The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Device Description

The dual port line of Infusors are a modification of Baxter's currently marketed Infusor line of elastomeric infusion devices. The modification consists of adding a "Y" fitting and an additional section of administration set tubing resulting in a bifurcated tubing. This allows solution flow through two ports. There are no new materials or technology associated with the modification. In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps. Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Baxter Dual Port Infusor. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria in the manner one would expect for a new, non-equivalent device. Therefore, many of the requested categories of information are not explicitly available in this type of submission.

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

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

The document does not explicitly state formal acceptance criteria and reported device performance in a quantitative table format. This type of 510(k) submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the Infusor SV and LV Elastomeric Infusion Device). The primary 'performance' aspect highlighted is that the "range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices."

Acceptance Criteria (Inferred from Substantial Equivalence Claim): The flow rates of the Dual Port Infusor (single and combined ports) must be equivalent to or within the established range of the predicate Infusor SV and LV devices.
Reported Device Performance: The document states that the flow rates "are within the current range of flow rates available in the single port Infusor devices."
Technological Characteristics: The document explicitly states, "The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices." This implies that other performance aspects (e.g., material compatibility, pressure resistance, etc.) are also considered to be equivalent.

Acceptance Criteria (Inferred)	Reported Device Performance
Flow rates (single & combined ports) within predicate device range	"range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices."
Identical technological characteristics to predicate device	"The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices."
No new materials or technology	"There are no new materials or technology associated with the modification."

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

The document does not specify a sample size for a "test set" in the context of a new performance study. As this is a 510(k) for a modification to an existing device where the "modification consists of adding a 'Y' fitting and an additional section of administration set tubing," the testing likely involved engineering verification/validation, rather than a large-scale clinical study with a "test set" as typically understood for AI or diagnostic devices. There is no mention of country of origin or whether data was retrospective or prospective, as these are not relevant for the type of comparison being made.

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 section is not applicable to this submission. The device is a physical medical device (an elastomeric infusion pump), not a diagnostic or AI system requiring expert consensus for ground truth.

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

This section is not applicable to this submission for the same reasons as point 3.

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 section is not applicable. The device is an infusion pump, not an AI system or diagnostic tool for human readers.

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

This section is not applicable for the same reasons as point 5.

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

This section is not applicable as the device is not a diagnostic tool requiring such ground truth. The "ground truth" equivalent here would be the established performance specifications and characteristics of the predicate devices, which serve as the benchmark for substantial equivalence.

8. The sample size for the training set

This section is not applicable. The document does not describe the development of an algorithm or AI model, thus there is no "training set."

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

This section is not applicable for the same reasons as point 8.

Summary of the Study / Basis for Substantial Equivalence:

The "study" or basis for this 510(k) submission is a technical comparison to legally marketed predicate devices (Infusor SV and LV Elastomeric Infusion Device).

Rationale: The device is a modification of an existing device. The modification consists solely of "adding a 'Y' fitting and an additional section of administration set tubing" to create a bifurcated flow path.
Key Argument for Equivalence:
- "There are no new materials or technology associated with the modification."
- "In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps."
- "Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices."
- The "technological characteristics... are identical" to the predicate.
Evidence: While not detailed in the provided text, the submission implicitly relies on engineering verification and validation testing to confirm that the modification does not alter the fundamental performance characteristics (especially flow rates) outside the established parameters of the predicate devices. The focus is on demonstrating that the device remains functionally equivalent despite the addition of the second port.
Conclusion: The FDA reviewed the submission and determined that the device is "substantially equivalent" to the predicate devices, allowing it to be marketed. A contraindication for intravenous, intra-arterial, and epidural use was added to the labeling for the Dual Port Infusors.

Summary

{0}------------------------------------------------

K02/274

MAY 1 7 2002

ATTACHMENT 6

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:

April 19, 2002

Proposed Device(s):

Baxter Dual Port Infusor

Baxter Pain Mate™ Pain Management System (Convenience Kits containing the Baxter Dual Port Infusor)

Comparison Device(s):

Infusor SV and LV Elastomeric Infusion Device

Description of Device(s):

Indications for Use:

The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Technological Characteristics:

The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices. The Dual Port Infusor incorporates a bifurcated tubing to allow for solution flow through two ports.

{1}------------------------------------------------

510(k) Premarket Notification Dual Port Infusor

A contraindication has been added to the labeling of the Pain-Mate Pain Management Systems with dual port Infusors. The Dual Port Infusor devices are contraindicated for intravenous, intra-arterial, and epidural use.

6 May 14, 2002

S:\510K\Dual Port\Attachment 6_8 Rev, 1.doc Last Saved On 5/15/2002 1:02 PM

** TOTAL PAGE.03 *>

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2002

Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I. V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073-0490

Re: K021274

Trade/Device Name: Baxter Dual Port Infusor Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: Unclassified Product Code: MEB Dated: April 19, 2002 Received: April 22, 2002

Dear Ms. Drews:

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.

{3}------------------------------------------------

Page 2 - Ms. Drews

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 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 yours,

Susan Runnor

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

Enclosure

{4}------------------------------------------------

K021274

510(k) Premarket Notification Dual Port Infusor

ATTACHMENT 8

INDICATIONS FOR USE

The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Patricia Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ 4 02/2

BAXTER CONFIDENTIAL

S:1510K\Dual Port\Attachment 6_8 Rcv. 1.doc Last Saved On 5/14/2002 4:40 PM

7 May 14, 2002

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).