The Hospira GemStar IV Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritionals fluids, and blood/blood products to patients.

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ is intended for use in Intravenous (central line or peripheral access), 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.

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 an AC main adaptor, a rechargeable battery pack, a docking station, and two disposable AA alkaline or lithium 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, alarm and program status, and the parameters of fluid flow. The infusers function as both pole mounted and ambulatory infusion pumps.

AI/ML Overview

The provided document is a 510(k) summary for the Hospira GemStar I.V. Infusion Pump. It does not describe a study involving acceptance criteria and device performance in the manner typically seen for AI/ML-driven devices or diagnostic tools. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth) are not applicable to this type of submission.

However, I can extract the information relevant to its substantial equivalence claim, which serves as a form of "acceptance criteria" for regulatory clearance in this context.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of a 510(k) submission for an infusion pump, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it matches or is sufficiently similar to the predicate.

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance (as claimed by Hospira GemStar I.V. Infusion Pump)
Intended Use (Same as predicate)	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 to a patient.
Indications for Use (Same as predicate)	Hospital, ambulatory, and home care environments using sterile, dedicated, GemStar® administration sets.
Operating Principle (Same as predicate)	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.
Administration Sets and Fluid Contact Materials (Same as predicate)	Sterile, dedicated, non-pyrogenic, latex-free "GemStar" administration sets.
Physical Features (Same as predicate)	Materials, Size, Weight, Input Lines, Output Lines, Power Sources, Battery Type, Power Cord.
Environmental Features (Same as predicate)	Operating Temperature, Storage Temperature, Relative Humidity, Pressure.
Performance Features (Same as predicate)	Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, Delivery Modes, Therapies, Distal Occlusion Limits, Proximal Occlusion Limits, Alarm Types and Conditions, Default Drug Library.
BioMed Settings (Same as predicate)	Configuration settings available for customization.
Accessories (Same as predicate)	GemStar Connect™ Remote Communication Software (Clinician Kit, Patient Kit), Docking Station, Bolus Cord, Pole Clamps (2), Battery Pack, Lockboxes (3), AC Mains Adapters (2), Carrying Cases (4) and Carrier, Serial Cable.
Fundamental Scientific Technology (Same as predicate)	Same as predicate (implied through operating principle and performance claims).

2. Sample size used for the test set and the data provenance

Not Applicable (N/A). This document is a 510(k) summary for a medical device (infusion pump) based on substantial equivalence, not a clinical study or performance study that would involve a "test set" of data in the context of an AI/ML device. The "test" here refers to demonstrating that the device meets its own specifications and is equivalent to the predicate, which typically involves engineering verification and validation testing, not a specific "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). See explanation for point 2. No "ground truth" in the AI/ML sense is established from experts in this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable (N/A). See explanation for point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable (N/A). This device is an infusion pump, not a diagnostic or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A). This device is a physical infusion pump, not a standalone algorithm. While it has software, its performance is as a complete electromechanical system, always with human interaction for programming and monitoring.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable (N/A). For an electromechanical device like an infusion pump, "ground truth" typically refers to engineering specifications, physical measurements, and adherence to established standards (e.g., fluid delivery accuracy, occlusion pressure limits) rather than biological "ground truth" like pathology or expert consensus on a diagnosis. The "truth" is whether it performs to its design specifications consistently and equivalently to a legally marketed predicate.

8. The sample size for the training set

Not Applicable (N/A). This device does not use machine learning, so there is no training set in that context.

9. How the ground truth for the training set was established

Not Applicable (N/A). See explanation for point 8.

Summary

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Confidential

510(K) Summary

Name of Submitter:

Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Owner/Operator # 9063339

Manufacturer and Establishment Registration Number:

Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037

Establishment Registration # 2921482

Proprietary or Trade Name of Proposed Device: Hospira GemStar I.V. Infusion Pump

1. Common Name: Infusion Pump

Device Classification, Pancode and ProCode: Class II, 80-FRN (Infusion Pump) Class II, 80-FPA (Administration Sets)

1. 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:

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:

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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, alarm and program status, and the parameters of fluid flow. The infusers function as both pole 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
List #: 13000-04	List #: 13100-04	List #: 13150-04
TPN (Total Parenteral Nutrition)	TPN (Total Parenteral Nutrition)
Pain Management	Intermittent
Intermittent	Continuous
Continuous	Weight-Dosed	Pain Management Only
Weight-Dosed	mL/hr Only
Variable Time	Variable Time
ML/hr Only

10. Predicate Device Information:

Infusion pumps 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
K023062	Abbott GemStar® Infusion Pump System	09/30/2002
K000821	GemStar® I.V. Infusion Pump	05/24/2000

11. Statement of Substantial Equivalence:

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect® is substantially equivalent to the predicate Abbott GemStar® Infusion Pump Systems and Abbott GemStar Connect™ Software based on the following characteristics.

