Firefly Needleless Connector

K203796 · Puracath Medical, Inc. · FPA · Jul 30, 2021 · General Hospital

Device Facts

• Record ID: K203796
• Device Name: Firefly Needleless Connector
• Applicant: Puracath Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Firefly Needleless Connector is a neutral displacement, luer-activated, closed-access device for IV therapy. It functions as an external flow, normally closed elastomeric valve; valve opens upon male luer connection and closes upon removal. Used in clinical settings for direct injection, intermittent/continuous infusion, or aspiration of drugs, blood, and fluids. Supports power injection up to 325 psi at 10 mL/sec. Device is single-patient use, rated for 7 days and 200 activations. Disinfected via standard 70% IPA wipe. Clear housing design facilitates flushing. Contains an inactive electronic chip for future, non-approved functionalities. Eliminates needlestick injury risk; requires no specific clamping sequence.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993), sterility (ISO 11135), shelf life (ASTM F1980), MR compatibility, and performance testing per FDA guidance for Intravascular Administration Sets (2008), ISO 8536-4, and ISO 80369-7. All tests passed, confirming functional equivalence in valve actuation, pressure, leakage, and flow characteristics.

Technological Characteristics

Neutral displacement, luer-activated, normally closed elastomeric valve. Materials: unspecified. Dimensions: 0.16 mL priming volume. Connectivity: contains an inactive electronic chip. Sterilization: Ethylene Oxide. Packaging: Tyvek polyethylene. Standards: ISO 10993, ISO 11135, ISO 8536-4, ISO 80369-7, ASTM F756, ASTM F1980.

