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

Baxter's Infusor SV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 5mL/hr, depending on device configuration. The modifications made to the Infusor SV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.

AI/ML Overview

Given the provided text, the device in question is the "Infusor SV Elastomeric Infusion Device," which is an infusion pump. The document describes modifications made to this device and provides information on its conformity to safety and effectiveness through nonclinical testing.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Mechanical Testing	All test results meet the acceptance criteria.
Biocompatibility Testing	All test results meet the acceptance criteria.
Flow Rate Testing	All test results meet the acceptance criteria.
Risk Analysis (FMEA)	Performed according to ISO 14971 (2000), "Medical Devices - Application of Risk Management to Medical Devices." Modifications verified appropriate by meeting acceptance criteria from design verification tests.
Overall Equivalence	The device with modifications is as safe and effective as the predicate device and substantially equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for the mechanical, biocompatibility, and flow rate tests. It only mentions that "Design verification tests...were performed to verify the modifications" and that "Testing of the device and components included mechanical, biocompatibility, and flow rate testing."

The provenance of the data is not specified (e.g., country of origin, retrospective/prospective). This is a 510(k) summary for a modified medical device, and the focus is on demonstrating equivalence to predicate devices through engineering and bench testing, rather than clinical trial data.

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)

This document describes nonclinical testing for an infusion pump. Therefore, there is no mention of experts or qualifications for establishing ground truth as this is not a study involving human-interpreted diagnostic outcomes. The "ground truth" for this device would be established by objective measurements against engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is a nonclinical study involving engineering and bench testing of an infusion pump, there is no mention of an adjudication method used for a test set. Adjudication methods are typically relevant in clinical studies or studies involving subjective human interpretation of data where consensus among experts might be required.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often in the context of AI assistance. This document is for an infusion pump and focuses on confirming the safety and effectiveness of a device modification through nonclinical bench testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an elastomeric infusion pump, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance evaluated here is the physical device's ability to maintain specific flow rates and its mechanical and biocompatibility properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical tests (mechanical, biocompatibility, and flow rate testing), the "ground truth" would be established by predetermined engineering specifications, regulatory standards, and established test protocols. For example, for flow rate testing, the "ground truth" would be the expected constant flow rate (e.g., 0.5mL/hr to 5mL/hr) against which the device's actual delivery is measured. For biocompatibility, it would be compliance with relevant ISO standards for materials.

8. The sample size for the training set

Not applicable. This submission describes modifications to an existing physical medical device (an infusion pump), not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, the question of how its ground truth was established is not relevant to this document.

Summary

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K062457

5. 510(K) SUMMARY

SEP 2 1 2006

DATE PREPARED:

August 8, 2006

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Nanette Hedden Regulatory Affairs Manager 1620 Waukegan Rd. McGaw Park, IL 60085 Telephone: (847) 473-6281 Fax: (847) 785-5116

DEVICE NAME:

Trade name: Infusor SV Elastomeric Infusion Device

Singleday Infusor
· Half Day Infusor
· 2 Day Infusor
Multiday Infusor
· Seven Day Infusor

COMMON NAME:

Infusion Pump

CLASSIFICATION NAME:

Infusion Pump (21 CFR 880.5725, Product Code MEB, MEA,

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PREDICATE DEVICE(S):

Device	Previous 510(k)	Clearance date
Single day Infusor	K802820 K905778 K982102	November 7, 1980July 12, 1991September 4, 1998
Half Day Infusor	K853881 K905778 K982102	December 2, 1985July 12, 1991September 4, 1998
2 Day Infusor	K802820 K842479 K870242 K905778 K982102	November 7, 1980November 2, 1984March 13, 1987July 12, 1991September 4, 1998
Multiday Infusor	K842905 K905778 K982102	November 1, 1985July 12, 1991September 4, 1998
Seven Day Infusor	K842479 K842905 K870242 K905778 K982102	November 2, 1984,November 1, 1985March 13, 1987July 12, 1991September 4, 1998

Table 5-1. Previous 510(k)s

DESCRIPTION OF THE DEVICE AND MODIFICATION:

STATEMENT OF INTENDED USE:

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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.

TECHNOLOGICAL CHARACTERISTICS:

The plastic tubing flow restrictor, Luer lock connector and coupler are replacing the current glass flow restrictor and Luer housing. These components provide the equivalent performance; however the materials differ in that the glass is replaced by plastic tubing and the coupler and Luer together replace the function of the current Luer housing by connecting the restrictor to the device tubing set and providing a Luer lock for connection to the patient's catheter.

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare conducts risk analyses 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 the modifications. Testing of the device and components included mechanical, biocompatibility, and flow rate testing. All test results meet the acceptance criteria, and prove that the modifications are appropriate.

CONCLUSION:

The Infusor SV Elastomeric Infusion Device with the modifications is as safe and effective as the predicate device and the performance is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2006

Ms. Nanette Hedden Regulatory Affairs Manager Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085

Re: K062457

Trade/Device Name: Infusor Small Volume (SV) Elastomeric Infusion Device Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: August 22, 2006 Received: August 23, 2006

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 Federal 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, 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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INDICATIONS FOR USE

510(k) Number (if known):

K062457

Device Name: Infusor Small Volume (SV) Elastomeric Infusion Devices

Indications For Use: 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.

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)

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on Sign-Off)

ion of Anesthesiology, General Hospital,

tion Control, Dental Devices

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).