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 (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.

AI/ML Overview

Here's an analysis of the provided text regarding the Z-800 Infusion System, focusing on acceptance criteria and the supporting study:

The provided document, K100705, is a 510(k) summary for the Z-800 Infusion System. This particular submission concerns qualifying CareFusion's blood administration sets for use with the already marketed Z-800 infusion pump to extend its intended use to include intravenous administration of blood and blood products.

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria and reported performance specifically for the new intended use (blood administration) are related to hemolysis testing.

Acceptance Criteria	Reported Device Performance
Plasma free hemoglobin level	Less than 2 mg/mL for each blood sample
Correlation coefficient for	Greater than 0.95 for the hemoglobin standard curve
hemoglobin standard curve

Other general device performance specifications for the Z-800 Infusion Pump are found in the "Equivalency Matrix" (Table 1), establishing equivalence to predicate devices. These performance metrics include:

Volume and Rate Accuracy: +/- 5%
Occlusion Pressure Accuracy: Low: 4 psi, Medium: 16 psi, High: 30 psi (adjustable)
Rate Range: 1 ml/hr to 999 ml/hr in 1 ml/hr increment
Battery Life: 8 hours at 125 ml/hr

The document states that these general performance specifications of the Z-800 infusion pump remain the same as the currently marketed device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of blood samples or test runs performed for the hemolysis study. It mentions "production units" of the Z-800 infusion pump were used.
Data Provenance: The hemolysis test was conducted by a "certified lab" according to "recognized Good Laboratory Practices" following an "FDA recognized ASTM standard." The blood used was "human blood." The document does not explicitly state the country of origin but implies a US context given the FDA submission. The study appears to be prospective as it was performed specifically to address the incremental risk of hemolysis identified during the risk analysis for the extended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is a laboratory test (hemolysis testing) and not a clinical study involving experts establishing ground truth for diagnostic or clinical outcomes. The "ground truth" for the hemolysis test is objectively measured plasma free hemoglobin levels and statistical correlation, not expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies when multiple reviewers assess cases and discrepancies need to be resolved. The hemolysis test results are quantitative measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This is a medical device (infusion pump) and the study focuses on its physical performance and biological interaction (hemolysis), not on human reader performance with or without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study was performed regarding the functional aspects of the physical device. The hemolysis test evaluates the device's interaction with blood without human intervention in the hemolysis measurement process itself. The broader device validation summarized in "Z-800 Validation Summary Report TR800-2010-02" (mentioned as Appendix E) would further demonstrate the standalone performance of the infusion pump (e.g., flow rate accuracy, occlusion detection) without considering human-in-the-loop aspects.

7. Type of Ground Truth Used

For the hemolysis testing, the ground truth was objective laboratory measurements of "plasma free hemoglobin level" and "correlation coefficient for the hemoglobin standard curve." These are quantitative, biologically derived measurements based on established ASTM standards and Good Laboratory Practices.

8. Sample Size for the Training Set

This information is not applicable. The Z-800 Infusion System is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are validated through engineering tests and quality control, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

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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

Device Description:

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

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(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

