(211 days)
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.
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.
The provided text describes the acceptance criteria and the results of various tests conducted for the BD PosiFlush™ SafeScrub device (K213955). This device is a pre-filled saline syringe with an integrated disinfection unit.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance/Design Verification Tests | ||
| Container Closure Integrity | No dye within the syringe | Pass |
| Leakage Test | No leakage from the syringe | Pass |
| Torque Removal Test | Tip Cap can be twisted off as per BD validated force | Pass |
| Sterile Fluid Path | SAL: 10-6 | Pass |
| Axial Pull Force | DU cannot be pulled off per BD validated force | Pass |
| Torque | DU cannot be twisted off as per BD validated force | Pass |
| Particulate Ingress | USP <788> | Pass |
| Antimicrobial Efficacy | ≥ 4-log reduction | Pass |
| 70% IPA Concentration | 70±7% | Pass |
| Foam Rotation | Foam should not rotate >90 degrees within the DU housing during use | Pass |
| Foam Retention (before and during use) | Foam must be retained within the DU | Pass |
| Foam Retention (after use) | Foam must be retained within DU after scrubbing | Pass |
| Foam Durability | No ripped or ragged material and debris or particulate | Pass |
| Foam Compressibility and Wetness | Foam must be wet and compressible | Pass |
| 70% IPA Ingress | Maximum dose of 2 mg IPA/kg body mass/day per US EPA | Pass |
| Package integrity of DU | ||
| Bubble Leak | as per ASTM F2096 | Pass |
| Seal Width | ≥ 0.58 mm | Pass |
| Delamination | No delamination | Pass |
| Peel Force | USL: ≤ 12.9 N, LSL: ≥ 3.69 N | Pass |
| Microbial properties | as per ISO 11607-1:2019 | Pass |
| Biocompatibility | ||
| Cytotoxicity | Grade ≤ 2 (ISO 10993-5:2009) | Pass |
| Sensitization | Non-Sensitizer (ISO 10993-10:2010) | Pass |
| Irritation or Intracutaneous Activity | Final Test Sample Score ≤ 1 (ISO 10993-10:2010) | Pass |
| Acute Systemic Toxicity | No significantly greater biological reaction than the control (ISO 10993-11:2017) | Pass |
| Material Mediated Pyrogenicity | No temperature rise ≥ 0.5° C (ISO 10993-11:2017) | Pass |
| Hemocompatibility | ≤ 5% hemolysis (ISO 10993-4:2017, ASTM F756-17) | Pass |
| LAL Endotoxin | Below the Endotoxin Limit 20 EU/device (USP 43-NF38 <161>) | Pass |
| Extractable and Leachable Analysis | N/A (Result is a Toxicological Risk Assessment) | Toxicological Risk Assessment |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each test in the provided table. It mentions "BD validated force" for several tests, implying internal validation studies by the manufacturer. The document details that "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 data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but it implies a prospective testing approach as part of the device's development and regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The tests performed are primarily bench performance, engineering, chemical, and biological evaluations, not requiring human expert interpretation in the way, for example, a medical imaging AI product would. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ISO, ASTM, USP guidelines) rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, these are objective physical and chemical tests, not requiring human interpretation or adjudication panels. The "Pass" results are based on meeting predetermined quantitative or qualitative criteria from recognized standards.
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 device is a medical product (a pre-filled syringe with a disinfection unit), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As mentioned, this is not an AI algorithm. The performance of the device itself (standalone) is what was tested through the various bench performance tests, antimicrobial efficacy, and biocompatibility studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the various tests relies on:
- Established scientific and engineering principles: e.g., for container closure integrity, leakage, torque, pull force.
- Recognized industry standards and guidelines: ISO 10993 series for biocompatibility, ASTM F2096 for package integrity, USP <788> for particulate ingress, USP 43-NF38 <161> for LAL Endotoxin.
- Predetermined chemical concentrations: 70±7% for IPA concentration.
