < 0.4 AU | Pass |
| Bacterial Endotoxin | Determine the amount of endotoxin in saline pre-filled syringes | 0.9% NaCl Injection USP Monograph and USP43-NF38 <85> 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 | Sterile; No growth | Pass |
| Particulate Matter | Measure the number of particulates in saline pre-filled syringes | USP43-NF38 <788> 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 Tests | 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 | Pass | ||
| 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 Tests | |||
| 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 <151> Pyrogen Test (USP Rabbit Test) | No temperature rise ≥ 0.5° C | 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 | ≤ 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 <161> Medical Devices – Bacterial Endotoxin / USP43-NF38 <85> Bacterial Endotoxins Test / ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | Below the Endotoxin Limit 0.5 EU/device | Pass |
| 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 | Under the condition of the chemical characterization testing, there were no extractables and leachables identified that indicated significant risk concerns. | Note 1 |
Note 1: Result is a qualitative statement, not a numerical pass/fail against a specific threshold listed in the table.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify numerical sample sizes for each of the performance, packaging, or biocompatibility tests. It only states that "appropriate performance tests and biocompatibility tests were performed" and the gamma sterilized test samples were evaluated. The data provenance (country of origin, retrospective/prospective) is also not specified, as these are bench and lab-based tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This submission is for a physical medical device, not an AI/ML imaging device. Ground truth, in this context, refers to the established standards, monograph requirements (e.g., USP, ISO), and validated internal specifications to which the device performance is measured against. Experts here would be the laboratory personnel and engineers performing the tests and
interpreting results against these defined criteria, but their specific number or detailed qualifications are not provided in the summary.
4. Adjudication Method for the Test Set:
Not applicable. Since this is not an AI/ML diagnostic device, there is no "adjudication" of expert opinions on image interpretation. The tests performed are laboratory or bench-based, with results measured against predetermined quantitative or qualitative acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device, and no MRMC study was performed. The device's safety and effectiveness are demonstrated through non-clinical performance, packaging, and biocompatibility testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (saline syringe), not an algorithm or software. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used:
The "ground truth" for this device's evaluation is primarily based on:
- Established Standards: e.g., ISO 10993 series for biocompatibility, ASTM F2096-11 for vacuum bubble leak, ANSI AAMI ST72:2019 for Bacterial Endotoxins.
- Pharmacopoeia Monographs: e.g., USP43-NF38 for NaCl Injection, pH, Iron, Heavy Metals, Particulate Matter, Bacterial Endotoxin.
- Validated Internal Specifications: "BD validated force" or "BD validated internal value" for mechanical/physical properties like tip cap removal torque, reflux, breakout force, sustaining force, retaining ring force, and seal strength.
- Qualitative Observations: e.g., "No evidence of Tip Cap leakage," "No leakage of solution past the stopper ribs," "Solution and components are clear," "No defects in packaging seals when visually inspected."
Essentially, the ground truth is defined by recognized industry standards, pharmacopoeial requirements, and the manufacturer's own validated specifications for product performance and safety.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for an AI/ML model, this question does not apply.