Indications for Use

Indicated for needleless access to IV lines and/or IV catheters for direct injection, intermittent infusion, continuous infusion, or aspiration in patients, including pediatric and immunocompromised populations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CareFusion, MaxZero Needleless Connector, MZ1000 (K132413)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 210<br>Newark, CA 94560<br>USA |
| | Company Telephone: | 415.305.4134 |
| | Official Contact: | Julia Rasooly |
| | Telephone: | 415.305.4134 |
| | email: | [e-mail] |
| | Date Prepared: | July 26, 2021 |
| 5.2. | Device Information | |
| | Common Name: | IV Administration Set,<br>Needleless Connector, Closed Access |
| | Trade Name: | Firefly Needleless Connector |
| | Classification: | Class II, 21 CFR 880.5440<br>Product Code: FPA |
| | Predicate Device: | CareFusion, MaxZero Needleless Connector,<br>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 or<br>Different | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------|
| Device name | Firefly Needleless<br>Connector | MaxZero (MZ1000)<br>Needleless Connector<br>(K132413) | N/A | |
| Common<br>Name | IV Administration Set | IV Administration Set | Same | |
| Classification | Class II,<br>IV Administration Set,<br>Needle Connector, Closed<br>Access | Class II,<br>IV Administration Set,<br>Needleless Connector,<br>Closed Access | Same | |
| Indications for<br>use | The PuraCath™ Firefly™<br>Needleless Connector is a<br>sterile single patient use<br>connector for needleless<br>access to the IV line<br>and/or IV catheter during<br>IV therapy and can be<br>used for direct injection,<br>intermittent infusion,<br>continuous infusion or<br>aspiration. | The MZ1000 Is a<br>sterile single patient<br>use connector for<br>needleless access to the<br>IV line and/or IV<br>catheter during IV<br>therapy. The MZ1000<br>can be used for direct<br>Injection, Intermittent<br>infusion, continuous<br>infusion or aspiration | Same | |
| General<br>System<br>Design<br>(Mechanism<br>of Action) | External Flow<br>Normally Closed<br>Elastomeric Valve, Luer<br>Activated | External Flow<br>Normally Closed<br>Elastomeric Valve,<br>Luer Activated | Same | |
| Characteristic | Subject Device | Predicate Device | Same or<br>Different | |
| Proximal<br>Configuration | Female Luer Lock with<br>Luer Actuated Valve | Female Luer Lock with<br>Luer Actuated Valve | Same | |
| | Distal<br>Configuration | Male Luer Lock | Male Luer Lock | Same |
| Priming<br>Volume | | 0.16 ml | 0.16 ml | Same |
| Hemolysis | Non-hemolytic | Non-hemolytic | Same | |
| Connector<br>Gravity Flow<br>rate | Flow rate at gravity with<br>1 m head height ≥<br>67ml/minute | Flow rate at gravity<br>with 1 m head height ≥<br>100ml/minute | Different | |
| | Connector<br>Fluid<br>Displacement | <9 µL | 16 µL | Different |
| | | Flush Volume | 5 ml | 5 ml |
| Power Infusion<br>Flow Rate | | 10ml/sec @325 PSI | 10ml/sec @325 PSI | Same |
| Use | Single patient | Single patient | Same | |
| Duration of<br>Use | 7 days | 7 days | Same | |
| Number of<br>Activations | 200 | 200 | Same | |
| Method of<br>Disinfection | 70% IPA | 70% IPA | Same | |
| | Electronic<br>Chip | Yes | No | Different |
| Sterilization<br>Method | | Ethylene Oxide | Gamma Irradiation | Different |
| | Sterile Barrier<br>Packaging | Tyvek polyethylene; heat-<br>sealed | Tyvek polyethylene;<br>heat-sealed | Same |
| Packaged<br>Quantity | | Single Unit per Package | Single Unit per<br>Package | 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,<br>Biological Evaluation of<br>Medical Devices Part 5: Tests<br>for <i>in vitro</i> Cytotoxicity | Pass- No reactivity |
| Intracutaneous reactivity<br>Irritation in Rabbits | ISO 10993-10: 2013<br>Biological evaluation of<br>medical devices Part 10: Tests<br>for irritation and skin<br>sensitization | Pass - Non-irritant |
| Sensitization | ISO 10993-10: 2013<br>Biological evaluation of<br>medical devices Part 10: Tests<br>for irritation and skin<br>sensitization | Pass - Non-sensitizing |
| Acute Systemic Toxicity | ISO 10993-1 1:2017<br>Biological evaluation of<br>medical devices Part 11: Tests<br>for systemic toxicity | Pass – Did not cause acute<br>systemic toxicity |
| Hemolysis | ASTM F 756 – 17: Standard<br>Practice for Assessment of<br>Hemolytic Properties of<br>Materials | Pass - Non-hemolytic |
| Pyrogenicity | USP Pyrogen Test Procedure,<br>Section <151> (USP40) | Pass - Non-pyrogenic |
| TEST | STANDARD | RESULT |
| Particulate Matter | USP <788> Particulate Matter<br>in Injections | Pass |
| Sterility | ISO 11135:2014, Ethylene<br>oxide — Requirements for<br>development, v ISO 10993-<br>7:2008<br><br>ISO 10993-7:2008, Biological<br>evaluation of medical devices<br>— Part 7 - Ethylene oxide<br>sterilization residuals<br>validation and routine control | Pass |
| 6 Month Shelf Life | ASTM F1980-16: Standard<br>Guide for Accelerated Aging<br>of Sterile Barrier Systems<br>for Medical Devices<br><br>ISO 11607-1 Second Edition<br>2019-02: Packaging for<br>terminally sterilized medical<br>devices - Part 1.<br>Requirements for materials,<br>sterile barrier systems, and<br>packaging systems | Pass |
| MR Compatibility | FDA Guidance: Establishing<br>Safety and Compatibility of<br>Passive Implants in the<br>Magnetic Resonance (MR)<br>Environment: 2014 | Pass |
| FDA Guidance Compliance:<br>Microbial ingress<br>Fluid displacement<br>Flow rate at gravity<br>Power infusion flow<br>Flush volume<br>Priming volume<br>Size and weight<br>Valve actuation force<br>Valve recovery<br>Valve cycle test<br>Valve back pressure test | FDA Guidance: Intravascular<br>Administration Sets Premarket<br>Notification Submission<br>[510(k)]: 2008 | Pass |
| Valve pressure test<br>Tensile strength<br>Flexural strength | | |
| ISO 8536-4 Compliance<br>Particulate contamination<br>Leakage<br>Tensile strength<br>Male Conical fitting<br>Reducing matter<br>Metal ions<br>Titration acidity or alkalinity<br>Residue on evaporation<br>UV absorption | ISO 8536-4 Sixth edition<br>2019-09, Infusion equipment<br>for medical use - Part 4:<br>Infusion sets for single use,<br>gravity feed | Pass |
| ISO 80369-7 Compliance<br>Dimensional requirements<br>Positive pressure liquid<br>leakage<br>Sub-atmospheric pressure air<br>leakage<br>Stress cracking<br>Resistance to separation from<br>axial load<br>Resistance to separation from<br>unscrewing<br>Resistance to overriding | ISO 80369-7 First edition<br>2016-10-15, Small-bore<br>connectors for liquids and<br>gases in healthcare<br>applications - Part 7:<br>Connectors for intravascular<br>or 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