(22 days)
Not Found
No
The description focuses on the electromechanical and software-controlled aspects of a standard infusion pump, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is used for the administration of medications and fluids to patients.
No
This device is an infusion pump system, which delivers fluids to a patient. It does not analyze patient data or provide a diagnosis.
No
The device description explicitly states it is a "single channel, software controlled, electromechanical infusion pump" and details hardware components like a piston, cassette, power options (AC adaptor, battery pack, docking station, AA batteries), and a user interface with displays.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an infusion pump system for delivering fluids and medications directly into the body (intravenous, arterial, subcutaneous, epidural). This is a therapeutic and drug delivery function, not a diagnostic one.
- Device Description: The description details the mechanical and software components involved in controlling fluid flow. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's function is to administer substances to a patient, which falls under the category of medical devices used for treatment or support, not in vitro diagnosis.
N/A
Intended Use / 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.
Product codes
FRN, FPA, MRZ
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.
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 List #: 13000-04 TPN (Total Parenteral Nutrition) Pain Management Intermittent Continuous Weight-Dosed Variable Time ML/hr Only
6 Therapy Pump List #: 13100-04 TPN (Total Parenteral Nutrition) Intermittent Continuous Weight-Dosed mL/hr Only Variable Time
Pain Management Pump List #: 13150-04 Pain Management Only
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital, ambulatory, and home care environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
-
- 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 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.
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 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.
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 | Clearance
Date |
|----------|-----------------------------------------------------------------------------------|-------------------|
| K042980 | Hospira GemStar® Infusion Pump System with Hospira
GemStar ConnectTM Software | 11/17/2004 |
| K023062 | Abbott GemStar® Infusion Pump System | 09/30/2002 |
| K033576 | Lifeshield® Primary IV Pump Set with Two Pressure
Activated Anti-Siphon Valves | 12/09/2003 |
11. Comparison to Legally Marketed Device(s)
| Factors | Subject Device(s)
Hospira GemStar® Infusion Pump System with
Hospira GemStar® Spring Assist Mechanism Lockbox | Predicate Device(s)
Hospira GemStar®
Infusion Pump System
with Lockbox |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 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 as PCA Lockbox
(For pain management
using PCA Vials only) |
| Indications for 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.
The indications for use include hospital, ambulatory, and home care environments. The pump must be used with
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 |
| Administration Sets
and Fluid Contact
Materials | Sterile, dedicated, non-pyrogenic, latex-free "GemStar"
administration sets. | Different
(Two new dedicated
pain management sets
for use with the SAM
Lockbox only) |
| Physical Features | Materials, Size, Weight, Input Lines, Output Lines,
Power Sources, Battery Type, Power Cord | Same |
| Environmental
Features | Operating Temperature, Storage Temperature, Relative
Humidity, Pressure | Same |
3
Confidential
Hospira GemStar® Infusion Pump System Special 510(k) / March 2005
| Factors | Subject Device(s)
Hospira GemStar® Infusion Pump System with
Hospira GemStar® Spring Assist Mechanism Lockbox | Predicate Device(s)
Hospira GemStar®
Infusion Pump System
with Lockbox |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Performance
Features | Delivery Rates, VTBI Range, Dose Units, Delivery
Accuracy, Delivery Modes, Therapies, Distal Occlusion
Limits, Proximal Occlusion Limits, Alarm Types and
Conditions, 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), Bolus
Cord, 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
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