The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

Device Description

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.

Each reinforced introducer sheath features an integrated hemostasis valve system with a sideport extension and a 3-way stopcock. Fach introducer also has a radiopaque distal tip to aid the physician is correct placement of the device.

The RCIS dilator is lockable to the mating reinforced introducer sheath. The dilator has a straight curve configuration that extends approximately 2.5cm beyond the matching sheath when the dilator is locked to the sheath. The dilator is compatible with an up to 0.038" diameter guidewire.

AI/ML Overview

This document is a 510(k) summary for the submission of a Reinforced Catheter Introducer System (RCIS) by Thomas Medical Products, Inc. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

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

The provided document does not outline specific numerical acceptance criteria or quantitative performance metrics typically found in a study for a diagnostic AI device. Instead, it focuses on qualitative technological characteristics and claims substantial equivalence to predicate devices based on these features. The "acceptance criteria" here are implicitly the shared technological characteristics with the predicate devices.

Feature	Acceptance Criteria (Predicate Devices have this feature)	Reported Device Performance (TMP Reinforced Sheath has this feature)	Meets Criteria?
Hemostasis valve provided	Yes	Yes	Yes
Compatible with .038" guide wire	Yes	Yes	Yes
Introducer available in 90cm length	Yes	Yes	Yes
Introducer set available in 6F	Yes	Yes	Yes
Introducer reinforced with a flat metal wire	Yes	Yes	Yes
Wire reinforcement completely encapsulated	Yes	Yes	Yes
Radiopaque tip or marker	Yes	Yes	Yes
Sideport extension with 3-way stopcock	Yes	Yes	Yes
At least one matching dilator	Yes	Yes	Yes

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

This document describes a medical device (catheter introducer system), not an AI/diagnostic software. Therefore, there is no "test set" in the context of AI performance evaluation, and thus no information on sample size, data provenance, or data type for such a test set. The evaluation is based on a comparison of device features.

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)

Not applicable. As noted above, this submission is for a physical medical device, not an AI/diagnostic software that requires expert-established ground truth.

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

Not applicable. This submission is for a physical medical device, not an AI/diagnostic software.

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

Not applicable. This document is for a physical medical device, not an AI product. No MRMC study or comparative effectiveness study comparing human performance with and without AI assistance would be conducted for this type of submission.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

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

Not applicable. For a physical medical device like a catheter introducer, "ground truth" would relate to its physical properties, biocompatibility, sterility, and mechanical performance, which are evaluated through engineering tests, material analysis, and pre-clinical/clinical studies (though no full clinical study report is part of this 510(k) summary). The document indicates evaluation of "similar technological characteristics, and indications for use."

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no training set.

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

Not applicable. As there is no AI/machine learning aspect, there is no training set and no ground truth establishment for it.

Summary

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510(k) SUMMARY SECTION 5: [as required by section 807.92(c)]

A. Submitter's Information:

Name:	Thomas Medical Products, Inc.
Address:	65 Great Valley ParkwayMalvern, PA 19355
Telephone Number:	610.296.3000
Facsimile:	610.296.4591
Contact Person:	Tim Stoudt
Title:	Manager, QA / RA
Date Submission Prepared:	November 8, 2007
	MAY 14 2008

B. Device Information:

Trade name: Not assigned at the time of submission Classification Name(s): Catheter Introducer (21 CFR 8870.1340) Common or usual name(s): Reinforced Catheter Introducer System (RCIS)

C. Legally marketed device to which equivalence is claimed:

Arrow Transseptal Super Arrow-Flex Percutaneous Sheath (K970229) Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath (K051601)

D. Description of the device:

The RCIS consists of a spiral reinforced sheath introducer and an appropriately sized dilator packaged in a tyvek/polymylar pouch.

E. Intended use of the device:

The RCIS is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

KOB1341
p. Lot 2

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F. Summary of the technological characteristics of the device compared to the predicate devices:

Features	TMPReinforcedSheath[XD-2809-00]	SuperArrowFlex[CL-07690]	TerumoPinnacleDestination[RSC05]
Hemostasis valve provided	Yes	Yes	Yes
Compatible with .038" guide wire	Yes	Yes	Yes
Introducer available in 90cm length	Yes	Yes	Yes
Introducer set available in 6F	Yes	Yes	Yes
Introducer reinforced with a flat metal wire	Yes	Yes	Yes
Wire reinforcement completelyencapsulated	Yes	Yes	Yes
Radiopaque tip or marker	Yes	Yes	Yes
Sideport extension with 3-way stopcock	Yes	Yes	Yes
At least one matching dilator	Yes	Yes	Yes

G. Substantial equivalence rationalc:

Thomas Medical Products, Inc. considers the Reinforced Catheter Introducer System substantially equivalent to the currently marketed predicate devices. This assessment is based upon analysis of similar technological characteristics, and indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2008

Intertek Testing Services c/o Mr. Jay Y. Kogoma 2307 E. Aurora Road, Unit 87 Twinsburg, OH 44087

Re: K081341

Reinforced Catheter Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: May 12, 2008 Received: May 13, 2008

Dear Mr. Kogoma:

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 - Mr. Jay Y. Kogoma

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Page 1 of __ 1 _ .

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

The [Reinforced Catheter Introducer System]* is indicated for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

*[or tradename]

Prescription Use _X (Per 21 CFR 801 Subpart D) AND/OR

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

(Optional Format 11-13-03)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	ko 81341

510(k) "Indications For Use" Form (Replica of FDA Form)

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).