SABRATEK 4040 INFUSION PUMP

K980751 · Sabratek Corp. · FRN · Feb 24, 1999 · General Hospital

Device Facts

• Record ID: K980751
• Device Name: SABRATEK 4040 INFUSION PUMP
• Applicant: Sabratek Corp.
• Product Code: FRN · General Hospital
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Provide controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutaneous, arterial and intravenous applications. Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Linear peristaltic infusion pump; delivers fluids, blood, and blood products. Inputs: user-programmed flow rates (0.1-999 ml/hr) and infusion volumes. Operates via linear peristaltic mechanism; includes pressure sensors and ultrasound air-in-line detection. Outputs: controlled fluid delivery; audible and LCD alarms for air-in-line, occlusion, battery status, and malfunction. Used in clinical settings by healthcare professionals. Benefits: precise, controlled administration of intravenous/arterial/subcutaneous therapies; reduces risk of free-flow via anti-free-flow clamp. External communication capability included.

Clinical Evidence

Bench testing only. Included accuracy testing and comparison against stated performance claims. No clinical data provided.

Technological Characteristics

Linear peristaltic pump. Materials: PVC tubing, ABS spikes/luer locks, silicone rubber tubing, modified acrylic/supor filters. Power: 90-132/138-264Vac. Features: pressure sensors, ultrasound air-in-line detection, external communication. Software: embedded control for flow rates, volume limits, and alarm monitoring.

Indications for Use

Indicated for controlled delivery of fluids, blood, and blood products via enteral, epidural, subcutaneous, arterial, or intravenous routes. Contraindicated for use with blood sets not specifically designated and manufactured by Sabratek Corporation.

Regulatory Classification

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.

Predicate Devices

• Sabratek 6060 HOMERUN® Volumetric Infusion Pump (K941984)
• Sabratek 3030 Infusion Pump (K914581)

Submission Summary (Full Text)

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2/04/99

510(k) Submission, Sabratek 4040 Infusion Pump

K980751

Sabratek, Niles, IL 60714

The following is a Summary of the Sabratek 4040 Infusion Pump substantial equivalence and safety and efficacy.

| Classification Name: | Infusion Pump |
|------------------------|------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Infusion Pump |
| Proprietary Name: | Sabratek 4040 Infusion Pump |
| Classification: | Class II Medical Device |
| Performance Standards: | No applicable performance standards<br>Have been issued under Section 514 of<br>The Food, Drug and Cosmetic Act. |
| Predicate Device: | Sabratek 6060 HOMERUN® Volumetric Infusion Pump |

K941984 and Sabratek 3030 Infusion Pump, K914581.

