(60 days)
The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.
Baxter's Multirate Infusor devices with attached PCM, are single-use disposable infusion pumps designed to deliver solution at a constant flow rate of 1-12mL/hr, depending upon the device configuration and settings, as well as allow for intermittent bolus doses of medication on patient demand.
The provided text describes a 510(k) notification for a device modification of the Baxter Healthcare Corporation Multirate Infusor with PCM. The focus of the submission is to demonstrate substantial equivalence to previously cleared devices, primarily through risk analysis and design verification testing.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states: "Design verification tests based on the result of risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
However, the specific acceptance criteria (e.g., flow rate accuracy, bolus volume precision, mechanical integrity) and the reported device performance values are not explicitly detailed in the provided text. The submission focuses on the process of verifying the modifications rather than presenting quantitative performance data.
| Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|
| Not explicitly stated in the document - only that tests "meet the acceptance criteria" | Not explicitly stated in the document |
2. Sample size used for the test set and the data provenance
The document mentions "design verification tests" were performed, but it does not specify the sample size used for these tests.
Regarding data provenance: The tests were conducted internally by Baxter Healthcare Corporation to verify the design modifications. The country of origin of the data is implicitly the United States, as Baxter Healthcare Corporation is a US-based company and the submission is to the FDA. The tests are prospective in nature, as they were performed specifically to verify the recent design modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The concept of "experts" to establish ground truth is typically relevant for diagnostic devices that interpret signals or images. This document describes a modification to an infusion pump, which is a functional medical device. Therefore, the "ground truth" here would be objective engineering measurements and functional performance against specifications.
The document does not mention the use of external experts for establishing ground truth in this context. The verification would have been conducted by Baxter's internal engineering and quality teams.
4. Adjudication method for the test set
Given that the "ground truth" involves objective engineering measurements of device performance, an adjudication method (like 2+1 or 3+1 consensus commonly used in image analysis) is not applicable or mentioned in this context. Device performance is typically evaluated against defined engineering specifications and tolerances.
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
An MRMC comparative effectiveness study is not applicable here. This type of study is used for medical devices, particularly diagnostic aids that involve human interpretation (readers) of cases. The Multirate Infusor with PCM is an infusion pump, a therapeutic device, and does not involve "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. An infusion pump does not contain an "algorithm only" component or involve human-in-the-loop performance in the way a diagnostic AI would. Its performance is inherent to its mechanical and electronic design.
7. The type of ground truth used
The ground truth for this device's performance would be established through:
- Engineering Specifications: Pre-defined functional requirements and tolerances for flow rates, bolus volumes, safety mechanisms, material compatibility, and structural integrity.
- Measurement Standards: Adherence to recognized industry standards for device performance and safety (e.g., ISO, ASTM, or internal Baxter standards derived from such).
- Risk Analysis (FMEA): The document explicitly states that Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications. This process identifies potential failure modes and their effects, leading to verification tests designed to ensure these failures do not occur within acceptable limits.
8. The sample size for the training set
This question is not applicable. "Training set" refers to data used to train machine learning algorithms. The Multirate Infusor with PCM is a hardware medical device; its design and verification do not involve machine learning.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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KOS1253
510(k) Notification: Device Modification
JUL 1 5 2005
510 (K) SUMMARY
Baxter Healthcare Corporation Multirate Infusor with PCM
| Preparer/Contact | Nanette HeddenProject ManagerGlobal Regulatory Affairs1620 Waukegan Rd.McGaw Park, IL 60085Telephone: (847) 473-6281Fax: (847) 785-5116Baxter Healthcare CorporationOne Baxter ParkwayDeerfield, Illinois 60015 |
|---|---|
| Manufacturer | Manufacturing Location: 2025695Baxter Healthcare Corporation17511 Armstrong AvenueIrvine, California 92614Phone: (949) 474-6306Fax: (949) 474-6375 |
| Date summary was prepared: | May 6, 2005 |
| Name(s) of the device: | Multirate Infusor (LV and SV) withPCM |
| Identification of predicate device(s): | Baxter Multirate Infusor (LV and SV)Baxter PCM |
Description of the device and modifications:
Baxter's Multirate Infusor devices with attached PCM, are single-use disposable infusion pumps designed to deliver solution at a constant flow rate of 1-12mL/hr, depending upon the device configuration and settings, as well as allow for intermittent bolus doses of medication on patient demand.
The modifications made to the Multirate Infusor (K011317) line to incorporate a PCM (K002739) include the following:
- Inserting the same PVC "Y" connector from the single rate Infusors (K041738, . K884505) before the Multirate Flow Control Module so the fluid going to the PCM can bypass the Multirate Flow Control Module. (See Section 7.4.4 for drawings showing the Multirate Infusor with PCM.)
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510(k) Notification: Device Modification
- Providing an inline flow restrictor (the same glass flow restrictor already utilized in . this line) that provides a single flow rate for filling the PCM reservoir.
- Another PVC "Y" connector is added at the output of the Multirate Flow Control ● Module and connects with the output of the Patient Control Module to allow for a single line to the patient which provides continuous flow as well as bolus doses when needed (the same as for the single rate Infusors with PCM attached).
All of the changes above incorporate the same technology and materials that are already incorporated in the Baxter line of elastomeric infusion devices.
Intended Use: The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.
Evaluation of Design Modifications
As the basis for Baxter Healthcare's device evaluation studies and overall process for managing medical device risk, the company has performed a risk analysis using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the result of risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate.
Conclusion
The modified device, the Multirate Infusor with PCM, is substantially equivalent to the Multirate Infusor and PCM devices sold as stand alone devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2005
Ms. Nanette Hedden Project Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGraw Park, Illinois 60085
Re: K051253
Trade/Device Name: Multirate Infusor (LV and SV) with Patient Control Module Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB, MEA Dated: June 17, 2005 Received: June 20, 2005
Dear Ms. Hedden:
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 Eederal Register.
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Page 2 – Ms. Hedden
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 I-art 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,
Syrita Y. Michael Davis
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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Indications for Use .
510(k) Number (if known): Kos 1253
Device Name: Multirate Infusor LV and SV with Patient Control Module
Indications For Use:
maloutions i or 500.
The intended use of the Multirate Infusor with Patient Control Module includes slow, The intendou doe of throus or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intra-operative nitiations the olon, continuous and management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Rill C. Aym for me
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051253
§ 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).