NOVACATH SECURE IV CATHETER SYSTEM-18G

K120839 · Tangent Medical Technologies, Inc. · FOZ · Jul 20, 2012 · General Hospital

Device Facts

• Record ID: K120839
• Device Name: NOVACATH SECURE IV CATHETER SYSTEM-18G
• Applicant: Tangent Medical Technologies, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Jul 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 Gauge NovaCath™ devices are suitable for use with power injectors for up to a maximum of 300 psi.

Device Story

NovaCath™ Secure IV Catheter System is an over-the-needle peripheral intravascular catheter; features integrated extension tubing, secondary stabilization hub, female luer lock, clamp, and passive needle-shielding mechanism. Device functions as a closed system to contain blood during insertion and prevent exposure. Used by clinicians in clinical settings for vascular access; enables blood sampling, pressure monitoring, and fluid administration. Passive needle-shielding aids in preventing needlestick injuries. Stabilization platform and wings provide 360° catheter securement. 18G, 20G, and 22G versions support power injection up to 300 psi. Clinicians observe flashback via dual-flash feature to confirm vessel entry. Device benefits include reduced blood exposure risk and improved catheter stability.

Clinical Evidence

No prospective clinical trials were conducted. Evidence consists of bench testing and a simulated clinical use study performed in accordance with FDA Guidance for Medical Devices with Sharps Injury Prevention Features. Biocompatibility testing was conducted per ISO 10993 and FDA Blue Book Memorandum #G95-1. Performance testing confirmed compliance with ISO 10555-1 and ISO 10555-5 requirements.

Technological Characteristics

Radiopaque, flexible polyurethane catheter; integrated extension tubing with Y-configuration; passive needle-shielding mechanism; female luer lock. Stabilization via platform and wings. EO sterilized (ANSI/AAMI/ISO 11135-2). Materials meet ISO 10993 biocompatibility standards. Compatible with power injectors (18G, 20G, 22G) up to 300 psi. Shelf-life validated per ASTM F1980-07.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration. Suitable for any patient population based on vascular anatomy and procedure appropriateness. 18G, 20G, and 22G models are compatible with power injectors up to 300 psi.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• BD Nexiva™ Device (K032843)
• BD Insyte® Catheter(s) (K971339)
• Retractable Technologies' VanishPoint® IV Catheter (K051355)

Submission Summary (Full Text)

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JUL 20 2012

# TANGENT MEDICAL TECHNOLOGIES, INC. NOVACATH™ SECURE IV CATHETER SYSTEM

510(k) SUMMARY

## July 11, 2012

The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:

Submitter Information: Tangent Medical Technologies, Inc. 8170 Jackson Road, STE A Ann Arbor, MI 48103

9/23/2005.

| Contact Information: | Kay Fuller, RAC<br>VP, Regulatory and Clinical Affairs<br>kay @tangentmedical.com<br>1+734-527-4060 / 1+734-846-7852 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | NovaCath™ Secure IV Catheter System |
| Proprietary Name: | NovaCath™Secure IV Catheter System |
| Common Name: | Intravascular Catheter (short-term) |
| Classification Name: | Catheter, intravascular, therapeutic, short-term less than 30 days |
| Classification Code: | FOZ |
| Regulation Number: | 21 CFR § 880.5200 |
| Predicate Device Equivalence: | The Tangent NovaCath™ Secure IV Catheter System is<br>substantially equivalent to the BD Nexiva™ Device cleared for<br>U.S. commercialization via K032843 on 2/27/200, the BD Insyte®<br>Catheter(s), cleared for US commercialization via K971339 on |

12/24/1997 and the Retractable Technologies' VanishPoint® IV Catheter , cleared for US commercialization via K051355, on

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#### Device Description:

The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, peripheral intravascular catheter made from a radiopaque slender, flexible plastic, integrated extension tubing with a secondary stabilization hub system, a female luer lock and clamp, and a passive needle shielding mechanism. The design of the NovaCath™ System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. The needle is withdrawn through a septum that will seal after the needle has been withdrawn and the luer lock is closed, blood is contained within the NovaCath™ System during insertion. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap.

The NovaCath™ Secure IV Catheter System is inserted into the Indications for Use: patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ System may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 gauge NovaCath™ System catheters are suitable for use with power injectors for a maximum of 300 psi.

> The technological similarities between the subject NovaCath™ Secure IV Catheter System and the noted predicate devices are substantially equivalent. There are no new questions raised regarding safety or efficacy of the subject NovaCath™ Secure IV Catheter System. Table 1, below provides a summary comparison of the technological characteristics.

Comparison of Technological Characteristics:

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# Table 1: Comparison Between NovaCath™ Secure IV Catheter System and Predicates

