(229 days)
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. lt enables remote viewing of pump status within the hospital and enables comparisons of pharmacyentered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
The Pump Connectivity Interface has been developed to expand upon previously cleared external monitoring features of legally marketed infusion pumps. As described above, the Pump Connectivity Interface is a system of hardware and software that enables external infusion pumps to be integrated into existing hospital network infrastructure. It is intended to provide trained healthcare practitioners with access to additional information needed to more safely manage infusion therapy via external infusion pumps.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Baxter Healthcare Corporation's Pump Connectivity Interface:
Crucial Observation: The provided document is a 510(k) summary for a medical device (Pump Connectivity Interface). It primarily aims to demonstrate substantial equivalence to predicate devices, not necessarily to provide detailed performance study results against specific acceptance criteria. This type of document typically focuses on comparing technological characteristics and stating that performance data "indicate that the device will meet specified requirements" without detailing those requirements or the studies themselves.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies are not available in the provided text. The document is at a high level of regulatory summary.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific, quantitative acceptance criteria and detailed device performance metrics are not explicitly stated in this 510(k) summary. The document makes a high-level statement: "The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices."
Therefore, a table cannot be constructed with the information provided. The "acceptance criteria" here are implicitly that the device's performance is deemed sufficient to establish substantial equivalence to the predicate devices and meet safety and effectiveness requirements.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The implication is that the device must perform safely and effectively, demonstrating substantial equivalence to predicate devices for its intended use. | The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: The document does not mention an MRMC comparative effectiveness study. The device is a "Pump Connectivity Interface" for managing infusion therapy, enabling remote viewing and alarm notification, rather than an AI-powered diagnostic tool that human readers would interpret. Its primary function is data communication and display, not interpretation that would involve "human readers."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study is mentioned or relevant given the device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The document does not describe a "standalone" performance study in the context of an algorithm's diagnostic accuracy. The device's function inherently involves human interaction, as it provides "trained healthcare practitioners access to additional information" and "enables comparisons of pharmacy-entered prescription information to programmed pump settings." It's a connectivity and information display tool, not an autonomous decision-making algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not specified. Given the nature of the device (connectivity and information management for infusion pumps), "ground truth" would likely relate to the accuracy of data transmission, display, and alarm notification, rather than a clinical diagnosis confirmed by pathology or outcomes data. It would probably involve validation against direct pump readings or simulated scenarios.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. The document does not mention the use of machine learning or AI that would typically involve a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as the document does not mention a training set in the context of machine learning.
Summary of Missing Information:
This 510(k) summary provides a high-level overview for regulatory clearance based on substantial equivalence. It does not contain the granular detail about specific performance studies, sample sizes, expert involvement, or ground truth methodologies that would be required to answer most of your detailed questions. For a medical device like this in November 2004, the focus was heavily on demonstrating that the new device's technological characteristics and intended use were comparable to existing, legally marketed devices, and that it met basic safety and performance requirements without specifying the exact metrics or detailed study designs for those requirements.
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NOV 3 0 2004
510(k) Summary of Safety and Effectiveness
Submitted by:
Jennifer M. Paine Manager, Global Regulatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073
Name/Classification of Device:
Infusion Pump/ Class II, 80FRN/80MEA - 21 CFR 880.5725
Trade Name:
Pump Connectivity Interface
Predicate Devices:
Alaris Medley System with MMS B. Braun Horizon Outlook with DoseCom
Statement of Intended Use:
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs), hospital monitoring systems and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. It enables remote viewing of pump status within the hospital and enables comparisons of pharmacy-entered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
Device Description:
The Pump Connectivity Interface has been developed to expand upon previously cleared external monitoring features of legally marketed infusion pumps. As described above, the Pump Connectivity Interface is a system of hardware and software that enables external infusion pumps to be integrated into existing hospital network infrastructure. It is intended
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to provide trained healthcare practitioners with access to additional information needed to more safely manage infusion therapy via external infusion pumps.
Summary of Technological Characteristics of New Device to Predicate Devices:
A comparison of the technological characteristics of the Pump Connectivity Interface to the predicate devices has been performed. The results of this comparison demonstrate that the Pump Connectivity Interface is equivalent to the marketed predicate device in technological characteristics.
Performance Data:
The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2004
Mr. Robert L. Wilkinson, RAC Director, Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K040985
Trade/Device Name: Pump Connectivity Interface Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 23, 2004 Received: November 24, 2004
Dear Mr. Wilkinson:
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. Paine
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 (OS) 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/dsma/dsmamain.html
Sincerely yours.
Susan Runner
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
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Indications for Use
510(k) Number (if known):
Device Name: Pump Connectivity Interface
Indications For Use:
The Pump Connectivity Interface is a computerized wireless patient information and medication management tool that is integrated into an existing hospital network infrastructure and allows communications with external devices, including personal computers (PCs), Personal Digital Assistants (PDAs) or similar display/computing devices, hospital monitoring systems, and Hospital Information Management Systems (HIMS). Communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. It is intended for use in professional healthcare environments that use electronic, external infusion devices.
The Pump Connectivity Interface is intended to provide trained healthcare practitioners access to additional information needed to more safely manage infusion therapy via infusion pumps. lt enables remote viewing of pump status within the hospital and enables comparisons of pharmacyentered prescription information to programmed pump settings. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.
The Pump Connectivity Interface also enables secondary notification of pump alerts and alarms to remote users via a personal digital assistant (PDA) or similar display/computing device.
The Pump Connectivity Interface is intended for use by trained healthcare practitioners in accordance with the instructions provided in Pump Connectivity Interface labeling.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J. Thm. D.m.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number:_长中华ゆみぷ
§ 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).