(214 days)
The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
The PuraCath Firefly Needleless Connector, Model 9001, is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.
Here's a summary of the acceptance criteria and the study details for the Firefly Needleless Connector, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro Cytotoxicity | Pass - No reactivity |
| Intracutaneous reactivity / Irritation | ISO 10993-10: 2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass - Non-irritant |
| Sensitization | ISO 10993-10: 2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass - Non-sensitizing |
| Acute Systemic Toxicity | ISO 10993-11: 2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity | Pass – Did not cause acute systemic toxicity |
| Hemolysis | ASTM F 756 – 17: Standard Practice for Assessment of Hemolytic Properties of Materials | Pass - Non-hemolytic |
| Pyrogenicity | USP Pyrogen Test Procedure, Section <151> (USP40) | Pass - Non-pyrogenic |
| Particulate Matter | USP <788> Particulate Matter in Injections | Pass |
| Sterility | ISO 11135:2014, Ethylene oxide — Requirements for development, v ISO 10993-7:2008 & ISO 10993-7:2008, Biological evaluation of medical devices — Part 7 - Ethylene oxide sterilization residuals validation and routine control | Pass |
| 6 Month Shelf Life | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices & ISO 11607-1 Second Edition 2019-02: Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems, and packaging systems | Pass |
| MR Compatibility | FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment: 2014 | Pass |
| Microbial ingress (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Fluid displacement (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flow rate at gravity (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Power infusion flow (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flush volume (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Priming volume (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Size and weight (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve actuation force (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve recovery (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve cycle test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve back pressure test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve pressure test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Tensile strength (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flexural strength (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Particulate contamination (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Leakage (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Tensile strength (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Male Conical fitting (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Reducing matter (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Metal ions (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Titration acidity or alkalinity (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Residue on evaporation (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| UV absorption (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Dimensional requirements (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Positive pressure liquid leakage (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Sub-atmospheric pressure air leakage (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Stress cracking (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to separation from axial load (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to separation from unscrewing (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to overriding (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
Study Proving Device Meets Acceptance Criteria:
The document describes non-clinical bench testing as the study conducted to determine if the device is substantially equivalent to the predicate device. These tests covered biocompatibility testing and performance testing based on various international standards and FDA guidance documents.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (N-numbers) for each individual test conducted. It only states that "The following non-clinical data were provided in support of the substantial equivalence determination." and lists various test categories.
Regarding data provenance, the tests are non-clinical (bench testing), so there is no patient data involved from specific countries or retrospective/prospective collection. The provenance here refers to the standards and guidance followed (e.g., ISO, ASTM, USP, FDA Guidance).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) as the tests are non-clinical bench tests (e.g., material compatibility, mechanical performance) and do not involve human interpretation or clinical ground truth established by experts in the typical sense of a diagnostic device. The "ground truth" for these tests are the defined pass/fail criteria outlined in the referenced standards.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth for diagnostic decisions. In this case, the test results are objective measurements against predefined 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
There is no indication that an MRMC comparative effectiveness study was done. This device is a passive medical device (a needleless connector), not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable (N/A). The device is a physical medical device, not an algorithm, so standalone algorithm performance is not a relevant concept here.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by objective measurements and observations performed according to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. The acceptance criteria for each test are defined by these standards, and the device's performance is compared against these predetermined thresholds. For biocompatibility, this involves evaluating biological responses to materials. For performance, it involves mechanical, fluid dynamic, and durability assessments.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context. The "design" and "testing" of the device are based on engineering principles and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A), as it's not an AI/machine learning device requiring a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 30, 2021
PuraCath Medical, Inc Julia Rasooly CEO 37600 Central Court, Suite 210 Newark, California 94560
Re: K203796
Trade/Device Name: Firefly Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 26, 2021 Received: July 28, 2021
Dear Julia Rasooly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203796
Device Name Firefly Needleless Connector
Indications for Use (Describe)
The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the V line and/or IV catheter during IV therapy and can be used for direction, intermittent infusion, continuous infusion or aspiration.
| 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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ડ. 510(k) Summary K203796
| 5.1. | General Company Information | |
|---|---|---|
| Company Name: | PuraCath Medical, Inc. | |
| Company Address: | 37600 Central Court, Suite 210Newark, CA 94560USA | |
| Company Telephone: | 415.305.4134 | |
| Official Contact: | Julia Rasooly | |
| Telephone: | 415.305.4134 | |
| email: | julia@puracath.com | |
| Date Prepared: | July 26, 2021 | |
| 5.2. | Device Information | |
| Common Name: | IV Administration Set,Needleless Connector, Closed Access | |
| Trade Name: | Firefly Needleless Connector | |
| Classification: | Class II, 21 CFR 880.5440Product Code: FPA | |
| Predicate Device: | CareFusion, MaxZero Needleless Connector,MZ1000 (K132413) |
5.3. Device Description
5.3.1. Subject Device Overview
The PuraCath Firefly Needleless Connector, Model 9001, is listed in Table 1
| Table 1 Model Numbers for System Components | |
|---|---|
| Model Number | Model Name |
| 9001 | Firefly Needleless Connector |
5.4. PuraCath Firefly Needleless Connector
The PuraCath Firefly Needleless Connector is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or
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technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.
