(97 days)
The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic syringe infusion pump and pump accessories. The Perfusor Space Infusion Syringe Pump System utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral 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. 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 fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.
The provided text describes a 510(k) premarket notification for the B. Braun Medical Inc. Perfusor® Space Infusion Syringe Pump System. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical trial for a diagnostic AI device would.
Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study, standalone performance) is not present in the provided text.
Specifically, the document addresses new functionalities added to an existing device: barcode, out-bound wireless data transmission, and PCA (Patient-Controlled Analgesia) functionality. The primary claim is "substantial equivalence" to predicate devices, meaning it performs similarly and presents similar safety and effectiveness.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document focuses on substantial equivalence based on comparable type, indications for use, and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe a "test set" or a study designed to measure performance metrics. It's a regulatory submission for device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no mention of a ground truth being established by experts for a test set in this regulatory submission.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC study is mentioned. The document primarily discusses the technical features and intended use of the infusion pump system and its new functionalities. This is a medical device, not a diagnostic AI system, so MRMC studies are not typically conducted for this type of product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is an infusion pump system, not an AI algorithm designed to interpret data or diagnose conditions. Its performance is inherent in its mechanical and software functions for drug delivery.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as used in evaluating AI or diagnostic systems does not apply to this medical device submission. The "truth" here relates to the reliable and accurate functioning of the pump in delivering fluids/medications as intended.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a traditional medical device, not an AI/machine learning device that would typically involve a training phase on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of the document's content relevant to evaluation:
The document establishes that the Perfusor® Space Infusion Syringe Pump System, with its added barcode, out-bound wireless data transmission, and PCA functionalities, is substantially equivalent to predicate devices:
- Predicate device for the original pump system: The Perfusor® Space Infusion Syringe Pump System (K062699).
- Predicate device for barcode and out-bound wireless data transmission: B. Braun Medical Inc. Outlook® Safety Infusion System (K011975).
- Predicate device for PCA functionality: MEDLEY™ PCA Module (K032233) by ALARIS Medical Systems Inc.
The argument for substantial equivalence is based on:
- Comparable type: All are computer-controlled electrical, external, syringe infusion pumps.
- Similar indications for use: For infusion of parenteral fluids/medications, blood, and blood products for adults, pediatrics, and neonates.
- Similar technological characteristics: Implementing advanced features (barcode, wireless, PCA) in a similar manner, using communication protocols (CAN bus) for data exchange with hospital information systems. All data transmitted uses B. Braun's proprietary information protocol to ensure data integrity.
- Similar accessories: Providing clinician flexibility, organizing the bedside, central power supply, tubing retainers, ease of transportation, and customization of menu/drug library parameters.
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B. Braun Medical Inc. 510(k) Premarket Notification
5. 510(k) Summary - Revision
NOV - 4 2009
1092313
B. Braun Medical Inc. SUBMITTER: 901 Marcon Boulevard Allentown, PA 18109-9341 FDA Establishment Registration #: 2523676
Contact: Susan Olinger, J.D. Corporate Vice President, Regulatory Affairs Phone: 610.596.2517
DEVICE MANUFACTURER:
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen GERMANY FDA Establishment Registration #: 9610825
- The Perfusor Space Infusion Syringe Pump System DEVICE NAME:
COMMON OR USUAL NAME:
Infusion Pump
DEVICE CLASSIFICATION:
Class II per Code of Federal Regulation Title 21 §880.5725: Infusion Pump, product code FRN and PCA Infusion Pump, product code MEA
CLASSIFICATION General Hospital PANEL:
The Perfusor® Space Infusion Syringe Pump System PREDICATE DEVICE: is of comparable type and is substantially equivalent to the original submission of the The Perfusor® Space Infusion Syringe Pump System marketed under cleared 510(k) K062699. The predicate device for barcode and out-bound wireless data transmission functionalities is B. Braun Medical Inc. Outlook® Safety Infusion System, marketed under cleared 510(k) K011975. The predicate device for PCA functionality is the MEDLEYTM PCA Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K032233.
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DEVICE DESCRIPTION: The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic syringe infusion pump and pump accessories. B. Braun Medical Inc. has taken great efforts in consulting with groups of actual users of infusion systems as well as hospital from pharmacists to to information administrations technology professionals to develop barcode, out-bound wireless data transmission and PCA features that not only enhance the administration of infusions but are also tools in the development of medication error reduction programs while ensuring the validity of transferred data. The Perfusor Space Infusion Syringe Pump System can be customized to meet the needs of a particular institution by allowing facilities to enable or disable particular aspects of the bar coding and wireless features, such as nurse D matching, or by assigning dose or rate limits to particular medications.
