ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

{0}------------------------------------------------ K100705 ### Appendix G ## Summary of Safety and Efficacy ## 510(K) SUMMARY Zyno Medical LLC. 9 Tech Circle Natick, MA, 01760 #### Contact Person: Chaoyoung Lee President Zyno Medical LLC 9 Tech Circle Natick, MA, 01760 Fax: 508-650-2006 Phone: 508-650-2008 Ext 103 Email: cylee@careeverywhere.com Date Originated: March 5, 2010 Trade Name: Z-800 Infusion System Common Name: Volumetric Infusion Pump Classification Name: Infusion Pump Product code: FRN 880.5725 #### Predicate Devices -Z-800 Infusion pumps (K071545) -B. Braun Vista basic (formerly known as Infusomat P. K003029) -Sigma 8000 (K950766) -Abbott Acclaim Encore (K991501) #### Intended Use The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction of physician or other certified health care professional. #### Device Description: The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids. blood and blood products to a human patient under the direction of physician or other certified health care professional. The Z-800 Infusion System consists of the Z-800 Infusion Pump and approved external IV administration sets. The scope of this 510K is to qualify CareFusion's blood administration sets #### Z-800 Premarket Notification - Modified on June 2, 2010 in response to FDA request JUL -- 8 2010 {1}------------------------------------------------ (K882302) for use with the currently marketed Z-800 infusion pump system so as to extend the intended use of the Z-800 Volumetric Infusion Pumps to include intravenous administration of blood and blood products. The infusion pump remains the same as currently marketed Z-800 infusion pump, as in the predicated device Z-800 infusion system (K0717545). The Z-800 infusion system contains the following components: - The infusion delivery mechanism: Volumetric linear peristaltic pumping mechanism assembly. . - Approved IV administration sets include External IV sets for intravenous parenteral fluid delivery . and for intravenous blood and blood product delivery. - . User Interface consists of a 128 X 64 dot matrix LCD display; a 14 key membrane keypad; a LED flow rate display; two device status indicator LEDs; power status indicator LEDs (AC & Battery); an audio speaker; an external alarm light accessory; an software alarm handler. - The embedded software on the main CPU execute an infusion pump state machine, which monitors . the execution of currently programmed infusion as well as a collection of safety related alarm conditions. - A watchdog timer is set at 50ms interval. Fail to satisfy the watchdog timer will cause both main . CPU and motor control CPU reset, pump device parks at a fail safe state, and an audible alarm to sound. - Power supply consists of AC/DC power. Z-800 infusion pump is intended to be used as a pole . mounted pump. It contains a medical device grade switch power supply (input 100-240V 50-60Hz, 0-1.4A. output 15vdc) and a rechargeable 4700mA. 8X1.2 volt Nickel Metal Hydride battery pack. A fully charged new battery will power at least 8hr of continuous infusion (at 125mL/hr). A full battery charging time on a new battery is around 5hr. The battery charging circuitry has a dedicated controlling CPU, which manages the charging current as well as the battery safety monitoring. Redundant temperature sensor is embedded in the battery pack capable of shut off the charging current if battery pack temperature is above the safety threshold. - . There is 128K flash EPROM memory which stores the embedded software along with 8K NVRAM for user specified configuration as well as preserving infusion parameters between power cycles. - . Z-800 infusion pump uses linear peristaltic pumping mechanism driven by a step motor through driving belt. The ID/OD, wall thickness and the durometer of the IV set are specified by Zyno to the IV set manufacturers to ensure the accuracy specification of flow rate. - . The user interface design requirement of the Z-800 pump is focused on simplicity and intuitiveness. The keypad contains 3 groups of keys: the navigation key group; the data entry key group; and the action key group. There is no numeric data entry keypad. All data entry kevs are scroll key. This design is to focus user's attention to the data entry results on the display while entering the infusion parameters, so as to mitigate data entry error caused by key bounce or user hitting the wrong keys, - . The Z-800 infusion pump has an all metal casing to improve the durability of the pump and the integrity of the pumping/free flow protection mechanism. The pump door and the mating pump front panel are made in milled aluminum. The tubing guide cavity is designed to mitigate tubing loading error. If