The Infusomat® Space Volumetric Pump Administration Sets are 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 intra-arterial, subcutaneous, epidural, irrigation/ablation, and enteral. The sets are used for the delivery of medications 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 Infusomat Space Volumetric Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

Device Description

The Infusomat® Space Volumetric Infusion Pump administration sets are sterile, nonpyrogenic, single-use devices for use with the B. Braun Infusomat® Space Volumetric Infusion Pump for pump and gravity administration of fluids.

Each administration set contains a segment of silicone tubing intended to interface with the linear peristaltic mechanism of the pump. There are two connectors at each end of the pump tube segment and a line loading guide to assist the user in loading the pump segment into the pump. Each set also contains a free flow protection clamp. The clamp is specifically designed to interface with a mating receptacle in the pump and is intended to prevent free flow of fluid when the pump door is opened and the set is removed. There are multiple set configurations including basic sets, burette sets, additive sets, filtered sets, low adsorption sets, add-on sets, and blood sets.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Infusomat Space Volumetric Infusion Pump Administration Sets." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for a new clinical claim.

Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details about training sets, is not available in this type of submission. This document describes performance testing conducted to show the new administration sets perform as intended and similarly to the predicate device.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging its limitations for certain aspects of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use." However, specific numerical acceptance criteria and reported performance values for each test are not provided in this summary. The table below represents the types of testing performed and the general conclusion, but not specific pass/fail values or quantitative results.

Acceptance Criteria (Implied)	Reported Device Performance
Visual Inspection	Performs as intended
Simulated Use	Performs as intended
Durability	Performs as intended
Flow Rate	Performs as intended
Occlusion	Performs as intended
Tensile Strength	Performs as intended
Pressure Testing	Performs as intended
Volumetric Accuracy with Infusomat® Space Volumetric Infusion Pump	Performs as intended

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

Sample Size: This information is not provided in the document. The phrase "functional and performance testing" is used, but no specific number of units tested is mentioned.
Data Provenance: The testing was conducted by B. Braun Medical Inc. as part of their 510(k) submission. It's an internal test, and the data is retrospective in the sense that it was conducted before the submission, but not in the clinical trial sense. Country of origin of data is not specified beyond being part of a U.S. FDA submission.

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

This information is not applicable to the type of engineering performance testing described. The "ground truth" for these tests would be established by engineering specifications and standards, not expert medical consensus.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication typically refers to expert review of clinical cases. For engineering tests, results are usually measured against predefined specifications.

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, an MRMC comparative effectiveness study was not done. This document pertains to an administration set for an infusion pump, which is a hardware device, not an AI-powered diagnostic or decision support system that involves human readers.

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

This information is not applicable. The device is a physical administration set for an infusion pump, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of these administration sets would be based on engineering specifications and established performance standards for such medical devices (e.g., flow rate accuracy within a certain tolerance, pressure resistance, tensile strength). The document does not explicitly list these standards but implies their use through phrases like "perform as intended" and "performs similarly to the predicate device."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI device. The testing described is verification and validation of a physical medical device.

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

This information is not applicable for the reasons stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2014

B. Braun Medical Inc. Tracy Maddock Senior Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, PA 18109

Re: K142036

Trade/Device Name: Infusomat Space Volumetric Infusion Pump Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: July 25, 2014 Received: July 28, 2014

Dear Ms. Maddock:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Maddock

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) K142036

Device Name

Infusomat® Space Volumetric Infusion Pump Administration Sets

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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ട്. 510(k) Summary

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500Contact: Tracy Maddock, RACSr. Regulatory Affairs SpecialistPhone: (610) 596-2545Fax: (610) 266-4962E-mail: Tracy.Maddock@bbraun.com
DATE:	July 25, 2014
DEVICE NAME:	Infusomat® Space Volumetric Infusion Pump Intravascular Administration Sets
COMMON OR USUAL NAME:	Intravascular Administration Sets
DEVICE CLASSIFICATION:	Class II per 21 CFR 880.5440Intravascular Administration Set, product code FPABlood Transfusion Set, product code BRZClassification Panel: General Hospital
PREDICATE DEVICES:	Infusomat® Space Volumetric Infusion Pump System, K062700

DESCRIPTION:

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basic sets, burette sets, additive sets, filtered sets, low adsorption sets, add-on sets, and blood sets.

INTENDED USE:

The Infusomat® Space Volumetric Infusion Pump Administration Sets are 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 sets are 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 Infusomat® Space Volumetric Infusion Pump Administration Sets are intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments.

SUBSTANTIAL EQUIVALENCE:

Technological Characteristics

Predicate Device – Infusomat® Space Volumetric Infusion Pump System (K062700)

The Infusomat® Space Volumetric Infusion Pump Administration Sets have the same indications for use, principles of operation and technological characteristics as the predicate devices, the administration sets included in the Infusomat® Space Volumetric Infusion Pump System (K062700). The subject sets are constructed of similar materials and are manufactured and sterilized utilizing the same processes.

Performance Testing

The proposed Infusomat® Space Volumetric Infusion Pump Administration Sets were subjected to functional and performance testing to demonstrate that the sets perform as intended.

The following testing was performed:

Visual inspection ●
Simulated use
Durability
Flow rate ●
Occlusion ●
Tensile Strength ●
Pressure Testing ●
Volumetric accuracy with Infusomat® Space Volumetric Infusion Pump ●

Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively according to its intended use. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.

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CONCLUSION:

Results of functional and performance testing conducted on the proposed device demonstrate that the administration sets are safe and perform as intended. The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness. The Infusomat® Space Pump Administration Sets, therefore, are substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.