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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
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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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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 | |
|---|---|---|
| SubmitterInformation | Submitter Address: | 1 Becton DrFranklin LakesNJ 07417 |
| Contact Person: | Samhitha MohanSr. Staff Regulatory AffairsSpecialist | |
| 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 SalineFlush Syringe | |
| Subject Device | Common Name: | 0.9% Sodium Chloride InjectionFlush 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)
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| 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 – |
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| Attribute | Subject Device(0.9% SodiumChloride Injection,USP BD PosiFlush™SF Saline FlushSyringe) | Predicate Device(0.9% SodiumChloride Injection,USP BD PosiFlush™SF Syringe) -K153481 | Compar-ison |
|---|---|---|---|
| IntendedUse/Indicationsfor Use | The 0.9% SodiumChloride Injection,USP, BD PosiFlush™ SFSaline Flush Syringesare intended to beused only for theflushing of indwellingvascular accessdevices. | The 0.9% SodiumChloride Injection, USP,BD PosiFlush™ SFSyringes are intended tobe used only for theflushing of indwellingvascular access devices. | Similar;"SalineFlush" isadded to thename of thesubjectdevice |
| OperatingPrinciple | The tip cap is twistedoff from the barrel andplunger rod isdepressed to drive theflow of 0.9% sodiumchloride USP solutionthrough the indwellingvascular accessdevices. The salinesolution 'cleans out' ordisplaces any otherfluid and maintainspatency of the line. | The tip cap is twisted offfrom the barrel andplunger rod is depressedto drive the flow of0.9% sodium chlorideUSP solution throughthe indwelling vascularaccess devices. Thesaline solution 'cleansout' or displaces anyother fluid andmaintains patency of theline. | Identical |
| SyringeConfiguration | 10mL | 10mL | Identical |
| SingleUse? | Yes | Yes | Identical |
| Sterile? | Yes | Yes | Identical |
| Use inSterileField? | Yes | Yes | Identical |
| Content ofsyringepackage | One pre-filled syringeper pack | One pre-filled syringeper pack | Identical |
| DeviceComponents | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Barrel 0.9% NaCl USP solution Plunger Rod Tip Cap Stopper | Identical |
| BarrelMaterial | Polypropylene-PolyethyleneRandom Copolymer | PolypropyleneHomopolymer | Similar;Subject devicematerial isassessed as perISO 10993-1 |
| Barrel Lubricant | Silicone | Silicone | Identical |
| Plunger RodMaterial | Polypropylene | Polypropylene | Identical |
| StopperMaterial | Styrene-ButadieneRubber | Styrene-ButadieneRubber | Identical |
| Stopper Lubricant | Silicone | Silicone | Identical |
| Tip CapMaterial | Polypropylene-PolyethyleneRandom Copolymer | PolypropyleneHomopolymer | Similar;Subject devicematerial isassessed as perISO 10993-1 |
| Tip CapColorant | White | White | Identical |
| PackagingConfiguration | Blister pack Shelf Carton Case Carton | Blister pack Shelf Carton Case Carton | Identical |
| PrimaryPackagingMaterial | Film on film | Paper on film | Different;Appropriatepackaging testsare performedto ensuresterile barrierintegrity ismaintained |
| Mode ofSterilization | Gamma | Autoclave | Different |
| SAL | 10-6 | 10-6 | Identical |
| Shelf Life | 1 year | 3 years | Different;Subject deviceshelf life hasbeen assessedby appropriatebenchperformancetesting |
| Tip Cap RemovalTorque | Measure the torquerequired to removethe tip cap from thesyringe | Measure thetorque requiredto remove the tipcap from thesyringe | Same asPredicate |
| Tip Cap Leakage | Measure theresistance to leakagein between the Luerand the tip cap forpre-filled syringes | Measure theresistance toleakage inbetween the Luerand the tip capfor pre-filledsyringes | Same asPredicate |
| Breakloose Force | Measure the initialmaximum forcerequired to movethe plungerrod/stopper in thesyringe barrel | Measure the initialmaximum forcerequired to move theplunger rod/stopper inthe syringe barrel | Same asPredicate |
| Breakout Force | Measure themaximum forcerequired to move theplunger rod/stopperin the syringe barrela short time afterinitiallymoving theplungerrod/stopper | Measure themaximum forcerequired to movethe plungerrod/stopper inthe syringe barrela short time afterinitially movingthe plungerrod/stopper | Same asPredicate |