the tubing is not loaded correctly, the door can not be closed. Even user jam close the door, the mating pump door and the front panel will shut off the tubing to prevent free flow, and the drip sensor accessory will report no flow to alert user of misloaded tubine. - . There is no known contraindication. The equivalency matrix (Table 1) compares the Z-800 Infusion pump with the predicate devices. ### Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request {2}------------------------------------------------ ## Table 1: Equivalency Matrix | Parameter | Z-800 | B. Braun Vista basic | Sigma 8000 | Abbott Acclaim Encore | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pump Type | Volumetric Infusion Pump | Volumetric Infusion Pump | Volumetric Infusion Pump | Volumetric Infusion Pump | | Intended use | Intra-venous | Intra-venous<br>Enteral | Intravenous<br>Epidural | Intravenous<br>Enteral | | Units of delivery | ml/hr | mg/kg/min<br>mg/kg/hr<br>mg/min<br>mg/hr<br>mcg/kg/min<br>mcg/kg/hr<br>mcg/min<br>mcg/hr<br>g/kg/hr<br>g/hr<br>g/kg/min<br>g/min<br>U/kg/hr<br>U/kg/min<br>U/min<br>U/hr<br>ml/hr<br>ml/min | units/hr<br>units/kg/min<br>units/kg/hr<br>milliunits/min<br>grams/hr<br>mcg/kg/min<br>mcg/kg/hr<br>mcg/min<br>mcg/hr<br>mg/kg/min<br>mg/kg/hr<br>mg/min<br>mg/hr<br>ml/hr | ml/hr<br>mcg/min<br>mcg/kg/min | | Pumping<br>mechanism | Linear peristaltic pump | Linear peristaltic pump | Linear peristaltic pump | Linear peristaltic pump | | Free Flow<br>Protection | IV set based free flow<br>protection (Option)<br>Pump based free flow<br>protection YES | IV set based free flow<br>protection (Option)<br>Pump based free flow<br>protection YES | IV set based free flow<br>protection YES.<br>Pump based free flow<br>protection YES | IV set based free flow<br>protection YES.<br>Pump based free flow<br>protection YES | | Administration<br>sets | Approved standard PVC<br>gravity tubing | B. Braun basic pump<br>administration sets. | Approved standard PVC<br>gravity tubing | Approved standard PVC<br>gravity tubing | | Power source | AC: 100-250V 50-60 Hz<br>DC: Internal Nickel<br>Metal Hydride | AC: 100-120V 50-60 Hz<br>DC: Internal NiCd | AC:<br>105-135V 50/60 Hz<br>220-240V 50/60 Hz<br>DC: Sealed lead acid | AC: 100-130V 47-63 Hz<br>DC: Internal<br>rechargeable 8V battery | | Battery Life | 8 hours at 125 ml/hr | 3 hours at 125 ml/hr, | 5 hours | 8 hours at 125ml/hr | | Display | Program controlled dot<br>matrix LCD | Custom LCD | LED | Custom LCD | | Case construction | Milled Aluminum &<br>Sheet Metal Enclosure | Sheet Metal and<br>Injection Molded<br>Plastic Enclosure | High impact Injection<br>Molded Plastic<br>Enclosure | High impact Injection<br>Molded Plastic<br>Enclosure | | Size (inch) | 8.6H x 5.7W x 5.3D | 9.4Hx 5.5W x 7.8D | 9.5Hx 6.5Wx 6.75D | 8.25Hx7Wx5.74D | | Weight | 5.7 lbs | 6.8 lbs. | 10 lbs | 7 lbs | | Volume and Rate<br>Accuracy | +/- 5% | +/- 5% | +/- 5% | +/- 5% | | Occlusion<br>Pressure Accuracy | Low: 4 psi<br>Medium 16 psi<br>High: 30 psi<br>adjustable | Low: 8 psi, unspecified<br>accuracy<br>High 17 psi,<br>unspecified accuracy | Low 2 psi<br>High 15 psi<br>adjustable | Low 6 psi<br>Medium 10pis<br>High 20 psi | | Parameter | Z-800 | B. Braun Vista basic | Sigma 8000 | Abbott Acclaim Encore | | Rate Range | 1 ml/hr to 999 ml/hr in<br>1 ml/hr increment | 0.1 to 800 ml/hr | 0.1 to 99.9 ml/hr (in 0.1<br>ml/hr increments)<br>100 to 999 ml/hr (in 1<br>ml/hr increments) | 1.0 to 99.9 ml/hr (in<br>0.1ml/hr increments)<br>100 to 999 ml/hr (in 1<br>ml/hr increments) | | Warnings / Status | Low Battery<br>Near End<br>Infusion Complete<br>Pump unattended<br>KVO | Low Battery<br>Near End<br>Infusion Complete<br>Pump Stopped<br>Bag Empty (with Drip<br>Sensor)<br>KVO | Low battery<br>Improper IV set loading<br>Infusion Complete<br>Close Roller Clamp<br>PM Due<br>KVO | Battery<br>Check Settings<br>VTBI complete<br>Stopped (unattended)<br>No Slide Clamp<br>KVO | | Alarms | Occlusion<br>Battery Empty<br>Air-In-Line<br>Door Open<br>System Error<br>No Drip (with drip<br>sensor)<br>Drip sensor connection<br>(with drip sensor) | Occlusion<br>Plug In Now<br>Air-In-Line<br>Door Open<br>Unit Malfunction | Occlusion<br>Plug in<br>Air-In-Line<br>Pump Malfunctions | Occlusion<br>Battery Off<br>Air-In-Line<br>Check Door<br>Check Slide Clamp | | Inputs | Continuous Mode<br>Primary Rate<br>Primary VTBI<br>Secondary Rate<br>Secondary VTBI<br>Volume/Time<br>Primary VTBI<br>Primary Time<br>Secondary VTBI<br>Secondary Time<br>TPN<br>Total VTBI<br>Total Time<br>Ramp Up Time<br>Ramp Down Time<br>10 Step Sequence<br>Nth Rate<br>Nth VTBI<br>(N=1 to 10) | Continuous Mode<br>Primary Rate<br>Primary VTBD<br>Secondary Rate<br>Secondary VTBD<br>Volume/Time<br>Primary VTBD<br>Primary TIME<br>Secondary