(67 days)
No
The document describes standard volumetric infusion pumps and does not mention any AI or ML capabilities.
No.
An infusion pump delivers fluids or medication to a patient; it does not directly treat a disease or condition itself, which is the function of a therapeutic device.
No
Explanation: The device is an infusion pump designed for delivering fluids and medications, not for diagnosing medical conditions. Its function is to control the rate and monitor the flow of substances into a patient, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the devices are "electrical volumetric infusion pumps," which are hardware devices. The submission is for a line of infusion pumps, not software that runs on them.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are infusion pumps for delivering fluids, medications, blood, and blood products through various routes of administration (IV, IA, subcutaneous, epidural, enteral, irrigation). This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description reinforces that these are electrical volumetric infusion pumps used to control the rate or monitor the flow of solutions or medications. This is consistent with a delivery device, not a device that performs tests on biological samples to diagnose conditions.
- Lack of Diagnostic Language: The text does not mention any diagnostic procedures, analysis of biological samples (blood, urine, tissue, etc.), or the generation of diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. Infusion pumps, while used in healthcare, do not fit this definition.
N/A
Intended Use / Indications for Use
ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.
The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:
- IMED® Gemini Infusion Pump / Controllers model PC-1® ●
- IMED® Gemini Infusion Pump / Controllers model PC-2® .
- IMED® Gemini Infusion Pump/Controller model PC-2TX® .
- IMED® Gemini Infusion Pump/Controller model PC-40 .
- IVAC® Signature Edition® Infusion Pumps
- IVAC® MedSystem III®, Multi-channel Infusion Pumps .
- IVAC® MedSystem III® Multi-channel Infusion Pumps with DLE .
- . ALARIS Medical Medley" Patient Care System
Note: See the appropriate Directions for Use (DFU) for infusion system specifications.
Product codes
FRN
Device Description
ALARIS Medical Systems line of infusion pumps are electrical volumetric infusion pumps that are used to control the rate or monitor the flow of solution or medication. In general, infusion pumps are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural anesthesia, enteral delivery, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This 510(k) Premarket Notification is being submitted to expand the intended use to include specific indications for ALARIS Medical infusion pumps. The current indications will expand to include detailed information such as administration route, target population, and intended user. This expansion will serve to better represent the ALARIS Medical infusion pump as used in today's healthcare environment, as well as, provide a better competitive comparison with other infusion pumps. Expansion of the indications as described in this submission does not alter the intended use of the device nor does it affect performance, safety, or efficacy of any of the devices.
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
professional healthcare environment including hospitals, healthcare facilities, home care professional fransport that utilize infusion pumps
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)
There are no changes to the devices to support the expansion of indications. Therefore performance data is not necessary.
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 .45
SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems®, Inc.
SUBMITTER INFORMATION
| A. | Company Name: | ALARIS Medical Systems, Inc. |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7563 | |
| (858) 458-6223 | ||
| D. | Contact Person: | Renée L. Fluet |
| Principal Regulatory Affairs Specialist | ||
| E. | Date Summary Prepared: | July 26, 2001 |
DEVICE IDENTIFICATION
| B.
C. | Trade/Proprietary Name:
Classification | Pump, Infusion
Pump, Infusion, 21CFR 880.5725, Class II
Product Code FRN |
|----------|-------------------------------------------|--------------------------------------------------------------------------------|
| | | |
SUBSTANTIAL EQUIVALENCE
The ALARIS Medical Systems line of infusion pumps as listed below are of comparable type and are substantially equivalent to the predicate devices, the Abbott Plum XL and Baxter's line of Colleague® Infusion Pumps.