| Sustaining Force | Measure the averageforce required tomove the plungerrod/stopper in thesyringe barrel | Measure theaverage forcerequired to movethe plungerrod/stopper inthe syringe barrel | Same asPredicate |
| Reflux | Measure thepotential bloodreflux into thecatheter fromPosiFlush™ SFsyringe | Measure thepotential bloodreflux into thecatheter fromPosiFlush™ SFsyringe | Same asPredicate |
| Retaining RingForce | Measure the forcenecessary to removethe plunger rod /stopper assemblyfromthe syringe barrelafter assembly | Measure the forcenecessary to removethe plunger rod /stopper assembly fromthe syringe barrel afterassembly | Same asPredicate |
| Leakage pastStopper | Measure theresistance to leakagein betweenthe barrel andstopper for pre-filledsyringes | Measure theresistance to leakagein between the barreland stopper for pre-filled syringes | Same asPredicate |
| Expelled Volume | Measure the volumeof saline solution | Measure the volumeof saline solutionexpelled from thesyringe | Same asPredicate |
| Sterility | To verify 10-6Sterility AssuranceLevel (SAL) on allsurface (fluid pathand external surface)of syringe, fluid pathand insidesurface of primarypackaging | To verify 10-6Sterility AssuranceLevel (SAL) on allsurface (fluid pathand externalsurface) of syringe,fluid path and insidesurface of primarypackaging | Same asPredicate |
| NaCl SolutionStability | Following tests tocomply with 0.9%NaCI Injection USPMonograph – NaClAssay, pH,Endotoxin,Particulate Matter,Iron, Heavy metals,UV/Vis | Following tests tocomply with 0.9%NaCl Injection USPMonograph – NaClAssay, pH,Endotoxin,Particulate Matter,Iron, Heavy metals,UV/Vis | Same asPredicate |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same asPredicate |
| Sensitization | Non-Sensitizer | Non-Sensitizer | Same asPredicate |
| Irritation orIntracutaneousActivity | Non-irritant | Non-irritant | Same asPredicate |
| Acute SystemicToxicity | No acute systemictoxicity | No acute systemictoxicity | Same asPredicate |
| Material MediatedPyrogenicity | Not a materialmediated-pyrogen | Not a materialmediated-pyrogen | Same asPredicate |
| Hemocompatibility | Non-hemolytic | Non-hemolytic | Same asPredicate |
| Genotoxicity | Non-genotoxic | Non-genotoxic | Same asPredicate |
| LAL Endotoxin | Below the EndotoxinLimit 0.5 EU/device | Below the EndotoxinLimit 0.5 EU/device | Same asPredicate |
| Extractable andLeachableAnalysis | Extractable andleachable substancesshowedtoxicologicallyacceptable levels. | Extractable andleachable substancesshowedtoxicologicallyacceptable levels. | Under thecondition of thechemicalcharacterizationtesting, therewere noextractablesand leachablesidentified thatindicatedsignificant riskconcerns |
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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:
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| Test | Purpose | AcceptanceCriteria | Result | |
|---|---|---|---|---|
| Performance/Design Verification Tests | ||||
| Tip CapRemovalTorque | Measure the torque required toremove the tip cap from thesyringe | Tip Cap can betwisted off as perBD validated force | Pass | |
| Reflux | Measure the potential blood refluxinto the catheter from PosiFlush™SF syringe | Reflux greater thanBD validatedinternal value | Pass | |
| Tip CapLeakage | Evaluate the resistance to leakagebetween the barrel Luer and thetip cap for pre-filled syringes | No evidence of TipCap leakge | Pass | |
| Leakage pastStopper | Evaluate the resistance to leakagebetween the barrel and stopperribs | No leakage ofsolution past thestopper ribs | Pass | |
| Breaklooseforce | Measure the initial maximumforce required to move theplunger rod/stopper in the syringebarrel | Pass | ||
| BreakoutForce | Measure the maximum forcerequired to move the plungerrod/stopper in the syringe barrel ashort time after initially movingthe plunger rod/stopper | Force to moveplunger rod/stopperis less than the BDvalidated force | Pass | |
| SustainingForce | Measure the average forcerequired to move the plungerrod/stopper in the syringe barrel | Pass | ||
| RetainingRing Force | Measure the force necessary toremove the plunger rod/stopperassembly from the syringe barrelafter assembly | Force to moveplunger rod/stopperis greater than theBD validated force | Pass | |
