← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K955180 # CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP (K955180) _Sims Deltec, Inc. · FRN · May 23, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955180 ## Device Facts - **Applicant:** Sims Deltec, Inc. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** May 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Device Story Microcomputer-controlled ambulatory infusion pumps deliver medication via parenteral routes (intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, subarachnoid). Devices operate via programmed infusion parameters to deliver medication through compatible catheters. Used in clinical or ambulatory settings by healthcare providers or patients. Output consists of controlled fluid delivery; informs clinical pain management or therapeutic infusion regimens. Benefit includes expanded site-specific delivery options for existing pump platforms. ## Clinical Evidence No clinical studies or functional testing were performed. The submission relies on the existing clearance of the pump hardware and the established clinical indication for subarachnoid use associated with compatible catheter systems. ## Technological Characteristics Microcomputer-controlled ambulatory infusion pumps. No hardware or software modifications were made for this labeling expansion. Connectivity and materials are consistent with previously cleared versions of the CADD-PCA, CADD-Micro, and CADD-Prizm pump lines. ## Regulatory 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. ## Reference Devices - IPI AlgoLine™ Catheter Kits (PS Medical Corporation) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K955180 510(k) Summary Date Prepared: November 8, 1995 ## I. GENERAL INFORMATION 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 ## II. PRODUCT INFORMATION Common/Usual Name: Ambulatory Infusion Pumps Classification Name: Infusion Pump Proprietary Name: CADD-PCA® Model 5800 Pump CADD-PCA® Model 5800R Pump CADD-Micro® Model 5900 Pump CADD-Prizm™ Model 6100 Pump ## III. EQUIVALENCE DEVICE COMPARISON IPI AlgoLine™ Catheter Kits manufactured by PS Medical Coporation, Goleta, CA. ## IV. 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. Page 1 of 3 241 {1} 510(k) Summary Date Prepared: November 8, 1995 ## IV. DEVICE COMPARISON 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 (Model 5800 & 5800R) | CADD-Micro® Pump | AngoLine™ 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. Page 2 of 3 {2} 510(k) Summary Date Prepared: November 8, 1995 ## VI. SUMMARY OF STUDIES ### A. 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. ### B. Clinical Studies Clinical studies were not deemed necessary. ## VII. CONCLUSION 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. Page 3 of 3 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955180](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K955180) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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