- Microbiological reduction targets: ≥ 4-log reduction for antimicrobial efficacy, based on established efficacy standards for disinfectants.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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
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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
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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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BD PosiFlush™ SafeScrub - K213955
510(k) Summary (21 CFR §807.92)
| SubmitterInformation | Submitter Name:Submitter Address:Contact Person:Email Address:Phone Number:Fax Number:510(k) Number:Date of Preparation: | Becton, Dickinson and Company1 Becton DriveFranklin LakesNJ 07417Samhitha MohanStaff Regulatory Affairs SpecialistSamhitha.Mohan@bd.com(214) 971-0979(201) 847-5307K213955July 15, 2022 |
|---|---|---|
| Subject Device | Trade Name:Common Name:Regulation Number:Device Class:Classification Name:Classification ProductCode:Classification Panel: | BD PosiFlush™ SafeScrubPre-filled Saline Syringe with Disinfection Unit21 CFR 880.5200Class IISaline, Vascular Access FlushQTIGeneral Hospital |
| PrimaryPredicate Device | Trade Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SPSyringe |
| 510(k) Number:Classification Name:Regulation Number:Regulatory Class:Product Code:Classification Panel: | K161552Saline, Vascular Access Flush21 CFR 880.5200Class IINGTGeneral Hospital | |
| Predicate Device | Trade Name:510(k) Number:Classification Name:Regulation Number:Regulatory Class:Product Code:Classification Panel: | SiteScrub IPA DeviceK112791Pad, Alcohol, Device DisinfectantUnclassifiedUnclassifiedLKBGeneral Hospital |
| DeviceDescription | BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integratedDisinfection 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 hashigh density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in lowdensity polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilizedby moist heat and the DU is sterilized by gamma irradiation. The subject device isavailable only in 10mL syringe configuration. | |
| Indications forUse | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flushsyringe with an integrated disinfection unit is intended to be used as a disinfection cleanerfor needleless access devices attached to indwelling vascular access devices (VADs) andflushing of these VADs. | |
| TechnologicalCharacteristic-s | The following table provides a comparison between the subject and predicate devices – |
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| Attribute | Subject Device(BD PosiFlush™SafeScrub) | Primary PredicateDevice (0.9% SodiumChloride Injection, USPBD PosiFlush™ SPSyringe) – K161552 | Predicate Device(SiteScrub IPADevice) –K112791 | Comparison |
|---|---|---|---|---|
| IntendedUse/Indications forUse | The 0.9% SodiumChloride Injection,USP, BD PosiFlush™SafeScrub prefilledflush syringe with anintegrated disinfectionunit is intended to beused as a disinfectioncleaner for needlelessaccess devicesattached to indwellingvascular accessdevices (VADs) andflushing of theseVADs. | The 0.9% Sodium ChlorideInjection, USP, BDPosiFlush™ SP Syringe isintended to be used onlyfor the flushing ofindwelling vascular accessdevices. Catalog Number306547 10 mL BDPosiFlush™ SP Syringesare generally compatiblefor use with syringepumps. | The Site-Scrub IPADevice is intendedfor use oninjection ports andfemale Luer hubsas a disinfectingcleaner. | The intended use ofthe subject device iscreated by combiningthe intended use ofboth the predicates.The subject device'sintended use does notinclude pumpcompatible statementsince PosiFlush™SafeScrub is notintended to be usedwith pumps.Additionally, subjectdevice's intended userefers to injectionports and female Luerhubs as needlelessaccess devices. |
| OperatingPrinciple | Same as predicates | The pre-filled USP 0.9%saline syringe flushesindwelling vascular accessdevices | 70% IPA solutioni.e., antimicrobialagent and activemechanical frictionfrom the foam aidsin disinfection | Identical |
| Disinfectio-n Time | Same as predicate | N/A | Twist back andforth for at least 8repetitions, for aminimum of 10seconds | Identical |
| Targetmicroorganismsfor in vitroantimicrob-ialefficacy | • Staphylococcusaureus• Staphylococcusepidermidis• Escherichia coli• Pseudomonasaeruginosa• Candida albicans• Candida glabrata• Acinetobacterbaumannii | N/A | • Staphylococcusaureus• Staphylococcusepidermidis• Escherichia coli• Pseudomonasaeruginosa• Candida albicans• Candidaparapsilosis | Identical exceptfor Acinetobacterbaumannii, Candidaglabrata and Candidaparapsilosis. Invitro antimicrobialefficacy testingwas performed forall themicroorganisms |
| SyringeConfigura-tion | 10mL only | 3mL, 5mL and 10mL | N/A | Subject device doesnot include 3 and 5mLsyringe configurations |
| DeviceCompone-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% IPAsolution | All the components areidentical in design withthe exception of tipcap and housing. Thedistal end of tip capand DU housing aremodified to snap fitwith each other toform PosiFlush™SafeScrub |
| BarrelMaterial | Same as predicate | Polypropylene | N/A | Identical |
| PlungerRodMaterial | Same as predicate | Polypropylene | N/A | Identical |
| StopperMaterial | Same as predicate | Styrenebutadiene rubber | N/A | Identical |
| StopperLubricantMaterial | Same as predicate | Silicone | N/A | Identical |
| Tip CapMaterial | Same as predicate | Polypropylene w/White Colorant | N/A | Identical |
| DUHousingMaterial | Same as predicatew/white colorant | N/A | High DensityPolyethylene(HDPE) w/bluecolorant | HDPE material in DU isidentical to SiteScrub'shousing material. Thesubject device's DUhas white colorant tomatch with the color ofthe tip cap. Colorantdifferences areassessed as perISO 10993-1 |
| FoamMaterial | Same as predicate | N/A | Low DensityPolyethylene(LDPE) | Identical |
| FoamBaseColorant | Same as predicate | N/A | Copperphthalocyanineblue | Identical |
| PackagingConfiguration | Same as predicates | • Flow wrap• Shelf Carton• Case Carton | Top Foil | Identical with theexception of top foilmaterial. Appropriatepackaging tests areperformed to ensuretop foil maintainssterile barrier to theDU |
| Sterilizatio-n Mode | Same as predicates | Moist heat | Gamma | Identical |
| SAL | Same as predicates | 10-6 (Sterile Fluid Path) | 10-6 (Sterile FluidPath) | Identical |
| Shelf Life | 0.5 years | 3 years | 9 months | Subject device shelflife has been assessedby appropriate benchperformance testing |
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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).
