(14 days)
The Abbott GemStar® Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
The Abbott GemStar® Infusion Pump can function as both a pole-mounted and an ambulatory infusion pump and it is intended for use in hospital, ambulatory and home care environments. All GemStar® pumps are single channel pumps and they are offered for sale in the following configurations: 7 Therapy Pump, 6 Therapy Pump, Pain Management Pump. The Abbott GemStar® Infusion Pump is an electromechanical infusion pump that functions on a volumetric, piston driven, fluid displacement principle. The pump delivers I.V. fluids through an intravenous administration set that is also manufactured and distributed by Abbott Laboratories. The sets are described as "GemStar Pump Sets" because they are dedicated for use in this system. The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units including grams. micrograms, milliliters and other units per specified time interval. The display on the pump provides visible indication of multiple functions including active pump operations, alarm and program status and the parameters of fluid flow. The pump can also be used for standard or piggyback fluid delivery. The administration set incorporates integral, set-based free flow protection through a flow stop cassette and other free flow protection measures such as a roller or slide clamp, and an anti-siphon valve. The pump includes a check cassette software function in all modes. Lastly, the labeling for both the sets and the user manual has been revised to highlight these features.
Here's an analysis of the provided text regarding the Abbott GemStar® Infusion Pump System, focusing on acceptance criteria and study details:
This document is a 510(k) Summary for a device modification, not an initial market clearance. Therefore, the "study" described is a design validation and verification rather than a full clinical trial establishing initial safety and efficacy for a novel device. The core argument for clearance is substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria or detailed quantitative performance metrics for the modified device. Instead, it makes a general statement about the outcome of testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable functional performance of the modified device and sets. | "The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device." |
| No new issues of safety and effectiveness raised by modifications. | "These differences [minor changes to mechanical parts, software enhancements, anti-siphon valve, revised labeling] do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document states "Data regarding the functional performance... has been generated and reviewed" and "results of testing conducted to validate and verify the design modifications." This implies a series of engineering and functional tests rather than a patient-based clinical study with a defined sample size.
- Data Provenance: Not specified, but given the nature of a 510(k) for a device modification involving mechanical and software changes, the testing would almost certainly have been conducted retrospectively in a lab/engineering environment at Abbott Laboratories, rather than involving prospective patient data acquisition. The country of origin of the data is not mentioned and likely not relevant for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was a technical validation and verification of device modifications, not a study requiring expert clinical assessment to establish ground truth for a test set. The "ground truth" would have been defined by the device's technical specifications and intended functional performance.
4. Adjudication Method for the Test Set
Not applicable. This was a technical validation, not a multi-expert review or adjudication scenario.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes a 510(k) submission for a modification to an existing infusion pump, focused on technical validation. MRMC studies are typically performed for diagnostic imaging devices or AI algorithms where human interpretation is involved, which is not the case here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device is an infusion pump, which inherently involves human interaction for programming and operation. While there are software enhancements mentioned ("modifying and enhancing the software to incorporate changes requested by users"), the term "standalone performance" in the context of AI algorithms is not directly applicable. The device's software performs its functions (e.g., controlling fluid delivery, displaying information) in a "standalone" computational sense, but it operates within a system where a human programs and oversees its use. The "testing" referred to would have evaluated the software's functional correctness.
7. The Type of Ground Truth Used
The ground truth for this submission would have been established by:
- Engineering Specifications: The design requirements and specifications for the modified mechanical parts and enhanced software.
- Predicate Device Performance: The established, acceptable performance of the original Abbott GemStar™ I.V. Infusion Pump served as the baseline for substantial equivalence.
- Regulatory Standards: Adherence to relevant performance standards for infusion pumps.
The documentation relies on "functional performance" as the basis for acceptability.
8. The Sample Size for the Training Set
Not applicable. This project involves a medical device (infusion pump) with embedded software, not a machine learning or AI algorithm that requires a training set in the conventional sense. The software changes were enhancements and modifications, likely developed and tested against defined engineering requirements rather than trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the software development (if one were to loosely interpret it) would be the correct implementation of the new features and modifications as per design specifications and user requirements.
