UPSTREAM SUPPORT CATHETER

K112886 · Upstream Peripheral Technologies · DQY · Feb 23, 2012 · Cardiovascular

Device Facts

• Record ID: K112886
• Device Name: UPSTREAM SUPPORT CATHETER
• Applicant: Upstream Peripheral Technologies
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange. The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

Device Story

The Upstream Support Catheter is a sterile, single-lumen, polymer-coated stainless steel hypotube designed for peripheral vascular access. It features a tapered distal tip and a proximal hub for guidewire access. Used in conjunction with 0.014" steerable guidewires, the device is operated by clinicians to navigate discrete regions of the peripheral vasculature and perform guidewire exchanges. It does not incorporate active components or software. The device provides mechanical support to the guidewire during navigation, potentially facilitating access to challenging vascular anatomy. It is intended for use in clinical settings.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, hemolysis, thromboresistance, complement activation) and mechanical performance (ISO 10555-1: tensile force, air leakage, corrosion resistance, liquid leakage pressure, catheter torque, hub compatibility, surface/dimensional analysis, radiopacity, package integrity, and sterilization validation).

Technological Characteristics

Sterile, single-lumen, polymer-coated stainless steel hypotube. Dimensions: 95 cm length, 0.8 mm (0.0315") outer diameter. Compatible with 0.014" guidewires. Features tapered distal tip and proximal hub. Mechanical device; no energy source or software.

Indications for Use

Indicated for use with 0.014" steerable guidewires to access peripheral vasculature and facilitate guidewire exchange. Contraindicated for use in coronary, cerebral, or carotid vasculature.

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)
• Spectranetics Quick-Cross Extreme Support Catheter (K082561, K092396)

Submission Summary (Full Text)

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K112886

FEB 2 3 2012

# 510(k) SUMMARY

# Upstream Peripheral Technologies Support 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: | February 16, 2012 |

Device Information:

| Trade Name: | Upstream Support Catheter |
|-----------------------|---------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
| Predicate Device: | Asahi Tornus Support Catheter (K051772)<br>Spectranetics Quick-Cross Extreme Support Catheter<br>(K082561, K092396) |

#### Intended Use / Indications for Use:

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

The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

#### Technological Characteristics:

The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.

The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.

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## Safety and Performance Data:

The Upstream Support 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. Biocompatibility tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, hemolysis, thromboresistance and complement activation. Additionally, in vitro bench testing has been performed, based on Upstream in-house requirements and requirements listed in ISO-10555-1, Sterile, single-use intravascular catheters-part-1; including: tensile force testing; air leakage testing; corrosion resistance testing; liquid leakage pressure testing; catheter torque testing; hub compatibility testing; surface and dimensional analysis; radiopacity testing; component bio-compatibility testing; package testing; and sterilization validation testing. All of these tests demonstrated that the Upstream Support Catheter meets its intended performance specifications.

#### Substantial Equivalence:

The Upstream Support Catheter and the predicate devices have the same intended use and very similar indications, technological characteristics and principles of operation. The minor technological differences between the Upstream Support Catheter and its predicate devices raise no new types of safety or effectiveness questions. In vitro verification testing demonstrates that the Upstream Support Catheter performs as intended and meets all design specifications with respect to its mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream Support Catheter is substantially equivalent to the Tornus Support Catheter and the Ouick-Cross Extreme Support Catheter.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 three lines forming its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.

#### Public Health Service

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

FEB 2 3 2012

Upstream Peripheral Technologies c/o Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K112886

Trade/Device Name: Upstream Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 17, 2012 · Received: February 17, 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

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Page 2 – Ms. Janice Hogan

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I cacial reegalations) Tour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issuance of a baceannal equites with other requirements of the Act that FDA hade a decembination that your de roo ver correst on other Federal agencies. You must comply
or any Federal statutes and regulations administered by other Federal ag of any Federal Statutes and regulations and limited to: registration and listing (21 CFR with an the Act s requirements, mercumes, mercesses in the can
Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-Part 807), labeling (21 CFR 803); good manufacturing practice requirements as set forth in related adverse events) (21 CFR 802), good manasti, and if applicable, the electronic product
the quality systems (QS) regulation (21 CFR Part 820), and 1980, 1960, 1960, the quality systems (QS) regulation (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 If you desire specific advice for your devices of the softices/ucm II 5809.htm for a go to http://www.rua.gov/Abouti Drive.com/street/Compliance. Also, please, please, please, please, please, please, part the Center for Devices and Radionogical Heath of (22 cm market notification" (21 CFR Patt )
note the regulation entitled, "Misbranding by reference to premarket notifical (1) note the regulation entitled, "Misoranants of receives to pears under the MDR regulation (21 CFR Part 803), please go to

CFK Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office nttp://www.radigometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may of all other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] 01 (301) //2017) 121 (2017) 12 01 // 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

Sincerely yours,

M.A. Hillemann

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): K11 صاکه & G

Device Name: Upstream Support Catheter

Indications for Use:

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

The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

X Prescription Use (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)

M.A. Killebrew

(Division Sign-Off) Division of Čardiovascular Devices

11/12886 510(k) Number_