(32 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a catheter system, with no mention of AI or ML.
No
The device is used for introducing other devices and does not directly treat a disease or condition itself.
No.
Explanation: The "Intended Use/Indications for Use" states that the device is intended for the "introduction of interventional/diagnostic devices," meaning it facilitates the use of other diagnostic devices, but is not one itself.
No
The device description clearly outlines a physical catheter system comprised of a sheath and dilator, which are hardware components. The performance studies also focus on biocompatibility, sterilization, and bench-top testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature." This describes a device used within the body for access during medical procedures, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a catheter system designed for insertion into blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.
Therefore, the Onset Medical Access Catheter System is a medical device used for accessing the vasculature, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Onset Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Cytotoxicity, Sensitization, Intracutaneous Reactivity (Irritation), Systemic Toxicity (Acute), Haemocompatibility (Complement Activation, Hemolysis, Inactivated Partial Thromboplastin Time Test, In vivo thrombogenicity), Pyrogenicity.
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 °.
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: Dimensional and Visual Inspection, Guidewire Compatibility, Torque Response, Torque Strength, System Deployment Cycle Test, Kink Resistance, Flexibility Test, Tensile Strength, Catheter Leak Test (Liquid Leakage), Catheter Leak Test (Air Leakage), Dynamic Pressure Test, Static Burst Test, Aspiration Test, Hub Gauging, Corrosion Resistance, USP Particulate Test, Navigation and Accessibility Capabilities in vitro, In vivo Tests (System Deliverability, Compatibility, Visibility and Aspiration Performance, Acute histopathology of treated vessels, Biocompatibility testing). All tests met established criteria.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 949-716-1100 Fax: 949-716-1101 email: jbishop@Onsetmedical.com
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
(Town, State) | 510(k) Number |
|------------------------------------------|-------------------------------------------------|---------------|
| Reverse RePort™ Guide
Catheter System | Reverse Medical Corporation
Irvine, CA 92618 | K102418 |
OCT 1 1 2011
11 112629
1
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 |
| introduction of interventional / | ||
| diagnostic devices into the peripheral, | ||
| coronary, and neuro vasculature. | ||
| Material | ||
| - Shaft Materials | SAME | PTFE lined nylon/polyurethane with |
| stainless steel and nitinol braid support | ||
| - Proximal End | ||
| Configuration | SAME | Luer Hub |
| - Radiographic markers / | ||
| Radiopacity | SAME | • Sheath: Platinum/tungsten bands |
| embedded at junction of expandable | ||
| section; gold marker at tip of | ||
| expandable section; | ||
| • Dilator: shaft is radiopaque throughout | ||
| - Packaging | SAME | Catheter in polyethylene hoop |
| attached to packaging card inside | ||
| PET/PE/Tyvek pouch inside SBS | ||
| carton | ||
| Sterilization | SAME | EtO |
4.9 Comparison to Predicate Devices
2
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:
3
| 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 | ||
| 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.
4
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.
5
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 (800) 638-2041 or (301) 796-7100 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
6
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