CROSSOVER

K083269 · Thomas Medical Products, Inc. · DYB · Feb 3, 2009 · Cardiovascular

Device Facts

• Record ID: K083269
• Device Name: CROSSOVER
• Applicant: Thomas Medical Products, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Reinforced Catheter Introducer System (RCIS) facilitates percutaneous access for intravascular devices or fluids. System comprises 5-7F spiral reinforced sheath, integrated hemostasis valve, sideport extension, 3-way stopcock, and lockable dilator. Radiopaque distal tip assists physician in correct placement. Dilator compatible with guidewires up to 0.038" diameter. Used in clinical settings by physicians for arterial and venous procedures. Device provides stable access point for diagnostic or therapeutic interventions, minimizing trauma during insertion.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

5-7F spiral reinforced sheath introducer; integrated hemostasis valve; sideport extension; 3-way stopcock; radiopaque distal tip; lockable dilator; compatible with 0.038" guidewires; sterile, single-use.

Indications for Use

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

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

• Reinforced Catheter Introducer System (K081341)

Submission Summary (Full Text)

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6093269

Reinforced Catheter Introducer System (5-7F) Special 510(k): Device Modification

| SECTION VI: | 510(k) SUMMARY<br>[as required by section 807.92(c)] | | |
|-------------|------------------------------------------------------|---------------------------|-------------------------------|
| | A. | Submitter's Information: | FEB - 3 2009 |
| | | Name: | Thomas Medical Products, Inc. |
| | | Address: | 65 Great Valley Parkway |
| | | | Malvern, PA 19355 |
| | | Telephone Number: | 610.296.3000 |
| | | Facsimile: | 610.296.4591 |
| | | Contact Person: | Tim Stoudt |
| | | Title: | Manager, QA / RA |
| | | Date Submission Prepared: | October 24, 2008 |
| | B. | Device Information: | |

Trade name: Classification Name(s): Common or usual name(s): Crossover, et al. Catheter Introducer (21 CFR §870.1340) Reinforced Catheter Introducer System 5-7F (RCIS)

### Legally marketed device to which equivalence is claimed:

Thomas Medical Products, Inc., Reinforced Catheter Introducer System - k081341

#### D. Description of the device:

ત.

The RCIS consists of a 5-7F 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. Each 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. Indications for use:

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

Summary of the technological characteristics of the device compared to the predicate device:

The technological characteristics of the device are identical to those of the predicate devices.

## G.

F.

### Substantial equivalence rationale:

The Thomas Medical Products Inc. 5-7F Reinforced Catheter Introducer Systems have identical intended use / indications for use and technological characteristics as the previously cleared device. Based on these similarities, the Thomas Medical Products, Inc. 5-7F Reinforced Catheter Introducer Systems are substantially equivalent to the legally marketed predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB -3 2009

Thomas Medical Products, Inc. c/o Mr. Tim Stoudt Manager, Quality Assurance/Regulatory Affairs 65 Great Valley Parkway Malvern, PA 19355

Re: K083269

Reinforced Catheter Introducer System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 23, 2008 Received: December 24, 2008

## Dear Mr. Stoudt:

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. Tim Stoudt

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 Biometrics' (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,

Daria R. Holmes

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): K083269

Device Name: Reinforced Catheter Introducer System (5 - 7 F)

Indications For Use:

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

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

p. volumes

Juvision Sign-Off) Division Olgh-Shylascular Devices

51000 Number

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