SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS

K112407 · Smiths Medical MD, Inc. · DYB · Feb 9, 2012 · Cardiovascular

Device Facts

• Record ID: K112407
• Device Name: SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
• Applicant: Smiths Medical MD, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system.

Device Story

Device consists of dilator and peelable sheath; hubs at proximal end allow manipulation as single unit. Some versions include proximal valve. Available in French sizes 6-11; interior diameters .085-.147 inches; outside diameters .116-.182 inches. Used to facilitate catheter insertion into vascular system by dilating vessel and introducing sheath. Once sheath is in place, dilator is removed; catheter is inserted through sheath. Sheath hubs are broken and sheath is peeled away/removed from catheter. Used by clinicians in clinical settings.

Clinical Evidence

No clinical data. Human clinical studies were deemed unnecessary to evaluate safety or effectiveness. Evidence consists of bench testing of physical properties, compatibility with co-packaged accessories, and biocompatibility assessment of materials.

Technological Characteristics

Materials: PEBAX, polyethylene, polycarbonate; silicone for valved versions. Sensing/actuation: Mechanical dilation and sheath introduction. Dimensions: French sizes 6-11; lengths 5-8 inches. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for the introduction of catheters into the subclavian vein. Prescription use only.

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

• Adelante® Introducer Set Models: Adelante® and Adelante® S-Lite (K0073110)
• Smiths Medical Subclavian Introducers (K871132)

Submission Summary (Full Text)

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_Summary Page 1 of 3 K112407 510(k) Number:__

Date Prepared August 18, 2011

# Submitter Information

| Submitter's Name: | Smiths Medical ASD, Inc. |
|-------------------|--------------------------|
| Address: | 1265 Grey Fox Road |
| | St. Paul, MN 55112 |

Establishment Registration: 2183502

| Contact Person: | Thomas Bliss<br>Sr. Regulatory Affairs Specialist |
|-----------------|---------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |

## Device Information

| Trade Name: | Smiths Medical Peel-Away Sheath Introducers |
|----------------------|---------------------------------------------|
| Common Name: | Introducer Sets |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
| Regulation: | 21 CFR 870.1340 |

### Predicate Device(s)

The predicate devices are the currently marketed Adelante® Brand Introducers manufactured by Oscor, Inc. and Smiths Medical Subclavian Introducer Sets.

The reference 510(k) numbers for these devices is provided below:

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#### Summary Page 2 of 3 510(k) Number:

| Predicate Device | 510(k) |
|-----------------------------------------------------------------|----------|
| Adelante® Introducer Set Models: Adelante® and Adelante® S-Lite | K0073110 |
| Smiths Medical Subclavian Introducers | K871132 |

### Device Description

Each Smiths Medical Peel-Away Sheath Introducer consists of a dilator and a peelable sheath. Both the dilator and the sheath have a hub at the proximal end. The dilator slides inside the sheath and the hubs are engaged so that sheath and dilator may be manipulated as a single unit. One version of the Smiths Medical Peel-Away Sheath Introducer has a valve on the proximal end of the hub.

The introducers are available in French sizes ranging from 6 to 11. Interior diameters of the sheath range from .085 to .147 inches. Outside diameters range from .116 to .182 inches. The length of the dilator for the non-valved introducer is nominally 8 inches from hub to tip with a 6 inch sheath. The dilator for the valved introducer is 7 inches long with a 5 inch sheath.

The Peel-Away Sheath Introducer is used to facilitate the insertion of a catheter into the vascular system by dilating a vessel and introducing the sheath. The hubs are then disengaged and the dilator is removed leaving the sheath through which a catheter may be inserted. The sheath hubs are then broken and the sheath is peeled away and removed from the catheter.

#### Indications for Use

The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system.

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### Summary of Non-Clinical Testing

The non-clinical testing included assessment of the physical properties of the Peel-Away Sheath Introducer and its compatibility with co-packaged accessories. Biocompatibility assessment of the device was performed on the materials used to construct the introducers. The materials used in the introducer include PEBAX, polyethylene and polycarbonate. The valve used on valved introducers is made of silicone. The device is biocompatible based on the testing of the materials and reinforced by a history of use in the medical device industry.

### Summary of Clinical Testing

Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Smiths Medical Peel-Away Sheath Introducer.

#### Statement of Equivalence

The Smiths Medical Peel-Away Sheath Introducer is identical to the currently marketed Adelante® and Adelante® S-Lite Introducer and is packaged with accessories and in configurations substantially equivalent to the Subclavian Introducer currently marketed by Smiths Medical.

#### Conclusion

Based on the indications for use, technological characteristics, materials of construction, configuration and packaging, the proposed Smiths Medical Peel-Away Sheath Introducer is Substantially Equivalent to the identified predicate devices. Bench tests have confirmed compatibility with common accessories and conformance with specifications.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

## FEB 09 2012

Smiths Medical ASD, Inc. c/o Mr. Thomas Bliss Senior Specialist Regulatory Affairs 1265 Grey Fox Road St. Paul, MN 55112

K112407 Re:

Trade Name: Smiths Medical Peel-Away Sheath Introducers Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: February 2, 2012 Received: February 6, 2012

Dear Mr. Bliss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained 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 commerce prior in May 20, 1970, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval opp and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, dierelore, market the Act include requirements for annual registration, listing of general controls provisions of the 1.67 labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trease note: CDFC. Coos not on the truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (see acove) into views affecting your device can be may be subject to additional controlly " and thing and 800 to 898. In addition, FDA may louid in the Code of reach. Nogancerning your device in the Federal Register.

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### Page 2 - Mr. Thomas Bliss

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 that I Dri has made a and regulations administered by other Federal agencies. You must or any I court statures and including, but not limited to: registration and listing comply war an all als not to the Part 801); medical device reporting (reporting of medical (21 CFR 807); accemes (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (2) OFF Part 820); and if applicable, the electronic ion in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice for your comters offices/CDRH/CDRHOffices/ucm115809.htm for go to mig.//www.ida.gov.rroodiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" note the legulation entitled, "Misolanding of reference vents under the MDR regulation (21 CFR Part 803), please go to

regulation (21 CFK Pat 803), picase go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain outch general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] of (501) 7700 vices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hilleben

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

# Indications for Use Statement

#### K112407 510(k) Number:

Desice Name: Smiths Medical Peel-Away Sheath Introducers

### Indications for Use:

The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein. ...

Prescription Use X (Per 21 CFR 801 .109)

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)

M.L. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

K112407 510(k) Number_