(363 days)
Provides controlled delivery of fluids, blood and blood products and can be used in enteral, epidural, subcutaneous, arterial and intravenous applications.
Linear Peristaltic Infusion Pump
Here's an analysis of the provided text regarding the Sabratek 4040 Infusion Pump, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided information, the key performance characteristic highlighted and compared is the Flow Accuracy.
| Acceptance Criteria (Predicate Devices - 6060 & 3030) | Reported Device Performance (Sabratek 4040 Pump) | Meets Acceptance Criteria? |
|---|---|---|
| +/-6% (Sabratek 6060 Pump) | +/-5% | Yes |
| +/-5% (Sabratek 3030 Pump) | +/-5% | Yes |
It's important to note that the document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting explicit acceptance criteria for a new device against a predefined benchmark. The "acceptance criteria" here are derived from the performance of the predicate devices. The Sabratek 4040 meets or exceeds the flow accuracy of both predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non-clinical tests included accuracy testing and comparison with Sabratek's stated accuracy claim and recording of data."
- Sample Size: Not specified. The document does not provide any details regarding the number of units tested, the number of measurements taken, or specific test protocols that would allow for the determination of sample size.
- Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the U.S. FDA, it is highly likely that the testing was conducted domestically (US) or by a manufacturer associated with US regulatory requirements. There is no information to indicate if the data was retrospective or prospective, but for device approval, it would typically be prospective testing specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is an infusion pump, and its "ground truth" for performance is established through objective engineering and metrological measurements (e.g., flow rate calibration, volume dispensed) rather than subjective expert interpretation (like a radiologist reading an image). There would be no need for medical experts to establish a "ground truth" for the device's accuracy performance.
4. Adjudication Method for the Test Set
- Not applicable. As the "ground truth" is based on objective measurements, there would be no subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for an infusion pump. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, implicitly. The "accuracy testing" mentioned is a standalone performance test of the device itself. The infusion pump operates without human intervention in its core pumping and accuracy functions. The stated performance of "+/-5%" for Flow Accuracy is a standalone performance metric of the device.
7. The Type of Ground Truth Used
- Engineering/Metrological Measurements. The ground truth for infusion pump accuracy is objective and quantifiable. It involves precisely measuring the volume of fluid dispensed over a given time and comparing it to the programmed flow rate. This would involve calibrated equipment and measurement standards.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical/electronic infusion pump, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its engineering design, calibration, and manufacturing specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this device.
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2/04/99
510(k) Submission, Sabratek 4040 Infusion Pump
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 standardsHave been issued under Section 514 ofThe Food, Drug and Cosmetic Act. |
| Predicate Device: | Sabratek 6060 HOMERUN® Volumetric Infusion Pump |
K941984 and Sabratek 3030 Infusion Pump, K914581.
| ELEMENT OFCOMPARISON | 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,subcutaneous & intracavityinfusions | Intravenous, Intra-arterial,subcutaneous & intracavityinfusions | Linear Peristaltic |
| Administration Sets-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-Anti Free Flow Clamp (Set) | Yes | Yes | No |
| -Free Flow Clamp (Pump) | Yes | No | Yes |
| Specific Drug, biologic use:-Blood/Blood Products | Blood/Blood Products | No | No |
| Components-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 | Switchable90-132/138-264Vac 50/60hz | 12 - 18 Volts DC, 50 mamaximum | 110V AC, 10 watts, 50/60hz |
| 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 CommunicationCapability | 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 bloodproducts and can be used in enteral, epidural, subcutaneous,arterial and intravenous applications. |
|---|---|
| Contraindications | The Sabratek 4040 Infusion Pump is contraindicated for usewith a blood set, other than those specifically designated assuch and manufactured by Sabratek Corporation. |
| Non-Clinical Tests | Non-clinical tests included accuracy testing and comparisonwith Sabratek's stated accuracy claim and recording of data. |
| Conclusions | The Sabratek 4040 Infusion Pump is equivalent in safety andefficacy 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 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).