The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation. The device is, also, designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice.

The flexibility offered by the PDS Personal Infusor with Drug Disposal Septal Port will enable physicians to choose from a variety of fluid flow rates and drug concentrations. It will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients, as well as allow for proper disposal of device and unused fluid medications.

Device Description

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36-inch tubing set that adjoins a preexisting venous access site. The unit has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in multiple volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details for the Science Incorporated Personal Infusor with Drug Disposal Septal Port:

The provided document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical report of a standalone clinical study with extensive acceptance criteria. Therefore, many of the requested categories for a comprehensive study will not be fully satisfied by this type of document.

Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Flow Performance Equivalence to Predicate Device	The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port exhibits equivalent flow performance when compared to the predicate device.
Linearity of Flow (within ±10%)	The new devices displayed linearity of ±10% over a temperature range of 10-40° C.
Effectiveness across Various Diluents	Demonstrated linearity of flow when used with various diluents.
Effectiveness across Broad Temperature Range (10-40° C)	Demonstrated linearity of flow over a temperature range of 10-40° C.
Accuracy and Consistency of Fluid Flow (Prototype models)	Prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities. (Note: This refers to prototype models, and the 510(k) likely relies on the "equivalent flow performance" for the final device).
Proper Drug Disposal Functionality	The unit has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. The device is also designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice. (This is a design feature and intended functionality, not explicitly a measurable performance criterion reported from a study in this document, but implied as a functional requirement).
Single Use and Disposable Nature	The unit is disposable following a single use. (Functional description)
Visual Flow Status Indicator Functionality	Features a novel visual flow status indicator that facilitates patient monitoring. (Functional description)

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document mentions "In our studies" but does not quantify the number of devices or experimental runs.
- Data Provenance: The studies were conducted by Science Incorporated as part of their 510(k) submission. The context suggests these were internal, non-human, laboratory-based performance tests rather than clinical trials. It's retrospective in the sense that the data was collected prior to the 510(k) submission. There is no information regarding the country of origin, but it is implied to be within the company's research and development facilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely not applicable to this type of performance study. The "ground truth" for device performance (flow rate, linearity) would be established by scientific measurement standards and instrumentation, not by expert human consensus or interpretation of medical images. Expert involvement would be in designing the test protocols and analyzing the objective physical data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None applicable in the context of this document. Adjudication methods like "2+1" typically apply to studies where human interpreters (e.g., radiologists) review medical cases, and their disagreements are resolved by an independent third party. This document describes laboratory performance testing of an infusion pump, which involves objective measurements against predefined specifications.
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:
- No, an MRMC study was not done. This type of study applies to diagnostic imaging devices or AI-assisted interpretation, where human readers (e.g., radiologists) interpret cases with and without AI assistance. The device in question is an infusion pump, not a diagnostic or AI-driven interpretative tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance data presented (linearity of flow, temperature range) represents the standalone physical performance of the device itself, independent of immediate human intervention during its operation (beyond initial setup). This is a purely "device-only" performance assessment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims (flow rate accuracy, linearity) would be based on objective physical measurements using calibrated instruments and standardized test methods. For example, a flow meter would measure the actual flow rate, and this would be compared against the target flow rate to determine accuracy and linearity.
The sample size for the training set:
- Not applicable. This device is an elastomeric infusion pump, not an AI/machine learning algorithm that requires a "training set." The development process for such a device involves engineering design, prototyping, and iterative physical testing, not data-driven model training.
How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of this device.

Summary

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3/25/99

K990208

Science Incorporated Personal Infusor with Drug Disposal Septal Port 510(k) 8-1

SUMMARY OF SAFETY AND EFFECTIVENESS 8.0

Submitters name:

Science Incorporated 7760 France Avenue South, Suite 1060 Bloomington, MN 55435 (612)835-1333 (612)835-1716 (fax) Contact person: Ralph E. Hogancamp, Director of Quality and Regulatory Affairs

Device name:
Proprietary name:	To be determined
Common name:	Elastomeric pump
Classification name:	Infusion pump
Predicate devices:	Science Incorporated Personal Infusor(510 number K971362)

Device description:

Intended use:

The PDS Personal Infusor with Drug Disposal Septal Port is intended for the ambulatory infusion of physician-prescribed parenteral medications. The device will

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Science Incorporated Personal Infusor with Drug Disposal Septal Port 510(k) 8-2

be filled and prepared for administration by pharmacists, and administered by eligible patients and providers who have been trained in the pump's operation.

The flexibility offered by the device design will enable physicians to select from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for the administration of beneficial drugs to patients.

Technological characteristics:

The PDS Personal Infusor with Drug Disposal Septal Port is technologically identical to the Science Incorporated Personal Infusor except for the addition of the drug disposal septal port.

Performance data:

The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port exhibits equivalent flow performance when compared to the predicate device. In our studies, the new devices displayed linearity of ±10% over a temperature range of 10-40° C when used with various diluents

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

Mr. Ralph E. Hoqancamp Director of Quality and Regulatory Affairs Science. Incorporated 7760 France Avenue South, Suite 1060 Bloomington, Minnesota 55435

Re : K990208 Personal Infusor with Drug Disposal Septal Trade Name: Port II Requlatory Class: Product Code: MEG January 20, 1999 Dated: January 21, 1999 Received:

Dear Mr. Hoqancamp

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Hoqancamp

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Runper

ta Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cucente

vision of Dental, Infection Control. and General Hospital Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use_ OR

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).