(28 days)
The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and accessories is intended for use in intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.
The Hospira GemStar® Infusion Pump Systems are a family of single channel, software controlled, electromechanical infusion pumps that operate on a volumetric, piston driven, fluid displacement principle. An in-line cassette is used to meter IV fluids through sterile dedicated administration sets designed to be used exclusively with GemStar infusers. Power options included AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. The pump displays provide visible indication of several functions, including active pump operations, alarms, program status, and the parameters of fluid flow. The infusers function as both pole mounted and ambulatory infusion pumps.
This document, a 510(k) summary for the Hospira GemStar® Infusion Pump System, does not contain the specific type of information requested about acceptance criteria and a study proving a device meets those criteria, as it relates to performance metrics of an AI/ML powered device.
The provided text describes a traditional medical device (an infusion pump) and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it details the intended use, indications for use, operating principles, physical features, and performance features of the infusion pump itself, rather than evaluating an AI/ML algorithm's performance against defined acceptance criteria using a study.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Sample size used for a test set or its provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study.
- Details about a standalone algorithm performance study.
- Type of ground truth used (in the context of an AI/ML algorithm).
- Sample size for a training set (for an AI/ML algorithm).
- How ground truth for a training set was established (for an AI/ML algorithm).
The "Performance Features" section mentions "Delivery Accuracy" for the infusion pump, which is a performance criterion, but it doesn't provide the acceptance limits or the study data demonstrating compliance. It simply states that the subject device's performance features are "Different" from the predicate device in specific ways (e.g., increased programming and delivery precision for pain management therapies), implying that these differences were evaluated without detailing the specific study design or results.
In essence, this document is a regulatory submission for a hardware medical device, not an AI/ML software as a medical device (SaMD) or a device incorporating AI/ML. Therefore, the requested information type is not present.
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510(K) Summary
1. Name of Submitter: Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045
APR 2 1 2006
Owner/Operator # 9063339
- Manufacturer and Establishment Registration Number:
Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037
3. Proprietary or Trade Name of Proposed Device:
Hospira GemStar® Infusion Pump Systems
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- Common Name: Infusion Pump IV Administration Sets
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- Device Classification, Pancode and ProCode: Class II, FRN (Infuser)
Class II, FPA (IV Administration Sets) Class II, MRZ (Infusion Pump Lockboxes)
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- Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps. Infusion pumps are listed in 21 CFR 880.5725.
7. Intended Use:
The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and accessories is intended for use in intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
8. Indications for Use:
The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.
9. Proposed Device Description:
The Hospira GemStar® Infusion Pump Systems are a family of single channel, software controlled, electromechanical infusion pumps that operate on a volumetric, piston driven, fluid displacement principle. An in-line cassette is used to meter IV fluids through sterile dedicated administration sets designed to be used exclusively with GemStar infusers. Power options included AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. The pump displays provide visible indication of several functions, including active pump operations, alarms, program status, and the parameters of fluid flow. The infusers function as both pole
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mounted and ambulatory infusion pumps.
As of May 03, 2004, both the infusers and the dedicated GemStar® sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.
All Hospira GemStar® I.V. Infusion Pumps are single channel pumps that are available in the following configurations:
| Overview of GemStar® I.V. Infusion Pump Therapies and Configurations | ||
|---|---|---|
| 7 Therapy Pump | 6 Therapy Pump | Pain Management Pump |
| TPN (Total Parenteral Nutrition) | TPN (Total Parenteral Nutrition) | |
| Pain Management | Intermittent | |
| Intermittent | Continuous | |
| Continuous | Weight-Dosed | Pain Management Only |
| Weight-Dosed | Variable Time | |
| Variable Time | ||
| mL/hr Only | mL/hr Only |
10. Predicate Device Information:
Devices cleared for commercial distribution and determined to be appropriate for use as predicates are summarized in the following table.
