(67 days)
Not Found
No
The summary describes a mechanical guidewire system for stent positioning and does not mention any AI or ML components or capabilities. The performance studies focus on mechanical and material properties.
No
The device is described as a "Stent Positioning System" and a "guidewire system" which is intended to "introduce and position stents" and "facilitate the alignment of interventional devices". It does not directly treat a disease or condition.
No
The device is described as a "Stent Positioning System" intended for introducing and positioning stents and other interventional devices, and for facilitating alignment of interventional devices. It is a guidewire system used for precise stent implantation. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "medical grade, disposable guidewire system," which is a physical hardware component used in interventional procedures. The performance studies also focus on physical properties and testing of the guidewire system.
Based on the provided information, the Ostial Pro Stent Positioning System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for introducing and positioning stents and other interventional devices within the coronary and peripheral vasculature. This is an in-vivo (within the living body) procedure, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The description details a guidewire system used by interventional cardiologists and radiologists for precise stent implantation. This aligns with an interventional medical device used directly on a patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) or to provide diagnostic information about a patient's condition. Its function is purely procedural – facilitating the placement of other devices.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the device (dimensions, strength, compatibility, etc.) and its sterilization and packaging. These are typical tests for a medical device used in a procedure, not for an IVD which would involve analytical performance testing.
In summary, the Ostial Pro Stent Positioning System is a medical device used in interventional procedures within the body, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. This product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional cardiologists and interventional radiologists
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)
Performance testing of the subject Ostial Pro Stent Positioning System was conducted based on the risk analysis and based on the requirements of the following FDA guidance document and international standards:
- AAMI/ANSI/ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- AAMI/ANSI/ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 2233:2000, Packaging complete, filled transport packages and unit loads - conditioning and testing
- ASTM D4169-09, Standard practice for performance testing of shipping containers and systems
- AAMI/ANSI/ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F1980:2007 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Coronary and Cerebrovascular Guidewire Guidance Jan 1995
- Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems -April 2010.
The following is a list of all significant testing that was successfully completed: Design Verification, Dimensions, Torque Strength, Torque-Ability, Feet Deflection Force Test, Body Af (Austenite Finish Temperature) Test, Wire Af Test, Coating Adherence/Integrity, Catheter Compatibility, Radio-opacity, Feet Force Deflection/Compression Test, Fatigue Loading of Feet, Linear Tensile Strength, Angular Tensile Strength.
The results of the testing demonstrated that the subject Ostial Pro Stent Positioning System met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
SEP 21 2012
510(k) Summary Submitter Name: Merit Medical Systems, Inc. Address: 1600 West Merit Parkway South Jordan, UT 84095 General Telephone Number: (801) 316-4956 Provisions Fax Number: (801) 253-6982 Contact Person: David Thomas Date of Preparation: . July 11, 2012 Registration Number: 1721504 Ostial Pro Stent Positioning System Trade Name: Subject Common/Usual Name:Stent Positioning System Device Classification Name: Catheter Guidewire Trade Name: Ostial Pro Stent Positioning System Common/Usual Name: Stent Positioning System Classification Name: Catheter Guidewire Predicate Device Premarket Notification:K062192 Manufacturer: Merit Medical Systems, Inc. Class II Classification 21 CFR § 870.1330 Cardiovascular The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral Intended Use vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
Section 5
20
1
| Device Description | The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. This product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters. |
|---|---|
| Technological Characteristics | The technological characteristics of the subject Ostial Pro Stent Position System are substantially equivalent to those of the predicate device, the Ostial Pro Stent Positioning System, 510(k) K062192. |
:
- Production Comments of Children
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K122089 Page 2 of 4
2
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Ostial Pro Stent Positioning System was conducted based on the risk analysis and based on the requirements of the following FDA guidance document and international standards:
- . AAMI/ANSI/ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- AAMI/ANSI/ISO 11607-1: 2006, Packaging for terminally . sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 2233:2000, Packaging complete, filled transport . packages and unit loads - conditioning and testing
Safety & Performance Tests
- . ASTM D4169-09, Standard practice for performance testing of shipping containers and systems
- AAMI/ANSI/ISO 10993-7: 2008 Biological Evaluation of . Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ASTM F1980:2007 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices.
- Coronary and Cerebrovascular Guidewire Guidance Jan ● 1995
- Non-Clinical Engineering Tests and Recommended Labeling . for Intravascular Stents and Associated Delivery Systems -April 2010.
The following is a list of all significant testing that was successfully completed:
3
| Safety &
Performance
Tests cont. | Design Verification
Dimensions
Torque Strength
Torque-Ability
Feet Deflection Force Test
Body Af (Austenite Finish Temperature) Test
Wire Af Test
Coating Adherence/Integrity
Catheter Compatibility
Radio-opacity
Feet Force Deflection/Compression Test
Fatigue Loading of Feet
Linear Tensile Strength
Angular Tensile Strength |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety &
Performance
Tests cont. | The results of the testing demonstrated that the subject Ostial Pro
Stent Positioning System met the pre-determined acceptance
criteria applicable to the safety and efficacy of the device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, and safety and
performance testing, the subject Ostial Pre Stent Positioning
System meets the requirements that are considered essential for
its intended use and is substantially equivalent to the predicate
device, the Ostial Pro Stent Positioning System, manufactured by
Ostial Solutions LLC. |
and the comments of the comments of
23
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. K122089
Page 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 1 2012
Merit Medial Systems, Inc.
c/o David Thomas
1600 West Merit Parkway
South Jordan, Utah 84095
Re: K122089
Trade/Device Name: Ostial Pro Stent Positioning System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: August 23, 2012 Received: August 24, 2012
Dear Mr. Thomas:
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
5
Page 2 – Mr. David Thomas
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
W. A. Hillen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section 4
Indications for Use
510(k) Number (if known):
Device Name: Ostial Pro Stent Positioning System
Indications for Use:
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
× 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
U.A. Miller
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ 11 122089