This document describes the 510(k) premarket notification for the AirGuard™ Valved Introducer (K042036). This is a traditional 510(k) for a medical device and therefore does not include a study related to Artificial Intelligence (AI) or machine learning. The requested information regarding acceptance criteria and study data would typically pertain to a clinical trial or performance study, which is not the primary focus of this type of regulatory submission concerning substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not applicable:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the way one might expect from a clinical trial or a detailed engineering performance report. Instead, it states:

Criterion Type	Acceptance Statement
Biocompatibility	Met the requirements of ISO-10993 and FDA Modified ISO 10993 Test Profile.
Design Verification	Met all requirements of in-house protocols, applicable standards, and comparable to predicate device.
Substantial Equivalence	All test results confirm the subject device to be substantially equivalent to the predicate device.

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

This information is not provided in the document. The submission references "in-house protocols" and "biological evaluation of medical devices Part 1: Evaluation and testing" for non-clinical performance data, but does not specify sample sizes or data provenance for these evaluations.

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 is not applicable to this 510(k) submission. This filing is for a medical device (catheter introducer), not an AI/ML algorithm that requires expert-established ground truth for image analysis or diagnosis. The "ground truth" for a device like this would be its physical and functional performance according to engineering specifications and biological safety standards.

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

This is not applicable to this 510(k) submission as it does not involve expert adjudication of results. Testing would likely follow standard engineering and biological assessment methodologies.

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 is not applicable. This submission is for a physical medical device (catheter introducer) and does not involve AI or human readers for diagnostic interpretation.

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

This is not applicable. This submission is for a physical medical device and does not involve any 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 objective measurements and validated testing against industry standards and safety regulations. These include:

AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation and testing: This standard defines the acceptable biological response of the device when in contact with the body. The "ground truth" here is meeting the established safety thresholds for biocompatibility.
AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of ethylene oxide sterilization: Establishes sterility assurance levels.
ISO 11070:1998(E), Sterile single-use intravascular catheter introducers: Defines performance and safety requirements for catheter introducers.
In-house protocols: These would cover functional performance characteristics like air/blood leakage reduction, peelability, and material integrity, with acceptance criteria defined by the manufacturer and validated through testing.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set.

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

This is not applicable. This is not an AI/ML device and does not have a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states that "Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:"

AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
ISO 11070:1998(E), Sterile single-use intravascular catheter introducers

The results from this testing are summarized as:

"Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices."
"All test results confirm the subject device to be substantially equivalent to the predicate device."
"AirGuard Valved Introducers met all performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs."

The "study" in this context is a series of non-clinical, bench performance tests and evaluations against established industry standards and internal protocols to demonstrate the device's safety and effectiveness, and critically, its substantial equivalence to the predicate device (MedAmicus FlowGuard™Peelable Introducer, K040150). The primary acceptance criterion for a 510(k) is demonstrating this substantial equivalence.

Summary

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K042036

AUG 2 3 2004

AirCinard 510(k)

AirGuard™ Valved Introducer 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).

General Information:

Submitter Name:	Bard Access Systems, Inc. (BAS)[Wholly owned Subsidiary of C. R. Bard, Inc.]
Address:	5425 W. Amelia Earhart DriveSalt Lake City, UT 84116
Telephone Number:	(801) 595-0700 ext. 5525
Fax Number:	(801) 595-5425
Contact Person:	Glenn Norton
Date of Preparation:	August 20, 2004

Device Information:

Device Name:	AirGuard™ Valved Introducer
Trade Name:	AirGuard™
Common/Usual Name:	Catheter Introducer
Classification Name:	74DYB - Introducer, Catheter21 CFR 870.1340 - Class II
Classification Panel:	Cardiovascular and Respiratory Devices

Predicate Device:

MedAmicus FlowGuard™Peelable Introducer, 510(k) K040150, FDA clearance date 02/18/2004

Summary of Change:

The modification to the MedAmicus FlowGuard™Peelable Introducer is a passive valve design for improved reduction of air and blood leakage during percutaneous catheter placement.

Device Description:

AirGuard™ Valved Introducers have a PTFE sheath and are available in 15Fr and 16.5Fr sizes, and in lengths of 13cm and 18cm.

Intended Use of Devices:

AirGuard is recommended for use in the percutaneous insertion of cathelers in the venous system.

Technological Comparison to Predicate Devices:

The technological characteristics of the AirGuard Valved Introducer are substantially equivalent to those of the predicate FlowGuard Peelable Introducer in terms of intended use, application, user population, basic design, performance, labeling, packaging, and sterilization method. Bench performance test results met all requirements and were comparable to the predicate device.

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Air Juarc 510(k)

Non-Clinical Performance Data

Design verification testing was conducted in conformance to in-house protocols, and performed or evaluated based on the following standards:

AAMI/ANSI/ISO-10993-1: 1997, Biological evaluation of medical devices Part 1: Evaluation . and testing, and the FDA Modified ISO 10993 Test Profile
. AAMI/ANSI/ISO 11135:1994, Medical devices – Validation and routine control of elhylene oxide sterilization
. ISO 11070:1998(E), Sterile single-use intravascular catheter introducers

Results from biocompatibility testing met the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating, direct blood-contacting, limited-exposure devices.

All test results confirm the subject device to be substantially equivalent to the predicate device.

Conclusion

AirGuard Valved Introducers met all performance criteria of design verification as specified by applicable standards, test protocols and/or customer inputs. Based on FDA's decision trees, the AirGuard Valved Introducer is substantially equivalent to the legally marketed predicate device, the MedAmicus FlowGuard™ Peelable Introducer, 510(k)# K040150, clearance date 02/18/2004.

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Public Health Service

AUG 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Access Systems, Inc. (BAS) c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K042036
Trade/Device Name: AirGuard™ Valved Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: July 27, 2004 Received: July 29, 2004

Dear Mr. Mosenkis:

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 for associous 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 (IPMA). 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.

Please be advised that FDA`s issuance of a substantial equivalence determination does not mean I rease of a novel 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

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Page 2 - Mr. Robert Mosenkis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rend wt 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) I ms lotter will and in yourse finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and th . . permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you a some of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other generalional 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,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1-B

AirGuard™ Valved Introduccr 510(K)

INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the AirGuard™ Valved Introducer is indicated for the following:

"The AirGuard™ Valved Introducer is indicated for use in the percutaneous insertion of catheters in the venous system."

Signature of 510(k) Submitter:

Printed Name of Submitter:

Glenn Norton

Date:

7-7-04

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801. 4 of the Code of Federal Regulations, Title 21.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Division Sign-Off
Office of Device Evaluation

000005

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).