(13 days)
No
The document describes a medical device (extension set with needleless connector) for fluid administration. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on physical and biological properties of the device.
No.
The device is an extension set with needleless connectors used for the administration or aspiration of fluids, not for treatment or diagnosis of a condition.
No
The device is an extension set for administration or aspiration of fluids, not a diagnostic tool used to identify or analyze a condition or disease.
No
The device description clearly describes a physical medical device (intravascular extension sets with needleless connectors) and the performance studies focus on physical properties and testing, not software validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for direct injection, intermittent infusion, continuous infusion, or aspiration of drugs, blood, and fluids. These are procedures performed on the patient, not on a sample taken from the patient to diagnose a condition.
- Device Description: The description reinforces the intended use by stating it's an "intravascular extension set" used for administering substances to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
The device described is a medical device used for administering substances into the bloodstream, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
Non Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Product codes
FPA
Device Description
The CareFusion MaxZero Extension Sets with Needleless Connector are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. All MaxZero Extension Sets with Needleless Connector include the previously cleared zero reflux MZ1000 Needleless Connector (K132413) bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needlestick injuries. The MaxZero Extension Sets with Needleless Connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
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
hospital environment
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)
Non-Clinical Data
CareFusion performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate devices. All test results met their acceptance criteria and support that the MaxZero Extension Sets with Needleless Connector are appropriately designed for their intended use.
Testing performed included:
- Microbial ingress and barrier testing
- Hemolysis testing
- Shelf life performance testing
- Harsh Infusates testing
- ISO Testing
- Priming volume/flow rate testing
- Biocompatibility testing to applicable section of ISO 10993
- Sterilization validation testing
The results of the non-clinical testing exhibited that no new issues of safety and efficacy are raised with the proposed introduction of the MaxZero Extension Sets with Needleless Connector. The device met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices. The conclusion drawn from the performance testing demonstrate that the MaxZero Extension Set with Needleless Connector is as safe as effective and performs at least as safe and effectively as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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CAREFUSION
K140831
510(k) Summary
APR 1 5 2014
Submitter Information
| A. Company Name: | CareFusion |
|---|---|
| B. Company Address: | 10020 Pacific Mesa Blvd. |
| San Diego, CA 92121 | |
| C. Company Phone: | (858) 617-3042 |
| D. Company Fax: | (858) 617-5982 |
| E. Contact Person: | Larry Walker |
| F. Date Summary Prepared: | March 20, 2014 |
Device Identification
| A. Trade Name | MaxZero Extension Sets with Needleless Connector |
|---|---|
| B. Common Name: | IV Administration Sets |
| C. Classification: | IV Administration Set, Needleless Connector, |
| Closed Access, 21 CFR 880.5440, (Product code FPA) |
Legally Marketed Predicate Device for Substantial Equivalence
| Predicate Device | Manufacturer | 510(k) # | Date Cleared |
|---|---|---|---|
| MZ1000 Needleless Connector | CareFusion | K132413 | August 29, 2013 |
| Medegen Pressure Rated | |||
| Extension Sets | CareFusion (formerly | ||
| Medegen) | K083472 | December 9, 2008 | |
| Medegen Intravascular | |||
| Administration Set and | |||
| Extension Set | CareFusion (formerly | ||
| Medegen) | K051499 | June 22, 2005 |
Rational for Substantial Equivalence
The information provided in the premarket notification demonstrates that the subject CareFusion MaxZero Extension Set with Needleless Connector is substantially equivalent to the legally marketed predicated devices. The subject MaxZero Extension Sets with Needleless Connector and the predicate Medegen Extension Sets are intended to be used for the delivery and/or aspiration of fluids to/from an IV catheter in a hospital environment. The subject and the predicate devices are similar in physical properties, materials, and configuration. Each device includes connectors that allow for needleless access to the IV line during IV therapy eliminating the risk of needle injury. The subject device incorporates the predicate MZ1000 Needleless Connector bonded directly to IV tubing. Components of the subject devices are made of materials that are substantial equivalent to the predicate devices listed above and this submission includes comprehensive biocompatibility testing for all device materials included in this submission.
