ONSET ACCESS CATHETER SYSTEM

K112629 · Onset Medical Corporation · DQY · Oct 11, 2011 · Cardiovascular

Device Facts

• Record ID: K112629
• Device Name: ONSET ACCESS CATHETER SYSTEM
• Applicant: Onset Medical Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Onset Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Device Story

The Onset Access Catheter System is a two-component device consisting of a sheath and a dilator. It is designed to facilitate the introduction of interventional or diagnostic devices into the peripheral, coronary, and neuro vasculature. The sheath features a distal region that expands when the dilator is advanced. The system is compatible with hydrophilic guidewires up to 0.038 inches in diameter. Proximal luer fittings allow for the infusion of liquids and attachment of accessories. The device is used by clinicians in a medical setting. It is provided sterile for single use. The system's design, including radiopaque markers, aids in navigation and placement within the vasculature. By providing a stable access path, the device enables the delivery of therapeutic or diagnostic tools, potentially improving procedural outcomes for patients requiring vascular intervention.

Clinical Evidence

No clinical data from human trials provided. Evidence consists of bench-top testing and in vivo animal testing. Bench testing included dimensional inspection, torque response, kink resistance, tensile strength, leak testing, and aspiration performance. In vivo testing evaluated system deliverability, compatibility, visibility, aspiration performance, and acute histopathology of treated vessels. All tests met established criteria.

Technological Characteristics

Two-component system (sheath and dilator). Materials: PTFE-lined nylon/polyurethane with stainless steel and nitinol braid support. Radiopacity: Platinum/tungsten bands at expandable section junction; gold marker at tip; radiopaque dilator shaft. Connectivity: None. Sterilization: EtO (ANSI/AAMI/ISO 11135). Form factor: Various sizes with luer hubs.

Indications for Use

Indicated for the introduction of interventional or diagnostic devices into the peripheral, coronary, and neuro 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

• Reverse RePort™ Guide Catheter System (K102418)

Submission Summary (Full Text)

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# 4. 510(k) Summary according to 807.92

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Onset Medical Corporation is providing the summary of Substantial Equivalence for the Onset Access Catheter System.

## 4.1 Sponsor /Applicant Name and Address

Onset Medical Corporation 13900 Alton Parkway Suite 120 Irvine, CA 92618

## 4.2 Sponsor Contact Information

Joseph Bishop President, CEO Onset Medical Corporation Phone: [phone] Fax: [phone] email: [e-mail]

### 4.3 Date of Preparation of 510(k) Summary

September 8, 2011

## 4.4 Device Trade or Proprietary Name

Onset Access Catheter System

## 4.5 Device Common/Usual or Classification Name

Catheter, Percutaneous (Product Code: DQY)

## 4.6 Identification of the Legally Marketed Devices to which Equivalence is Being Claimed:

| Name of Predicate Device | Name of Manufacturer<br>(Town, State) | 510(k) Number |
|------------------------------------------|-------------------------------------------------|---------------|
| Reverse RePort™ Guide<br>Catheter System | Reverse Medical Corporation<br>Irvine, CA 92618 | K102418 |

OCT 1 1 2011

11 112629

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### 4.7 Device Description

The Onset Access Catheter System is a two-catheter system comprised of a Sheath and a Dilator. The Sheath has a distal region which expands when the Dilator is advanced. The Onset Access Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy.

The proximal ends of the Sheath and the Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the Sheath's distal expandable region into the catheter introducer sheath. The Catheter System is provided sterile, non-pyrogenic, and is intended for single use only.

#### 4.8 Intended Use

The Onset Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

| | Onset Access Catheter System | RePort™ Guide Catheter System |
|-----------------------------------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K102418 |
| Classification | SAME | Class II, DQY |
| Indication | SAME | The RePort Catheter is indicated for the<br>introduction of interventional /<br>diagnostic devices into the peripheral,<br>coronary, and neuro vasculature. |
| | Material | |
| - Shaft Materials | SAME | PTFE lined nylon/polyurethane with<br>stainless steel and nitinol braid support |
| - Proximal End<br>Configuration | SAME | Luer Hub |
| - Radiographic markers /<br>Radiopacity | SAME | • Sheath: Platinum/tungsten bands<br>embedded at junction of expandable<br>section; gold marker at tip of<br>expandable section;<br>• Dilator: shaft is radiopaque throughout |
| - Packaging | SAME | Catheter in polyethylene hoop<br>attached to packaging card inside<br>PET/PE/Tyvek pouch inside SBS<br>carton |
| Sterilization | SAME | EtO |

### 4.9 Comparison to Predicate Devices

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## 4.10 Summary of Non-clinical Data

#### 4.10.1 Biocompatibility and Sterilization

The Onset Access Catheter System is classified as Externally Communicating Devices, Circulating Blood, Limited Contact (≤ 24 hours). Results of testing demonstrate that the blood contacting materials are biocompatible.

