(13 days)
No
The summary describes a standard electromechanical infusion pump with software for programming and dose limits. There is no mention of AI or ML capabilities, image processing, or data sets for training/testing.
Yes
The device is an infusion pump designed to administer fluids, medications, and nutritional fluids intravenously, subcutaneously, or epidurally, which directly falls under the definition of a therapeutic device as it delivers treatment to the patient.
No
The device is described as an "Infusion System" and "electromechanical infusion pumps" used for "intravenous, arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids and blood/blood products." Its primary function is to deliver fluids and medications, not to diagnose medical conditions.
No
The device description clearly states it is a family of single channel electromechanical infusion pumps, which are hardware devices. While it includes software (GemStar™ SP Infusion Suite), the core device is a physical pump.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an "Infusion System" for administering fluids, medications, and blood products intravenously, arterially, subcutaneously, and epidurally. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a "single channel electromechanical infusion pump" that operates on a "volumetric, piston driven, fluid displacement principle." This mechanism is for delivering substances into the body, not for analyzing samples taken from the body.
- No mention of diagnostic activities: The text does not mention any activities related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for 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.
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.
Product codes
FRN
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.
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
| 1. Submitted by: | Hospira, Inc.
D-389 Bldg. H2
275 N. Field Drive
Lake Forest, IL 60045
Contact: Yuliya Matlin | Phone: (224)212-4857
Fax: (224) 212-5401 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| 2. Date Prepared: | August 11, 2008 | |
| 3. Name/Classification
of Device: | Infusion Pump, Class II
80 FRN – 21 CFR Parts 880.5725
Administration Sets, Class II
80-FPA -21 CFR Parts 880.5725 | |
| 4. Trade Name of
Proposed Device: | GemStar™ SP Infusion System with
GemStar™ SP Infusion Suite software | |
6. Proposed 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.
1
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:
-
- Same Intended Use and Indications for Use
-
- Same fundamental scientific technology
-
- 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.
2
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.
3
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
4
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 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.
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: _______________________________________________________________________________________________________________________________________________________________