The intended use of the Perfusor® compact with fm system is to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Perfusor® compact and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.

The new incorporation of a barcode reader and programmable dosing limits are intended to aid in medication error reduction by decreasing the steps necessary to program an infusion and to alert the clinician when dose amounts are not within facility defined parameters.

The Perfusor@compact with fm system is intended for but not limited to use in the hospital and/or other healthcare facilities. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump and system before use in a clinical setting

Device Description

The Perfusor® compact is a battery and AC powered transportable syringe delivery system intended to provide infusion of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Perfusor® compact by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Perfusor® compact with fm system introduces some additional features to aid the clinician in fluid delivery and maintenance.

These features include the addition of a barcode reader to minimize the potential for programming errors, an external power source to reduce the number of electrical outlets required at the bedside, and the convenience of a large interactive monitor that displays the status of all Perfusor compacts being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input. In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Inc. intends to introduce into interstate commerce the Perfusor® compact with fm system.

The infusion pump contains the following hardware assemblies: swivel-drive pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord can be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of four AA alkaline batteries. The display subassembly contains an LCD display and a keypad used to input data into the pump as well as to present pump status and information to the user.

The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems.

The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data.

AI/ML Overview

The provided 510(k) summary for the Perfusor® compact with fm system does not contain information regarding a standalone study with acceptance criteria and a detailed analysis of device performance.

This 510(k) is a submission for substantial equivalence to predicate devices (Horizon Outlook™ and Alaris Medley™ Patient Care System) and focuses on demonstrating that the new device does not raise new issues of safety or effectiveness. The general approach for this type of submission is to compare the new device's characteristics and intended use to those of already cleared devices, rather than conducting new, detailed performance studies against specific acceptance criteria for a novel technology.

The document lists "Subject device system and software test plans" and "Subject device system and software hazard analysis," which indicate that testing was performed. However, it does not provide the results of these tests or the specific acceptance criteria used for them in this public summary.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sized used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is described.
Adjudication method: Not applicable as no such study is described.
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 device is an infusion pump, not an AI-powered diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No detailed standalone performance study is described in this summary.
The type of ground truth used: Not applicable as no such study is described.
The sample size for the training set: Not applicable as no AI training set is mentioned for this device.
How the ground truth for the training set was established: Not applicable as no AI training set is mentioned.

Summary of available information related to performance (implicit in 510(k) process):

The submission asserts that the differences between the subject device and the predicate devices "do not raise new issues of safety and effectiveness." This implies that any internal testing or validation performed by B. Braun Medical Inc. confirmed that the device performs as intended and is safe, similar to the predicate devices. However, the specific details of that testing and the acceptance criteria are not included in this 510(k) summary.

Summary

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Ko22575

AUG 2 1 2002

510(k) SUMMARY

"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. "

"The assigned 510(k) number is:

Submitter Information:

July 31, 2002

B. Braun Medical Inc. 1601 Wallace Drive Ste. 150 Carrollton, TX. 75006 (972) 245-2243 ext. 206

Contact Person:

Ms. Linda Morgan Regulatory Affairs Specialist Phone: 972.245.2243 ext. 339 FAX: 972.245.1612

2: Name of Device:

Infusion Pump

Trade Name:

Perfusor® compact with fm system

Classification Name:

Class II, 80FRN 21 CFR 880.5725

3: Predicate Device:

The predicate devices that B. Braun Medical Inc. is claiming substantial equivalence to are the Horizon Outlook™ and the Alaris Medley™ Patient Care System. The Horizon Outlook™ is marketed by B. Braun Medical under cleared 510(k) K994375. The Medley™ Patient Care System is marketed by Alaris under cleared 510(k) 950419. This substantial equivalence claim is intended for Food, Drug and Cosmetic Act purposes only. There are no new issues of safety or effectiveness raised by the Perfusor® compact with fm system.

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1 The term "substantially equivalent" as used herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

4: Description of the Subject Device:

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The software also provides communication abilities from external devices to the pump. This feature is only accessible by a trained Biomedical Technician. Programming of the pump is to be performed by trained Biomedical professionals.

5: Intended Use of the Subject Device:

The intended use of the Perfusor® compact with fm system remains to provide accurate and continuous flow of parenteral, including blood, and enteral fluids to the patient. The addition of the fm system extends the abilities of the Perfusor® compact and creates a versatile system that will enhance the administration and management of infusion therapy. The fm system may be used in a variety of configurations depending on the level of needs of the healthcare facility.

6: Technological Characteristics of the Subject Device

The subject device, Perfusor® compact with fm system is substantially equivalent to the predicate devices, the Horizon Outlook™ and the Alaris Medley™ Patient Care System. The subject and predicate devices are similar in design, material composition, components, manufacturing process, intended use and labeling. There are technological differences between the subject and predicate device, however, these differences do not raise new issues of safety and effectiveness. The substantial equivalence claim between the subject and predicate device is supported by the information and data provided in this 510(k) submission. This includes the following information:

Description of the subject and predicate devices. ●
Intended use of the subject and predicate devices. ●
Material composition of the subject and predicate devices. .
Labels and labeling for the subject and predicate devices. .

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Comparison tables of attributes and specifications of the subject and predicate ● devices.
Subject device customer functional specification. .
Subject device system and software hazard analysis. .
Subject device system and software requirements. .
Subject device system and software test plans. .
Subject device system and software trace matrix. .

7: Signature of Applicant

B. Braun Medical Inc. Linda Morgan RN, BSN Regulatory Affairs Specialist

Surria Murgan
Signature

7/31/02

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2002

Ms. Linda Morgan Regulatory Affairs Specialist B. Braun Medical, Incorporated 1601 Wallace Drive, Suite 150 Carrollton, Texas 75006

Re: K022575

Trade/Device Name: Perfusor® Compact with FM System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 31, 2002 Received: August 2, 2002

Dear Ms. Morgan:

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.

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.

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Page 2 - Ms. Morgan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Russo

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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Indications For Use Statement

510(k) Number (if known)

Device Name: Perfusor@ compact with fm system

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)

Patux Ciucanti

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

000004

510(k) Number: K022573

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).