| | NovaCath<br>Secure IV Catheter System | K032843<br>Nexiva | K971339<br>Insyte | K051355<br>VanishPoint |
|------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------|
| Comparison Criteria | | | | |
| Same Intended Use | Yes | Yes | Yes | Yes |
| Prescription Device (Rx Only) | Yes | Yes | Yes | Yes |
| Biocompatible Polyurethane Catheter | Yes | Yes | Yes | Yes |
| Biocompatible Materials of Fabrication | Yes | Yes | Yes | Yes |
| Closed System | Yes | Yes | No | No |
| Built-In Extension from Main Assembly | Yes, connecting tubing & reverse Y-configuration | Yes, connecting tubing & Y-configuration | No | No |
| Flashback Visualization | Yes, dual flash feature, allows for visualization at pre-priming & upon insertion | Yes, single, allows flash view upon insertion | Yes, single, allows flash view upon insertion | Yes, single, allows flash view upon insertion |
| Sharps Injury Prevention Feature | Yes, integrated sharps injury prevention device (passive) | Yes, integrated sharps injury prevention device | Yes integrated sharps injury prevention device | No, Automatic needle retraction occurs with depression of the needle housing |
| General Specifications | Yes, overall size is consistent w/ other IV catheter devices once extension tubing is added | Yes, overall size is slightly different than other IV catheter devices, due to Y-connector tubing & manual needle retraction | Yes, overall size is consistent w/ other IV catheter devices | Yes, overall size is consistent with other IV catheter devices |
| Intended anatomical location | Yes, peripheral vasculature | Yes, peripheral vasculature | Yes, peripheral vasculature | Yes, peripheral vein or artery |
| Distal End Configuration | Yes, Catheter & Needle consistent w/ ISO 10555-5 | Yes, Catheter & Needle consistent w/ ISO 10555-5 | Yes, Catheter & Needle consistent w/ ISO 10555-5 | No, Hub w/ female locking luer fitting per ISO 594 |
| Proximal End Configuration | Yes, female luer access port | Yes, female luer access port & open hub | Yes, Open hub | Yes, Tube w/ tapered tip & one outlet. No side ports<br>UNK |
| Flow Rate (ml/min) | Yes,<br>20G: 52.55 ml/min | Yes,<br>20G 45 ml/min | Yes,<br>20G: 65 ml/min | UNK |
| Mechanical | Needle retraction is manual | Needle retraction is manual | Stainless steel spring for needle retraction | Automatic needle retraction w/slight depression of the needle housing |
| Catheter Stabilization | Yes, primary & secondary stabilization (platform and wings) provide 360° stabilization | Yes, stabilization wings | Yes, available w/winged hub | No |
| EO Sterilization Method | Yes | Yes | Yes | Yes |
| Packaged Sterile, Single Use | Yes | Yes | Yes | Yes |
| Non-pyrogenic | Yes | Yes | Yes | Yes |
| Made without Latex Rubber? | Yes | Yes | Yes | Yes |
| Made without DEHP? | Yes | Yes | No | Yes |
| Multiple Gauge Sizes & Needle Lengths | Yes | Yes | Yes | No |
| For use w/ Power Injectors up to 300 psi | Yes<br>18G,20G,22G; | Yes | Yes | No |

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# Summary of Device Evaluation:

The NovaCath™ Secure IV Catheter System is substantially equivalent in device description, intended use, function, principle of operation, and basic composition to the predicate devices noted herein.

The NovaCath™ Secure IV Catheter System has been designed and tested to meet the requirements of relevant FDA consensus standards, voluntary standards and FDA regulations and guidance documents applicable to the subject and predicate devices. Results of the non-clinical testing support the conclusion of substantial equivalence to the NovaCath™ Secure IV Catheter System to the predicate devices noted herein.

#### Performance Testing:

The NovaCath™ Secure IV Catheter System has been designed and successfully tested to meet the applicable requirements outlined in ISO 10555-1 Sterile, single use intravascular catheters - Part 1 General requirements and ISO 10555-5 Sterile, single use intravascular catheters - Part 5 Over-needle perioheral catheters.

#### Biocompatibility Testing:

The NovaCath™ Secure IV Catheter System is classified as an external communicating, prolonged (24hrs to less than 30 days) circulating blood contact device. The device was successfully tested per the FDA Blue Book Memorandum - #G95-1 Table 1 Initial Evaluation Test for Consideration and relevant ISO 10993 related biocompatibility standards to establish that the NovaCath™ Secure IV Catheter System meets the appropriate biocompatibility testing requirements.

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Sterilization and Shelf-life Testing:

The NovaCath™ System will be released to market with a Sterility Assurance Level of 10-6, per the requirements set forth in ANSI/AAMI/ISO 11135-2. The NovaCath™ System is intended for single use only and not intended for reuse or re-sterilization by the user. The maximum levels of residues of ethylene oxide and ethylene chlorohydrin will not exceed the limits presented in ISO 10993-7. Shelf-life and expiry dating meet the requirements of ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, which is also supported by real-time shelf -life data.

#### Clinical Data:

A NovaCath™ Secure IV Catheter System simulated clinical use study was successfully conducted in accordance with: FDA Guidance for Medical Devices with Sharps Injury Prevention Features.

No prospective clinical trials were conducted in support of this Traditional 510(k).

Conclusions:

Based on the information contained herein, we conclude the NovaCath™ Secure IV Catheter System is substantially equivalent to the noted legally marketed Predicate devices and is safe and effective for its intended use.

pwie Sats

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Ms. Kay Fuller, RAC Vice President, Regulatory & Clinical Affairs Tangent Medical Technologies, Incorporated 8170 Jackson Road, Suite A Ann Arbor, Michigan 48103

JUL 20 2012

Re: K120839

Trade/Device Name: NovaCath™ Secure IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 3, 2012 Received: July 5, 2012

Dear Ms. Fuller:

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.

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#### Page 2 - Ms. Fuller

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 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/CDRH/CDRHOffices /ucm 1 1 5809 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/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 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,

Antony D. arar

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): K120839

Device Name: NovaCath™ Secure IV Catheter System

### Indications for Use:

The NovaCath™ Secure IV Catheter System is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 Gauge NovaCath™ devices are suitable for use with power injectors for up to a maximum of 300 psi.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (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)

Atricia Bustos for David Chapman

Ivision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K 120039 Page 1 of