Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

Device Description

The proposed Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during administration of secondary medication. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The new check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set.

There is one material in the proposed check valve design which is new to Baxter devices. The valve itself will be formulated from a new polyisoprene material. The materials used on the proposed check valve cap and housing, are the same as those in use on the current check valve body and Y-injection site housing on Continu-Flo® solution sets. All other materials in the solution sets remain unchanged.

AI/ML Overview

The provided 510(k) summary for the Continu-Flo® Solution Sets with Modified Check Valve does not contain the detailed, quantitative acceptance criteria and study results typically found in a contemporary medical device submission for AI/ML validation. This is a pre-AI/ML device, and the submission predates the extensive regulatory guidance and expectations around performance metrics for such technologies.

However, based on the information provided, we can infer the acceptance criteria and the nature of the study conducted for this specific, non-AI device.

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence: Device prevents backflow of solution from secondary medication container into primary container during administration of secondary medication.	"The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets."
Material Biocompatibility: New polyisoprene material is safe and appropriate for medical device use.	"The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use."
Physical Characteristics: Maintains other performance characteristics of the predicate device (e.g., flow rates, leak integrity).	Implied by the statement "All other components of the solution administration sets remain unchanged" and the overall substantial equivalence claim.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document only states "Data regarding the functional performance of the proposed check valve have been generated." It doesn't provide the number of units tested or the number of tests performed.
- Data Provenance: Not explicitly stated, but given it's a submission by Baxter Healthcare Corporation, it's highly likely to be internal, prospective testing conducted in a laboratory setting by the manufacturer. Country of origin is the United States (Baxter is based in Illinois).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. For this type of device (medical tubing with a check valve), "ground truth" would be established through direct physical and chemical testing against defined specifications, rather than expert interpretation of data.
- Qualifications of Experts: N/A for establishing ground truth in this context. The experts involved would be engineers, material scientists, and quality control personnel.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Functional and material tests would yield objective quantitative or qualitative results that either meet or do not meet pre-defined specifications. There would be no need for expert adjudication in the way it's used for AI diagnostic performance.
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:
- MRMC Study: No. This is not an AI/ML device, and no human "readers" are involved in its primary function or assessment.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This is not an AI/ML algorithm. The performance described is that of the physical device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: Objective functional testing results and material characterization data. For the functional aspects, the ground truth is whether the valve physically prevents backflow under tested conditions. For materials, the ground truth is whether the material meets specified biocompatibility and physicochemical standards (e.g., as per ISO 10993-1, USP Physicochemical tests).
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process in this context.

Summary

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K 971701

JUN - 6 1997

510(k) SUMMARY

Continu-Flo® Solution Sets with Modified Check Valve

Submitted by:

Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

Date Prepared:

May 7, 1997

Proposed Device:

Continu-Flo® Solution Sets with Modified Check Valve

Predicate Devices:

Continu-Flo® Solution Sets with Check Valve

Proposed Device Description:

Statement of Intended Use:

Continu-Flo® solution sets with the proposed check valve the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient's vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

MAY 0 7 1997

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

Summary of Technological Characteristics of New Device to Predicate Devices

The proposed solution sets are identical to currently marketed Continu-Flo® Solution Sets with Check Valve, previously cleared under K881052, except for the design and location change of the check valve component. The current check valve is a disc valve and is positioned in the set tubing between the drip chamber and Y-injection site. The proposed check valve is a duck bill valve and is positioned inside the Y-injection site housing of the set. All other components of the solution administration sets remain unchanged.

Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

The biological and chemical reactivity of the new polyisoprene material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.

Data regarding the functional performance of the proposed check valve have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed check valve meets or exceeds all functional requirements and support its suitability for use in Continu-Flo® sets.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a human figure. The figure is composed of three curved lines that form the head, body, and legs. The figure is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 1997

Ms. Mary Ellen Snyder ·Manager, Regulatory Affairs Baxter Healthcare Corporation Route 120 And Wilson Road Round Lake, Illinois 60073

Re : K971701 Continu-Flo® Solution Sets with Modified Trade Name: Check Valve Requlatory Class: II Product Code: FPA Dated: May 07, 1997 Received: May 08, 1997

Dear Ms. Snyder:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 through 542 of the Act for devices under the Electronic Product Radiation

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Fage 2 - Ms. Snyder

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Smapl Manufacturers Assistance at its toll-free number (800) 638/2041 or at (301) 443-6597.

Sincerely yours

Claturd

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

Enclosure

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510(k) Number: Not Available

Continu-Flo® Solution Sets with Modified Check Valve Device Name:

Indication for Use:

Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a
container to the for a contrise vascular system. Continu-Floor sets contain a prevents backflow of solution from the secondary medication container into the primary ontainer during the administration of secondary medication.

(Division Sign-Off) Fabricia Encontr
Division of Dental, Infection Control,

Division of Dental, ENT,
and General Hospital Devices
§10(k) Number K971701

Prescription Use
(Per 21 CFR 801.109)

MAY 0 7 1997

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.