UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR

K112887 · Upstream Peripheral Technologies · DYB · Mar 21, 2012 · Cardiovascular

Device Facts

• Record ID: K112887
• Device Name: UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
• Applicant: Upstream Peripheral Technologies
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.

Device Story

Sterile, single-lumen rigid polymer tube; facilitates guidewire placement into vascular system. Distal end features male luer connector for standard needle interface; proximal end features female luer connector for guidewire access. Optional shut-off connector includes sliding element to open/close lumen and lock guidewire in position. Used in clinical settings by healthcare providers. Device provides mechanical conduit for guidewire insertion; ensures secure interface between needle and guidewire; aids in vascular access procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, PTT, platelet/leukocyte counts, complement activation). In vitro bench testing included tensile strength, air/liquid leakage under pressure, surface testing, dimensions, guidewire capture/passage, hub testing, environmental packaging, endotoxin, and sterilization/shelf-life validation.

Technological Characteristics

Sterile, single-lumen rigid polymer tube. Male luer (distal) and female luer (proximal) connectors. Optional shut-off connector with sliding element. Dimensions: 23 cm length; compatible with guidewires up to 0.0315" diameter. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for facilitating guidewire placement into the vascular system. Intended for use with guidewires up to 0.0315" diameter.

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

• BD Introsyte Precision Introducer (K013304)

Submission Summary (Full Text)

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# 510(k) SUMMARY

MAR 2 1 2012

# Upstream Peripheral Technologies Needle Holder-K112887

### 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 21, 2012 |

Device Information:

| Trade Name: | Upstream Needle Holder, Upstream Needle Holder with shut-off<br>connector |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Introducer Catheter |
| Classification: | Class II per 21 CFR 870.1340 |
| Product Code: | DYB |
| Predicate Device: | BD Introsyte Precision Introducer (K013304) |

### Intended Use / Indications for Use:

The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.

#### Technological Characteristics:

The Upstream Needle Holder is a sterile, single lumen rigid polymer tube having male luer connector at the distal end to provide connection to standard needle, and female luer connectors at the proximal end for guidewire access. The Upstream Needle Holder with shut-off connector includes a standard shut-off connector. The shut-off connector includes a sliding element that opens and closes the connector lumen.

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K112887
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The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.

## Safety and Performance Data:

The Upstream Needle Holder has been evaluated for biocompatibility in accordance with ISO 10993 to ensure that the materials used in the manufacturing of the device are biocompatible. The biocompatibility tests performed included the following:

- Cytotoxicity .
- Sensitization .
- Irritation .
- Acute Systemic Toxicity .
- . Hemolysis
- . Partial Thromboplastin Time
- Platelet and Leukocyte Counts ●
- Complement Activation Testing .

Additionally, the following in vitro bench testing has been performed:

- Tensile Strength .
- Air Leakage .
- Liquid Leakage Under Pressure .
- Surface Test .
- . Needle Holder Dimensions
- . Guidewire Capture and Passage Test
- . Hub Testing
- . Environmental Packaging Testing
- . Endotoxin Testing
- . Sterilization and Shelf-Life Validation Testing

All of these tests demonstrated that the Upstream Needle Holder meets its intended performance specifications.

## Substantial Equivalence:

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

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· their mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream Needle Holder is substantially equivalent to the BD Introsyte Precision Introducer.

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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 and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### Public Health Service

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

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

MAR 2 1 2012

Re: K112887

Trade/Device Name: Upstream Needle Holder, Upstream Needle Holder with shut-off connector Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II Product Code: DYB Dated: February 14, 2012 Received: February 14, 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. We remind you, however, 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 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 - Ms. Janice Hogan

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 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wm. A. Wilhelm.

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): K112887

Device Name: Upstream Needle Holder, Upstream Needle Holder with Shut-Off Connector

Indications for Use:

The Upstream Needle Holders are intended to facilitate the placement of guidewires into the vascular system.

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)

M.I. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KII 2807

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