The Perfusor Space Infusion Syringe Pump System includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).

Device Description

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic volumetric infusion pump and pump accessories. The Perfusor® Space is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space utilizes a swivel-drive pumping mechanism is intended to provide infusions of parenteral and enteral fluids. The system is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products. The Ferfusor Space uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space. The B. Braun Space Station is a 12V DC or battery powered flexible docking and communication system for the medical workplace, in particular the intensive medical care. It serves the perspicuous accommodation of the infusion and infusion-syringe pumps Infusomat® Space and Perfusor® Space. SpaceCover Standard or SpaceCover Comfort forms the top of each column. The DrugListEditor Space is a programm to create a drug pool with drug names including the corresponding parameter.

AI/ML Overview

This document is a 510(k) Premarket Notification for the B. Braun Medical Inc. Perfusor® Space Infusion Syringe Pump System. It details the device's description, intended use, and argues for its substantial equivalence to previously cleared predicate devices.

This document describes a medical device, specifically an infusion syringe pump system, and demonstrates its substantial equivalence to existing devices for market clearance. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics that would typically apply to AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here implicitly refers to meeting regulatory requirements for substantial equivalence to predicates.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format usually requested for AI/ML studies, nor can I answer questions 2 through 9, as they pertain to detailed study design and ground truth establishment for performance evaluation, which are not present in this regulatory submission for a medical pump.

The document's primary "study" is the comparison against predicate devices to establish substantial equivalence under the 510(k) pathway, which is a regulatory assessment, not a performance study in the AI/ML sense.

Here's a breakdown of what can be extracted or inferred based on the provided text's context:

1. Table of "Acceptance Criteria" and "Reported Device Performance" for Substantial Equivalence

Acceptance Criteria (for Substantial Equivalence to Predicates)	Reported Device Performance (vs. Predicates)
Intended Use: Same as predicate devices.	The Perfusor® Space Infusion Syringe Pump System has the "same intended use" as the Perfusor® compact with fm-System (K022575) and MEDLEY™ System with Medication Management System (K030459) together with MEDLEY™ Syringe Pump Module (K023264). Intended for adults, pediatrics, and neonates for intermittent or continuous delivery of parenteral and enteral fluids via various routes (intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, enteral). Used by trained HCPs in various environments.
Operation & Function: Similar to predicate devices.	The subject device and predicates are all "computer controlled electrical, external, swivel-driven infusion syringe pumps composed of injection molded thermoplastic components." They control infusion rate of parenteral and enteral fluids, use standard, single-use, disposable syringes (with luer-lock connectors) validated with the pumps. Provide possibilities to clean up/organize patient bedside, central power, tubing retainers, transportation, and customization of menu items/drug library.
Technology/Design: Similar to predicate devices.	The components of the subject and predicate pumps are "all non solution contact parts." The accessories are similar in offering clinician flexibility and providing filing and communication systems.
Safety and Effectiveness: No new questions of safety or effectiveness.	Not explicitly stated in a quantitative manner, but implied by the successful 510(k) clearance, indicating the FDA found no new questions of safety or effectiveness compared to the predicate devices.

Clarification: In the context of a 510(k) for a medical pump, "acceptance criteria" and "reported device performance" are judged against the predicate devices for establishing substantial equivalence, rather than a specific numerical diagnostic performance for an AI algorithm. The FDA's letter explicitly states: "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...".

The following questions cannot be answered from the provided text as they relate to performance studies, especially those relevant to AI/ML or diagnostic devices, which are not covered in this 510(k) summary for an infusion pump system.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Provided. This document does not describe a performance study with a test set in the diagnostic sense.
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/Provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided.
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/Provided. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Provided. This is an infusion pump, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Provided.
The sample size for the training set: Not applicable/Provided.
How the ground truth for the training set was established: Not applicable/Provided.

Summary

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B. Braun Medical Inc. 510(k) Premarket Notification

(p. 1 of 5)

August 18, 2006

OCT 2 6 2006

510(k) Summary

APPLICANT:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Contact: Scott Pease Manager, Regulatory Affairs Phone: 610-596-2376

SUBMITTER:

B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen GERMANY

Contact: Thomas Möller Manager, Regulatory Affairs Phone: 49 5661 71-1349

Perfusor® Space Infusion Syringe Pump System

DEVICE NAME:

COMMON OR USUAL NAME:

Infusion Syringe Pump

DEVICE CLASSIFICATION:

Class II per Code of Federal Regulation Title 21 $880.5725: Infusion Pump, product code FRN and Enteral Infusion Pump, product code LZH. Classification Panel: General Hospital.

PREDICATE

Predicate device for infusion syringe pump: B. Braun Medical Inc. Perfusor® compact with fm-System, marketed under cleared 510(k) K022575 and MEDLEY"M System with Medication Management System, marketed by ALARIS Medical Systems Inc. under cleared 510(k) K030459 together with MEDLEYTM Syringe Pump Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K023264

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CONSTITUTION

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R 462649
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DESCRIPTION:

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic volumetric infusion pump and pump accessories.

Perfusor® Space

The Perfusor® Space is a 12V DC or battery powered external, transportable, infusion syringe pump. The Perfusor® Space utilizes a swivel-drive pumping mechanism is intended to provide infusions of parenteral and enteral fluids. The Perfusor® Space is intended for but not limited to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting.

