The intended use of the Vista™ basic 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 Vista™ basic 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 Vista™ basic 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 Vista™ basic is an electrical external infusion pump intended to provide accurate infusions of parenteral and enteral fluids. The addition of the fm system will enhance the use of the Vista™ basic by allowing the user greater flexibilty in the administering and monitoring of a patients infusion status. Used as a complete system the Vista™ basic 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 Vista™ basics being used on one particular patient. This monitor also incorporates the use of a drug library, makes calculations based on user input.

The infusion pump contains the following hardware assemblies: linear peristaltic 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 a 12V rechargeable battery. The display subassembly contains an LCD display and a kevpad 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.

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.

AI/ML Overview

This 510(k) submission describes the B. Braun Medical Inc. Vista™ basic with fm system, an infusion pump. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics beyond a general claim of substantial equivalence to predicate devices.

Instead, the document focuses on:

Device Description: What the device is and how it works.
Intended Use: The clinical applications of the device.
Predicate Device Comparison: How this device is similar to existing, legally marketed devices (Horizon Outlook™ and Alaris Medley™ Patient Care System). This comparison focuses on design, material composition, components, manufacturing process, intended use, and labeling, as well as specific features.
Claim of Substantial Equivalence: The primary purpose of the 510(k) submission, asserting that the new device is as safe and effective as predicate devices.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text.

Here's what I can extract from the provided text regarding the device and its comparison to predicate devices, noting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on claims of "substantial equivalence" to predicate devices without listing specific performance metrics or acceptance criteria for the new device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document makes no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to predicate devices rather than a de novo performance study with a test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test set or study is detailed, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size.

This information is not provided. The document does not describe any MRMC comparative effectiveness study.

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

This information is not applicable/not provided. The device in question is an infusion pump with a "fm system" (which includes features like a barcode reader and drug library for programming) and is not described as an AI algorithm that would have standalone performance in that context. Its "performance" would relate to factors like flow accuracy and safety alarms.

7. The Type of Ground Truth Used

This information is not provided. No specific test for performance against a ground truth is described. The basis for safety and effectiveness is stated as "substantial equivalence" to legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not provided. Since no specific development or validation study with a "training set" (common for AI/machine learning devices) is described, this is not applicable. The device's software is mentioned, but its development process in terms of data sets is not detailed.

9. How the Ground Truth for the Training Set was Established

This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also not mentioned.

Summary of what is present:

The document serves as a 510(k) submission, asserting the "substantial equivalence" of the Vista™ basic with fm system infusion pump to two predicate devices: the Horizon Outlook™ and the Alaris Medley™ Patient Care System. The claim of equivalence is based on similarities in:

Design
Material composition (Injection Molded Thermoplastics for non-solution contact parts)
Components
Manufacturing process
Intended use (accurate and continuous flow of parenteral and enteral fluids, medication error reduction)
Labeling
Specific features like control pump activities from a monitor, drug calculation abilities, drug library, dosing limits, communication ports, and visual displays (Digital LCD).

The submission explicitly states: "There are no new issues of safety or effectiveness raised by the Vista™ basic with fm system." and "There are technological differences between the subject and predicate device, however, these differences do not raise new issues of safety and effectiveness." This indicates that the device's acceptable performance is implicitly demonstrated by its similarity to already cleared devices, rather than through independent studies with specific performance criteria.

Summary

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MAR 2 0 2003

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: |((23) 89 ."

1. Submitter Information:

September 20, 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:

Vista™ basic with fm system (formerly known as the Infusomat P K003029)

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 Vista™ basic 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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5: Intended Use of the Subject Device:

The intended use of the Vista™ basic 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 Vista™ basic 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. Vista™ basic 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

Duda Mingar
Signature

Signature

Date

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Predicate Device Description

The predicate device for the barcode that B. Braun Medical is claiming substantial equivalence to is the Horizon Lite. The Horizon Lite is marketed under cleared 510(k) K994375. B. Braun Medical Inc. submitted the device under the name Horizon Lite and is now marketed as the Horizon Outlook™.

The predicate device for the fm system that B Braun Medical is claiming substantial equivalence to is the Alaris Medley™ Patient Care System, marketed under cleared 510(k) K950419.

Comparison of the Subject and Predicate Barcode

The operation of the subject and predicate barcode label generators and readers are similar in that both require the scan of and medication name and dosage/rate information. Both systems require the clinician to view and validate the entry.

The Vista™ basic with fm system and the Horizon Outlook™ are similar in that they are both infusion pumps that that can accommodate barcode scanned data. They are similar in that they are both computer controlled, external, volumetric, infusion pumps composed of injection molded thermoplastic components. The components of the Vista™ basic and the Horizon Outlook™ are all non-solution contact parts. The subject and predicate devices are similar in their intended use, that is, to deliver fluids at a controlled rate.

The subject and predicate devices are similar in that they are both intended for use in the hospital or health care settings to control the infusion rate of parenteral fluids to patients.

Comparison of the fm system and Medley™ Patient Care System

The fm controller and Alaris Medley™ are similar in that they are both used in conjunction with infusion pumps or pumping modules that can be controlled while connected to them. Both the subject and the predicate devices have a large interactive screen that displays pump status. Both subject devices incorporate drug list, calculations and dosing limits.

2017-02-23 13:53:33

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The subject and predicate devices are different in that the fm system is an accessory, to the Vista™ basic. The Vista™ basic is a stand alone infusion pump and can function without the fm system whereas the pumping modules of the Alaris Medley™ cannot operate when removed from the programming module.

A table further identifying the similarities and differences between the fm controller and Alaris Medley™ Patient Care System is listed below. The table compares the features and specifications of the devices. The contents of these tables support the substantial equivalence claim between the fm controller and the Alaris Medley™.

SPECIFICATIONS AND FEATURES
Attribute	Subject Device-Vista™ basicwith fm system	Predicate Device-Alaris Medley™ PATIENT CARESYSTEM
Control pump activitiesfrom monitor	yes	yes
Pump or pumpingmodule can function on its'own	yes	no
Barcode capabilities	yes	no
Drug calculationabilities	yes	yes
Drug library	yes	yes
Dosing limits	yes	yes
Display all pumpsattached to monitor	yes	yes
Communication port	yes	yes
Print screen data	yes	yes
Provide AC power topumps	yes	yes
Materials	Injection Molded Thermoplastics	Injection Molded Thermoplastics
Visual Display	Digital LCD	Digital LCD

A. Table of Comparisons

Material Composition

The material composition of the subject and predicate devices are similar in that they are both composed of injection molded thermoplastics. None of the components of the pump or accessories are in contact with any solution delivered by the pump.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

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

Re: K023189

Trade/Device Name: Vista™ Basic with fm system Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 17, 2002 Received: December 20, 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.

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Page 2 - Ms. Morgan

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,

Oss L/s
Susan Runner, DDS/MA

Susan Runner, DDS 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 Statement

510(k) Number (if known) KU23 | 84

Device Name: Vista™ basic with fm system

Indications For Use:

The intended use of the Vistare basic 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 Vista™ basic 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Patric Ciente
(Division Sign Off)

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

510(k) Number: K623/87

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).