| ExpelledVolume | Measure the volume of salinesolution expelled from the syringe | USP43-NF38<697>ContainerContent forInjections | Pass | |
| NaCl Assay | Measure the NaCl concentrationsaline solution in syringe samples | 0.9% NaCl InjectionUSP Monograph | Pass | |
| pH | Measure the pH of saline solutionin syringe samples | 0.9% NaCl InjectionUSP Monograph andUSP43-NF38 <791>pH | Pass | |
| Iron | Measure the amount of iron insaline solution | 0.9% NaCl InjectionUSP Monograph and | Pass | |
| USP43-NF38 <241>Iron | ||||
| HeavyMetals | Measure the heavy metals such asCadmium, Arsenic, Cobalt,Vanadium, Copper, Lead, Nickel,Lithium, Antimony and Mercury insaline solution | USP43-NF38 <232>Elemental Impurities- Limits | Pass | |
| NaCl solutionweight loss | Measure the weight loss of salinesolution in pre-filled salinesyringes | USP43-NF38 <671>ContainersPerformance Testing | Pass | |
| UV Analysis | Measure the UV absorbancebetween 220-360 nm for pre-filledsaline syringes | < 0.4 AU | Pass | |
| BacterialEndotoxin | Determine the amount ofendotoxin in saline pre-filledsyringes | 0.9% NaCl InjectionUSP Monograph andUSP43-NF38 <85>Bacterial EndotoxinsTest | Pass | |
| Sterility | To verify 10-6 SAL in the fluidpath. | Sterile; No growth | Pass | |
| SurfaceSterility | To verify 10-6 SAL on all surface ofsyringe and inside surface ofprimary packaging | in media | Pass | |
| ParticulateMatter | Measure the number ofparticulates in saline pre-filledsyringes | USP43-NF38 <788>Particular Matter inInjections | Pass | |
| Appearanceand SolutionClarity/BarrelTransparency | Examine the appearance, solutionclarity and barrel transparency inpre-filled saline syringes | Solution andcomponents areclear | Pass | |
| PrimaryPackageIntegrity | Evaluates the sterile barriersystem of the pre-filled syringethroughout shelf life | No leaks whentested by VacuumBubble Leak (ASTMF2096-11) | Pass | |
| Non-porousSeal strength andwidth value as perBD validated forceand widthmeasurementsrespectively | Pass | |||
| No defects inpackaging sealswhen visuallyinspected | Pass | |||
| Clean peel of blisterpack with no foreignmatter | Pass | |||
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5:2009Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity | Grade ≤ 2 | Pass | |
| Sensitization | ISO 10993-10:2021Biological Evaluation of MedicalDevices - Part 10: Tests for SkinSensitization | Non-Sensitizer | Pass | |
| Irritation | ISO 10993-23:2021Biological Evaluation of MedicalDevices - Part 23: Tests forIrritation | Final Test SampleScore ≤ 1 | Pass | |
| AcuteSystemicToxicity | ISO 10993-11:2017Biological evaluation of medicaldevices — Part 11: Tests forsystemic toxicity | No significantlygreater biologicalreaction than thecontrol | Pass | |
| MaterialMediatedPyrogenicity | ISO 10993-11:2017Biological evaluation of medicaldevices — Part 11: Tests forsystemic toxicityUSP43-NF38 <151>Pyrogen Test(USP Rabbit Test) | No temperature rise≥ 0.5° C | Pass | |
| Hemocompat-ibility | ISO 10993-4:2017 Biologicalevaluation of medical devices Part4: Selection of tests forinteractions with bloodASTM F756-17 Standard Practicefor Assessment of HemolyticProperties of Materials | ≤ 5% hemolysis | Pass | |
| Genotoxicity | ISO 10993-3: 2014 Biologicalevaluation of medical devices –Part 3: Tests for genotoxicity,carcinogenicity and reproductivetoxicity | Non-mutagenic | Pass | |
| LALEndotoxin | USP 43-NF38 <161> MedicalDevices – Bacterial Endotoxin | Below the EndotoxinLimit 0.5 EU/device | Pass | |
| USP43-NF38 <85> BacterialEndotoxins TestANSI AAMI ST72:2019 Bacterialendotoxins - Test methods,routine monitoring, andalternatives to batch testing | ||||
| ExtractableandLeachableAnalysis | ISO 10993-18: 2020 Biologicalevaluation of medical devices -Part 18: Chemical characterizationof materialsISO 10993-17: 2002 Biologicalevaluation of medical devices -Part 17: Establishment ofallowable limits for leachablesubstances | N/A | SeeNote1below |
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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 thatthe BD PosiFlush™ SF is as safe, as effective, and performs as wellas or better than the legally marketed predicate device clearedunder K153481. |
§ 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).