The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

Device Description

The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.

AI/ML Overview

The provided document is a 510(k) summary for the ALARIS Medical Systems® Medley™ PCA Module. It states that the device is substantially equivalent to predicate devices and meets specified performance requirements. However, it does not provide specific acceptance criteria or detailed results from a study proving these criteria are met.

Therefore, I cannot populate the table or answer most of the questions using the information given. The document explicitly states: "The performance data indicate that the Medley PCA Module meets specified requirements, and is substantially equivalent to the predicate devices," but it does not detail those requirements or the specific performance data.

Here's what can be inferred or stated based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Not specified in document	Meets specified requirements (specific criteria not detailed)

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

Sample size for test set: Not specified.
Data provenance: Not specified (country of origin or retrospective/prospective nature of any studies).

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 specified, as no detailed study or ground truth establishment is described.

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

Not applicable/Not specified.

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

No mention of an MRMC study, AI, or human reader improvement. This device is a PCA infusion pump, not an AI-assisted diagnostic tool.

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

Not applicable/Not specified. This is a medical device (infusion pump), not an algorithm.

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

Not applicable/Not specified, as no detailed study or ground truth establishment is described. The performance data would likely relate to engineering specifications for pump accuracy, safety features, etc.

8. The sample size for the training set

Not applicable/Not specified, as no machine learning or AI training is described.

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

Not applicable/Not specified.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA 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) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisRegulatory Affairs AssociateALARIS Medical Systems, Inc.
E.	Date Summary Prepared:	July 17, 2003

DEVICE IDENTIFICATION

A.	Generic Device Name:	PCA Infusion Pump
B.	Trade/Proprietary Name:	MedleyTM PCA Module
C.	Classification:	Class II
D.	Product Code:	MEA, PCA Infusion Pump

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module Page 2 of 2

SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® Medley" PCA Module is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Medley Syringe Module	ALARIS MedicalSystems, Inc.	K023264	12/19/02
Baxter PCA II Pump	Baxter HealthcareCorporation	K921994	8/3/92

INTENDED USE

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Medley" PCA Module and the predicate devices has been performed. The results of this comparison demonstrate that the Medley" PCA Module is equivalent to the marketed predicate devices in technological characteristics.

PERFORMANCE DATA

The performance data indicate that the Medley" PCA Module meets specified requirements, and is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Regulatory Affairs Associate Alaris Medical System, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772

Re: K032233

Trade/Device Name: PCA Infusion Pump Regulation Number: 880.5275 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, FRN Dated: July 17, 2003 Received: July 21, 2003

Dear Ms. Lewis:

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. Lewis

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 applicable, 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Runner

Susan Runner, DDS, MA Interim 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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INDICATIONS FOR USE

510(k) Number:

K032233 (To Be Assigned By FDA)

Device Trade Name:

Medley™ PCA Module

Indications For Use: The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use __

(Per 21 CFR 801.109)

Patricio Cucenite

ivision Sian-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

0002

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).