The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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.

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 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

This document is a 510(k) summary for the Hospira GemStar® Infusion Pump System and related components. It seeks to establish substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving those are met is not present in the provided text.

Based on the content, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating equivalence to predicate devices, implying that the subject device meets the performance characteristics demonstrated by those predicates. The "Performance Features" section in the comparison table mentions categories such as "Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy, Delivery Modes, Therapies, Distal Occlusion Limits, Proximal Occlusion Limits, Alarm Types and Conditions, Default Drug Library." The subject device is stated to have the "Same" performance features as the predicate device.

Acceptance Criteria Category	Reported Device Performance
Delivery Rates	Same as predicate device
VTBI Range	Same as predicate device
Dose Units	Same as predicate device
Delivery Accuracy	Same as predicate device
Delivery Modes	Same as predicate device
Therapies	Same as predicate device
Distal Occlusion Limits	Same as predicate device
Proximal Occlusion Limits	Same as predicate device
Alarm Types and Conditions	Same as predicate device
Default Drug Library	Same as predicate device
Overall Safety and Effectiveness	Meets functional claims as described in product labeling; as safe and effective as predicate devices.

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

The document does not describe a specific "test set" in the context of a performance study with a sample size. The information provided is a 510(k) summary, which typically relies on demonstrating equivalence through comparison to existing devices and verification/validation testing without necessarily detailing a large-scale, controlled clinical "test set" as one might find in a drug trial.

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

No information is provided regarding experts establishing ground truth for a test set, as a standalone performance study with such a methodology is not described.

4. Adjudication method for the test set:

No information is provided regarding an adjudication method for a test set, as a standalone performance study with such a methodology is not described.

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:

This device is an infusion pump system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable or mentioned in this document.

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

The document focuses on the entire system (infusion pump and administration sets). While the pump is a "software controlled, electromechanical infusion pump," the submission is about the device as a whole and its equivalence. There is no mention of a standalone algorithm-only performance study.

7. The type of ground truth used:

Given the nature of the device (infusion pump) and the 510(k) submission type, the "ground truth" for demonstrating safety and effectiveness would likely be based on established engineering principles, recognized standards (if any, though the document states no performance standards exist under Section 514 for these pumps), detailed design specifications, and performance testing data to confirm the device operates as intended and is equivalent to the predicate. The document highlights "functional claims" and "performance specifications."

8. The sample size for the training set:

As this is a physical medical device (infusion pump) and not a machine learning model, the concept of a "training set" in that context is not applicable.

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

Same as above, the concept of a "training set" is not applicable for this type of device.

Summary of Study (as described in the 510(k) context):

The "study" presented here is a substantially equivalent comparison to predicate devices. The document asserts that the Hospira GemStar® Infusion Pump System with the new lockbox and pump sets is substantially equivalent to previously cleared Hospira/Abbott GemStar Infusion Pump Systems and pump sets.

The core of this "proof" lies in demonstrating similarities across various factors:

Intended Use and Indications for Use: Stated to be the same.
Fundamental Scientific Technology: Stated to be the same (volumetric, piston-driven, fluid displacement).
Physical, Operational, and Performance Specifications: Stated to be the same. This implies that testing (e.g., for delivery accuracy, occlusion limits) would have been performed to ensure these specifications are met and are comparable to the predicate.
Materials of Construction: Stated to be the same for infuser components and administration sets.

The document does not provide raw data, specific test protocols, or results of detailed performance testing. Instead, it makes assertions of equivalence for these characteristics, which would have been supported by underlying design documents and testing reports submitted to the FDA as part of the 510(k) process. The FDA's clearance (K051079) signifies their agreement that sufficient evidence of substantial equivalence was provided.

Summary

{0}------------------------------------------------

MAY 1 9 2005

Hospira GemStar® Infusion Pump System Special 510(k) / March 2005

Confidential

510(K) Summary

Hospira, Inc. 1. Name of Submitter: 275 North Field Drive Lake Forest, Illinois 60045

Owner/Operator # 9063339

2. Manufacturer and Establishment Registration Number:

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

Establishment Registration # 2921482

Southmedic, Inc 50 Alliance Blvd. Barrie Ontario L4M 5K3 Canada

Establishment Registration # 8022032

Hospira Holdings de Costa Rica Ltd Zona Franca Global La Aurora De Heredia Costa Rica

Establishment Registration # 9615050

3. Proprietary or Trade Name of Proposed Device:

Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox

Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves and Y-Extension with Backcheck Valve, 97 inch -SL

Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL

Infusion Pump with Infusion Pump Lockbox 4. Common Name: IV Administration Sets

Device Classification, Pancode and ProCode: Class II, FRN (Infuser)

Class II, FPA (IV Administration Sets)

Class II, MRZ (Infusion Pump Lockbox)

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.

