REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)

K081341 · Thomas Medical Products, Inc. · DYB · May 14, 2008 · Cardiovascular

Device Facts

• Record ID: K081341
• Device Name: REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
• Applicant: Thomas Medical Products, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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

Device Story

Reinforced Catheter Introducer System (RCIS) facilitates percutaneous access for intravascular devices; consists of spiral reinforced sheath, integrated hemostasis valve, sideport extension with 3-way stopcock, and lockable dilator. Radiopaque distal tip aids physician placement. Dilator compatible with up to 0.038" guidewire. Used in clinical settings by physicians for arterial/venous procedures. Device provides stable access path for diagnostic/therapeutic tools; benefits patient by enabling minimally invasive vascular interventions.

Clinical Evidence

No clinical data; substantial equivalence based on technological characteristics and design comparison to predicate devices.

Technological Characteristics

Reinforced sheath introducer with flat metal wire reinforcement; encapsulated wire design; integrated hemostasis valve; sideport extension with 3-way stopcock; radiopaque distal tip; lockable dilator; compatible with 0.038" guidewire; sterile, single-use.

Indications for Use

Indicated for patients undergoing arterial or venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices.

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

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

Submission Summary (Full Text)

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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 Parkway<br>Malvern, 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.

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.

#### 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 | TMP<br>Reinforced<br>Sheath<br>[XD-<br>2809-00] | Super<br>Arrow<br>Flex<br>[CL-<br>07690] | Terumo<br>Pinnacle<br>Destination<br>[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 completely<br>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 |

#### 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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)