| ALARIS Medical Infusion Pumps | 510(k) # | Date Cleared |
|---|---|---|
| IMED Gemini PC-1 Volumetric Infusion Pump | K883993 | 12/19/88 |
| IMED Gemini PC-4 Volumetric Infusion Pump | K921370 | 06/09/92 |
| IVAC Signature Edition Volumetric Infusion Pumps | K931549 | 10/12/93 |
| IMED Gemini PC-2TX Volumetric Infusion Pump | K933144 | 10/12/93 |
| IVAC MedSystem III Volumetric Infusion Pumps | K933545 | 09/29/94 |
| ALARIS Medical Medley Patient Care System | K950419 | 6/21/95 |
| IVAC MedSystem III Volumetric Infusion Pump with | ||
| DLE | K961486 | 04/17/98 |
Confidential
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ALARIS Medical Systems, Inc. Page 2 of 3
Predicate Device(s)
| Manufacturer and Device | 510(k) # | Date Cleared |
|---|---|---|
| Abbott Plum XL Infusion Pump | K010924 | 04/06/01 |
| Colleague Volumetric and CX Volumetric Infusion | ||
| Pumps | K002211 | 08/28/00 |
DEVICE DESCRIPTION
ALARIS Medical Systems line of infusion pumps are electrical volumetric infusion pumps that are used to control the rate or monitor the flow of solution or medication. In general, infusion pumps are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural anesthesia, enteral delivery, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This 510(k) Premarket Notification is being submitted to expand the intended use to include specific indications for ALARIS Medical infusion pumps. The current indications will expand to include detailed information such as administration route, target population, and intended user. This expansion will serve to better represent the ALARIS Medical infusion pump as used in today's healthcare environment, as well as, provide a better competitive comparison with other infusion pumps. Expansion of the indications as described in this submission does not alter the intended use of the device nor does it affect performance, safety, or efficacy of any of the devices.
07/26/01
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ALARIS Medical Systems, Inc. Page 3 of 3
INTENDED USE
ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including hospitals, healthcare facilities, home care professional fransport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.
The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intennitions (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:
- IMED® Gemini Infusion Pump / Controllers model PC-1® .
- IMED Gemini Infusion Pump / Controllers model PC-2® ●
- IMED Gemini Infusion Pump/Controller model PC-2TX® ●
- IMED Gemini Infusion Pump/Controller model PC-4® ●
- IVAC® Signature Edition® Infusion Pumps .
- IVAC MedSystem III® Multi-channel Infusion Pumps .
- IVAC MedSystem III* Multi-channel Infusion Pumps with DLE .
- ALARIS Medical Medley™ Patient Care System ●
Note: See the appropriate Directions for Use (DFU) for infusion system specifications.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ALARIS Medical line of infusion purps and the predicate devices has been performed. The results of this comparison pamps and that the ALARIS Medical Line of infusion pumps with expanded indications for use are equivalent to the original 510(k) devices as well as, the Abbott Plum XL Infusion Pump (K010924) and the Baxter Healthcare line of Colleague® Infusion Pumps (K002211).
PERFORMANCE DATA
There are no changes to the devices to support the expansion of indications. Therefore performance data is not necessary.
Confidential
07/26/01
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, with two wavy lines below it. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
OCT - 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Renee L. Fluet Regulatory Affairs Specialist Alaris Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733
Re: K012383
Trade/Device Name: ALARIS Medical Systems® Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 26, 2001 Received: July 27, 2001
Dear Ms. Fluet:
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 vour 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.
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.
4
Page 2 - Ms. Fluet
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number:
K012383 (To Be Assigned By FDA)
Device Trade Name:
ALARIS Medical Systems Infusion Pumps
Indications for Use:
ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.
The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:
- IMED® Gemini Infusion Pump / Controllers model PC-1® ●
- IMED® Gemini Infusion Pump / Controllers model PC-2® .
- IMED® Gemini Infusion Pump/Controller model PC-2TX® .
- IMED® Gemini Infusion Pump/Controller model PC-40 .
- IVAC® Signature Edition® Infusion Pumps
- IVAC® MedSystem III®, Multi-channel Infusion Pumps .
- IVAC® MedSystem III® Multi-channel Infusion Pumps with DLE .
- . ALARIS Medical Medley" Patient Care System
Note: See the appropriate Directions for Use (DFU) for infusion system specifications.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
faltana Cicerati
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number --
Confidential
0029 07/20/01