Single Lumen Introducers: The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Multiple Lumen Access Products: The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.

Device Description

The Baxter Hemostasis Valve Introducers are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The Baxter Hemostasis Valve Introducers are provided with and without AMC Thromboshield™ which is used on Baxter's catheters and introducer products. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Baxter Hemostasis Valve Introducers:

Missing Information:

It's crucial to note that the provided 510(k) summary is for a medical device (introducer sheath), not for an AI/algorithm-based diagnostic device. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of device submission and are not present in the document.

Acceptance Criteria and Device Performance for Baxter Hemostasis Valve Introducers

Given the nature of this medical device, the "acceptance criteria" are based on comparative technological equivalence to predicate devices and successful results in a series of in-vitro and biocompatibility tests. There are no performance metrics like sensitivity, specificity, or AUC that would be associated with an AI/diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description	Reported Device Performance
Technological Equivalence	Device construction and physical specifications are comparable to legally marketed predicate devices.	"The Baxter Hemostasis Valve Introducers are technologically comparable to the predicate devices in construction and physical specifications."
Functional Integrity/Performance (In-vitro)	Device demonstrates integrity and performance for its intended use through functional testing.	"Functional testing was performed on the Baxter Hemostasis Valve Introducers to evaluate the integrity and performance of the device. Based upon the results of this testing, the Baxter CardioVascular Group, Edwards Critical-Care has determined that the Baxter Hemostasis Valve Introducers are safe and effective and are acceptable in design and construction for its intended use."
Biocompatibility	Device meets established biocompatibility standards and is non-toxic.	"Biocompatability testing was performed on the Baxter Hemostasis Valve Introducers in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Baxter Hemostasis Valve Introducers were found to be biocompatable and nontoxic and acceptable for its intended use."
Clinical Safety/Efficacy	Clinical performance demonstrates safety and efficacy for the stated indications for use.	"Clinical testing was not performed on the subject catheter because the intended use and indications are the same as the predicate devices. Furthermore, the Baxter Hemostasis Valve Introducers exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed." This demonstrates equivalence was based on non-clinical data.

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

Sample Size for Test Set: Not applicable in the context of an AI/diagnostic algorithm. For an in-vitro device, "test set" refers to the units of the device subjected to functional and biocompatibility tests. The document does not specify a numerical sample size for these tests, which is common for this type of submission. It implies that a sufficient number of devices were tested to demonstrate performance and establish comparability.
Data Provenance: The in-vitro testing and biocompatibility testing were conducted directly on the manufactured Baxter Hemostasis Valve Introducers. No external patient data (country of origin, retrospective/prospective) was used, as clinical testing was explicitly waived due to equivalence with predicate devices.

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

Not Applicable. This document pertains to a physical medical device, not an AI/diagnostic algorithm where expert-established ground truth on a test set would be relevant. The assessment was based on engineering and laboratory testing protocols.

4. Adjudication Method for the Test Set

Not Applicable. There was no "test set" in the sense of patient cases requiring adjudication for ground truth. Device performance was evaluated against technical specifications and established standards through specific tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not relevant for this type of purely mechanical medical device.

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

Not Applicable. This is a physical introducer sheath, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable in the traditional sense of AI/diagnostic algorithms. For this device, the "ground truth" for the in-vitro and biocompatibility testing involved objective measurements and adherence to pre-defined engineering specifications and international standards (e.g., ISO 10993-1-1994 guidance). For "equivalence," the predicate devices served as the benchmark.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" for a physical medical device. Manufacturing processes and design iterations, while involving testing, are not analogous to training an AI model.

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

Not Applicable. As there is no training set for an AI algorithm, no ground truth was established in this context.

Summary

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K981909

510(k) Summary, Safety and Effectiveness

Submitter:	Baxter Healthcare CorporationCardioVascular GroupCritical Care17221 Red Hill AvenueIrvine, California 92614 USA
Contact:	Scott BegginsPhone: 949-250-2568Fax: 949-250-3579
Device Trade Name:	Baxter Hemostasis Valve Introducers
Common Name:	Percutaneous Sheath Introducer
Classification:	Class II (Reference 21 CFR 870.1340)
Predicate or LegallyMarketed Device:	Baxter Healthcare Intro-Flex® Percutaneous SheathIntroducer, Cook Critical Care Intro DeuceHemostasis Valve set and Bard Access SystemsPeel-Apart Percutaneous Introducer Kit
Date prepared:	May 29, 1998

Device Description:

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Indications for Use:

The Baxter Healthcare Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter).

Technology Comparison

The Baxter Hemostasis Valve Introducers are technologically comparable to the predicate devices in construction and physical specifications. Furthermore, design, manufacturing, and sterilization procedures are representative of current industry practices.

Test Summary, In-vitro

Functional testing was performed on the Baxter Hemostasis Valve Introducers to evaluate the integrity and performance of the device. Based upon the results of this testing, the Baxter CardioVascular Group, Edwards Critical-Care has determined that the Baxter Hemostasis Valve Introducers are safe and effective and are acceptable in design and construction for its intended use.

Test Summary, In-vivo

Clinical testing was not performed on the subject catheter because the intended use and indications are the same as the predicate devices. Furthermore, the Baxter Hemostasis Valve Introducers exhibited comparable design characteristics to the predicate devices in the in vitro testing, thus clinical testing was not performed.

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Test Summary, Biocompatibility:

Biocompatability testing was performed on the Baxter Hemostasis Valve Introducers in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Baxter Hemostasis Valve Introducers were found to be biocompatable and nontoxic and acceptable for its intended use.

Rational for Substantial Equivalence Determinations:

The battery of non-clinical tests discussed above demonstrates that the Baxter Hemostasis Valve Introducers exhibits comparable mechanical and functional specifications to the predicate devices in addition to being biocompatible and chemically acceptable. Based upon those characteristics, the Baxter Hemostasis Valve is substantially equivalent to the predicate devices in safety and effectiveness in addition to being intended for the same uses.

Scott Beyer 5/29/98

Scott Beggins Date Senior Manager, gulatory Affairs CardioVascular Group Baxter Healthcare Corporation

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration Rockville MD 20857

NOV 24 1000

Mr. Scott Beggins Senior Manager, Regulatory Affairs Baxter Edwards 17221 Red Hill Ave. Irvine, CA 92614-5686

Re: K981909 Trade Name: Baxter Hemostasis Valve Introducers Regulatory Class: II Product Code: DYB Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Beggins:

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 regulatory 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

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Page 2 - Mr. Scott Beggins

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4586. 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ of

510(k) Number (if known): K981909

Device Name: Baxter Hemostasis Valve Introducers

Indications For Use:

artery or infusion catheter) and central venous pressure monitoring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office OF Device Evaluation (ODE)

A. Doyal Youtt for TJCallahan

Division of Cardiovascular, Respiratory, and Neurological D 510(k) Number

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).