MODIFICATION TO GLIDESHEATH

K062858 · Terumo Medical Corp. · DYB · Oct 20, 2006 · Cardiovascular

Device Facts

• Record ID: K062858
• Device Name: MODIFICATION TO GLIDESHEATH
• Applicant: Terumo Medical Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Device Story

Glidesheath is an introducer sheath and dilator system used to facilitate percutaneous catheter placement into veins or arteries. Kit includes mini guide wire, Surflo IV catheter, syringe, and scalpel for vessel access. Device components contain bismuth for fluoroscopic visibility. Operator (physician/clinician) gains initial vessel access, inserts guide wire, then advances sheath over wire. Dilator maintains vessel patency during insertion. Once sheath is in place, dilator and wire are removed to allow catheter insertion. RADIFOCUS Obturator provides occlusion and structural support to the indwelling sheath after catheter removal. Used in clinical settings for vascular procedures. Benefits include simplified vessel access and maintenance of access site integrity.

Clinical Evidence

Bench testing only. Verification tests included leakage/clogging, tensile strength of connections, separation force, internal/external sliding resistance, and penetration force. Biocompatibility testing performed per ISO-10993 for externally communicating devices with prolonged blood contact (24 hours to 30 days). Sterilization validated per ANSI/AAMI/ISO 11135 and EN 550.

Technological Characteristics

Introducer sheath and dilator system. Materials include bismuth for fluoroscopic visibility. Guide wire available in stainless steel or nickel-titanium alloy with polyurethane coating. Sizes: 4, 5, 6 French; lengths 10-25 cm. Manual operation. Sterilized via ethylene oxide to SAL 10^-6. Biocompatible per ISO-10993.

Indications for Use

Indicated for facilitating catheter placement through the skin into a vein or artery. Used in patients requiring vascular access. No specific age or gender contraindications stated.

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

• Glidesheath (K033681)

Reference Devices

• Nitinol mini guidewire (K863138)
• Surflo IV catheter (K891087)
• Syringe (K771205)
• RADIFOCUS Obturator (K954234)

Submission Summary (Full Text)

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# Kob2858

OCT 2 0 2006

# SECTION II. 510(K) SUMMARY

#### A. Device Name

| Proprietary Name | Glidesheath |
|---------------------|----------------------|
| Classification Name | Introducer, Catheter |
| Common Name | Introducer Sheath |

#### B. Intended Use

The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Note: This is the same intended use as the predicate device, Glidesheath K033681.

#### C. Device Description

The Glidesheath is comprised of an introducer sheath and a dilator.

The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The mini guide wire is available in a stainless steel or a nickel-titanium alloy polyurethane coated configuration. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The A kit also contains a Surflo IV catheter, 2.5ml syringe, and scalpel for use in priming the system and gaining initial access to the vessel. Once access is obtained, the Mini Guide Wire is inserted through the cannula which was placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Ditator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The

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Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

# D. Principle Of Operation / Technology

The Glidesheath and its accessories are operated manually or by a manual process.

# E. Design / Materials

Differences in materials between the modified device and the predicate device the Glidesheath cleared under K033681 raise no new issues of safety and effectiveness.

### F. Specifications

| Part | Modified Glidesheath | Glidesheath cleared under<br>K033681 |
|-------------------------------------|----------------------------------------------------------------------------|--------------------------------------|
| Introducer Sheath<br>Size<br>Length | 4, 5 & 6 French<br>10-25 cm | 5 & 6 French<br>10-25 cm |
| Dilator<br>Length | 15.5 – 30.5 cm | 15.5 – 30.5 cm |
| Guide Wire OD | 0.021" – 0.038" | 0.021" – 0.038" |
| Guide Wire<br>Configurations | Stainless Steel or<br>Nickel-Titanium alloy<br>coated with<br>Polyurethane | Stainless Steel |
| Accessory Devices | Obturator<br>Surflo IV catheter<br>Scalpel<br>2.5 ml Syringe | Obturator |

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# G. Performance

The Glidesheath is comprised of an introducer sheath and a dilator. Only the introducer sheath was modified. The dilator was not modified. The nitinol mini guidewire is the same guidewire as the one cleared under K863138. The Surflow IV catheter (cleared under K891087), Syringe (cleared under K771205), and the RADIFOCUS Obturator (cleared under K954234) have not been modified. The scalpel is a class I exempted devices.

The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (Glidesheath).

- Leakage/clogging .
- Tensile strength of connections .
- Separation force of dilator and sheath .
- Internal sliding resistance .
- . External sliding resistance
- Penetration force .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the modified Glidesheath is substantially equivalent to the performance of the predicate device the Glidesheath which was cleared under K033681.

## H. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".

The introducer sheath is classified as Externally Communicating Devices, Circulating Blood, Prolonged Contact (24 hrs to 30 days). Results of the testing demonstrate that the blood contacting materials are biocompatible.

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Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994, Medical Devices - Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 10-6

#### H. Substantial Equivalence

The modified Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Glidesheath, cleared under K033681. Differences between the two devices do not raise any significant issues of safety or effectiveness.

# I. Submitter Information

| Prepared By: | Mr. Mark Unterreiner<br>Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation<br>950 Elkton Blvd.<br>Elkton, MD 21921<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 22, 2006 |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 2006

Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Boulevard Elkton, MD 21921

Re:

K062858 Glidesheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: September 22, 2006 Received: September 25, 2006

#### Dear Mr. Unterreiner:

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. Mark Unterreiner

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 Dr Has Intal that the and regulations administered by other Federal agencies. You must or any I subtat Uthe 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 Erth 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 promated 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

R. bohner

Image /page/5/Picture/5 description: The image shows a stylized signature. The signature appears to be a combination of cursive letters, possibly an 'S' and an 'M' or 'N', connected in a fluid, looping manner. The overall impression is that of a quick, stylized autograph.

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

1062858 510(k) Number (if known):_

Glidesheath Device Name:

Indications For Use:

The Glidesheath is used to facilitate placing a catheter through the skin into a The Oldesheath to accure is an accessory device which is used for vem of artery. The sheath into the vein or artery. The RADIFOCUS Obturator is placement of the onealin intolicy is used by placing it into the sheath to create an also an accessory actrise who whe support to the indwelling sheath while it occlusion and farther promise in or artery after removal of a catheter.

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)

Duna R. Vochner

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

10/ki Number_4062 858

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