5.5. Indications For Use:
The PuraCath FireflyTM Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
5.6. Technological Comparison
Table 5.6.1 provides the key technological characteristics of the Firefly Needleless Connector compared to the Predicate Device (CareFusion, MaxZero Needleless Connector).
| Characteristic | Subject Device | Predicate Device | Same orDifferent | |
|---|---|---|---|---|
| Device name | Firefly NeedlelessConnector | MaxZero (MZ1000)Needleless Connector(K132413) | N/A | |
| CommonName | IV Administration Set | IV Administration Set | Same | |
| Classification | Class II,IV Administration Set,Needle Connector, ClosedAccess | Class II,IV Administration Set,Needleless Connector,Closed Access | Same | |
| Indications foruse | The PuraCath™ Firefly™Needleless Connector is asterile single patient useconnector for needlelessaccess to the IV lineand/or IV catheter duringIV therapy and can beused for direct injection,intermittent infusion,continuous infusion oraspiration. | The MZ1000 Is asterile single patientuse connector forneedleless access to theIV line and/or IVcatheter during IVtherapy. The MZ1000can be used for directInjection, Intermittentinfusion, continuousinfusion or aspiration | Same | |
| GeneralSystemDesign(Mechanismof Action) | External FlowNormally ClosedElastomeric Valve, LuerActivated | External FlowNormally ClosedElastomeric Valve,Luer Activated | Same | |
| Characteristic | Subject Device | Predicate Device | Same orDifferent | |
| ProximalConfiguration | Female Luer Lock withLuer Actuated Valve | Female Luer Lock withLuer Actuated Valve | Same | |
| DistalConfiguration | Male Luer Lock | Male Luer Lock | Same | |
| PrimingVolume | 0.16 ml | 0.16 ml | Same | |
| Hemolysis | Non-hemolytic | Non-hemolytic | Same | |
| ConnectorGravity Flowrate | Flow rate at gravity with1 m head height ≥67ml/minute | Flow rate at gravitywith 1 m head height ≥100ml/minute | Different | |
| ConnectorFluidDisplacement | <9 µL | 16 µL | Different | |
| Flush Volume | 5 ml | 5 ml | ||
| Power InfusionFlow Rate | 10ml/sec @325 PSI | 10ml/sec @325 PSI | Same | |
| Use | Single patient | Single patient | Same | |
| Duration ofUse | 7 days | 7 days | Same | |
| Number ofActivations | 200 | 200 | Same | |
| Method ofDisinfection | 70% IPA | 70% IPA | Same | |
| ElectronicChip | Yes | No | Different | |
| SterilizationMethod | Ethylene Oxide | Gamma Irradiation | Different | |
| Sterile BarrierPackaging | Tyvek polyethylene; heat-sealed | Tyvek polyethylene;heat-sealed | Same | |
| PackagedQuantity | Single Unit per Package | Single Unit perPackage | Same |
Table 5.6.1 Technology Characteristics
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Technological Characteristics and Substantial Equivalence
The indications for use of the Firefly Needless Connector are identical to the predicate MaxZero (MZ1000) Needleless Connector (K132413) in that they are both indicated as sterile single patient use connectors for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.
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The Firefly Needless Connector is identical to the predicate device with respect to material composition and device characteristics. The Firefly Needless Connector device and the predicate device are the identical in general system design and configuration in that they are both External Flow with a male luer lock and a female Luer Lock with Luer Actuated Valve Normally Closed Elastomeric Valve, Luer Activated same device and identical in materials and design. Both devices are very similar in technological characteristics however there are minor differences in the Firefly Needleless Connector compared to the previously cleared MaxZero MZ 1000 Needleless Connector predicate device that were highlighted in "Table 11.5.1 - Subject Device to Predicate Comparison Table".
- . The gravity flow rate of the two connectors is different. The MaxZero has a flow rate of 100ml/min whereas the Firefly Needleless connector has a flow rate of 67 ml/min. The flow rate through a 20G catheter is 60 ml/min and, according to authoritative references, is used for most infusions, rapid fluid replacement, and routine blood transfusion. Other commercially available needleless connectors have flow rates from 24 ml/min to 533 ml/min'.
- . Both the Firefly Needless Connector and the predicate MaxZero (MZ1000) Needleless connectors incorporate the same mechanism of action where the valve opens when a male luer is connected and closes when the luer is removed. Both are external flow. However, one minor difference is the connector fluid displacement for the predicate MaxZero device is slightly greater (16 µL) than for the subject, Firefly (<9 µL) connector.