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SEP 3 0 2002
Special 510(k): Device Modification Abbott GemStar® Infusion Pump System Page 1 of 4
510(k) SUMMARY
Abbott GemStar® Infusion Pump System
Submitted by:
Frank Pokrop Associate Director, Regulatory Affairs Abbott Laboratories D-389. Bldg. J-45 Abbott Park, IL 60064
Date Prepared:
September 13, 2002
Name/Classification of Device:
Infusion Pump, Class II 80 FRN - 21 CFR Part 880.5725
Intravascular Administration Set 80 FPA - 21 CFR Part 880.5440
Proposed Device:
Abbott GemStar® Infusion Pump System
Predicate Device:
Abbott GemStar™I.V. Infusion Pump
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Special 510(k): Device Modification Abbott GemStar® Infusion Pump System Page 2 of 4
Proposed Device Description:
The Abbott GemStar® Infusion Pump can function as both a pole-mounted and an ambulatory infusion pump and it is intended for use in hospital, ambulatory and home care environments. All GemStar® pumps are single channel pumps and they are offered for sale in the following configurations:
| 7 Therapy Pump | 6 Therapy Pump | Pain Management Pump |
|---|---|---|
| List #: 13000-04-05 | List #: 13100-04-05 | List #: 13150-04-05 |
| TPN (Total Parenteral Nutrition) | TPN (Total Parenteral Nutrition) | Pain Management Only |
| Pain Management | Intermittent | |
| Intermittent | Continuous | |
| Continuous | Weight Dosed | |
| Weight Dosed | mL/hr Only | |
| Variable Time | Variable Time | |
| mL/hr Only |
Overview of GemStar Infusion Pump Therapies and Configurations
The Abbott GemStar® Infusion Pump is an electromechanical infusion pump that functions on a volumetric, piston driven, fluid displacement principle. The pump delivers I.V. fluids through an intravenous administration set that is also manufactured and distributed by Abbott Laboratories. The sets are described as "GemStar Pump Sets" because they are dedicated for use in this system.
The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units including grams. micrograms, milliliters and other units per specified time interval.
The display on the pump provides visible indication of multiple functions including active pump operations, alarm and program status and the parameters of fluid flow. The pump can also be used for standard or piggyback fluid delivery.
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Special 510(k): Device Modification Abbott GemStar® Infusion Pump System Page 3 of 4
The administration set incorporates integral, set-based free flow protection through a flow stop cassette and other free flow protection measures such as a roller or slide clamp, and an anti-siphon valve. The pump includes a check cassette software function in all modes. Lastly, the labeling for both the sets and the user manual has been revised to highlight these features.
Statement of Intended Use:
The Abbott GemStar® Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general 1.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.
This is the same intended use as the predicate device.
The pump must be used with sterile, dedicated, intravenous GemStar® administration sets.
Summary of Technological Characteristics of the New Pump and Sets Compared to Predicate Devices
The proposed pump and sets have similar designs, materials of construction, components, labeling and manufacturing processes as the currently marketed Abbott GemStar™ Infusion Pump and New Wave sets.
Abbott proposes to modify the predicate device through minor changes to the mechanical parts, modifying and enhancing the software to incorporate changes requested by users, adapting the existing sets for use with an anti-siphon valve and revising the labeling to reflect the proposed changes.
These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device.
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Special 510(k): Device Modification
Abbott GemStar® Infusion Pump System Page 4 of 4
Discussion and Conclusions from Nonclinical Tests:
Data regarding the functional performance of the proposed Abbott GemStar® Infusion Pump and sets has been generated and reviewed.
The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
SEP 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Pokrop Associate Director, Regulatory Affairs Abbott Laboratories Hospital Products Division 200 Abbott Park Road Dept. 0389, Building J-45 Abbott Park, Illinois 60064-6133
Re: K023062
Trade/Device Name: Abbott GemStar® Infusion Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 13, 2002 Received: September 16, 2002
Dear Mr. Pokrop:
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Pokrop
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 labcling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timoth A. Ulatowski Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name: | Abbott GemStar® Infusion Pump System |
| Indications For Use: | The Abbott GemStar® Infusion Pump System has the following indications for use: |
| The Abbott GemStar® Infusion Pump is intended for use in intravenous arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. |
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_
Vick Hubbard for Pat Ciuciati
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancolnoology
Infection Control, Dental Devices
510(k) Number LO23062
§ 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).