LARGE BORE SPLITTABLE INTRODUCER KIT

K043438 · Thomas Medical Products, Inc. · DYB · Feb 15, 2005 · Cardiovascular

Device Facts

• Record ID: K043438
• Device Name: LARGE BORE SPLITTABLE INTRODUCER KIT
• Applicant: Thomas Medical Products, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Large bore splittable introducer kit is intended to provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads.

Device Story

Large bore splittable introducer kit provides percutaneous vascular access for delivery of catheters, pacing leads, and defibrillator leads. Device comprises a splittable sheath and vessel dilator; includes integrated proximal hemostasis valve to minimize blood loss during insertion. Splittable design allows sheath removal over inserted leads or catheters by splitting along longitudinal axis. Available as sterile sheath/dilator set, sterile procedural kit (with 18G XTW needle, guidewire, syringe), or bulk non-sterile. Used by clinicians in clinical settings to facilitate device placement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Splittable sheath introducer with proximal hemostasis valve and vessel dilator. Mechanical design for percutaneous vascular access. No electronic, software, or energy-based components.

Indications for Use

Indicated for percutaneous vascular access to facilitate the introduction of various types of catheters, pacing leads, and defibrillator leads.

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

• Tear-away sheath introducer kit (K934901)

Submission Summary (Full Text)

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# 643438

## FEB 1 5 2005

### 510(k) SUMMARY SECTION VI: [as required by section 807.92(c)]

#### Submitter's Information: A.

| 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 Engineering / RA |
| Date Submission Prepared: | December 7, 2004 |

#### Device Information: B.

Trade name: Classification Name(s): Common or usual name(s): Not assigned at the time of submission Catheter Introducer (21 CFR §870.1340) Large bore splittable introducer kit, Hemostatic, peel-away, dialysis introducer

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

Thomas Medical Products, Inc., Tear-away sheath introducer kit - k934901

#### Description of the device: D.

The Thomas Medical Products Inc. Large bore splittable introducer kit(s) consists of a splittable sheath introducer and appropriately sized vessel dilator. A hemostasis valve is incorporated at the proximal end of the sheath. The valve reduces blood loss through the sheath during the catheter / lead introduction. The 'splittable' function allows for removal of the sheath from the vascular system over the inserted catheter or lead and then removal the sheath from the lead by splitting the device along its' longitudinal axis.

The sheath is available packaged (1) sterile with an appropriately sized dilator, (2) sterile as a procedural convenience kit with an 18 gage XTW needle, guidewire, and 12 cc syringe, and (3) bulk non-sterile.

#### Intended use of the device: E.

The Large bore splittable introducer kit is intended to provide percutaneous access to the vascular system for the purpose of delivering various types of catheters, pacing leads, and defibrillator leads.

### Summary of the technological characteristics of the device compared to the F. predicate device:

The technological characteristics of the device are the same as those of the predicate devices.

#### Substantial equivalence rationale: G.

The Thomas Medical Products Inc. Large bore splittable introducer kit has similar general intended use / indications for use and technological characteristics as other previously cleared devices. Therefore, based on these similarities, the Thomas Medical Products, Inc. Large bore splittable introducer kit is substantially equivalent to the legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 5 2005

Mr. Tim Stoudt Manager, QA Engineering/RA Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355

Re: K043438

Trade/Device Name: Large Bore Splittable Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: II Product Code: DYB Dated: January 17, 2005 Received: January 18, 2005

Dear Mr. Stoudt:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce prox 201125 201125 2011 de necs that have been require approval of a premarket approval application (PMA). and Costictly (110) free ) 120) that the general controls provisions of the Act. The r ou may, merers, inisies of the Act include requirements for annual registration, listing of general oonly is free wing 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 11 your de for 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 r lease be actived had i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 - Mr. Tim Stoudt

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2005) (2005) (2005) (2005) (2005) (21) (2) 63) -542-642-481): 21 CFR 1000 forth in the quality systems (QS) regulation (2 ~21 cm 6 oee ,) ; 21 CFR 1000-1050.
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premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The PDA imaling of substantial equive 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
rs of the many of the many of 10, 276, 0100 - Also, massa note the regulati If you desire specific advice for your uc vice on our lassing segments the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note You contact the Office of Compilatics at (240) 270 - 1210 FR Part 807.97). You may obtain
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other general information on your responsibilities under the tall from pumber (800) 638 other general information on your responsion its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its today himl. Manufacturers, International and Consumer Assistance as to to to and industry/support/index.html.

Sincerely yours,

Duna D. Vochner

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

<043438

510(k) Number (if known): K043438

Device Name: Large bore splittable introducer kit

Indications for Use:

For the introduction of various types of pacing or defibrillator leads and catheters.

<AND>

For the introduction of various types of catheters.

Prescription Use __ × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

to be dner

Division Sir -Off) (Division of Cardiovascular Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number Ko 4343