(27 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a needleless connector, with no mention of AI or ML capabilities.
No
This device is a connector used for accessing IV lines during therapy, not a device that directly treats a condition or disease.
No
The MZ1000 is described as a "sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy," used for "direct injection, intermittent infusion, continuous infusion or aspiration." Its function is to facilitate the administration or withdrawal of substances, not to provide diagnostic information about a patient's condition.
No
The device description clearly describes a physical, sterile, single-patient-use connector for IV lines, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the MZ1000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the MZ1000 is a connector for accessing the IV line and/or IV catheter during IV therapy for direct injection, intermittent infusion, continuous infusion, or aspiration. This describes a device used in vivo (within the body) for administering or withdrawing substances.
- Device Description: The description reinforces its use with vascular access devices for administering or aspirating drugs, blood, and fluids.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the MZ1000 is a medical device used for patient care during IV therapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FPA
Device Description
The MZ1000 is a zero reflux needleless connector intended for single patient use, including pediatrics and immunocompromised patlents, for direct injection, intermlitent infusion, continuous infusion or aspiration of drugs, blood and fluids which using a vascular access device. The MZ1000 is a closed, luer activated device that eliminates the risk of needlestick injurles. The MZ1000 does not require a specific clamping sequence or technique in order to be used safely. The flush volume for the MZ1000 is five millillters (5ml). The MZ1000 can be used for seven (7) days and 200 activations.
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
The MZ1000 (subject device) met all of the acceptance criteria for all functional, microbial Ingress, sterility, blocompatiblity and other performance criteria which verify it to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the MZ1000.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
MZ1000
510(k) Summary
CareFusion
10020 Pacific Mesa Blvd.
San Dlego, CA 92121 (858) 617-5925
(858) 617-5977
April 22, 2013
Michelle J. Badal
SUBMITTER INFORMATION
- Company Name: A.
- Company Address: B.
- Company Phone: C. Company Fax:
- Contact Person: D.
- Date Summary Prepared: പ്
DEVICE IDENTIFICATION
- Trade Name: MZ1000 A.
- IV Administration Set Common Name: в.
- Classification: IV Administration Set, Needleless Connector, Closed ੁੱ Access, (21 CFR 880.5440, Product Code FPA)
PREDICATE DEVICES
The MZ1000 is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k)
No. | Date Cleared |
|--------------------------------------------------------|----------------------------------|---------------|-------------------|
| MaxPlus Tru-Swab
Positive Displacement
Connector | CareFusion (Formerly
Medegen) | Қ072542 | Sept 25, 2007 |
| Neutron | ICU Medical Inc. | K100434 | August 9,
2010 |
| Neutral Luer Activated
Device | Baxter Healthcare
Corporation | K120443 | May 22, 2012 |
Confidential
1
DEVICE DESCRIPTION
The MZ1000 is a zero reflux needleless connector intended for single patient use, including pediatrics and immunocompromised patlents, for direct injection, intermlitent infusion, continuous infusion or aspiration of drugs, blood and fluids which using a vascular access device. The MZ1000 is a closed, luer activated device that eliminates the risk of needlestick injurles. The MZ1000 does not require a specific clamping sequence or technique in order to be used safely. The flush volume for the MZ1000 is five millillters (5ml). The MZ1000 can be used for seven (7) days and 200 activations.
INTENDED USE
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.
TECHNOLOGICAL CHARACTERISTICS
| Technological Characteristics | |
|---|---|
| Zero reflux | |
| Low flush volume - 5ml | |
| 7 days & 200 activations | |
| Needleless Connector | |
| No interstitial or dead space internal to the connector | |
| Non-hemolytic | |
| Flow rate of >6L/hour | |
| 325 psi & maximum flow rate of 10ml/seconds | |
| Disinfect with 70% IPA | |
| Device can be cleansed with 2% chlorhexidine gluconate or | |
| iodine |
PERFORMANCE DATA
The MZ1000 (subject device) met all of the acceptance criteria for all functional, microbial Ingress, sterility, blocompatiblity and other performance criteria which verify it to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the MZ1000.
SUBSTANTIAL EQUIVALENCE
The results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the introduction of the MZ1000. The results also demonstrate substantial equivalence to the predicate devices, and that they are safe and effective for their intended use.
Confidentlal
028
2
CLINICAL AND NON-CLINICAL DATA:
There is no clinical data Included in this submission. Non-clinical data (bench testing) is included in the MZ1000 Performance Testion in the submission as simulated use environmental testing. The testing Included functional, microbial ingress, sterility, and other performance criterla to verify the safe and effectlye use of the device. The results of the testing demonstrates that there are no differences between the predicate and the subject device that raise any new Issues of safety or effectiveness
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
CareFusion C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street, NW BUFFALO MN 55313
Re: K132413
Trade/Device Name: Intravascular Administration Set, Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 31, 2013 Received: August 14, 2013
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 eonine.co proc to this 20, 1977, the accordance with the provisions of the Federal Food, Drug, de nees that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mererere, mans of the Act include requirements for annual registration, listing of general oblic of overving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability admontion. 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 may be subject to trainiens, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 (OS) 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/Resourcesfor You/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/ReportalProblem/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 vours,
Kwame O. Ulmer -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Carefusion
Indications for Use
510(k) Number (if known): K132413
Device Name: MZ1000
Indications For Use:
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 direction, intermittent infusion, continuous infusion or aspiration
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Richard C. Chapman 2013.08.28 15:47:16 -04'00'
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