(27 days)
The Abbott LifeCare® PCA 3 Infuser is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott LifeCare® PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) administration of analgesic drugs.
The Abbott LifeCare® PCA 3 Infuser is indicated for volumetric infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott LifeCare® PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) epidural administration of analgesic drugs.
The Abbott LifeCare® PCA 3 Infuser is a pole-mounted infusion pump that allows a patient to self-administer analgesia within physician programmed limits. Generally, a nurse programs the infuser with operating parameters which may include the following:
- Loading Dose
- Delivery Mode Setting, i.e., PCA, Continuous, or PCA+ Continuous
- PCA Dose
- Lockout Interval
- Rate of Continuous Flow
- 1 or 4 hour Dose Limit (factory setting at 4 hours)
- Stored Protocols (Hospital configured settings for both filled and custom vials)
The modifications in this submission consist of an update to a prior model including software revisions, an improved user interface, adding a bar code reader for drug identification and the incorporation of upgraded electrical and mechanical components that help improve fault detection.
Other chanqes to the proposed device include an improved liquid crystal display, a new patient pendant and the labeling has been revised to incorporate each of the modifications.
The Abbott LifeCare® PCA 3 Infuser is programmed to recognize bar coded drug vials and halts further programming if this recognition is not achieved.
The proposed device is a microprocessor-based pump that incorporates an enhanced LCD display. Pump operation is identical to prior Abbot models through the utilization of a stepper motor that exerts pressure on the drug vial so that precise amounts of analgesic drug are delivered per the prescription.
The proposed device has the same intended use as the predicate device and uses the same dedicated administration sets and the same empty and pre-filled vials as the predicate device.
The provided text is a 510(k) summary for the Abbott LifeCare® PCA 3 Infuser (K022203). This document is a regulatory submission for a medical device and describes modifications to an existing device rather than a new standalone device. As such, the document does not contain the typical information about a study with acceptance criteria and reported device performance in the way one would expect for a novel AI/software medical device.
The submission focuses on demonstrating substantial equivalence to a predicate device by emphasizing that the changes do not raise new issues of safety and effectiveness. The "acceptance criteria" here are implied by the regulatory standard of "acceptable performance" of the device modifications.
Here's an analysis based on the provided text, acknowledging the limitations in the content for an AI/software-focused request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device." However, it does not provide specific, quantifiable acceptance criteria or detailed reported performance data for each modification.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional performance of design modifications (e.g., software revisions, bar code reader, user interface, electrical/mechanical components, alarms) | "demonstrate acceptable performance of the device." (No specific metrics or quantitative data provided.) |
| Device operation consistency with predicate device | "Pump operation is identical to prior Abbot models through the utilization of a stepper motor that exerts pressure on the drug vial..." |
| Bar code reader functionality (recognition of drug/concentration, halting programming if not recognized) | "If recognition is achieved then programming will proceed. If the vial is not recognized then the pump will stop and not allow any further programming." (No specific success rates or error rates provided.) |
| Alarm functionality | "Visual and audible alarms are activated by deviations from established parameters. Modifications to the alarms from the predicate device are based on the addition of the bar code reader and new confirmation screens." (No specific performance data for alarms presented.) |
| Safety and effectiveness (overall) | "These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). The testing mentioned is "nonclinical tests" for "functional performance of the proposed Abbott LifeCare® PCA 3 Infuser."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. Given this is a hardware/software medical device submission focusing on functional changes, the "ground truth" would likely be established through engineering and quality assurance testing rather than expert clinical consensus in the way an AI diagnostic tool would require.
4. Adjudication Method for the Test Set:
This information is not applicable or provided.
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:
This type of study is not mentioned and is not relevant to this specific device submission. The device is an infusion pump, not an AI diagnostic or assistance tool in the context of "human readers."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device (an infusion pump) inherently has a "human-in-the-loop" for programming and use. The "algorithm" in question relates to the pump's control software, including features like the bar code reader logic and user interface. While these algorithms would be tested standalone in terms of their functionality (e.g., does the barcode reader correctly identify or reject vials), the document does not separate "algorithm only" performance data from the overall device performance in the way typically discussed for AI/ML devices. The "functional performance" testing would encompass the algorithm's correct execution.
7. The Type of Ground Truth Used:
For the "nonclinical tests" of functional performance, the ground truth would be established by engineering specifications, validated test protocols, and simulated conditions to ensure the device operates as designed (e.g., infusion accuracy, alarm activation, barcode recognition rules). It would not typically involve expert consensus, pathology, or outcomes data in this context.
8. The Sample Size for the Training Set:
This is not applicable or provided. This is a traditional medical device submission, not an AI/ML device that requires a "training set" in the context of machine learning. The software revisions are presumably developed and tested using standard software development lifecycle methodologies.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no concept of a "training set" in this submission.
