The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions.
The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions.
The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.

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.

AI/ML Overview

The provided document is a 510(k) summary for infusion pumps, specifically requesting to add "subarachnoid space infusion" to their labeling. It does not contain information about acceptance criteria or a study proving the device meets them in the way a diagnostic AI device summary would. This document focuses on demonstrating substantial equivalence to a predicate device (a catheter kit already indicated for subarachnoid space infusion) to expand the intended use of the infusion pumps.

Therefore, many of the requested details are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

Not Applicable/Not Found: This document does not describe specific numerical acceptance criteria or performance metrics for the infusion pump's functionality related to the new indication. The approval is based on substantial equivalence to a predicate device for the intended use (administering medication via subarachnoid space), not on new performance data for the pump itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Found: No test set or associated data provenance is mentioned as no functional or clinical studies were deemed necessary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Found: No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Found: No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable/Not Found: This is an infusion pump, not an AI diagnostic device, so MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Found: Not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable/Not Found: No ground truth is described. The basis for equivalence is the existing indication of the predicate device (IPI AlgoLine™ Catheter Kits) for subarachnoid space infusion.

8. The sample size for the training set

Not Applicable/Not Found: No training set is mentioned as no new functional or clinical studies were performed.

9. How the ground truth for the training set was established

Not Applicable/Not Found: No training set or ground truth establishment process is described.

Summary of the Document's Approach:

The core of this 510(k) notification is an "equivalence device comparison" (Section III and V) and a statement that "No software and/or functional modifications were required" and "no functional testing was deemed necessary" (Section VI). The justification for the new indication relies on the fact that these pumps already deliver medication via various parenteral routes, and the catheters used for subarachnoid space infusion are already commercially available and indicated for that purpose (e.g., IPI AlgoLine™ Catheter Kits). Therefore, the substantial equivalence argument is that the pumps, without modification, can be used for this route when paired with appropriately indicated catheters.

Summary

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K955180

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.

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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™ CatheterKits
Manufacturer	SIMS Deltec, Inc.	SIMS Deltec, Inc.	SIMS Deltec, Inc.	IPI PS MedicalCorporation
SYSTEM
Microcomputer controlledpump	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.

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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.

Regulation Number and Section

§ 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).