| 510(k) # | Product Name | Clearance Date |
|---|---|---|
| K051079 | Hospira GemStar Infusion Pump System with HospiraGemStar Spring Assist Mechanism Lockbox | 05/19/2005 |
| K042980 | Hospira GemStar® Infusion Pump System with HospiraGemStar Connect™ Software | 11/17/2004 |
| K023062 | Abbott GemStar® Infusion Pump System | 09/30/2002 |
11. Comparison to Legally Marketed Device(s)
| Factors | Subject Device(s)Hospira GemStar® Infusion Pump Systems | Predicate Device(s) |
|---|---|---|
| Intended Use | Intended for use in intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. | Same |
| Indications for Use | Hospital, ambulatory, and home care environments using sterile, dedicated, GemStar® administration sets. | Same |
| Operating Principle | Volumetric, piston driven, fluid displacement principle.Stepper motor with in-line cassette meters IV fluids through sterile dedicated administration sets.Programmable fluid delivery through a variety of weight and medication based units. Visible indication of several functions, including active pump operations, alarm and program status, and the parameters of fluid flow. | Same |
| Factors | Subject Device(s) | Predicate Device(s) |
| Administration Setsand Fluid ContactMaterials | Sterile, dedicated, non-pyrogenic, latex-free "GemStar"administration sets. | Different |
| Addition of (3) new sets toGemStar Set line sincelast cleared 510(k)) | ||
| Physical Features | Materials, Size, Weight, Input Lines, Output Lines,Power Sources, Battery Type, Power Cord | Different |
| 1) Slight increase inWeight and Height | ||
| 2) Removal of thedisposable AA lithiumbatteries, NiMH BatteryPack, and NiMH DockingStation as options. | ||
| 3) Change in Pump TopCap Material | ||
| EnvironmentalFeatures | Operating Temperature, Storage Temperature, RelativeHumidity, Pressure | Same |
| PerformanceFeatures | Delivery Rates, VTBI Range, Dose Units, DeliveryAccuracy, Delivery Modes, Therapies, Distal OcclusionLimits, Proximal Occlusion Limits, Alarm Types andConditions, Default Drug Library. | Different1) Addition of aprogramming optionwithin Weight DosedTherapy to permit deliveryof Precedex®(dexmedetomidinehydrochlorideinjection),2) Increased programmingand delivery precision forpain managementtherapies.3) Allowance for VTBItitration without changingcontainer size. |
| BioMed Settings | Configuration settings available for customization. | Different |
| Option to customconfigure air sensitivitydefault lockout. | ||
| Factors | Subject Device(s) | Predicate Device(s) |
| Key Accessories(Optional) | Hospira GemStar Infusion Pump SystemsGemStar Connect™ Remote Communication Software(Clinician Kit, Patient Kit), Docking Station (2), BolusCord, Battery Pack (2), Lockboxes (4), AC MainsAdapters (3), Carrying Cases (4) and Carrier, Serial Cable | DifferentAddition of optionalWall Mount Adapter,100-240VAC since lastcleared 510(k). |
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Hospira GemStar® Infusion Pump System Special 510(k) / March 2006
12. Statement of Substantial Equivalence:
Hospira GemStar® Infusion Pump Systems with the Hospira GemStar® Pump Scts and accessories are substantially equivalent to the predicate devices identified in the submission.
Similarities:
- l ) Same intended use and indications for use.
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- Same fundamental scientific technology.
- Similar physical, operational, and performance specifications. 3)
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- Similar materials of construction for all infuser components.
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- Same materials of construction for new administration sets as previously cleared sets.
13. Statement of Safety and Effectiveness
Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and accessories meet the functional claims and intended use as described in the product labeling, and are as safe and edited in terms of substantial equivalence as the predicate devices described in the submission.
Prepared and submitted by: Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: 224/212-4880 Fax: 224/212-5401
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
Ms. Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Incorporated 275 N. Field Drive, Building H-2, Dept. 389 Lake Forest, Illinois 60045
Re: K060806
Trade/Device Name: Hospira GemStar® Infusion Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 23, 2006 Received: April 24, 2006
Dear Ms. Melerski:
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 -- Ms. Patricia Melerski
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 labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Schutze by Miction Omd.
Chiu Lin, Ph.D. 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 Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name: | Hospira GemStar® Infusion Pump System |
| Indications for Use | The Hospira GemStar® Infusion Pump System is intended for use in intravenous arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets. |
Prescription Use メ (Part 21 801 Subpart D) AND/OR
Over-The_Counter Use_ (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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).