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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-venousEnteral	IntravenousEpidural	IntravenousEnteral
Units of delivery	ml/hr	mg/kg/minmg/kg/hrmg/minmg/hrmcg/kg/minmcg/kg/hrmcg/minmcg/hrg/kg/hrg/hrg/kg/ming/minU/kg/hrU/kg/minU/minU/hrml/hrml/min	units/hrunits/kg/minunits/kg/hrmilliunits/mingrams/hrmcg/kg/minmcg/kg/hrmcg/minmcg/hrmg/kg/minmg/kg/hrmg/minmg/hrml/hr	ml/hrmcg/minmcg/kg/min
Pumpingmechanism	Linear peristaltic pump	Linear peristaltic pump	Linear peristaltic pump	Linear peristaltic pump
Free FlowProtection	IV set based free flowprotection (Option)Pump based free flowprotection YES	IV set based free flowprotection (Option)Pump based free flowprotection YES	IV set based free flowprotection YES.Pump based free flowprotection YES	IV set based free flowprotection YES.Pump based free flowprotection YES
Administrationsets	Approved standard PVCgravity tubing	B. Braun basic pumpadministration sets.	Approved standard PVCgravity tubing	Approved standard PVCgravity tubing
Power source	AC: 100-250V 50-60 HzDC: Internal NickelMetal Hydride	AC: 100-120V 50-60 HzDC: Internal NiCd	AC:105-135V 50/60 Hz220-240V 50/60 HzDC: Sealed lead acid	AC: 100-130V 47-63 HzDC: Internalrechargeable 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 dotmatrix LCD	Custom LCD	LED	Custom LCD
Case construction	Milled Aluminum &Sheet Metal Enclosure	Sheet Metal andInjection MoldedPlastic Enclosure	High impact InjectionMolded PlasticEnclosure	High impact InjectionMolded PlasticEnclosure
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 RateAccuracy	+/- 5%	+/- 5%	+/- 5%	+/- 5%
OcclusionPressure Accuracy	Low: 4 psiMedium 16 psiHigh: 30 psiadjustable	Low: 8 psi, unspecifiedaccuracyHigh 17 psi,unspecified accuracy	Low 2 psiHigh 15 psiadjustable	Low 6 psiMedium 10pisHigh 20 psi
Parameter	Z-800	B. Braun Vista basic	Sigma 8000	Abbott Acclaim Encore
Rate Range	1 ml/hr to 999 ml/hr in1 ml/hr increment	0.1 to 800 ml/hr	0.1 to 99.9 ml/hr (in 0.1ml/hr increments)100 to 999 ml/hr (in 1ml/hr increments)	1.0 to 99.9 ml/hr (in0.1ml/hr increments)100 to 999 ml/hr (in 1ml/hr increments)
Warnings / Status	Low BatteryNear EndInfusion CompletePump unattendedKVO	Low BatteryNear EndInfusion CompletePump StoppedBag Empty (with DripSensor)KVO	Low batteryImproper IV set loadingInfusion CompleteClose Roller ClampPM DueKVO	BatteryCheck SettingsVTBI completeStopped (unattended)No Slide ClampKVO
Alarms	OcclusionBattery EmptyAir-In-LineDoor OpenSystem ErrorNo Drip (with dripsensor)Drip sensor connection(with drip sensor)	OcclusionPlug In NowAir-In-LineDoor OpenUnit Malfunction	OcclusionPlug inAir-In-LinePump Malfunctions	OcclusionBattery OffAir-In-LineCheck DoorCheck Slide Clamp
Inputs	Continuous ModePrimary RatePrimary VTBISecondary RateSecondary VTBIVolume/TimePrimary VTBIPrimary TimeSecondary VTBISecondary TimeTPNTotal VTBITotal TimeRamp Up TimeRamp Down Time10 Step SequenceNth RateNth VTBI(N=1 to 10)	Continuous ModePrimary RatePrimary VTBDSecondary RateSecondary VTBDVolume/TimePrimary VTBDPrimary TIMESecondary VTBDSecondary TIMERate & TimePrimary RatePrimary TimeSecondary RateSecondary TimeTPNTotal Bag VolumeTotal TimeRamp Up timeTaper Down Time10 Step SequenceNth RateNth VTBD(N=1 to 10)Dose Calc ModeConcentration ValueConcentration UnitBody WeightDrug Dose amountDrug Dose UnitDiluent VolumeDelay A ModeDelay Time Amount	Continuous ModePrimary RatePrimary VTBIPiggyback RatePiggyback VTBIVolume/TimePrimary VTBDPrimary TIMEPiggyback VTBDPiggyback TIMERate & TimePrimary RatePrimary TimePiggyback RatePiggyback TimeTPNVolume LimitMain RateRamp TimeTaper Time21 Step SequenceNth RateNth VTBI(N=1 to 21)Dose Rate ModeDrug Dose amountDrug Dose UnitBody WeightDiluent VolumeVolume LimitDelay Start ModeDelay Time AmountKVO option	Continuous ModePrimary RatePrimary VTBISecondary RateSecondary VTBIVolume/TimePrimary VTBIPrimary TIMESecondary VTBISecondary TIMETPNTotal VTBITotal TIMETaper up TIMETaper down TIMEDose Calc forMICROGRAM deliveryPatient WeightDrug amountDiluent VolumeDose Rate
Parameter	Z-800	B. Braun Vistabasic	Sigma 8000	Abbott AcclaimEncore
SerialCommunications	Bidirectional	Bidirectional	Bidirectional	None

Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request

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Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request

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Z-800 Premarket Notification – Modified on June 2, 2010 in response to FDA request

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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.

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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.

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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 (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

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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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).