The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.

Device Description

The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.

AI/ML Overview

The provided 510(k) Premarket Notification document (K981792) is for a "Solution Administration Set". This type of medical device is a physical product, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training set) are not applicable to this submission.

However, based on the non-clinical tests described, here's an attempt to extract relevant information and note the inapplicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Functional performance meets requirements for administering IV solutions.	"proposed paclitaxel device meets or exceeds all functional requirements"
Compatibility with paclitaxel (does not leach DEHP into solution).	Compatibility with paclitaxel "has been generated."
No DEHP plasticized PVC in contact with the solution (specific design feature).	"contains polyethylene-lined tubing... and no DEHP plasticized PVC in contact with the solution."
In-line 0.22 um filter is present and functional.	"contains... an in-line 0.22 um filter."
New device is substantially equivalent to predicate device (Baxter nitroglycerin set K83284A).	Stated as "similar" with "principal differences" accounted for (spike design, 0.22µm filter, TEHTM plasticizer).
All solution contact materials are identical to materials used in legally marketed devices.	"All solution contact materials to be used in the proposed set are identical to materials used in legally marketed devices under comparable conditions of use."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document. The document refers to "Data regarding the functional performance" being "generated," but does not provide details on the number of units tested.
Data Provenance: Not explicitly stated, but assumed to be generated from non-clinical laboratory testing performed by Baxter Healthcare Corporation. It is prospective testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This criterion is not applicable. The device is a physical administration set; its "ground truth" is its physical and chemical properties and functional performance, which are evaluated through direct testing, not expert interpretation of data.

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

This criterion is not applicable. Adjudication methods are typically used for expert consensus on image interpretation or complex clinical outcomes. The functional testing of a physical device does not involve such methods.

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 criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. No human reader studies with AI assistance were performed or are relevant.

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

This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for this device's performance would be established through direct physical and chemical testing standards and laboratory analyses. For example:
- Measurement of flow rates.
- Chemical analysis for DEHP leaching.
- Filtration efficacy.
- Material compatibility tests.
- Sterility validation (implied for an IV set, though not explicitly detailed here).

8. The sample size for the training set

This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. "Training sets" are for AI/ML models.

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

This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.

Summary

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K981792

510(k) Premarket Notification Solution Administration Set

AUG 1 4 1998

510(k) Summary

Solution Adminstration Set

Submitted by:

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

Date Prepared:

May 20, 1998

Proposed Device:

Solution Administration Set

Predicate Device:

Nitroglycerin Set Solution Administration Sets with 0.22 Micron Filter

Proposed Device Description:

Statement of Intended Use

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Summary of Technological Characteristics of New Device to Predicate Devices

The product is similar to the currently marketed Baxter nitroglycerin set, cleared under K83284A on December 29, 1983. The principal differences between the proposed solution set and the predicate nitroglycerin set include a modified spike design, addition of a 0.22 µm filter, and use of TEHTM to plasticize the PVC components. There are no new materials involved in the proposed device. All solution contact materials to be used in the proposed set are identical to materials used in legally marketed devices under comparable conditions of use.

Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed solution administration set including its compatibility with paclitaxel have been generated. A description of the functional testing along with test results has been provided. All data indicate that the proposed paclitaxel device meets or exceeds all functional requirements and thus support its suitability for use.

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Image /page/2/Picture/1 description: The image shows the seal of 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 an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 1998

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

Re: K981792 Solution Administration Set Trade Name: Requlatory Class: II Product Code: FPA Dated: May 20, 1998 Received: May 21, 1998

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. ਸਾ 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. Failure to comply with the GMP regulation may result in requlatory 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 Product Radiation Control 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 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. Dutman 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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K981792

510(k) Premarket Notification Solution Administration Set

Indication for Use

510(k) Number: Not Available

Device Name: Solution Administration Set

Indication for Use: The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.

(Division Sign-Off)/3.
Division of Dental, Infection Control,

and General Hospital Devices 14981792 510(k) Number _

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.