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Abbott Laboratories Confidential
AUG 01 2002
K622203
Special 510(H
ecial 510(k) 7/2/02
510(k) SUMMARY
Abbott LifeCare® PCA 3 Infuser
Submitted by:
Frank Pokrop Associate Director, Requlatory Affairs Abbott Laboratories D-389. Bldg. J-45 Abbott Park, IL 60064
Date Prepared:
July 2, 2002
Name/Classification of Device:
PCA Infusion Pump, Class II MEA - 21 CFR Part 880.5725 Panel 80
Proposed Device:
Abbott LifeCare® PCA 3 Infuser
Predicate Device:
Abbott LifeCare® 4100 PCA Infuser Plus II
Proposed Device Description:
The Abbott LifeCare® PCA 3 Infuser is a pole-mounted infusion pump that allows a patient to self-administer analgesia within physician programmed limits. Generally, a nurse programs the infuser with operating parameters which may include the following:
- Loading Dose ●
- Delivery Mode Setting, i.e., PCA, Continuous, or PCA+ Continuous ●
- . PCA Dose
- Lockout Interval
- Rate of Continuous Flow
- . 1 or 4 hour Dose Limit (factory setting at 4 hours)
- Stored Protocols (Hospital configured settings for both filled and custom vials) .
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Proposed Device Description: (cont'd)
The modifications in this submission consist of an update to a prior model including software revisions, an improved user interface, adding a bar code reader for drug identification and the incorporation of upgraded electrical and mechanical components that help improve fault detection.
Other chanqes to the proposed device include an improved liquid crystal display, a new patient pendant and the labeling has been revised to incorporate each of the modifications.
The Abbott LifeCare® PCA 3 Infuser is programmed to recognize bar coded drug vials and halts further programming if this recognition is not achieved.
The proposed device is a microprocessor-based pump that incorporates an enhanced LCD display. Pump operation is identical to prior Abbot models through the utilization of a stepper motor that exerts pressure on the drug vial so that precise amounts of analgesic drug are delivered per the prescription.
The proposed device has the same intended use as the predicate device and uses the same dedicated administration sets and the same empty and pre-filled vials as the predicate device.
Statement of Intended Use:
The Abbott LifeCare® PCA 3 Infuser is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient demanded (PCA) intravenous administration. The Abbott LifeCare® PCA 3 Infuser is also indicated for short-term continuous (less than 96 hours) administration of analgesic drugs.
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Summary of Technological Characteristics of New Device Compared to Predicate Device
The proposed pump has a similar design, the same intended use, the same method of operation and the same materials of construction as the currently marketed PCA Infuser Plus II.
Abbott proposes to modify the predicate device through enhancements to electrical and mechanical components. The major modification is the incorporation of a bar code reader that has been integrated into the enhanced software.
When the practitioner places a vial into the pump, the bar code reader electronically scans the vial for recognition of the drug and the drug concentration. If recognition is achieved then programming will proceed. If the vial is not recognized then the pump will stop and not allow any further programming.
The Abbott LifeCare® PCA 3 Infuser has been updated to include a modified user interface, a new patient pendant, an LCD display to show the dose delivered, a new user manual and new TIP cards to aid the user in programming the pump in the healthcare setting.
Visual and audible alarms are activated by deviations from established parameters. Modifications to the alarms from the predicate device are based on the addition of the bar code reader and new confirmation screens.
Lastly, the proposed device incorporates revised software that provides for a reordering of data entry steps, the inclusion of confirmation screens and improved clarity when selecting units of drug concentration.
These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the Abbott LifeCare ® 4100 PCA Infuser Plus II – the predicate device.
Discussion and Conclusions from Nonclinical Tests:
Data regarding the functional performance of the proposed Abbott LifeCare® PCA 3 Infuser has been generated and reviewed.
The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or abstract shape, composed of three curved lines.
Public Health Service
AUG 01 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Pokrop Associate Director, Regulatory Affairs Hospital Products Division Abbott Laboratories 200 Abbott Park Road Department-389, Building J-45 Abbott Park, Illinois 60064-6157
Re: K022203
Trade/Device Name: Abbott LifeCare® PCA 3 Infuser, Model 12384 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: July 3, 2002 Received: July 5, 2002
Dear Mr. Pokrop:
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 -- Mr. Pokrop
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
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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Abbott Laboratories Confidential
Special 510(k) 7/2/02
| Indications for Use Statement | |
|---|---|
| 510(k)Number(if known) | K022203 |
| DeviceName: | Abbott LifeCare® PCA 3 Infuser |
| IndicationsFor Use: | The Abbott LifeCare® PCA 3 Infuser is indicated for volumetricinfusion of analgesic drugs by continuous or patient demanded(PCA) intravenous administration. The Abbott LifeCare® PCA 3Infuser is also indicated for short-term continuous (less than 96hours) epidural administration of analgesic drugs. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ ﮯ (per 21 CFR 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
..
Pattica Cicconite
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_A 020
§ 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).