SHORT INTRODUCER SHEATH

K032569 · Rex Medical · DYB · Sep 16, 2003 · Cardiovascular

Device Facts

• Record ID: K032569
• Device Name: SHORT INTRODUCER SHEATH
• Applicant: Rex Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.

Device Story

Vascular access device consisting of central lumen, angled side arm extension, and hemostasis valve; includes dilator accessory for occlusion and wall support. Used by clinicians to facilitate catheter insertion into dialysis grafts. Device simplifies design of predicate by removing retention feature and coaxial tubing, resulting in single lumen design. Operates as mechanical conduit for catheter placement.

Clinical Evidence

No clinical data. Bench testing only, performed per ISO 11070 standards to evaluate design modifications.

Technological Characteristics

Vascular access sheath; 6F and 7F sizes; single lumen design; 5cm length; 0.118" hub ID; 0.010" wall thickness. Materials identical to predicate with addition of color additive. Tested per ISO 10993-1 (biocompatibility) and ISO 11070 (sterile intravascular catheter introducers).

Indications for Use

Indicated for facilitating catheter placement through the skin into a dialysis graft.

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

• Rex Medical Inner-Lock Locking Introducer Sheath (K022170)

Submission Summary (Full Text)

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K032569

# SEP 1 6 2003

EXHIBIT #1

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

#### Submitter's Identification: 1.

Rex Medical 555 North Lane, Suite 6101 Conshohocken, PA 19428

Date Summary Prepared: August 19, 2003

Contact:

Mr. Michael Paris Catheter Engineer

#### 2. Name of the Device:

Short Introducer Sheaths

#### 3. Predicate Device Information:

K#022170, Rex Medical Inner-Lock Locking Introducer Sheath, Rex Medical

#### Device Description: 4.

The Rex Medical Short Introducer Sheaths, offered in both 6F and 7F sizes, are vascular access devices consisting of a central lumen, angled side arm extension, and a hemostasis valve. The device is used under identical indications for use as the predicate device, as well other substantially equivalent 510(K) cleared devices.

#### 5. Intended Use:

The Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.

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### 6. Comparison to Predicate Devices:

# Discussion of Similarities:

The Rex Medical Short Introducer Sheaths are identical to the Rex Medical Inner-Lock Locking Introducer Sheaths as follows: Both devices make use of a dilator with a central lumen to pass over a guidewire during insertion; both devices incorporate the same integrated hemostasis valve, extension tube, clamp, female luer, and proximal cap. Both devices are indicated for dialysis graft access.

# Discussion of Differences:

The Short Introducer Sheaths differ from the Inner-Lock Locking Introducer Sheaths by means that the retention feature has been eliminated for the short introducer sheath design. When eliminating the retention feature, the coaxial sheath tubing design, which is required to create the retention feature in the Inner-Lock, is no longer necessary so a less complicated single sheath lumen design was incorporated. The combined wall thickness for the Inner-Lock Sheath Coaxial Tubing is 0.012" (each tubing has a specified wall thickness of .006") and the Short Introducer sheath single lumen design has a wall thickness of 0.010". The usable sheath length for the Short Introducer Sheath design will be 5cm as opposed to the 4cm specified length of the Inner-Lock. The bore ID of the hub is specified as .110" for the Inner-Lock and will be increased to 0.118" for the Short Introducer Sheath. The distal cap used to manufacture the Inner-Lock sheath introducer provided a cut-out section for the rotator knob which is used to activate the retention feature. The Short Introducer Sheath does not require a rotator knob so the distal cap will not provide the cut-out section.

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

All testing performed on the Short Introducer Sheath were derived from the risk assessment which evaluated the slight deviation in design from the Inner-Lock Sheath Introducer. Test methodology and acceptance criteria were derived form ISO 11070. Sterile single-use intravascular catheter introducers. All materials used in the Short Introducer Sheath are identical to the Inner-Lock Locking Introducer Sheath with the exception that a color additive was added to the base extrusion. All materials used in the Inner-Lock Locking Introducer Sheath were tested according to ISO 10993-1, Biological Evaluation of Medical Devices.

#### Discussion of Clinical Tests Performed: 8.

# Not Applicable

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### 9. Conclusions:

The subject device, Short Introducer Sheath, has identical indications use as the Rex Medical Inner-Lock Introducer Sheath. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new question of safety or effectiveness. Thus, the Short Introducer Sheath is substantially equivalent to the Rex Medical Inner-Lock Introducer Sheath.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines above a wavy line.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Rex Medical c/o Ms. Susan D. Goldstein-Falk mdi Consultants 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K032569

Trade Name: Short Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: August 19, 2003 Received: August 20, 2003

Dear Ms. Goldstein-Falk:

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.

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

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Page 2 - Ms. Susan D. Goldstein-Falk

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 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/dsma/dsmamain.html

Sincerely yours,

N. McCarthy

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

Enclosure

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# Exhibit B

of Page 1 1

510(k) Number (if known): K022561

Device Name: Rex Medical Short Introducer Sheaths

Indications For Use:

The Short Introducer Sheaths are used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheaths to create an occlusion and further provide support to the wall of the indwelling system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

YQlaru

(Division Sign-Off)
Division of Cardiovascular Devices

OR

**510(k) Number** K032569