ENABLER-P SUPPORT CATHETER

K082339 · Endocross, Ltd. · DQY · Nov 20, 2008 · Cardiovascular

Device Facts

• Record ID: K082339
• Device Name: ENABLER-P SUPPORT CATHETER
• Applicant: Endocross, Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ENABLER-P Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

Device Story

Dual-lumen intravascular catheter; used with 0.035" steerable guidewire. Operates by providing distal anchoring and support for guidewire advancement in peripheral vasculature; facilitates guidewire exchange. Used in clinical settings by physicians. Provides mechanical support to navigate remote cardiovascular locations. Benefits patient by enabling access to difficult-to-reach peripheral vascular regions.

Clinical Evidence

Bench testing and animal studies conducted. Biocompatibility testing confirmed materials are biocompatible. Performance testing demonstrated device meets functional requirements for intended use.

Technological Characteristics

Dual-lumen intravascular catheter; 0.035" guidewire compatibility; sterile, single-use; ethylene oxide gas sterilization; Tyvek/Poly pouch packaging.

Indications for Use

Indicated for patients requiring access to discrete regions of the peripheral vasculature for guidewire exchange and support during guidewire advancement.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Asahi Tornus Support Catheter (K051772)
• Ultra-Thin SDS Balloon Dilatation Catheter (K011889)
• ILT MODEL C114NL2 with Advancing Mechanism (K001992)

Submission Summary (Full Text)

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082339

#### 510(k) SUMMARY

NOV 2008

#### EndoCross's ENABLER-P Support Catheter

#### Applicant's Information

| Date Prepared: | October 15, 2008 |
|----------------------|--------------------------------------------------------------------------------------|
| Name and Address: | EndoCross Ltd<br>New Industrial Park, Building 7<br>P.O.B 620, Yoqneam 20692, Israel |
| Contact Person: | Yaron Eshel<br>Tel: [phone]<br>Fax: [phone] |
| Device Information | |
| Classification: | DQY |
| Trade Name: | ENABLER-P Support Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |

#### Predicate Devices

- Asahi Tornus Support Catheter manufactured by Asahi Intecc (K051772) ◆
- Ultra -Thin SDS Balloon Dilatation Catheter manufactured by Boston Scientific . Corporation (K011889)
- ILT MODEL C114NL2 with Advancing Mechanism manufactured by IntraLuminal . Therapeutics Inc. (K001992)

#### Intended Use / Indications for Use

The ENABLER-P Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

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#### Technological Characteristics

The ENABLER-P Support Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Support Catheter can provide distal anchoring and support the advancement of the guidewire.

The ENABLER-P Support Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.

The ENABLER-P Support Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices.

### Biocompatibility And Performance Data

Biocompatibility testing, in vitro bench studies and animal studies were conducted to evaluate the biological and performance characteristics of the ENABLER-P Support Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.

#### Substantial Equivalence

The ENABLER-P Support Catheter is substantially equivalent to the Asahi Tornus Support Catheter manufactured by Asahi Intecc, the Ultra -Thin SDS Balloon Dilatation Catheter manufactured by Boston Scientific Corp Ltd and the ILT MODEL C114NL2 with Advancing Mechanism manufactured by IntraLuminal Therapeutics Inc

The ENABLER-P Support Catheter has the same intended uses as the Asahi Tornus Support Catheter and similar technological characteristics as the Ultra -Thin SDS Balloon Dilatation Catheter and the ILT MODEL C114NL2 with Advancing Mechanism. The technological differences between the ENABLER-P Support Catheter and its predicate devices raise no new issues of safety or effectiveness.

Performance data demonstrate that the ENABLER-P Support Catheter is substantially equivalent to the Asahi Tornus Support Catheter, the Ultra -Thin SDS Balloon Dilatation Catheter and the ILT MODEL C114NL2 with Advancing Mechanism.

Thus, the ENABLER-P Support Catheter is substantially equivalent.

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Image /page/2/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 depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2008

EndoCross, Ltd. c/o John J. Smith, M.D., J.D. Hogan & Hartson LLP Columbia Square 555 Thirteenth Street N.W. Washington, D.C. 20004

Re: K082339

Trade/Device Name: ENABLER-P Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: October 17, 2008 Received: October 17, 2008

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Dr. John J. Smith

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 prodicate 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 Surveillancc and Biometric's (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 vours.

e R. bochner

\ 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 Statement |
|---------------------------|-------------------------------|
| 510(k) Number (if known): | K082339 |

Device Name: ENABLER-P Support Catheter

Intended Use / Indications for Use:

.

The ENABLER-P Support Catheter is intended to be used in conjunction with a stecrable guidewire to access discrete regions of the peripheral ve culture and for guidewire exchange.

Prescription Use V (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 C.F.R. 807 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Durna R. Vachner

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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K082339