MEDCOMP VASCU-SHEATH INTRODUCER SET

K022513 · Medcomp · DYB · Oct 25, 2002 · Cardiovascular

Device Facts

• Record ID: K022513
• Device Name: MEDCOMP VASCU-SHEATH INTRODUCER SET
• Applicant: Medcomp
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Medcomp Vascu-Sheath® Introducer Set is a single-use medical device designed to facilitate vascular access. The system consists of an introducer sheath and a vessel dilator. It is used by clinicians to gain access to the central venous system, allowing for the subsequent insertion of catheters or pacing leads. The device functions as a mechanical conduit for percutaneous procedures. No electronic, software, or algorithmic components are involved.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through in vitro bench testing, including peel force measurements, comparing the device to the legally marketed predicate.

Technological Characteristics

Single-use introducer sheath and vessel dilator. Mechanical device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring central venous access for catheter insertion or placement of pacing leads into the central venous system.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• TFX Medical Introducer Assembly (K993191)

Submission Summary (Full Text)

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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 [phone] Telephone [phone] 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.

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.

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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