(192 days)
Not Found
Not Found
No
The summary describes microcomputer-controlled infusion pumps and focuses on expanding the intended use to include subarachnoid space infusion. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is an infusion pump designed to deliver medication, which is a therapeutic function.
No
The device description clearly states it is an "ambulatory infusion pump intended for the delivery of medication," which is a treatment function, not a diagnostic one.
No
The device description explicitly states the devices are "microcomputer controlled ambulatory infusion pumps," indicating they are hardware devices with embedded software, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to deliver medication via various routes (intravenous, subcutaneous, epidural, subarachnoid, etc.). This is a therapeutic function, not a diagnostic one.
- Device Description: The device is described as an "ambulatory infusion pump" for delivering medication. This aligns with a therapeutic device.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for this purpose.
The device is a medical device used for administering treatment (medication delivery), not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The subject devices are microcomputer controlled ambulatory infusion pumps intended for the delivery of medication via various parenteral routes, i.e., intravenous, intra-arterial, subcutaneous, intraperitoneal, or epidural space infusion. The purpose of this 510(k) Notification is to add subarachnoid space infusion to the labeling and thereby expanding the intended use of each pump. The subject devices, as a matter of course, will be used for the delivery of medication through catheters that have this indication.
CADD-PCA" Model 5800 or 5800R Pump:
The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions.
CADD-Micro Model 5900 Pump:
The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions.
CADD-Prizm™ Model 6100 Pump:
The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.
Product codes
Not Found
Device Description
The subject devices are microcomputer controlled ambulatory infusion pumps intended for the delivery of medication via various parenteral routes, i.e., intravenous, intra-arterial, subcutaneous, intraperitoneal, or epidural space infusion. The purpose of this 510(k) Notification is to add subarachnoid space infusion to the labeling and thereby expanding the intended use of each pump. The subject devices, as a matter of course, will be used for the delivery of medication through catheters that have this indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravenous, Intra-arterial, Subcutaneous, Intraperitoneal, Epidural space, Subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Functional Testing: No software and/or functional modifications were required as it relates to the addition of the subarachnoid space infusion indication to the labeling of each subject device, therefore, no functional testing was deemed necessary.
Clinical Studies: Clinical studies were not deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
IPI AlgoLine™ Catheter Kits
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
510(k) Summary Date Prepared: November 8, 1995
GENERAL INFORMATION 1.
| Applicant's name and address: | SIMS Deltec, Inc. |
|---|---|
| 1265 Grey Fox Road | |
| St. Paul, MN 55112 |
Contact:
David H. Short Manager, Regulatory Affairs (612)628-7214
PRODUCT INFORMATION II.
Common/Usual Name:
Classification Name:
Proprietary Name:
Ambulatory Infusion Pumps
Infusion Pump
CADD-PCA® Model 5800 Pump CADD-PCA Model 5800R Pump CADD-Micro Model 5900 Pump CADD-Prizm™ Model 6100 Pump
BOUIVALENCE DEVICE COMPARISON III.
IPI AlgoLine™ Catheter Kits manufactured by PS Medical Coporation, Goleta, CA.
DEVICE DESCRIPTION IV.
The subject devices are microcomputer controlled ambulatory infusion pumps intended for the delivery of medication via various parenteral routes, i.e., intravenous, intra-arterial, subcutaneous, intraperitoneal, or epidural space infusion. The purpose of this 510(k) Notification is to add subarachnoid space infusion to the labeling and thereby expanding the intended use of each pump. The subject devices, as a matter of course, will be used for the delivery of medication through catheters that have this indication.
1
510(k) Summary Date Prepared: November 8, 1995
DEVICE COMPARISON 发彩。
Provided in Table 1 is a comparison of devices and their respective indications for use.
Table 1. Comparison of indications for use of various devices.
| | CADD-Prizm™
Pump | CADD-PCA®
Pump
(Models 5800 & 5800) | CADD-Micro®
Pump | AngeLine™ Catheter
Kits |
|----------------------------------|---------------------|-------------------------------------------|---------------------|-------------------------------|
| Manufacturer | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | IPI PS Medical
Corporation |
| SYSTEM | | | | |
| Microcomputer controlled
pump | YES | YES | YES | n/a |
| INDICATIONS FOR USE | | | | |
| Intravenous | YES | YES | YES | n/a |
| Intra-arterial | YES | NO | YES | n/a |
| Subcutaneous | YES | YES | YES | n/a |
| Intraperitoneal | YES | NO | YES | n/a |
| Epidural space | YES | YES | YES | YES |
| Subarachnoid space | NO | NO | NO | YES |
V " INTENDED USE
CADD-PCA" Model 5800 or 5800R Pump:
The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions.
CADD-Micro Model 5900 Pump:
The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions.
CADD-Prizm™ Model 6100 Pump:
The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.
2
510(k) Summary Date Prepared: November 8, 1995
VI. SUMMARY OF STUDIES
Functional Testing A.
No software and/or functional modifications were required as it relates to the addition of the subarachnoid space infusion indication to the labeling of each subject device, therefore, no functional testing was deemed necessary.
B. Clinical Studies
Clinical studies were not deemed necessary.
CONCLUSION VII.
Based upon the information provided above, the addition of subarachnoid space infusion to the labeling of each subject device is substantially equivalent to the labeling of commercially available catheters, such as the IPI AlgoLine™ Catheter Kits manufactured by PS Medical Coporation, with this indication.