1
Device Description
The CareFusion MaxZero Extension Sets with Needleless Connector are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. All MaxZero Extension Sets with Needleless Connector include the previously cleared zero reflux MZ1000 Needleless Connector (K132413) bonded to the extension set tubing. The MZ1000 needleless connector allows thorough and easy disinfection due to a solid, flat smooth surface and eliminates the risk of needlestick injuries. The MaxZero Extension Sets with Needleless Connectors are sterile single patient devices that can be used for seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
| Model
Number | Description | Tubing
ID | Tubing
OD |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| MZ5301 | Pressure rated extension set, MaxZero connector, slide clamp, spin male
luer lock [≈ 7" (18 cm); ≈ 0.40 ml] | 0.042" | 0.079" |
| MZ5302 | Pressure rated extension set, MaxZero connector, slide clamp, spin male
luer lock [≈ 7" (18 cm); ≈ 0.40 ml] | 0.042" | 0.079" |
| MZ5303 | Pressure rated extension set, MaxZero connector, slide clamp, spin male
luer lock [≈ 7" (18 cm); ≈ 0.50 ml] | 0.060" | 0.144" |
| MZ5304 | Pressure rated extension set, MaxZero connector, slide clamp, spin male
luer lock [≈ 7" (18 cm); ≈ 0.50 ml] | 0.060" | 0.144" |
| MZ5305 | Pressure rated extension set, MaxZero connector, spin make luer lock [≈
7" (18 cm); ≈ 0.50 ml] | 0.060" | 0.144" |
| MZ5306 | Pressure rated extension set, minibore tubing, MaxZero connector, spin
make luer lock. [≈ 7" (18 cm); ≈ 0.40 ml] | 0.042" | 0.079" |
| MZ5307 | Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero
connectors, (2) side clamps, spin male luer lock. [≈ 7" (18 cm); ≈ 0.80
ml] | 0.042" | 0.079" |
| MZ5308 | Bi-fuse pressure rated extension set, (2) MaxZero connectors, (2) slide
clamps, spin make luer lock. [≈ 6" (15 cm); ≈ 0.90 ml] | 0.060" | 0.144" |
| MZ9284 | Bi-fuse extension set, (2) MaxZero connectors, (2) check valves (2) slide
clamps, spin make luer lock [≈ 7" (18 cm); ≈ 0.90 ml] | 0.042" | 0.079" |
| MZ9285 | Bi-fuse extension set, (2) MaxZero connectors, (2) slide clamps, spin
make luer lock [≈ 7" (18 cm); ≈ 0.90 ml] | 0.60" | 0.144" |
The following model numbers are subject to this submission:
Intended Use .
Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
Non Pressure Rated: The MaxZero multi fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
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Substantial Equivalence Table
| Device | CareFusion MaxZero
Extension Sets with
Needleless Connector | CareFusion (formerly
Medegen) Pressure Rated
Extension Sets | CareFusion (formerly
Medegen) Intravascular
Administration Set and
Extension Set |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | TBD Subject device | K083472 | K051499 |
| Fluid contacting
materials | Tubing- PVC
Luer- Co-polyester
Needleless Connector -
Polycarbonate/silicone
Male Spin lock - ABS
thermoplastic
Bifurcated Connecter-
PVC | Tubing- PVC
Luer- Co-polyester
Check Valves- ABS
thermoplastic
Needleless Connector -
Polycarbonate/silicone
Male Spin lock - ABS
thermoplastic
Bifurcated Connecter- ABS | Tubing- PVC
Luer- Co-polyester
Check Valves- ABS
thermoplastic
Needleless Connector -
Polycarbonate/silicone
Male Spin lock - ABS
thermoplastic
Bifurcated Connecter-
ABS |
| Needleless
Connector | CareFusion MZ1000
(K132413) | CareFusion MaxPlus Tru-
Swab Connector
(K072542) | CareFusion NAC Plus
Needleless Connector
(K011193) |
| Functional Use | Direct Injection,
intermittent infusion,
continuous infusion,
aspiration | Direct Injection,
intermittent infusion,
continuous infusion,
aspiration | Direct Injection,
intermittent infusion,
continuous infusion,
aspiration |
| Packaging | Tyvek/film pouch | Tyvek/film pouch | Tyvek/film pouch |
| Sterilization Method | E-Beam | E-Beam | Irradiation |
| Usable Life | 7 days 200 activations | 3 days 96 activations | Per CDC guidelines |
Technical Characteristics
| Technological Characteristics |
|---|
| Zero Reflux Needleless Connector |
| Designed to prevent microbial ingress |
| Needleless connector can be disinfected with 3 sec scrub with 70% IPA |
| Maximum clinical use of 7 days 200 activations (single patient use) |
| Non-hemolytic |
| Can be used with low power injectors with maximum of 325 psi & flow rate of |
| 10ml/second (pressure rated sets) |
| Not made with DEHP |
| Safe for use in MRI environment |
| Not made with natural latex rubber |
| Sets can be used with harsh infusates |
Clinical Data
There is no clinical data included in this submission.
Non-Clinical Data
CareFusion performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate devices. All test results met their acceptance criteria and support that the MaxZero Extension Sets with Needleless Connector are appropriately designed for their intended use.
Testing performed included:
- . Microbial ingress and barrier testing
3
- . Hemolysis testing
- . Shelf life performance testing
- . Harsh Infusates testing
- . ISO Testing
- . Priming volume/flow rate testing
- . Biocompatibility testing to applicable section of ISO 10993
- . Sterilization validation testing
A complete list of functional/performance testing protocols and reports are included in Section 18 of this submission.
Conclusion
The results of the non-clinical testing exhibited that no new issues of safety and efficacy are raised with the proposed introduction of the MaxZero Extension Sets with Needleless Connector. The device met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices. The conclusion drawn from the performance testing demonstrate that the MaxZero Extension Set with Needleless Connector is as safe as effective and performs at least as safe and effectively as the legally marketed predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2014
CareFusion C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo MN 55313
Re: K140831
Trade/Device Name: MaxZero Extension Sets with Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 27, 2014 Received: April 4, 2014
Dear Mr. Job:
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. 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.
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Page 2 - Mr. Job
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140831
Device Name
MaxZero Extension Set with Needleless Connector
Indications for Use (Describe)
Pressure Rated: The MaxZero nulti fuse extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10mL per second.
Non Pressure Rated: The MaxZero multi fise extension set with needleless connector(s) is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE THE FORIEDA USE ONLY AND THE ONLY AND THE ORIENT 1. . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.04.15 11:15:24 -04'00'
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