The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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.

Device Description

GemStar™ SP Infusion System is a family of single channel electromechanical infusion pumps (7-therapy, 6-therapy and Pain Management Pumps). It operates 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. The pumps display provides visible indication of several functions, including active pump operations, alarms, program status and the parameters of fluid flow. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. Power options include AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The infusers function as both pole mounted and ambulatory infusion pumps.

The subject device is based on modifications of the predicate infusion pumps. The modifications to the Hospira GemStar® Infusion System are made to allow for download of the Infusion Suite to the pump from the PC –based software (GemStar™ SP Infusion Suite) in order to facilitate the programming of the pump and to provide the ability to enforce dosing limits for applicable therapies. GemStar™ SP Infusion Suite software will be distributed separately as an accessory to the pump. No changes are made to the pump performance specifications or to the administration sets used with the pump.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GemStar™ SP Infusion System.

Important Note: The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or safety through new clinical trials as would be required for a PMA (Premarket Approval). Therefore, the document primarily highlights the similarities to existing devices and the absence of new safety/effectiveness concerns, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission focused on substantial equivalence and modifications to an existing device, explicit numerical acceptance criteria and a detailed "reported device performance" table are not present in the provided document. The acceptance criteria are implicitly met by demonstrating that the modified device performs "as safe and effective" as the predicate device and that "no changes are made to the pump performance specifications."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Intended Use: Identical to predicate device.	The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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. This is identical to the predicate Hospira GemStar® Infusion Pump System (K060806).
Technological Characteristics: Similar in design, materials, components, and fundamental scientific technology to predicate device.	The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. "Same fundamental scientific technology" "Same physical operational and performance specifications"
Safety and Effectiveness: No new issues of safety and/or effectiveness are raised by the modifications.	The proposed modifications do not raise new issues of safety and/or effectiveness. "GemStar™ SP Infusion System with GemStar™ SP Infusion Suite meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission."
Performance Specifications: Pump performance specifications remain unchanged.	"No changes are made to the pump performance specifications or to the administration sets used with the pump."
Software Functionality: Similar concept of protocol download from PC application to infuser, facilitating programming and enforcing dosing limits.	Similar concept of the protocol download from GemStar™ SP Infusion Suite PC application to the GemStar™ SP Infuser as from the Hospira MedNet™ application to LifeCare PCA® Infuser. (This implies that the new software performs its intended function of downloading protocols and enforcing dose limits as effectively as the predicate software).

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific "test set" in the context of an independent performance study. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices already on the market and cleared by the FDA. The "testing" in such a submission typically involves verification and validation of the modified components (e.g., software functionality, electrical safety, EMC compatibility) against established standards and internal requirements, rather than a clinical performance study with a distinct test set of patients or medical scenarios.

Therefore, information on:

Sample size used for the test set: Not applicable/not provided in this type of submission.
Data provenance (country of origin, retrospective/prospective): Not applicable/not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable/not provided because the document does not describe a study involving human expert adjudication to establish ground truth for a test set. This is a premarket notification for a Class II medical device (infusion pump), where the primary focus is on engineering and performance specifications, and substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Not applicable/not provided. There is no described study requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided document. This type of study is more common for diagnostic imaging devices where human interpretation directly impacts clinical outcomes, and the goal is to show the AI's impact on reader performance or diagnostic accuracy. For an infusion pump, the effectiveness is primarily mechanical and software-driven, verified through engineering tests and comparison to predicate device performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The document does not describe a standalone algorithm-only performance study. The device is an infusion pump system with associated software. The "performance" is a holistic function of the hardware and software working together to deliver fluids, with the software facilitating programming and safety features (dose limits). The safety and effectiveness are established through the entire system's functionality, not just an isolated algorithm. The software component, "GemStar™ SP Infusion Suite," is an accessory to the pump facilitating programming, and its performance is implicitly validated by demonstrating "similar concept of the protocol download" to a predicate device's software.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" is established by:

Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate devices (Hospira GemStar® Infusion Pump System K060806 and LifeCare PCA® Infusion System with Hospira MedNet™ Software K042800). The current device demonstrates that it is "as safe and effective" as these.
Engineering Standards and Specifications: Implicitly, the pump's mechanical and electrical performance (e.g., flow accuracy, alarm functionality, dose limit enforcement) is verified against established engineering standards and the device's own design specifications, which are themselves benchmarked against predicate devices and regulatory requirements.

There is no mention of pathology, expert consensus on patient data, or extensive clinical outcomes data specific to this submission.

8. The Sample Size for the Training Set

The document does not mention a "training set" as described in the context of machine learning. This device, an infusion pump with programming software, would likely have its software developed and verified through standard software engineering practices (e.g., unit testing, integration testing, system testing, regression testing) rather than through training on a dataset in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" (in the AI/ML sense) is not mentioned or implied by the nature of this device and submission, the method for establishing its ground truth is not applicable/not provided. The ground truth for the product's design and verification is based on established engineering principles, regulatory compliance, and the performance characteristics of its predicate devices.

Summary

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1. Submitted by:	Hospira, Inc.D-389 Bldg. H2275 N. Field DriveLake Forest, IL 60045Contact: Yuliya Matlin	Phone: (224)212-4857Fax: (224) 212-5401
2. Date Prepared:	August 11, 2008
3. Name/Classificationof Device:	Infusion Pump, Class II80 FRN – 21 CFR Parts 880.5725Administration Sets, Class II80-FPA -21 CFR Parts 880.5725
4. Trade Name ofProposed Device:	GemStar™ SP Infusion System withGemStar™ SP Infusion Suite software

1. Predicate Devices: Hospira GemStar® Infusion Pump System (K060806) LifeCare PCA ® Infusion System with Hospira MedNet™ Software (K042800)

6. Proposed Device Description:

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7. Statement of Intended Use:

GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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 of the subject device are identical to the predicate Hospira GemStar® Infusion Pump System cleared under K060806.

8. Summary of Technological Characteristics of New Device Compared to Predicate Device

The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes.

9. Statement of Substantial Equivalence

GemStar™ SP Infusion System with GemStar™ SP Infusion Suite is substantially equivalent to the predicate devices identified in the submission based on the following similarities:

Infuser similarities to Hospira GemStar® Infusion Pump System:

1. Same Intended Use and Indications for Use
1. Same fundamental scientific technology
1. Same physical operational and performance specifications
Same materials of construction for all infuser components

Software application similarities to LifeCare PCA® Infusion System with Hospira MedNet™ software:

Similar concept of the protocol download from GemStar™ SP Infusion Suite PC application to the GemStar™ SP Infuser as from the Hospira MedNet™ application to LifeCare PCA® Infuser.

The proposed modifications do not raise new issues of safety and/or effectiveness. GemStar™ SP Infusion System with GemStar™ SP Infusion Suite meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of an eagle, with three distinct lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

Hospira, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K083019

Trade/Device Name: GemStar™ SP Infusion System with GemStar™ SP Infusion Suite Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 9, 2008 Received: October 9, 2008

Dear Mr. Devine:

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. Devine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu S. Lin, Ph. D Division 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

510(k) Number (if known)	K483019
Device Name:	GemStar™ SP Infusion System with GemStar™ SP Infusion Suite software
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.

Prescription Use _ × (Part 21 CFR 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)

Ctenn Uln

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

1 483419 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).