| ELEMENT OF<br>COMPARISON | SABRTATEK 4040 PUMP | SABRATEK 6060 PUMP | SABRATEK 3030 PUMP |
|-------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------|
| 510(k)# | | K941984 | |
| Pump type | Linear Peristaltic | Rotary Peristaltic | Linear Peristaltic |
| Intended use(s) | Intravenous, Intra-arterial,<br>subcutaneous & intracavity<br>infusions | Intravenous, Intra-arterial,<br>subcutaneous & intracavity<br>infusions | Linear Peristaltic |
| Administration Sets<br>-Captive Standard Set | Yes | Yes | No |
| -Captive 1.2 Micron Filter | Yes | Yes | No |
| -Captive .22 Micron Filter | Yes | Yes | No |
| -Standard Sabraset | Yes | No | Yes |
| -Approved Competitive Sets | Yes | No | Yes |
| Free Flow Clamp<br>-Anti Free Flow Clamp (Set) | Yes | Yes | No |
| -Free Flow Clamp (Pump) | Yes | No | Yes |
| Specific Drug, biologic use:<br>-Blood/Blood Products | Blood/Blood Products | No | No |
| Components<br>-Pumping Mechanism | Yes | Yes | Yes |
| -Battery | Yes | Yes | Yes |
| -Pressure Sensor | Yes | Yes | Yes |
| -Ultrasound Air In Line | Yes | Yes | Yes |
| Pumping mechanism | Linear Peristaltic | Rotary Peristaltic | Linear Peristaltic |
| Power Requirements | Switchable<br>90-132/138-264Vac 50/60<br>hz | 12 - 18 Volts DC, 50 ma<br>maximum | 110V AC, 10 watts, 50/60<br>hz |
| Battery Life | 6-6.5 hrs at 125 ml/hr | 25 hrs at 125 ml/hr | 7-8 hrs at 125 ml/hr |
| Recharge Time | 24 hrs | N/A | 24 hrs |
| | | | |
| Fluid Path Material: | | | |
| -Tubing | PVC | PVC | PVC |
| -Spike | ABS | ABS | ABS |
| -Check Valve | N/A | N/A | N/A |
| -Silicone Rubber Tubing | Silicone Rubber | Silicone Rubber | Silicone Rubber |
| -1.2 or .22 Micron Filter | Modified acrylic/supor | Modified acrylic/supor | Modified acrylic/supor |
| -MLL (Male Luer Lock) | ABS | ABS | ABS |
| -Connecting Barbs | Acrylic | Acrylic | Acrylic |
| -Y-Site | Acrylic | Acrylic | Acrylic |
| -Fluid Bag | N/A | EVA | N/A |
| -Solvent bonding Solution | Cyclohexanone | Cyclohexanone | Cyclohexanone |
| Infusion Parameters: | | | |
| -Flow Rate Range | 0.1 - 999 ml/hr | 0.1 400 ml/hr | 1- 999 ml/hr |
| -Flow Accuracy, % | +/-5% | +/-6% | +/-5% |
| -KO rate | 0.1 - 10 ml/hr | 0.1- 10 ml/hr | 1 - 9 ml/hr |
| -Infusion volume limit | 0.1 - 999.9 ml | 1.1 - 9999 ml | 1 - 999 ml |
| -Prime/purge mode | No | Yes | No |
| Profiles | | | |
| -Continuous | Yes | Yes | Yes |
| -Auto-Ramp | Yes | Yes | Yes |
| -Intermittent | Yes | Yes | Yes |
| -25 Period | Yes | Yes | Yes |
| -PCA | No | Yes | No |
| Alarm Type: | | | |
| -Air-In-Line | Audible, LCD | Audible, LCD | Audible, LCD |
| -Cassette Not Installed | N/A | Audible, LCD | N/A |
| -Check Internal 9V Batteries | N/A | Audible, LCD | N/A |
| -Complete XX ml (or mg) | Audible, LCD | Audible, LCD | Audible, LCD |
| -Door Open | Audible, LCD | Audible, LCD | Audible, LCD |
| -Down Occlusion | Audible, LCD | Audible, LCD | Audible, LCD |
| -Empty Bag or Up Occlusion | Audible, LCD | Audible, LCD | Audible, LCD |
| -Empty Battery | Audible, LCD | Audible, LCD | Audible, LCD |
| -Hold | Audible, LCD | Audible, LCD | Audible, LCD |
| -Low Bag | None | Audible, LCD | None |
| -Low Battery | Audible, LCD | Audible, LCD | Audible, LCD |
| -Malfunction | Audible, LCD | Audible, LCD | Audible, LCD |
| -Move Tubing | Audible, LCD | None | Audible, LCD |
| -Nicad Depleted | Audible, LCD | Audible, LCD | Audible, LCD |
| -Rate Exceeds Microset Limits | N/A | Audible, LCD | N/A |
| -Release/Remove PCA Cord | N/A | Audible, LCD | N/A |
| -Reprogram | Audible, LCD | Audible, LCD | Audible, LCD |
| -Stuck Key | Audible, LCD | Audible, LCD | Audible, LCD |
| -High Pressure | Audible, LCD | Audible, LCD | Audible, LCD |
| -Low Pressure | Audible, LCD | Audible, LCD | Audible, LCD |
| External Communication<br>Capability | Yes | Yes | Yes |

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## 510(k) Submission, Sabratek 4040 Infusion Pump

## Sabratek, Niles, IL 60714

:

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| Indications | Provides controlled delivery of fluids, blood and blood<br>products and can be used in enteral, epidural, subcutaneous,<br>arterial and intravenous applications. |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | The Sabratek 4040 Infusion Pump is contraindicated for use<br>with a blood set, other than those specifically designated as<br>such and manufactured by Sabratek Corporation. |
| Non-Clinical Tests | Non-clinical tests included accuracy testing and comparison<br>with Sabratek's stated accuracy claim and recording of data. |
| Conclusions | The Sabratek 4040 Infusion Pump is equivalent in safety and<br>efficacy to its predicate devices. |

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 1999

Mr. Charles P . Gill Manager, Regulatory Affairs Sabratek Corporation 8111 North St.Louis Avenue Skokie, Illinois 60076

K980751 Re : Sabratek 4040 Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN Dated: November 13, 1998 December 3, 1998 Received:

Dear Mr. Gill

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Gill

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ﻴﺔ

510(k) Number (if Known)

Device Name: Sabratek 4040 Infusion Pump

Provide controlled delivery of fluids, blood and blood products and can be Indications for use: used in enteral, epidural, subcutancous, arterial and intravenous applications.

Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

## (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use -----

Labacia Cucente (Optional Format 1-2-96)
(Division)

(Division Sign-Off) Division of Denial. Infection Control, and General Hospital Devices

510(k) Number K980751