THE MEDCOMP Vascu-Sheath® INTRODUCER SETS ARE INDICATED FOR USE IN ORTAINING CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION OR PLACING PACING LEADS INTO THE CENTRAL VENOUS SYSTEM.

Device Description

The Medcomp Vascu-Sheath® Introducer Set is a single use device used to obtain vascular access and facilitate catheter insertion. The Medcomp Vascu-Sheath® Introducer Set consists of an introducer sheath and vessel dilator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Medcomp Vascu-Sheath® Introducer Set." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a clinical trial for a novel device.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance for Medcomp Vascu-Sheath® Introducer Set

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from Substantial Equivalence Claim)	Reported Device Performance
Safety	Equivalent to predicate device (K993191 TFX Medical Introducer Assembly) in terms of unintended effects and risks.	Demonstrated in-vitro performance, including peel force, showing substantial equivalence to the legally marketed predicate device.
Effectiveness	Equivalent to predicate device (K993191 TFX Medical Introducer Assembly) in achieving intended use: obtaining vascular access and facilitating catheter insertion for central venous access or placing leads.	Demonstrated in-vitro performance, including peel force, showing substantial equivalence to the legally marketed predicate device.
Design	Equivalent to predicate device.	Stated as "substantially equivalent ... in terms of design."
Material Type	Equivalent to predicate device.	Stated as "substantially equivalent ... in terms of ... material type."
Sterilization Method	Equivalent to predicate device.	Stated as "substantially equivalent ... in terms of ... method of sterilization."

Explanation: In a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. This means the new device performs at least as safely and effectively as the predicate for its intended use. The performance data presented (in-vitro peel force) is used to support this claim of equivalence. Specific numerical thresholds for acceptance are not detailed in this summary, but rather the performance being "substantially equivalent" to the predicate is the overarching criterion.

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

Sample Size: Not explicitly stated. The document mentions "In Vitro performance data," but does not specify the number of units tested.
Data Provenance: The study was "in-vitro," meaning it was conducted in a lab environment (e.g., bench testing) rather than on human or animal subjects. The country of origin for this data is not specified. It is an in-vitro study, not retrospective or prospective in a clinical sense.

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

Not applicable. This study relied on in-vitro testing comparing the device to a predicate, not expert assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no human "test set" requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study was not conducted as this was an in-vitro substantial equivalence assessment, not a clinical effectiveness study involving human readers.

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

While this wasn't an "algorithm," the "standalone" concept could loosely apply to the in-vitro testing. The device's physical properties (like peel force) were tested in isolation, directly compared to the predicate device's known performance characteristics, without human judgment involved in interpreting results beyond standard laboratory procedures.

7. The type of ground truth used

The "ground truth" for this substantial equivalence submission was the established safety and effectiveness profile of the predicate device (K993191 TFX Medical Introducer Assembly), as demonstrated through its legally marketed status. The in-vitro test results for the new device were compared to the performance characteristics expected or known of the predicate device to show equivalence.

8. The sample size for the training set

Not applicable. This was an in-vitro comparison study, not a machine learning study requiring a training set.

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

Not applicable. There was no training set.

Summary

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510(k) SUMMARY

Submitter Information: A.

Submitter:

Contact:

Date Prepared:

B. Trade Name: Common Name: Classification: C.F.R. Section:

OCT 2 5 2002

MEDCOMP® 1499 Delp Drive Harlevsville, PA 19438 (215) 256-4201 Telephone (215) 256-0818 Fax Florence A. Caikoski Regulatory Affairs Associate July 9, 2001

Medcomp Vascu-Sheath® Introducer Set Introducer, Catheter DYB 870.1340

C. Predicate Device:

K993191 TFX Medical Introducer Assembly

Device Description: D.

E. Intended Use:

The Medcomp Vascu-Sheath® Introducer Sets are indicated for use in obtaining central venous access to facilitate catheter insertion or placing leads into the central venous system.

F. Comparison to Predicate Device:

The technological characteristics of the Vascu-Sheath® Introducer Set are substantially equivalent to the predicate device in terms of intended use, design, material type, performance, and method of sterilization.

G. Performance Data:

In Vitro performance data for the Medcomp Vascu-Sheath® Introducer Set, including peel force, demonstrates that this device is substantially equivalent to the legally marketed device.

Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2002

MEDCOMP® Ms. Florence A. Caikoski Regulatory Affairs Associate 1499 Delp Drive Harleysville. PA 19438

Re: K022513

Medcomp Vascu-Sheath® Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: 74 DYB Dated: July 29, 2002 Received: July 30, 2002

Dear Ms. Caikoski:

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.

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

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Page 2 -- Ms. Florence A. Caikoski

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) 594-4618. 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.

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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INDICATIONS FOR USE

510(k) Number: | | 022513

Device Name; MEDCOMP Vascu-Sheath® INTRODUCER SET

Indications for use:

THE MEDCOMP Vascu-Sheath® INTRODUCER SETS ARE INDICATED FOR USE IN ORTAINING CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION OR PLACING PACING LEADS INTO THE CENTRAL VENOUS SYSTEM.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter_

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K022513

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).