VTBD<br>Secondary TIME<br>Rate & Time<br>Primary Rate<br>Primary Time<br>Secondary Rate<br>Secondary Time<br>TPN<br>Total Bag Volume<br>Total Time<br>Ramp Up time<br>Taper Down Time<br>10 Step Sequence<br>Nth Rate<br>Nth VTBD<br>(N=1 to 10)<br>Dose Calc Mode<br>Concentration Value<br>Concentration Unit<br>Body Weight<br>Drug Dose amount<br>Drug Dose Unit<br>Diluent Volume<br>Delay A Mode<br>Delay Time Amount | Continuous Mode<br>Primary Rate<br>Primary VTBI<br>Piggyback Rate<br>Piggyback VTBI<br>Volume/Time<br>Primary VTBD<br>Primary TIME<br>Piggyback VTBD<br>Piggyback TIME<br>Rate & Time<br>Primary Rate<br>Primary Time<br>Piggyback Rate<br>Piggyback Time<br>TPN<br>Volume Limit<br>Main Rate<br>Ramp Time<br>Taper Time<br>21 Step Sequence<br>Nth Rate<br>Nth VTBI<br>(N=1 to 21)<br>Dose Rate Mode<br>Drug Dose amount<br>Drug Dose Unit<br>Body Weight<br>Diluent Volume<br>Volume Limit<br>Delay Start Mode<br>Delay Time Amount<br>KVO option | Continuous Mode<br>Primary Rate<br>Primary VTBI<br>Secondary Rate<br>Secondary VTBI<br>Volume/Time<br>Primary VTBI<br>Primary TIME<br>Secondary VTBI<br>Secondary TIME<br>TPN<br>Total VTBI<br>Total TIME<br>Taper up TIME<br>Taper down TIME<br>Dose Calc for<br>MICROGRAM delivery<br>Patient Weight<br>Drug amount<br>Diluent Volume<br>Dose Rate | | Parameter | Z-800 | B. Braun Vista<br>basic | Sigma 8000 | Abbott Acclaim<br>Encore | | Serial<br>Communications | Bidirectional | Bidirectional | Bidirectional | None | ## Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request {3}------------------------------------------------ Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request · 36 . {4}------------------------------------------------ . - . Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request . · , 37 : {5}------------------------------------------------ System validation for the Z-800 Volumetric Infusion Pump was performed according to the Z-800 System Validation Plan in compliance with the FDA guidance "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE) issued in April 23, 2010, and Zyno Medical's Quality Development Procedure. Assurance case report has been generated to demonstrate there is no incremental risk to patient and user safety as well as to the Z-800 infusion system efficacy has been introduced by qualifying CareFusion blood IV set (K882302) to be used with Z-800 infusion pump device. Hemolysis was identified as incremental risk. As a result of this risk analysis assessment, flowing blood hemolysis test with human blood was performed using production units which are identical to the currently marketed Z-800 infusion pumps. Per Zyno Medical LLC request, the test was conducted by a certified lab according to recognized Good Laboratory Practices following FDA recognized ASTM standard for assessment of hemolytic properties. All acceptance criteria were met (Each blood sample had a plasma free hemoglobin level that is less than 2 mg/mL; the correlation coefficient for the hemoglobin standard curve is greater than 0.95). Risk management activity has been incorporated into the device design/development process. A risk management report has been compiled to document risk level assessment for the list of FDA identified risks for infusion pump systems in Appendix A of "Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE) issued in April 23, 2010. Z-800 Validation Summary Report TR800-2010-02 submitted in Appendix E summarized the validation test results, which supports the conclusion which indicates that adding CareFusion blood set (K882302) to be used with Z-800 infusion pump for intravenous delivery of blood and blood products does not introduce any incremental risk to the user/patient safety. {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines representing wings or snakes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Chaoyoung Lee President Zyno Medical LLC 9 Tech Circle Natick, Massachusetts 01760 JUL - 8 2010 Re: K100705 Trade/Device Name: Zyno Z-800 Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Dated: June 8, 2010 Received: June 10, 2010 Dear Mr. Lee: We have reviewed vour 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. {7}------------------------------------------------ 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, Ctim U.m Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Z-800 Volumetric Infusion System Indications for Use: The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood and blood products to a human patient under the direction or supervision of physician or other certified health care professional. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Rill C. An 7/8/10 (Division Sign-Off) (Division Sign-On) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1 510(k) Number: k/00705