The BD Introsyte™ products identified in this 510(k) notification are splittable, polyethylene catheter introducers. The BD Introsyte™ Autoguard™ Shielded Introducer includes a needle-shielding feature that the BD Introsyte™ Precision Introducer does not include. Autoguard products incorporate spring-activated needle-shielding technology. BD Introsyte introducers are available in sizes ranging from 16 to 24 gauge. BD Splittable Needle Introducers range from 16 to 24 gauge.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for various BD Introsyte Catheter Introducer products. It details their intended use, technological characteristics, and a conclusion of substantial equivalence to predicate devices based on nonclinical tests.

Acceptance Criteria and Device Performance

Based on the provided text, the acceptance criteria are not explicitly stated in numerical or statistical targets. Instead, the primary acceptance criterion for these modified devices (BD Introsyte™ Precision Introducer, BD Introsyte-N™ Precision Introducer, BD Introsyte™ Autoguard™ Shielded Introducer, BD Introsyte-N™ Autoguard™ Shielded Introducer, and BD Splittable Needle Introducer) is substantial equivalence to their unmodified predicate devices. This substantial equivalence is demonstrated through nonclinical tests.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance	Study Conclusion
Substantial Equivalence in:	Penetration: Tested side-by-side with unmodified devices.	Data demonstrated substantial equivalence in product performance.
- Product Performance	Catheter Drag: Tested side-by-side with unmodified devices.	Data demonstrated substantial equivalence in product performance.
- Biocompatibility	Not explicitly detailed what specific biocompatibility tests were performed, but a general statement of equivalence.	Data demonstrated substantial equivalence in biocompatibility.

The key modification highlighted is the change in lubrication systems to be "ozone friendly." The study aimed to show that this change did not adversely affect the device's performance or safety compared to the existing, legally marketed versions.

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size (number of devices or tests performed) for the side-by-side testing. It states "Side-by-side testing of modified and unmodified devices was conducted."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be entirely nonclinical (laboratory testing) rather than involving human subjects. It is retrospective in the sense that the new devices are compared to previously established devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a nonclinical study involving physical performance tests (penetration, catheter drag) and biocompatibility, not a diagnostic or clinical study requiring expert interpretation of results or establishment of ground truth in a clinical context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As a nonclinical, objective performance test, there would typically be no human adjudication process of test results in the way it's done for clinical image interpretation or diagnosis. The data would be quantitatively compared against predefined parameters.
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:
- Not applicable. This is a nonclinical study of physical medical devices (catheter introducers), not a study involving AI, human readers, or image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This study does not involve an algorithm or AI. It is a nonclinical performance evaluation of physical devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for evaluating the modified devices was the established performance and biocompatibility of the unmodified predicate devices. The tests aimed to demonstrate that the modified devices performed equivalently to these established benchmarks.
The sample size for the training set:
- Not applicable. This is a nonclinical performance study, not a machine learning study that would involve training sets.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of nonclinical device performance evaluation.

Summary

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BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com

JUN 12 2002

Ko20834

Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun-like symbol on the left and the letters "BD" on the right. Below the letters, the word "Indispensable" is written in a smaller font. The logo is black and white and appears to be a company logo.

Indispensable to human health

Premarket Notification [510(k)] Summary of Safety and Effectiveness for
BD Introsyte™ Precision Introducer, BD Introsyte-N™ Precision Introducer,
BD Introsyte™ Autoguard™ Shielded Introducer,
BD Introsyte-N™ Autoguard™ Shielded Introducer, and
BD Splittable Needle Introducer

Submitter:	Becton Dickinson Infusion Therapy Systems Inc.
Address:	9450 South State StreetSandy, UT 84070
Contact Person:	Leslie Wood, Manager, Regulatory Affairs
Telephone Number:	(801) 565-2504
FAX Number:	(801) 565-2749
Date Summary Prepared:	March 5, 2002
Trade Names:	BD Introsyte™ Precision Introducer,BD Introsyte-N™ Precision IntroducerBD Introsyte™ Autoguard™ Shielded IntroducerBD Introsyte-N™ Autoguard™ Shielded IntroducerBD Splittable Needle Introducer
Common Name:	Catheter Introducer
Classification Name:	Catheter Introducer
Predicate Devices:	Same as trade names listed above.

Product Descriptions:

BD Introsyte introducers are available in sizes ranging from 16 to 24 gauge. BD Splittable Needle Introducers range from 16 to 24 gauge.

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KO20834

Intended Use:

As provided in 21b CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Technological Characteristics Comparison:

The catheter design and technological characteristics have not changed. The lubrication systems used have been modified to make the manufacturing process 'ozone friendly.'

Nonclinical Tests Support Substantial Equivalence:

Side-by-side testing of modified and unmodified devices was conducted to compare penetration and catheter drag.

Conclusions from Nonclinical Tests:

Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of three human profiles facing right, with flowing lines suggesting movement or connection. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2002

Becton Dickinson Infusion Therapy Systems, Inc. Ms. Leslie Wood Manager, Regulatory Affairs 9450 South State Street Sandy, UT 84070

Re: K020834

BD Introsyte™ Precision Introducer BD Introsyte-N™ Precision Introducer BD Introsyte™ Autoguard™ Shielded Introducer BD Introsyte-N™ Autoguard™ Shielded Introducer BD Splittable Needle Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: March 13, 2002 Received; March 14, 2002

Dear Ms. Wood:

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 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) 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 (PMA), 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.

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Page 2 – Ms. Leslie Wood

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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) 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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 vours.

V. Da. Tuleh

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1020834

INDICATIONS FOR USE

Device Name:

BD Introsyte™ Precision Introducer BD Introsyte-N™ Precision Introducer BD Introsyte™ Autoguard™ Shielded Introducer BD Introsyte-N™ Autoguard™ Shielded Introducer BD Splittable Needle Introducer

As provided in 21 CFR 870.1340, a catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Division of Cardiovascular & Respiratory Devices
510(k) Number K920834

Prescription Use
(Per 21 CFR 801.109)

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).