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1 guidelines "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The Catheter System successfully passed all of the following biocompatibility tests:

| Test | Method |
|----------------------------------------|----------------------------------------------|
| Cytotoxicity | L929 MEM Elution Test |
| Sensitization | Kligman Maximization |
| Intracutaneous Reactivity (Irritation) | Intracutaneous Injection Test |
| Systemic Toxicity (Acute) | ISO Acute Systemic Injection Test |
| Haemocompatibility | Complement Activation |
| | Hemolysis |
| | Inactivated Partial Thromboplastin Time Test |
| | In vivo thrombogenicity |
| Pyrogenicity | USP Material Mediated Rabbit Pyrogen Test |

Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135, Sterilization of Health Care Products-Part 1: Requirement, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10 °.

## 4.10.2 Design Verification (Bench-Top Testing)

The physical, mechanical and performance testing of the Catheter System demonstrated that the product is substantially equivalent to currently marketed predicate devices. Design Verification testing was conducted to evaluate the physical and mechanical properties of the Catheter System. All testing was performed on units which were twice sterilized and met all inspection criteria. Tests on the Catheter System included:

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| y | Bench Tests | Result |
|---|--------------------------------------------------------------------------------|--------------------------|
| | Dimensional and Visual Inspection | Met established criteria |
| | Guidewire Compatibility | Met established criteria |
| | Torque Response | Met established criteria |
| | Torque Strength | Met established criteria |
| | System Deployment Cycle Test | Met established criteria |
| | Kink Resistance | Met established criteria |
| | Flexibility Test | Met established criteria |
| | Tensile Strength | Met established criteria |
| | Catheter Leak Test (Liquid Leakage) | Met established criteria |
| | Catheter Leak Test (Air Leakage) | Met established criteria |
| | Dynamic Pressure Test | Met established criteria |
| | Static Burst Test | Met established criteria |
| | Aspiration Test | Met established criteria |
| | Hub Gauging | Met established criteria |
| | Corrosion Resistance | Met established criteria |
| | USP Particulate Test | Met established criteria |
| | Navigation and Accessibility Capabilities in vitro | Met established criteria |
| | In vivo Tests | Result |
| | System Deliverability, Compatibility, Visibility and<br>Aspiration Performance | Met established criteria |
| | Acute histopathology of treated vessels | Met established criteria |
| | Biocompatibility testing | Met established criteria |

Verification and Test Summary

The physical, mechanical and performance testing of the subject Catheter System demonstrated that the product is safe and effective for its labeled indications and is Substantially Equivalent to currently marketed predicate devices.

#### 4.11 Substantial Equivalence

The Onset Access Catheter System is the same device as the RePort™ Guide Catheter System. The only difference is that it is manufactured and marketed by Onset Medical rather than Reverse Medical. Therefore, it is equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device.

The data presented in K102418 demonstrated that the RePort™ Guide Catheter System was safe and effective for its labeled indications and Substantially Equivalent to currently marketed predicate devices. The Onset Access Catheter is the same Catheter System and is, therefore, also safe and effective for its labeled indications and Substantially Equivalent to currently marketed predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized symbol resembling a bird or a wing, composed of three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

Onset Medical Corporation c/o Mr. Joseph Bishop President. CEO 13900 Alton Parkway Suite 120 Irvine, CA 92618

OCT 1 1 2011

Re: K112629

> Trade Name: Onset Access Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: 11 (two) Product Code: DQY Dated: September 7, 2011 Received: September 9. 2011

Dear Mr. Bishop:

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 - Mr. Joseph Bishop

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/ucm113809.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" (21 CFR 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.

Mu c

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

Enclosures

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# 3. Indications for Use

6112629 510(k) Number (if known): _

Device Name: Onset Medical Access Catheter System

Indications for Use:

The Onset Medical Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

on Sign-Off) Division of Cardiovascular Devices

510(k) Number K112629