- The Firefly Connector is ethylene oxide gas sterilized compared to the predicate ● MaxZero (MZ1000) Needleless connector device which is sterilized by radiation. Both methods of sterilization are widely used in the medical device industry and utilize FDA recognized standards for sterilization validation. Both devices were functionally evaluated after all manufacturing processes including exposure to sterilization conditions which demonstrates no issues of safety or effectiveness.
- The device contains an electronic chip in its design for future functionalities that are not yet approved. The performance data demonstrate the chip does not impact the safety and effectiveness of the current device.
These minor differences in technological characteristics between the Firefly Needleless Connector and the predicate MaxZero (MZ1000) Needleless connector device do not raise new issues of safety or effectiveness. The Firefly Needleless Connector has been evaluated in bench, laboratory, and clinician use tests with results that are equivalent in terms of functional and dimensional performance.
1http://hadawayassociates.com/uploads/3/5/4/4/35447364/needleless_connectors_for_iv_catheter s 23.pdf
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Therefore, this information demonstrates that there are no new issues of safety or effectiveness and provides evidence of substantial equivalence of the Firefly Needless Connector to the MaxZero (MZ1000) Needleless connector subject of K132413.
5.7. Performance Testing
The following non-clinical data were provided in support of the substantial equivalence determination:
Biocompatibility
Conducted per Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Jun 16, 2016 and "Guidance for Industry and FDA Staff -Intravascular Administration Sets Premarket Notification Submissions [510(k)]," July 11, 2008, as recognized by the FDA. Biocompatibility testing was conducted in accordance with the cited guidance and standards as required for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
| TEST | STANDARD | RESULT |
|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009,Biological Evaluation ofMedical Devices Part 5: Testsfor in vitro Cytotoxicity | Pass- No reactivity |
| Intracutaneous reactivityIrritation in Rabbits | ISO 10993-10: 2013Biological evaluation ofmedical devices Part 10: Testsfor irritation and skinsensitization | Pass - Non-irritant |
| Sensitization | ISO 10993-10: 2013Biological evaluation ofmedical devices Part 10: Testsfor irritation and skinsensitization | Pass - Non-sensitizing |
| Acute Systemic Toxicity | ISO 10993-1 1:2017Biological evaluation ofmedical devices Part 11: Testsfor systemic toxicity | Pass – Did not cause acutesystemic toxicity |
| Hemolysis | ASTM F 756 – 17: StandardPractice for Assessment ofHemolytic Properties ofMaterials | Pass - Non-hemolytic |
| Pyrogenicity | USP Pyrogen Test Procedure,Section <151> (USP40) | Pass - Non-pyrogenic |
| TEST | STANDARD | RESULT |
| Particulate Matter | USP <788> Particulate Matterin Injections | Pass |
| Sterility | ISO 11135:2014, Ethyleneoxide — Requirements fordevelopment, v ISO 10993-7:2008ISO 10993-7:2008, Biologicalevaluation of medical devices— Part 7 - Ethylene oxidesterilization residualsvalidation and routine control | Pass |
| 6 Month Shelf Life | ASTM F1980-16: StandardGuide for Accelerated Agingof Sterile Barrier Systemsfor Medical DevicesISO 11607-1 Second Edition2019-02: Packaging forterminally sterilized medicaldevices - Part 1.Requirements for materials,sterile barrier systems, andpackaging systems | Pass |
| MR Compatibility | FDA Guidance: EstablishingSafety and Compatibility ofPassive Implants in theMagnetic Resonance (MR)Environment: 2014 | Pass |
| FDA Guidance Compliance:Microbial ingressFluid displacementFlow rate at gravityPower infusion flowFlush volumePriming volumeSize and weightValve actuation forceValve recoveryValve cycle testValve back pressure test | FDA Guidance: IntravascularAdministration Sets PremarketNotification Submission[510(k)]: 2008 | Pass |
| Valve pressure testTensile strengthFlexural strength | ||
| ISO 8536-4 ComplianceParticulate contaminationLeakageTensile strengthMale Conical fittingReducing matterMetal ionsTitration acidity or alkalinityResidue on evaporationUV absorption | ISO 8536-4 Sixth edition2019-09, Infusion equipmentfor medical use - Part 4:Infusion sets for single use,gravity feed | Pass |
| ISO 80369-7 ComplianceDimensional requirementsPositive pressure liquidleakageSub-atmospheric pressure airleakageStress crackingResistance to separation fromaxial loadResistance to separation fromunscrewingResistance to overriding | ISO 80369-7 First edition2016-10-15, Small-boreconnectors for liquids andgases in healthcareapplications - Part 7:Connectors for intravascularor hypodermic application | Pass |
Table 5.7.1 Biocompatibility Testing
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The following nonclinical bench testing was conducted on the Firefly Needleless Connector to determine the proposed device is substantially equivalent to the predicate device.
Table 5.7.2 Performance Testing
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5.8. Conclusion Statement
The conclusions drawn from the nonclinical tests above demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.