Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

Device Description

A design modification is being made to Baxter's Infusor SV line of Elastomeric Infusion Devices. This modification is being made to facilitate filling and priming the device. The modification involves the relocation of the fill port to the end of the housing and the addition of a piece of coiled tubing to connect the relocated fill port to the volume indicator. Standard flow rate testing was performed to confirm performance characteristics.

AI/ML Overview

This document describes a 510(k) submission for a modified elastomeric infusion device. The information provided is primarily related to the regulatory approval process and device labeling, rather than a detailed study report demonstrating performance against acceptance criteria. Therefore, I cannot fully complete all sections of your request based on the provided text.

However, I can extract the relevant information and indicate where specifics are missing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Standard flow rate characteristics maintained	"Standard flow rate testing was performed to confirm performance characteristics." (No specific flow rate values or criteria are provided in the document.)

Missing Information: The document states that "Standard flow rate testing was performed to confirm performance characteristics," but it does not specify the numerical acceptance criteria for these flow rates (e.g., +/- x% of nominal flow rate) or the actual measured performance values.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions "Standard flow rate testing was performed."
Data Provenance: Not specified. It can be inferred that the testing was conducted by Baxter Healthcare Corporation to support the 510(k) submission, likely in the United States, but this is not explicitly stated as retrospective or prospective or the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the study described is a device performance test (flow rate testing), not a diagnostic or clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication Method for the Test Set

Not applicable for a device performance test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No. The document describes a device modification and subsequent standard flow rate testing, not a clinical effectiveness study involving human readers or comparative effectiveness with or without AI assistance.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

The device is a physical elastomeric infusion device, not an algorithm. Therefore, an "algorithm only" standalone performance study is not applicable. The provided text describes physical performance testing of the device.

7. Type of Ground Truth Used

For the flow rate testing, the "ground truth" would be the expected or designed flow rate of the device, against which the measured flow rates were compared. This is an objective physical measurement, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this type of device.

Summary of Device and Study:

The submission describes a design modification to Baxter's Infusor SV line of Elastomeric Infusion Devices. The modification involves relocating the fill port and adding a coiled tubing piece. To demonstrate that this modification does not adversely affect the device's function, "Standard flow rate testing was performed to confirm performance characteristics." The document states that the modified devices have the "same intended use" as the comparison devices.

The document is purely a regulatory submission (510(k)) and does not contain detailed study reports with specific acceptance criteria thresholds or measured performance data. It confirms that the necessary testing was conducted to support substantial equivalence for FDA approval but does not provide the specifics of that testing.

Summary

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4 1998 SEP

Section 9.0 Page 1

K 982/62

JUN 1 2 1998

SECTION 9.0

SMDA INFORMATION

SUMMARY OF SAFETY AND EFFECTIVENESS

" Submitted by:

Vicki L. Drews Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073

Date of Submission: June 12, 1998

Proposed Device(s):

Singleday Infusor Infusor SV 2 Day Infusor

Multiday Infusor Seven Day Infusor

Comparison Device(s):

Singleday Infusor Infusor SV 2 Day Infusor

Multiday Infusor Seven Day Infusor

Intended Use:

The modified devices have the same intended use as the comparison devices. They are indicated for slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications. They are also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. These devices are suitable for use in the hospital and home setting.

Technological Characteristics:

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 4 1998

Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

Re : K982102 Trade Name: Baxter Infusor SV-Elastomeric Infusion Device Unclassified Requlatory Class: Product Code: MEB Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Drews:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨਾ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation-(21-CFR-Part 820) and that; -through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. J Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Drews

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general→ information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

S. Autran for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 11.0

INDICATION FOR USE

Patricia Ciuente
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Intection and General Hospital Devices

510(k) Number K982102

Prescription Use
(Per 21 CFR 801.109)

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SEP 0 3 1998

Regulation Number and Section

§ 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).