The MEDLEY™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

The MEDLEY™ Syringe Pump is indicated for use on adults, pediatrics and neonates 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.

Device Description

The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM.

The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available:

Back-off .
. Fast Start
Customizable Pressure Alarm Settings ●
Pressure Tracking Display ●
Auto Pressure .

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device, specifically the ALARIS Medical Systems® MEDLEY™ Syringe Pump Module. This document does not contain the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria and study particulars for a software-based AI device.

Here's why and what information can be extracted:

Information NOT Found in the Document:

Acceptance Criteria Table: The document states "The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices." however, it does not list the specific performance acceptance criteria (e.g., accuracy percentages, specific error rates) or detailed reported device performance against those criteria.
Sample Size for Test Set and Data Provenance: This information is not provided. The document focuses on regulatory equivalence, not detailed testing methodologies.
Number of Experts/Qualifications for Ground Truth: Not applicable and not mentioned for this type of device.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a hardware device (syringe pump), not an AI/software device. Therefore, an MRMC study is not relevant or described.
Standalone Performance (AI context): Not relevant as this is not an AI device.
Type of Ground Truth: Not relevant in the AI sense. This refers to the accuracy of the pump's mechanical operation, not image interpretation or diagnostic performance validated against a ground truth.
Sample Size for Training Set: Not applicable, as this is a hardware device lacking a "training set" in the AI/machine learning sense.
How Ground Truth for Training Set Was Established: Not applicable.

Information That Can Be Extracted (Pertaining to the Device Type):

The document describes the device, its intended use, and its substantial equivalence to predicate devices. For a hardware device like this, "performance data" would typically refer to engineering tests demonstrating accuracy of fluid delivery, pressure settings, alarm function, and safety features.

Summary based on the provided text (and noting what's not there for your specific request):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly listed as specific quantitative metrics in this document. The general criterion is that "The MEDLEY™ System Syringe Pump meets specified requirements."
- Reported Device Performance: Not detailed in this document. It broadly states that "performance data indicate that [it] meets specified requirements, and is substantially equivalent to the predicate devices."
Sample sized used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of hardware device. Performance is determined through engineering tests and calibration.
Adjudication method for the test set: Not applicable for this type of hardware device.
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. This is a hardware syringe pump, not an AI diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware syringe pump.
The type of ground truth used: For a syringe pump, 'ground truth' would generally refer to established engineering standards for fluid delivery accuracy, pressure measurement, and alarm functionality. The document doesn't detail the specific methods (e.g., flow rate measurements, pressure sensor calibration).
The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML system.
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a hardware medical device (syringe pump) seeking substantial equivalence. The questions you've asked are largely tailored for the evaluation of AI/software devices, which involve very different types of studies, metrics, and "ground truth" establishment. Therefore, most of the requested information is not present or applicable in this source text.

Summary

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K023264 SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® MEDLEY™ Syringe Pump Module

SUBMITTER INFORMATION

A.	Company Name:	ALARIS Medical Systems, Inc.
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7563(858) 458-6114
D.	Contact Person:	Renée L. FluetPrincipal Regulatory Affairs SpecialistALARIS Medical Systems, Inc.
E.	Date Summary Prepared:	September 27, 2002
DEVICE IDENTIFICATION
A.	Generic Device Name:	Syringe Infusion Pump
B.	Trade/Proprietary Name:	MEDLEY™ Syringe Pump Module
C.	Classification:	Class II

Product Code: FRN, Infusion Pump D.

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2

DEVICE DESCRIPTION (Continued)

Back-off .
. Fast Start
Customizable Pressure Alarm Settings ●
Pressure Tracking Display ●
Auto Pressure .

SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® MEDLEY™ Syringe Pump is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer	510(k) No.	DateCleared
Model P7000 Variable SyringePump	ALARIS MedicalSystems, Inc.	K974332	12/29/98
Medex 3000 Series SyringeInfusion Pump, Model 3010a	Medex. Inc.	K982640	4/6/99

INTENDED USE

The MEDLEY" Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

The MEDLEY" Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration

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SUMMARY OF SAFETY AND EFFECTIVENESS Page 3

INTENDED USE (Continued)

such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the MEDLEY™ Syringe Pump and the predicate devices has been performed. The results of this comparison demonstrate that the MEDLEY™ Syringe Pump is equivalent to the marketed predicate devices in technological characteristics.

PERFORMANCE DATA - The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Renée L. Fluet Principal Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733

Re: K023264

Trade/Device Name: MEDLEY™ Syringe Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 27, 2002 Received: September 30, 2002

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 your 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.

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Page 2 - Ms. Fluet

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. 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 appliedble, 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), 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,

Susan Runser

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

Enclosure

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ALARIS MEDICAL SYSTEMS*, INC.

INDICATIONS FOR USE

510(k) Number:

K 023264	(To Be Assigned By FDA)
----------	-------------------------

Device Trade Name:

MEDLEY™ Syringe Pump

Indications For Use: The MEDLEY™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

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)

Over-The-Counter Use

Tittina Cucurita

Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Confidential

510(k) Number. _K023264

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).