(297 days)
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, 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. The product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.
The provided text describes a 510(k) premarket notification for the "Ostial Pro Stent Positioning System," a medical device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness through extensive clinical trials.
Therefore, many of the typical acceptance criteria and study design elements for AI/machine learning devices (like sample sizes for test/training sets, expert ground truth methods, multi-reader multi-case studies, or standalone performance) are not applicable and not present in this document.
The application asserts substantial equivalence through design verification testing, biocompatibility testing, and preclinical animal testing. These tests are designed to show that the device performs as intended and is as safe and effective as existing, legally marketed devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the traditional sense of performance metrics (like accuracy, sensitivity, specificity) for an AI or diagnostic device. Instead, it states that the device's safety was evaluated through various tests, and these collective results demonstrated substantial equivalence.
| Acceptance Criteria Category | Device Performance (as stated in submission) |
|---|---|
| Safety | Evaluated through design verification testing, biocompatibility testing, and preclinical animal testing. Results "demonstrated that the Ostial Pro Stent Positioning System is safe." |
| Substantial Equivalence | "The Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices." (based on indications for use, technological characteristics, and safety/efficacy testing). |
| Compatibility | Compatible with 6, 7, and 8 French catheters. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/not specified. The testing involved design verification, biocompatibility, and preclinical animal testing, not a "test set" of patient data for algorithm performance.
- Data Provenance: Not applicable. No patient data (e.g., country of origin, retrospective/prospective) is described since this is not an AI/diagnostic device performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment for a test set is not described as this is not an AI/diagnostic device performance study. The evaluation focused on engineering and biological safety characteristics.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-powered diagnostic or assistive device. It is a guidewire system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm.
7. The type of ground truth used:
- The concept of "ground truth" as typically applied to machine learning or diagnostic imaging evaluation is not directly relevant here. The "truth" in this context is adherence to engineering specifications, biological compatibility, and observable performance in preclinical models, which is established through standard laboratory and animal testing protocols rather than expert consensus on patient data.
8. The sample size for the training set:
- Not applicable. This is not an AI device that involves a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of the Study per the Document:
The study described is a series of design verification tests, biocompatibility tests, and preclinical animal tests. These studies aim to demonstrate that the physical device (Ostial Pro Stent Positioning System) is safe, performs its intended function (to introduce and position catheters/stents and facilitate alignment), and is substantially equivalent to existing predicate guidewires. The specific details of these tests (e.g., number of animals, specific stress levels in design tests) are not provided in this summary but would be part of the full 510(k) submission. The "substantially equivalent" determination is the key finding that allows the device to be marketed.
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510(k) SUMMARY
510(k) Notification K062192
GENERAL INFORMATION
Applicant:
Ostial Solutions, LLC 1111 Short Road Kalamazoo, MI 49008 Phone: 269-383-3797 FAX: 269-383-3714
Contact Person:
Michael J. Billig Regulatory Consultant Experien Group, LLC 155 Moffett Park Dr., Suite A-210 Sunnyvale, CA 94089 Phone: 408-400-0856 FAX: 408-400-0865 Email: mjb@experiengroup.com
Date of Submission:
July 28, 2006
DEVICE INFORMATION
Classification:
Class II - Standards
Trade Name:
Ostial Pro Stent Positioning System
Common/Classification Name/Product Code:
Product Code: DQX Device Classification: Catheter Guidewire Regulation Number: 870.1330
PREDICATE DEVICES
- Cordis® Corporation, ATW™ Marker Wire Steerable Guidewire, K994358 .
- Lake Region Manufacturing, Inc., Coronary, Peripheral and Renal Steerable . Hydrophilic Guidewire, K042338
- EV3® Inc., Nitrex® Guidewire, K031864 .
- BioSphere Medical, Inc., Sequitor" Steerable Guidewire, K061171 .
MAY 2 4 2007
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INTENDED USE
The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, 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 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. The product is provided sterile and intended for single use.
This finished product will be compatible with 6, 7 and 8 French catheters.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for the Ostial Pro Stent Positioning System. The technological characteristics for the Ostial Pro Stent Positioning System are also substantially equivalent to the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The safety of the Ostial Pro Stent Positioning System was evaluated through design verification testing, biocompatibility testing and preclinical animal testing. The collective results have demonstrated that the Ostial Pro Stent Positioning System is safe and is substantially equivalent to the respective predicate devices with regard to safety and efficacy. Any differences in technological characteristics between the Ostial Pro Stent Positioning System and the predicate devices do not raise any new issues of safety or efficacy.
SUMMARY
The Ostial Pro Stent Positioning System is substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Ostial Solutions, LLC c/o Mr. Michael J Billig Regulatory Consultant 1111 Short Road Kalamazoo, MI 49008
K062192 Re:
Ostial Pro Stent Positioning System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: II (two) Product Code: DQX Dated: May 14, 2007 Received: May 15, 2007
Dear Mr. Billig:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Michael J Billig
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Valmus
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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OSTIAL SOLUTIONS, LLC 1111 SHORT ROAD KALAMAZOO, MI 49008
INDICATIONS FOR USE
510(k) Number (if known): K062192
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 V (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)
uma R. Vaches
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K062192
§ 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.