{1}------------------------------------------------

Confidential

7. Intended Use:

The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar Spring Assist Mechanism Lockbox 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:

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	Pain Management Only
Continuous	Weight-Dosed
Weight-Dosed	mL/hr Only
Variable Time
ML/hr Only	Variable Time

{2}------------------------------------------------

10. Predicate Device Information:

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	ClearanceDate
K042980	Hospira GemStar® Infusion Pump System with HospiraGemStar ConnectTM Software	11/17/2004
K023062	Abbott GemStar® Infusion Pump System	09/30/2002
K033576	Lifeshield® Primary IV Pump Set with Two PressureActivated Anti-Siphon Valves	12/09/2003

11. Comparison to Legally Marketed Device(s)

Factors	Subject Device(s)Hospira GemStar® Infusion Pump System withHospira GemStar® Spring Assist Mechanism Lockbox	Predicate Device(s)Hospira GemStar®Infusion Pump Systemwith Lockbox
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.	Same as PCA Lockbox(For pain managementusing PCA Vials only)
Indications for 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.The indications for use include hospital, ambulatory, and home care environments. The pump must be used withsterile, 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 and program status, and the parameters of fluid flow.	Same
Administration Setsand Fluid ContactMaterials	Sterile, dedicated, non-pyrogenic, latex-free "GemStar"administration sets.	Different(Two new dedicatedpain management setsfor use with the SAMLockbox only)
Physical Features	Materials, Size, Weight, Input Lines, Output Lines,Power Sources, Battery Type, Power Cord	Same
EnvironmentalFeatures	Operating Temperature, Storage Temperature, RelativeHumidity, Pressure	Same

{3}------------------------------------------------

Confidential

Hospira GemStar® Infusion Pump System Special 510(k) / March 2005

Factors	Subject Device(s)Hospira GemStar® Infusion Pump System withHospira GemStar® Spring Assist Mechanism Lockbox	Predicate Device(s)Hospira GemStar®Infusion Pump Systemwith Lockbox
PerformanceFeatures	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 ConnectTM Remote Communication Software(Clinician Kit, Patient Kit), Docking Station (2), BolusCord, Pole Clamps (2), Battery Pack (2), Lockboxes (4),AC Mains Adapters (2), Carrying Cases (4) and Carrier,Serial Cable	Different(New SAM Lockbox)

12. Statement of Substantial Equivalence:

Statelinent of Substantial Equivalenes.
Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox, the Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves the Hospira Gentiour - Painp Soctively, 97 inch -SL and the Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch are substantially equivalent to the predicate devices identified in the submission.

Similarities:

Same intended use and indications for use. 1)
Same fundamental scientific technology. 2)
Same physical, operational, and performance specifications. 3)
Same materials of construction for all infuser components and administration sets. 4)

13. Statement of Safety and Effectiveness

Statement of Sarey and Enectivelless
Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox, Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves the Hospira Gemocal - Panietar - Valve, 97 inch -- SL and the Hospira GemStar Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL meet the functional claims ngeover, you an as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate devices described in the submission.

Prepared and submitted by: Yuliya Matlin Senior Specialist, Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: 224/212-4857 Fax: 224/212-5401

{4}------------------------------------------------

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three parallel lines extending from its head, resembling feathers or wings.

MAY 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Yuliya Matlin Senior Specialist, Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Re: K051079

Trade/Device Name: Hospira GemStar Infusion Pump System with Hospira GemStar Spring Assist Mechanism Lockbox Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA, MRZ Dated: April 26, 2005 Received: April 27, 2005

Dear Ms. Matlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to review 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de rises and liertic Act (Act) that do not require approval of a premarket the rederal 1 ood, Drag, and Connenay, therefore, market the device, subject to the general approvin apprevances (the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 MA), it may of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Ms. Matlin

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissualled of a substanter ice complies with other requirements
mean that FDA has made a determination that your device complies with organisa mean that FDA nas made a decemination administered by other Federal agencies. of the Act or any rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements of manufacturing programs You must comply with an the Fet 5 read 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rest 800); god i and listing (21 CFR Part 807), laboring (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set fortif in the quality systems (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) This letter will anow you to begin mationing of substantial equivalence of your device to a premarket notification. The PDA midness of substantial of any 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), If you desire specific advice for your de received in a miplease contact the Other of Other of Other and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain offer general information on Jour Cep-DIVIsion of Simall Manufactar (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

{6}------------------------------------------------

Indications for Use Statement
510(k) Number (if known)	K051079
Device Name:	Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox
	Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves and Y-Extension with Backcheck Valve, 97 inch -SL
	Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL
Indications for Use	The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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)

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 Sign-Off)
Division of Anesthesiblogy, General Hospital,
Infection Control, Dental Deviless

Kyslp29 510(k) Number: ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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).