The Medcomp Vascu-Sheath® II is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Vascu-Sheath® II consists of a peel-able introducer sheath and vessel dilator. The dilator is comprised of a cylindrical tube with a hub; the sheath is also a cvlindrical tube with a hub. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The device is available in three dilator lengths, 5cm, 10cm and 13.5cm and a range of French sizes from 5F thru 7F for the 5 and 10cm lengths and 5F thru 18F for the 10cm length. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate in the dilator for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.

AI/ML Overview

The provided 510(k) summary for the Medcomp Vascu-Sheath® II describes an introducer set, not an AI/ML medical device. Therefore, many of the requested elements for describing studies proving a device meets acceptance criteria, particularly those related to algorithms, AI performance, ground truth, and human reader studies, are not applicable.

However, I can extract the relevant information regarding acceptance criteria and the type of study conducted for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by equivalence claim)	Reported Device Performance
Substantial equivalence to predicate devices (K993191, K022513) in:	In Vitro performance data for the Medcomp Vascu-Sheath® II, including peel force, demonstrates that this device is substantially equivalent to the legally marketed device.
- Intended Use	- Intended Use: "to obtain central venous access to facilitate catheter insertion into the central venous system." (Matches predicate)
- Design	- Design: Two-part, single-use device (peel-able introducer sheath and vessel dilator) with specific materials (HDPE with Barium Sulfate for dilator, PTFE for sheath). Available in 5F-18F sizes and 5cm, 10cm, 13.5cm lengths.
- Material Type	- Material Type: Polyethylene, Barium Sulfate, PTFE (Components listed match those typically used in such devices, implicitly equivalent to predicate).
- Performance (e.g., peel force, ease of insertion, patency)	- Performance: "In Vitro performance data... including peel force, demonstrates that this device is substantially equivalent."
- Method of Sterilization	- Method of Sterilization: Implicitly equivalent to predicate.

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

Sample Size: Not specified. The submission states "In Vitro performance data," which implies testing of units, but the number of units tested is not provided.
Data Provenance: The data is "In Vitro," meaning it was conducted in a lab setting, not on human subjects. No information on country of origin.

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

Not Applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. Performance was evaluated against engineering specifications and comparison to predicate device characteristics.

4. Adjudication Method for the Test Set

Not Applicable. See point 3.

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

No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. Clinical studies were explicitly "not deemed necessary."

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

Not Applicable. This is not an algorithm. Benchtop "In Vitro performance data" was conducted for the physical device.

7. The Type of Ground Truth Used

Engineering Specifications and Predicate Equivalence: The "ground truth" (or basis for acceptance) was the ability of the device to meet specified performance criteria (e.g., peel force) and to demonstrate substantial equivalence in design, materials, and intended use as compared to the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not Applicable. This device uses traditional materials and manufacturing, not AI/ML, so there is no "training set."

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

Not Applicable. See point 8.

Summary

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510(k) SUMMARY

< 053092

Introducer Set

Submitter Information: A.

MEDCOMP® Submitter: AUG () 1 2006 1499 Delp Drive Harlevsville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Contact: Jean Callow Regulatory Specialist Date Prepared: October 25, 2005 B. Trade Name: Vascu-Sheath® II Common Name: Introducer, Catheter Classification: DYB 870.1340 C.F.R. Section: C. Predicate Device: K993191 TFX Medical Introducer Assembly K022513 Medcomp Vascu-Sheath®

Device Description: D.

E. Intended Use:

Vascu-Sheath® II introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

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г. Comparison to Predicate Device:

The technological characteristics of the Vascu-Sheath® II are substantially equivalent to the predicate devices 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® II, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 1 2006

Medcomp c/o Ms. Jean Callow Regulatory Specialist 1499 Dale Drive Harleysville, PA 19438

Re: K053092 Vascu-Sheath® II Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: June 29, 2006 Received: June 30, 2006

Dear Ms. Callow:

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. Iisting 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. Jean Callow

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 Office of Compliance at (240) 276-0120. 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 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 vours.

tin R. Richner

Image /page/3/Picture/5 description: The image shows a hand-drawn sketch of a symbol. The symbol appears to have a curved line with an arrow pointing downwards, connected to a horizontal line at the bottom. Above the curved line, there is another curved line that is dashed.

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 (if known): 053092________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

VASCU-SHEATH II® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENTRAL VENOUS CHIPEL CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.

Prescription Use __X _______________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diving P b. Junes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_i 5 2 2 10(k) 10(510

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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).