MZ1000

K132413 · Care Fusion · FPA · Aug 29, 2013 · General Hospital

Device Facts

• Record ID: K132413
• Device Name: MZ1000
• Applicant: Care Fusion
• Product Code: FPA · General Hospital
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

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.

Device Story

MZ1000 is a zero-reflux, luer-activated needleless connector for IV therapy; facilitates direct injection, infusion, or aspiration of drugs, blood, and fluids. Device eliminates needlestick injury risk; requires no specific clamping sequence. Used in clinical settings for up to 7 days and 200 activations. Operates as a closed system; prevents reflux; maintains flow rates >6L/hour; supports 325 psi and 10ml/second flow. Healthcare providers attach device to vascular access lines to provide safe, needle-free access, reducing infection risk and simplifying maintenance for patients, including pediatric and immunocompromised individuals.

Clinical Evidence

No clinical data included. Bench testing only; included functional, microbial ingress, sterility, and biocompatibility testing to verify performance against predicate devices.

Technological Characteristics

Zero-reflux needleless connector; 5ml flush volume; 7-day/200-activation lifespan; non-hemolytic; flow rate >6L/hour; 325 psi rating; 10ml/second max flow; compatible with 70% IPA, 2% chlorhexidine gluconate, or iodine disinfection.

Indications for Use

Indicated for needleless access to IV lines/catheters for direct injection, intermittent/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

• MaxPlus Tru-Swab Positive Displacement Connector (K072542)
• Neutron (K100434)
• Neutral Luer Activated Device (K120443)

Submission Summary (Full Text)

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MZ1000

## 510(k) Summary

CareFusion

10020 Pacific Mesa Blvd.

San Dlego, CA 92121 [phone]

[phone]

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)<br>No. | Date Cleared |
|--------------------------------------------------------|----------------------------------|---------------|-------------------|
| MaxPlus Tru-Swab<br>Positive Displacement<br>Connector | CareFusion (Formerly<br>Medegen) | Қ072542 | Sept 25, 2007 |
| Neutron | ICU Medical Inc. | K100434 | August 9,<br>2010 |
| Neutral Luer Activated<br>Device | Baxter Healthcare<br>Corporation | K120443 | May 22, 2012 |

Confidential

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## 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

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# 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

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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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