Baxter solution administration sets with capped luer activated valves are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.

Device Description

The subject of this submission is a capped luer activated valve which Baxter intends to incorporate into currently marketed solution sets. The capped luer activated valve will replace the Y-injection site on the set for continuous or intermittent fluid administration or the withdrawal of fluids. The normally closed valve is opened by removing the cap and inserting a standard male luer adapter such as on syringes or sets to the female end of the valve automatically closes when the male luer is disconnected. The valve is intended to be capped when not in use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Solution Administration Sets with Capped Luer Activated Valve:

Acceptance Criteria and Study Analysis

The provided 510(k) summary for the "Solution Administration Sets with Capped Luer Activated Valve" describes a device intended to replace a Y-injection site on existing solution administration sets. The submission focuses on demonstrating substantial equivalence to a predicate device, the Abbott I.V. Sets with Capped Reflux Valve Port.

It's important to note: The provided document is a 510(k) summary, not a full study report. As such, detailed information regarding specific acceptance criteria, test methodologies, and data breakdowns is very limited. The document states that "A description of the functional testing along with test results has been provided," implying these details were part of the complete 510(k) submission to the FDA, but they are not present in this public summary.

Therefore, many of the requested fields below cannot be fully populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)
Functional Performance	(Not explicitly detailed in this summary)	"The data indicate that the proposed valve meets or exceed all functional requirements and support its suitability for use in Baxter solution administration sets."

Explanation: The document broadly states that the device was evaluated for "functional performance" and met "all functional requirements." However, it does not specify what those functional requirements were (e.g., specific flow rates, pressure resistance, leakage limits, number of activations without failure, material compatibility, sterilization effectiveness, etc.).

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

Sample Size (Test Set): Not specified in the provided text.
Data Provenance: Not specified in the provided text. The testing would have been conducted by Baxter Healthcare Corporation, likely at their facilities, but no geographic origin or retrospective/prospective nature is mentioned.

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

Number of Experts: Not applicable. This device is a mechanical medical device (solution administration set). The "ground truth" for its performance is established through engineering and functional testing, not typically through human expert adjudication as would be the case for diagnostic AI.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. For a mechanical device, testing results are objectively measured against predefined engineering specifications. There is no subjective adjudication process mentioned or typically used for this type of device.

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

MRMC Study Done? No. This type of study is relevant for diagnostic devices that humans interpret (e.g., radiology AI). This submission is for a mechanical solution administration set, which does not involve human interpretation in its primary function, nor does it involve "AI."
Effect Size of AI Assistance: Not applicable.

6. Standalone Performance (Algorithm Only)

Standalone Performance Done? N/A. This device does not have an "algorithm" in the sense of AI or software interpreting data. Its performance is entirely "standalone" in that it functions as a mechanical component.

7. Type of Ground Truth Used

Type of Ground Truth: Engineering specifications and performance metrics. For example, leakage tests, flow rate measurements, pressure resistance, ability to connect and disconnect luer adapters, durability/number of cycles, material biocompatibility, and sterilization validation would all contribute to the "ground truth" of the device's functional performance. The document only broadly refers to "functional requirements."

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This submission is for a mechanical medical device, not an AI/ML model that requires a training set. The development of such devices involves design, prototyping, and iterative functional testing, but not a "training set" in the computational sense.

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

Ground Truth Establishment (Training Set): Not applicable.

Summary of Limitations from the Document:

The provided 510(k) summary is a high-level overview. It confirms that functional testing was performed and that the device met its requirements for substantial equivalence. However, it lacks the detailed technical specifications and study breakdowns that would be present in the full original 510(k) submission to the FDA. Specifically, it does not provide:

Exact numerical acceptance criteria for any functional test.
Quantified test results (e.g., "passed 1000 cycles" vs. "meets requirements").
The number of units tested (sample size).
Specific test methodologies.
Any information related to clinical trials or human factors testing, beyond "intended for use with a vascular access device."

The document's primary purpose is to declare substantial equivalence to a predicate device (Abbott I.V. Sets with Capped Reflux Valve Port) based on similar technological characteristics and demonstrated functional performance, allowing the device to be marketed.

Summary

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K 974571

MAY 21 1998 510(k) SUMMARY

Solution Administration Sets with Capped Luer Activated Valve

Submitted by:

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

Date Prepared:

December 5, 1997

Proposed Device:

Solution Administration Sets with Capped Luer Activated Valve

Predicate Device:

Abbott I.V. Sets with Capped Reflux Valve Port

Proposed Device Description:

Statement of Intended Use:

Baxter solution administration sets with capped luer activated valve are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.

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Summary of Technological Characteristics of New Device to Predicate Devices

Baxter sets with the proposed valve are identical to currently marketed Baxter sets except for the change from a Y-injection site to a capped T-shaped luer activated valve. All other components of the solution administration sets remain unchanged. The T-shaped valve is very similar to the Y-shaped valve contained in currently marketed Abbott IV solution sets. The main difference between the proposed Tshaped valve and the currently marketed Y-shaped valve are the material and geometry of the valve housing.

Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed capped luer activated valve have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed valve meets or exceed all functional requirements and support its suitability for use in Baxter solution administration sets.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a series of abstract shapes resembling a bird or a stylized human figure. The text is in all caps.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Ellen Synder Requlatory Affairs Manager Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

MAY 21 1998

K974571 Re : Solution Administration Set with Capped Luer Trade Name: Activated valve Regulatory Class: II Product Code: FPA Dated: May 12, 1998 May 13, 1998 Received:

Dear Ms. Synder:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Praction (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. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. Snyder

through 542 of the Act for devices under the Electronic chrough 542 or the not all provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debtriaca in your six (x) puivalence of your device to a legally rinding of bubbeancear equite in a classification for your markets produce 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 requlation entitled, "Misbranding by reference to ene regardon" (21CFR 807.97). 1 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeation free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure______

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K 974571

510(k) Premarket Notification Solution Administration Sets with Capped Luer Activated Valve

Not Available 510(k) Number:

Solution Administration Sets with Capped Luer Activated Valve Device Name:

Indication for Use:

Patricio Escosete

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K974571

Prescription Use
(Per 21 CFR 801.109)

s:\510k\lavcov.doc

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.