The system is intended to provide intermittent or continuous flow of parenteral and enteral fluids to the patient. Parenteral fluids may include all standard fluids and/or medications indicated for infusion as well as blood and blood products.

The Ferfusor Space uses standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated on the Perfusor® Space. For a list of compatible, FDA cleared syringes please refer to the instructions for use of the Perfusor® Space.

SpaceStation

The B. Braun Space Station is a 12V DC or battery powered flexible docking and communication system for the medical workplace, in particular the intensive medical care. It serves the perspicuous accommodation of the infusion and infusion-syringe pumps Infusomat® Space and Perfusor® Space. The pillar and mounting system synchronized system components enables the individualized workplace design.

The SpaceStation module allows the set-up of a complete pump system with up to 24 pumps. Up to four pumps can be installed in every SpaceStation. The pumps are supplied with power via the integrated power supply and the built-in connectors. Up to six SpaceStations can be set-up as a column with a total of 24 pumps. SpaceStation placed next to each other can be connected via special connection

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cables, if the maximum number of 24 pumps in maximum three columns is not exceeded.

SpaceCover

SpaceCover Standard or SpaceCover Comfort forms the top of each column. Every SpaceStation or a column of SpaceStations must be closed with a cover. Alarms are signalled by a row of LEDs and a loudspeaker in the SpaceCover Comfort.

The SpaceCover Standard does not contain any additional electronics. It protects the upper connectors from humidity and camage and allows a single SpaceStation to be used as a carrying unit. The SpaceCover standard housing mainly consists of the bottom part and the upper part. The design of the SpaceCover comfort corresponds to that of the SpaceCover standard. SpaceCover Comfort offers a greater system functionality and operating facility. The cover is equipped on its front side with a large and very well readable status and alarm display. All status and alarm conditions of the pumps within the system as well as of the pumps themselves are displayed.

DrugListEditor

The DrugListEditor Space is a programm to create a drug pool with drug names including the corresponding parameter. The DLE-Space only may be used together with the infusion pumps Infusomat® Space and Perfusor® Space. A download of a drug list into the respective pump is possible by using the HiBaSeD service tool. The DrugListEditor is able to hold up to 3500 drug names with corresponding parameters. From this pool, single drug libraries can be compiled and stored. The drug pool is saved as a binary file on the computer.

The Perfusor® Space Infusion Syringe Pump System INTENDED USE: includes an external transportable electronic infusion syringe pump and pump accessories. The system is intended for use on adults, pediatrics, and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes include, but are not limited to intravenous, intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The system is used for the delivery of medications indicated for infusion therapy including but

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August 18, 2006

not limited to drugs like anesthetics, sedatives, analgesics, catecholamines, anticoagulants etc., blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments (only road ambulances).

SUBSTANTIAL EQUIVALENCE:

The Ferfusor® Space Infusion Syringe Pump System, including an external transportable electronic volumetric infusion pump and pump accessories has the same intended use, operation, and function as the Perfusor® compact with fm-System, marketed under cleared 510(k) K022575 and MEDLEY™ System with Medication Management System, marketed by ALARIS Medical Systems Inc. under cleared 510(k) K030459 together with MEDLEYTM Syringe Pump Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K023264.

The subject and the predicates are all computer controlled electrical, external, swivel-driven infusion syringe pumps composed of injection molded thermoplastic components. The components of the subject and predicate pumps are all non solution contact parts. The subject and predicates are also similar in that they are used in the hospital or home health care setting to control the infusion rate of parenteral and enteral fluids to the patient. The subject and predicates achieve fluid delivery in a similar manner while using standard, single-use, disposable syringes (with luer-lock connectors) designed for use on syringe pumps and validated with the pumps.

The included accessories of the Perfusor® Space Infusion Syringe Pump System are similar to the predicate devices in that they all offer the clinician maximum flexibility in providing infusion therapy. The subject and predicate systems provide possibilities to clean up and organize the patierit bedside by storage different pumps in a filing and communication system. This filing and communication system provides central power supply to the single pumps and tubing retainers to prevent IV line confusion. Also the subject and the predicate provide a means for easy transportation of the modules as well as of the system. Additionally the subject and predicate devices are used to customize the menu items and drug library parameters for

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B. Braun Medical Inc. 510(k) Premarket Notification

each facility. The calibration preventive maintenance of the pump can also be stored in each device and the users notified when such calibration or routine maintenance is due to be completed.

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DEPARTMENT OF HEALTH 8. HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

B. Braun Melsungen AG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV America, Incorporated 1775 Old Hwy 8 NW New Brighton, Minnesota 55 12-1891

OCT 26 2006

Re: K062699

Trade/Device Name: Perfusor Space Infusion Syringe Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 4, 2006 Received: October 11, 2006

Dear Mr. Preiss:

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 aga nst 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 - Mr. Preiss

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours.

Susan Runno

Chiu Lin, Ph.D. 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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Page

510(k) Number (if known): __

Device Name:

Perfusor Space Infusion Syringe Pump System

Indications For Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onton On
(24)

Anesthesiology, General Hospital,
Control, Dental Devices

K462649

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).