(11 days)
The intended use of the Infusor LV and Infusor SV Devices includes the slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. It may also include the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
The modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.
A modified design is being added to Baxter's Infusor line of Elastomeric Infusion Devices.
This document is a 510(k) premarket notification for a medical device called "Infusor LV and Infusor SV". It does not describe a study involving AI or algorithmic performance, but rather a modification to an existing elastomeric infusion device.
Therefore, many of the requested categories are not applicable to the provided text. However, I can extract the relevant information presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a detailed table of acceptance criteria with specific numerical targets. It states:
| Criterion | Reported Performance |
|---|---|
| Flow Rate Performance (for modified design) | "Standard flow rate testing was performed to confirm performance characteristics." |
| Flow Rate Performance (routine manufacturing) | "Routine testing in manufacturing includes 100% testing for flow rates and pressure." |
| Pressure Performance (routine manufacturing) | "Routine testing in manufacturing includes 100% testing for flow rates and pressure." |
Explanation: The document indicates that the modification to the Infusor line required "standard flow rate testing" to confirm its performance characteristics. For ongoing manufacturing, both flow rates and pressure are 100% tested, implying these are critical performance criteria. However, explicit quantitative acceptance limits or detailed results of these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified. The document only mentions "Standard flow rate testing" was performed.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This device is an infusion pump, and its performance is assessed through objective engineering tests (flow rate, pressure) rather than expert interpretation of data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Performance is based on objective measurements, not expert adjudication.
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
Not applicable. This document describes a physical medical device (infusion pump), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance would be the direct, objective measurement of flow rates and pressure using calibrated instruments, compared against pre-defined engineering specifications. It's not based on subjective assessment or biological outcomes in the context of this 510(k) summary for device modification.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This document describes a physical medical device, not a machine learning model.
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JUL - 9 2004
Attachment 6
510 (k) Summary
Submitted by:
Karen Spranger Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073
Date of Submission:
June 11, 2004
Proposed Device(s): Infusor SV
Infusor LV
Comparison Device(s):
Infusor SV Infusor LV
Intended Use:
The intended use of the proposed devices has not changed as compared to the marketed devices. The intended use of the Infusor LV and Infusor SV Devices includes the slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. It may also include the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management. This is consistent with the intended use for the Infusor SV and Infusor LV devices as cleared under premarket notification K002380.
Technological Characteristics:
A modified design is being added to Baxter's Infusor line of Elastomeric Infusion Devices. Standard flow rate testing was performed to confirm performance characteristics. Routine testing in manufacturing includes 100% testing for flow rates and pressure.
BAXTER CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2004
Ms. Karen Spranger Regulatory Affairs Associate III Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490
Re: K041738
Trade/Device Name: Infusor LV and Infusor SV Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, MEB Dated: June 25, 2004 Received: June 28, 2004
Dear Ms. Spranger:
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. Spranger
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. or the For or any 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 and insting (21 CFR 2 th in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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) rms leter witification. The FDA finding of substantial equivalence of your device to a premainter nour one 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), rl you donto the Office of Compliance at (301) 594-4618. 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.
Carl Shin, Ph.D.
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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510(k) Premarket Notification Infusor LV and Infusor SV
Attachment 3 Indications for Use
510(k) Number (if known):_K662380
Device Name:___ Infusor LV and Infusor SV
Indications For Use:
The modified Infusion Pumps can be utilized for slow, continuous delivery though clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications. In addition, the intended use of the devices includes continuous infusion of medications directly into an intraoperative site or subcutaneously for post operative pain management.
Arene Naceure for ADw
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041738
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)
S:1510K\INFUSOR\Attachment 3.DOC Last Saved On 6/25/2004 8:20 AM BAXTER CONFIDENTIAL
Page 31 JUN.25.2004
§ 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).