(67 days)
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.
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.
The provided 510(k) summary for the Ostial Pro Stent Positioning System (K122089) states that no performance standards have been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act for this type of device.
Instead, the submission relies on performance testing conducted based on a risk analysis and in accordance with various FDA guidance documents and international standards for medical device sterilization, packaging, and biological evaluation, along with specific guidance for guidewires and stents.
The testing conducted was primarily non-clinical engineering tests to demonstrate the device's safety and performance and its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available as this is a medical device and not an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Sterilization | AAMI/ANSI/ISO 11135-1: 2007 (Ethylene oxide sterilization) | Met pre-determined acceptance criteria for safety and efficacy. |
| Packaging | AAMI/ANSI/ISO 11607-1: 2006 (Packaging for terminally sterilized medical devices) | Met pre-determined acceptance criteria for safety and efficacy. |
| ISO 2233:2000 (Packaging complete, filled transport packages) | Met pre-determined acceptance criteria for safety and efficacy. | |
| ASTM D4169-09 (Performance testing of shipping containers) | Met pre-determined acceptance criteria for safety and efficacy. | |
| ASTM F1980:2007 (Accelerated Aging of Sterile Barrier Systems) | Met pre-determined acceptance criteria for safety and efficacy. | |
| Biocompatibility | AAMI/ANSl/ISO 10993-7: 2008 (Ethylene Oxide Sterilization Residuals) | Met pre-determined acceptance criteria for safety and efficacy. |
| Device Design & Function | Coronary and Cerebrovascular Guidewire Guidance Jan 1995 | Met pre-determined acceptance criteria for safety and efficacy. |
| Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents (April 2010) | Met pre-determined acceptance criteria for safety and efficacy. | |
| Design Verification (Dimensions, Torque Strength, Torque-Ability, Feet Deflection Force, Body Af Test, Wire Af Test, Coating Adherence/Integrity, Catheter Compatibility, Radio-opacity, Feet Force Deflection/Compression, Fatigue Loading of Feet, Linear Tensile Strength, Angular Tensile Strength) | The results "demonstrated that the subject Ostial Pro Stent Positioning System met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each test. The testing described is primarily for the physical and material characteristics of the device, not clinical performance data from a patient population. Therefore, terms like "test set," "data provenance," and "country of origin" as typically used for AI/software evaluations are not applicable here. The "data" refers to the results of engineering and laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the "ground truth" for this type of device is established through adherence to engineering standards and laboratory testing protocols, not through expert consensus on clinical cases. The "experts" would be the engineers and technicians performing the tests and comparing results against established technical specifications.
4. Adjudication Method for the Test Set
This is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically refer to a process for resolving discrepancies in expert interpretations of clinical data, which is not relevant for the engineering tests performed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not the subject of this 510(k) summary for a physical medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical stent positioning system, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Engineering specifications and design requirements: Each physical property (e.g., dimensions, torque strength, radio-opacity) has a defined acceptable range or performance target.
- International standards and FDA guidance documents: These documents define the testing methodologies and acceptable limits for various aspects like sterilization, packaging integrity, and biocompatibility.
- Comparison to predicate device characteristics: Substantial equivalence implies that the new device performs similarly to or better than the legally marketed predicate device across critical parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning system. Therefore, there is no "training set" in the context of data used to train an algorithm. The device design and manufacturing process are validated through engineering principles and quality control.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
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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
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| 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. |
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K122089 Page 2 of 4
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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:
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| Safety &PerformanceTests cont. | Design VerificationDimensionsTorque StrengthTorque-AbilityFeet Deflection Force TestBody Af (Austenite Finish Temperature) TestWire Af TestCoating Adherence/IntegrityCatheter CompatibilityRadio-opacityFeet Force Deflection/Compression TestFatigue Loading of FeetLinear Tensile StrengthAngular Tensile Strength |
|---|---|
| Safety &PerformanceTests cont. | The results of the testing demonstrated that the subject Ostial ProStent Positioning System met the pre-determined acceptancecriteria applicable to the safety and efficacy of the device. |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, and safety andperformance testing, the subject Ostial Pre Stent PositioningSystem meets the requirements that are considered essential forits intended use and is substantially equivalent to the predicatedevice, the Ostial Pro Stent Positioning System, manufactured byOstial Solutions LLC. |
and the comments of the comments of
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. K122089
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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
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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
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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
§ 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.