** Although the only additions to the The Perfusor® Space Infusion Syringe Pump System are barcode, out-bound wireless data transmission and PCA functionality, for convenience of review, the device description may include previously cleared features **
The mechanics of the The Perfusor® Space Infusion Syringe Pump System have not changed since the original submission.
The Perfusor Space Infusion Syringe Pump System utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral 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. 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 fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.
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SpaceStation with SpaceCom
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.
SpaceCom is a communication software that has been integrated into the SpaceStation. SpaceCom supports different interfaces like Ethernet, PS2-Keyboard, Serial, USB ports and PCMCIA network card. For bar-coding, a barcode image reader can be connected to the PS2-Keyboard or USB interface. The pumps are connected with connectors on the inner backside to the SpaceStation. These connectors provide the voltage supply, distribute the addresses in the Space system via a serial interface, transfer data via a bus system (CAN bus) and transmit a staff call, which may be pending.
The Perfusor® Space Infusion Syringe Pump System must be housed in a SpaceStation that has SpaceCom software installed in order to accomplish the advanced features of bar coding and out-bound wireless data transmission. (SpaceStations are available with or without SpaceCom).
The software communication (CAN bus) allows out-bound flow of information from the infusion pump to an existing hospital information management system. The PCMCIA network card resides in the SpaceStation with SpaceCom. All data transmitted must use the B. Braun information protocol for proprietary data exchange.
The implementation of the PCA feature furthers B. Braun's vision that one pump system can be used throughout an entire facility. The intent of B. Braun is pain therapy management, not only to add a new "pain pump" feature to the existing platform, but to facilitate the hospital-wide management of post-operative pain treatment. Having one system that may be used to administer a wide variety of infusion therapies allow healthcare professionals the benefit of only having to learn one device hospital-wide. The use of one device house-wide helps to ensure consistency in infusion protocols. Medication delivery will be enhanced by understanding and using the advanced features of the
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B. Braun Medical Inc. 510(k) Premarket Notification
Perfusor® Space and will optimize asset utilization within a healthcare institution. Increased functionality and data acquisition of the Perfusor® Space Infusion Syringe Pump System support medication error reducing programs and can be used to audit the effectiveness of those programs.
Like the predicate device, the Space Cover/Comfort is a feature of the Perfusor Space Syringe Pump System. The Space Cover/Comfort provides a "top" for the Space Station with a battery indicator and audible/visual alarm that functions as a back up to the pump.
INDICATIONS FOR USE: The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.
SUBSTANTIAL EQUIVALENCE:
The Perfusor® Space Infusion Syringe Pump System is of comparable type and is substantially equivalent to the original submission of the Perfusor® Space Infusion Syringe Pump System marketed under cleared 510(k) K062699. The predicate device for barcode and out-bound wireless data transmission functionalities is B. Braun Medical Inc. Outlook Safety Infusion System, marketed under cleared 510(k) K011975. The predicate device for PCA functionality is the MEDLEYTM PCA Module marketed by ALARIS Medical Systems Inc. under cleared 510(k) K032233.
The subject device is a computer- controlled electrical, external, syringe infusion pump composed of injection molded thermoplastic components. The components of the subject and all non-solution contact parts. The subject and predicates have implemented the advanced features of infusion therapies in a similar manner by developing communication protocols that send and receive infusion data in a barcode or wireless (out-bound) format. The software communication (CAN bus) allows flow of information from the infusion pump to an existing hospital information management system. The PCMCIA network card resides in the SpaceStation with SpaceCom. All data
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transmitted must be use the B. Braun proprietary information protocol, ensuring the integrity of data received or sent.
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 patient bedside by storage of 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 each facility. The barcode readers and PCA button accessories are similar in that they both allow for ease of patient use and safeguard the controlled medications being administered.
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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The words are arranged on a single line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV - 4 2009
Susan Olinger, J.D. Corporate Vice President, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K092313
Trade/Device Name: The Perfusor® Space Infusion Syringe Pump System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, MEA Dated: July 27, 2009 Received: August 25, 2009
Dear Dr. Olinger:
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 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- Dr. Olinger
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Suser Runner
Susan Runner, D.D.S., M.A. Acting Division 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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B. Braun Medical Inc. 510(k) Premarket Notification .
4. Indications for Use Statement
Page l
Ko4-2313 510(k) Number (if known): _
Device Name:
The Perfusor® Space Infusion Syringe Pump System
Indications For Use:
The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and is intended to provide infusions of parenteral fluids/medications, blood products indicated for infusion through FDA approved routes of administration.
Prescription Use _ X (Per 21 CFR 801.109)
OR
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)
Lijl Munoz for AC Anthony Watson
(Divisio Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092313
§ 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).