UPSTREAM GR CATHETER

K120964 · Upstream Peripheral Technologies · DQY · May 25, 2012 · Cardiovascular

Device Facts

• Record ID: K120964
• Device Name: UPSTREAM GR CATHETER
• Applicant: Upstream Peripheral Technologies
• Product Code: DQY · Cardiovascular
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Upstream GR 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

The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter designed for peripheral vascular access. It features a distal anchoring balloon and funnel, and a proximal Y-connector. The device is used by clinicians to navigate the peripheral vasculature in conjunction with a steerable guidewire (up to 0.035"). The distal balloon provides anchoring and centering, while the funnel acts as a soft tip and stopper upon reaching an occlusion. The Y-connector facilitates guidewire access and balloon inflation/deflation. By providing a stable platform and facilitating guidewire exchange, the catheter assists physicians in accessing challenging vascular regions, potentially improving procedural efficiency and success in peripheral interventions.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, complement activation, hemocompatibility, pyrogenicity) and in vitro bench testing (tensile force, air/liquid leakage, corrosion, torque, kink, tip, balloon burst, radiopacity, and sterilization validation) per ISO 10555-1 and ISO 10555-4.

Technological Characteristics

Sterile, single-use, dual-lumen catheter. 100 cm effective length, 5F (1.7mm) outer diameter. Features distal anchoring balloon and funnel, proximal Y-connector. Compatible with up to 0.035" guidewires. Materials are biocompatible per ISO 10993. Bench testing performed per ISO 10555-1 and ISO 10555-4.

Indications for Use

Indicated for use in patients requiring access to discrete regions of the peripheral vasculature for guidewire exchange or navigation in conjunction with a steerable guidewire.

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

• Endocross Ltd Enabler-P Support Catheter (K082339)

Submission Summary (Full Text)

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K120964
MAY 25 2012

# 510(k) SUMMARY

# Upstream Peripheral Technologies GR Catheter

### Applicant Information;

Upstream Peripheral Technologies Ltd. ARAN Building P.O. Box 3067 43 Haeshel Street Caesarea 38900 Israel

| Phone: | (972) 4-6239014 |
|-----------------|-----------------|
| Facsimile: | (972) 4-6273260 |
| Contact Person: | Dan Rottenberg |
| Date Prepared: | March 30, 2012 |

Device Information:

| Trade Name: | Upstream GR Catheter |
|-----------------------|----------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
| Predicate Device: | Endocross Ltd Enabler-P Support Catheter (K082339) |

# Intended Use / Indications for Use:

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

# Technological Characteristics:

The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end.

The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The

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distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.

# Safety and Performance Data:

The Upstream GR Catheter has been evaluated for biocompatibility in accordance with ISO 10993 to ensure that the materials used in the manufacturing of the device are biocompatible. These tests included:

- cytotoxicity, .
- sensitization,
- . irritation/intracutaneous reactivity,
- systemic toxicity (acute), .
- complement activation,
- hemocompatibility (hemolysis and thromboresistance), and .
- . pyrogenicity.

Additionally, in vitro bench testing has been performed, based on Upstream's internal requirements and requirement listed in ISO-10555-1. Sterile, single-use intravascular catheterspart-1, and ISO-10555-4, Balloon dilatation catheters, including:

- . tensile force testing;
- air leakage testing; .
- corrosion resistance testing: ●
- liquid leakage pressure testing; .
- . catheter torque testing;
- . kink testing;
- . tip test;
- freedom from leakage;
- . balloon burst testing;
- . surface and dimensional analysis;
- . radiopacity testing;
- package testing; and .
- sterilization validation testing. ●

All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications.

#### Substantial Equivalence:

The Upstream GR Catheter and the predicate device have intended use and indications for use and very similar technological characteristics and principles of operation. The minor technological differences between the Upstream GR Catheter and its predicate device raise no new types of safety or effectiveness questions. In vitro verification testing demonstrates that the Upstream GR Catheter performs as intended and meets all design specifications with respect to

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its mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream GR Catheter is substantially equivalent to the Enabler-P Support Catheter.

.

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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 features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

Upstream Peripheral Technologies c/o Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, PA 19103

MAY 2 5 2012

Re: K120964

Trade Name: Upstream GR Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 30, 2012 Received: March 30, 2012

Dear Ms. Hogan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be fridy of our 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 - Ms. Janice M. Hogan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lotto be devices and i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I vithe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related develop (21 OFF 2007) 8 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 n you atti.it bpvc.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note and regarding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please 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 I valual of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. Y. Hillebert

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

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# Indications for Use Statement

510(k) Number (if known): K 120964

Device Name: Upstream GR Catheter

Indications for Use:

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

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sm A. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

11/20964 510(k) Number_

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