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-
- 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 | ||||
| ContainerClosureIntegrity | Evaluate sterile barrier systemfor the syringe | No dye within thesyringe | Pass | |
| Leakage Test | Evaluate sterile barrier systemfor the syringe | No leakage from thesyringe | Pass | |
| TorqueRemovalTest | Evaluate tip cap removal | Tip Cap can be twistedoff as per BD validatedforce | Pass | |
| Sterile FluidPath | Evaluate the syringe's fluid pathsterility | SAL: 10-6 | Pass | |
| Axial PullForce | Evaluate the potential separation | DU cannot be pulled offper BD validated force | Pass | |
| Torque | of Tip Cap from Disinfecting Unit(DU) | DU cannot be twisted offas per BD validatedforce | Pass | |
| ParticulateIngress | Evaluate per USP <788> | USP <788> | Pass | |
| AntimicrobialEfficacy | Evaluate disinfection efficacy ofthe DU | ≥ 4-log reduction | Pass | |
| 70% IPAConcentrat-ion | Evaluate IPA concentration overshelf life for the DU | 70±7% | Pass | |
| FoamRotation | Evaluate foam rotation duringuse | Foam should not rotate>90 degrees within theDU housing during use | Pass | |
| Foam | Evaluate foam retention beforeand during use | Foam must be retainedwithin the DU | Pass | |
| Retention | Evaluate foam retention after use | Foam must be retainedwithin DU afterscrubbing | Pass | |
| FoamDurability | Evaluate foam for evidence ofripped or ragged material anddebris or particulate | No ripped or raggedmaterial and debris orparticulate | Pass | |
| FoamCompressibili | Evaluate foam for wetness andcompressibility | Foam must be wet andcompressible | Pass | |
| ty andWetness | ||||
| 70% IPAIngress | Evaluate IPA ingress that mayenter the patient IV line | Maximum dose of 2 mgIPA/kg body mass/dayper US EPA | Pass | |
| Packageintegrity ofDU | Evaluate sterile barrier system ofthe DU | Bubble Leak as perASTM F2096 | Pass | |
| Seal Width $\geq$ 0.58 mm | Pass | |||
| No delamination | Pass | |||
| Peel Force shall bewithin:USL: $\leq$ 12.9 NLSL: $\geq$ 3.69 N | Pass | |||
| Microbial properties asper ISO 11607-1:2019 | Pass | |||
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5:2009Biological evaluation of medicaldevices - Part 5: Tests for in vitrocytotoxicity | Grade $\leq$ 2 | Pass | |
| Sensitization | ISO 10993-10:2010Biological evaluation of medicaldevices - Part 10: Tests forirritation and skin sensitization | Non-Sensitizer | Pass | |
| Irritation orIntracutaneous Activity | ISO 10993-10:2010Biological evaluation of medicaldevices - Part 10: Tests forirritation and skin sensitization | Final Test Sample Score$\le$ 1 | Pass | |
| AcuteSystemicToxicity | ISO 10993-11:2017Biological evaluation of medicaldevices — Part 11: Tests forsystemic toxicity | No significantly greaterbiological reaction thanthe control | Pass | |
| MaterialMediatedPyrogenicity | ISO 10993-11:2017Biological evaluation of medicaldevices - Part 11: Tests forsystemic toxicity | No temperature rise $\ge$0.5° C | Pass | |
| Hemocompatibility | ISO 10993-4:2017 Biologicalevaluation of medical devicesPart 4: Selection of tests forinteractions with blood | $\le$ 5% hemolysis | Pass | |
| ASTM F756-17 Standard Practicefor Assessment of HemolyticProperties of Materials | ||||
| LALEndotoxin | USP 43-NF38 <161> MedicalDevices - Bacterial Endotoxin | Below the EndotoxinLimit 20 EU/device | Pass | |
| ExtractableandLeachableAnalysis | ISO 10993-18:2020 Biologicalevaluation of medical devices -Part 18: Chemicalcharacterization of materials | N/A | Toxicolo-gical RiskAssessm-ent |
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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
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| 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 irradiationThe subject device met all the predetermined acceptance criteria for the above listed performance tests. |
§ 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).