Similarities:

1. Same intended use and indications for use.
1. Same fundamental scientific technology.
1. Same physical, operational, and performance specifications,
1. Same features for programmability of therapy protocols.

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12. Comparison to Legally Marketed Device(s)

Factors	Subject Device(s)Hospira GemStar I.V. Infusion Pump System withHospira GemStar Connect	Predicate Device(s)Abbott GemStarInfusion Pump System
Intended Use	Intended for use in intravenous arterial, subcutaneous,short term epidural infusion and parenteral administrationof general I.V. fluids, medications, nutritional fluids, andblood/blood products to a patient.	Same
Indications for Use	Hospital, ambulatory, and home care environments usingsterile, dedicated, GemStar® administration sets.	Same
Operating Principle	Volumetric, piston driven, fluid displacement principle.Stepper motor with in-line cassette meters IV fluidsthrough sterile dedicated administration sets.Programmable fluid delivery through a variety of weightand medication based units. Visible indication of severalfunctions, including active pump operations, alarm andprogram status, and the parameters of fluid flow.	Same
Administration Sets andFluid Contact Materials	Sterile, dedicated, non-pyrogenic, latex-free "GemStar"administration sets.	Same
Physical Features	Materials, Size, Weight, Input Lines, Output Lines,Power Sources, Battery Type, Power Cord	Same
Environmental Features	Operating Temperature, Storage Temperature, RelativeHumidity, Pressure	Same
Performance Features	Delivery Rates, VTBI Range, Dose Units, DeliveryAccuracy, Delivery Modes, Therapies, Distal OcclusionLimits, Proximal Occlusion Limits, Alarm Types andConditions, Default Drug Library.	Same
BioMed Settings	Configuration settings available for customization.	Same
Accessories (Optional)	GemStar Connect™ Remote Communication Software(Clinician Kit, Patient Kit), Docking Station, BolusCord, Pole Clamps (2), Battery Pack, Lockboxes (3), ACMains Adapters (2), Carrying Cases (4) and Carrier,Serial Cable	Same

13. Summary of Substantial Equivalence

Summary of Subtainar Digar Micheles
The Hospira GemStar® I.V. Infusion Pump System with Hospira GemStar Connect" as described in This submission is substantially equivalent to the predicate Abbott GemStar® Infusion Pump System
this submission is substantially equivalent to the predicate Abbott GemStar"

1. intended use,
1. indication for use,
1. fundamental technology and operating principle,
1. physical, environmental and performance features, and
1. materials of construction for all infuser components and administration sets.

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14. Statement of Safety and Effectiveness

The Hospira GemStar® I.V. Infusion Pump System with Hospira GemStar Connect™ meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Abbott GemStar® Infusion Pump System with Abbott GemStar Connect™.

Prepared and submitted on October 28, 2004 by:

Patricia Miderki

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 of three wavy lines, which are meant to represent the human form.

Public Health Service

NOV 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Melerski Manager, Global Regulatory Affairs Hospira, Incorporated Dept. 389, Bldg. H-2 275 North Field Drive Lake Forest, Illinois 60045-5045

Re: K042980

Trade/Device Name: Hospira GemStar® Infusion Pump System Hospira GemStar Connect™ Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 28, 2004 Received: October 29, 2004

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. 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/dsma/dsmamain.html

Sincerely yours,

Clive
Shia-Lirn, Ph.D.

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)	K042980
Device Name:	Hospira GemStar ® Infusion Pump SystemHospira GemStar Connect ™ Software
Indications for Use	The Hospira GemStar ® Infusion Pump System with Hospira GemStar Connect ™ Software 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 X(Part 21 801 Subpart D)	AND/OR	Over-The Counter Use(Part 21 CFR 807 Subpart C)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).