(214 days)
Not Found
No
The summary describes a mechanical needleless connector for IV lines and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a needleless connector for accessing IV lines and catheters during IV therapy and is used for injection, infusion, or aspiration, not for treating a disease or condition itself.
No.
The device is a needleless connector for IV lines, used for administering substances or aspirating fluids; it does not perform any diagnostic function.
No
The device description clearly outlines a physical, mechanical needleless connector with specific material properties and performance characteristics related to fluid flow, pressure, and physical strength. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a device used for administering substances to or withdrawing substances from a patient's vascular system.
- Device Description: The description reinforces this by detailing its function as a "neutral displacement needleless connector intended for single patient use... for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device."
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment. IVDs are specifically designed for these types of in vitro (outside the body) tests.
This device is a medical device used for patient care and therapy, not for diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatrics
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
- Cytotoxicity: Pass- No reactivity
- Intracutaneous reactivity Irritation in Rabbits: Pass - Non-irritant
- Sensitization: Pass - Non-sensitizing
- Acute Systemic Toxicity: Pass – Did not cause acute systemic toxicity
- Hemolysis: Pass - Non-hemolytic
- Pyrogenicity: Pass - Non-pyrogenic
- Particulate Matter: Pass
- Sterility: Pass
- 6 Month Shelf Life: Pass
- MR Compatibility: Pass
- FDA Guidance Compliance (Microbial ingress, Fluid displacement, Flow rate at gravity, Power infusion flow, Flush volume, Priming volume, Size and weight, Valve actuation force, Valve recovery, Valve cycle test, Valve back pressure test, Valve pressure test, Tensile strength, Flexural strength): Pass
- ISO 8536-4 Compliance (Particulate contamination, Leakage, Tensile strength, Male Conical fitting, Reducing matter, Metal ions, Titration acidity or alkalinity, Residue on evaporation, UV absorption): Pass
- ISO 80369-7 Compliance (Dimensional requirements, Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to unscrewing, Resistance to overriding): Pass
The nonclinical bench testing was conducted on the Firefly Needleless Connector to determine that the proposed device is substantially equivalent to the predicate device. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
ડ. 510(k) Summary K203796
| 5.1. | General Company Information | |
|---|---|---|
| Company Name: | PuraCath Medical, Inc. | |
| Company Address: | 37600 Central Court, Suite 210 | |
| Newark, CA 94560 | ||
| USA | ||
| 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 880.5440 | |
| Product 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
4
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
Different | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------|
| Device name | Firefly Needleless
Connector | MaxZero (MZ1000)
Needleless Connector
(K132413) | N/A | |
| Common
Name | IV Administration Set | IV Administration Set | Same | |
| Classification | Class II,
IV Administration Set,
Needle Connector, Closed
Access | Class II,
IV Administration Set,
Needleless Connector,
Closed Access | Same | |
| Indications for
use | 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 MZ1000 Is a
sterile single patient
use connector for
needleless access to the
IV line and/or IV
catheter during IV
therapy. The MZ1000
can be used for direct
Injection, Intermittent
infusion, continuous
infusion or aspiration | Same | |
| General
System
Design
(Mechanism
of Action) | External Flow
Normally Closed
Elastomeric Valve, Luer
Activated | External Flow
Normally Closed
Elastomeric Valve,
Luer Activated | Same | |
| Characteristic | Subject Device | Predicate Device | Same or
Different | |
| Proximal
Configuration | Female Luer Lock with
Luer Actuated Valve | Female Luer Lock with
Luer Actuated Valve | Same | |
| | Distal
Configuration | Male Luer Lock | Male Luer Lock | Same |
| Priming
Volume | | 0.16 ml | 0.16 ml | Same |
| Hemolysis | Non-hemolytic | Non-hemolytic | Same | |
| Connector
Gravity Flow
rate | Flow rate at gravity with
1 m head height ≥
67ml/minute | Flow rate at gravity
with 1 m head height ≥
100ml/minute | Different | |
| | Connector
Fluid
Displacement | 1http://hadawayassociates.com/uploads/3/5/4/4/35447364/needleless_connectors_for_iv_catheter s 23.pdf
7
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 of | ||
| Medical Devices Part 5: Tests | ||
| for in vitro Cytotoxicity | Pass- No reactivity | |
| Intracutaneous reactivity | ||
| Irritation in Rabbits | 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 10993-1 1:2017 | |
| 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 (USP40) | Pass - Non-pyrogenic | |
| TEST | STANDARD | RESULT |
| Particulate Matter | USP 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 |
| FDA Guidance Compliance:
Microbial ingress
Fluid displacement
Flow rate at gravity
Power infusion flow
Flush volume
Priming volume
Size and weight
Valve actuation force
Valve recovery
Valve cycle test
Valve back pressure test | FDA Guidance: Intravascular
Administration Sets Premarket
Notification Submission
[510(k)]: 2008 | Pass |
| Valve pressure test
Tensile strength
Flexural strength | | |
| ISO 8536-4 Compliance
Particulate contamination
Leakage
Tensile strength
Male Conical fitting
Reducing matter
Metal ions
Titration acidity or alkalinity
Residue on evaporation
UV absorption | ISO 8536-4 Sixth edition
2019-09, Infusion equipment
for medical use - Part 4:
Infusion sets for single use,
gravity feed | Pass |
| ISO 80369-7 Compliance
Dimensional requirements
Positive pressure liquid
leakage
Sub-atmospheric pressure air
leakage
Stress cracking
Resistance to separation from
axial load
Resistance to separation from
unscrewing
Resistance to overriding | 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 |
Table 5.7.1 Biocompatibility Testing
8
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
9
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