K Number
K062192
Device Name
OSTIAL PRO STENT POSITIONING SYSTEM
Date Cleared
2007-05-24

(297 days)

Product Code
Regulation Number
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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. The product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.
More Information

Not Found

No
The summary describes a mechanical guidewire system for positioning devices and does not mention any computational or analytical capabilities that would suggest AI/ML.

No
The device is a guidewire system intended to introduce and position other interventional devices and facilitate their alignment, not to provide therapy itself.

No

The device is described as a guidewire system for positioning interventional devices, facilitating alignment, and ensuring precise stent implantation. Its purpose is to aid in interventional procedures rather than to diagnose medical conditions or provide diagnostic information.

No

The device description explicitly states it is a "medical grade, disposable guidewire system," which is a physical hardware component.

Based on the provided information, the Ostial Pro Stent Positioning System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Ostial Pro Stent Positioning System Function: The description clearly states that the Ostial Pro Stent Positioning System is a guidewire system used within the body (in vivo) to introduce and position catheters, stents, and other interventional devices in the coronary and peripheral vasculature. It facilitates alignment during procedures performed directly on the patient.

The device's function is entirely focused on assisting with interventional procedures performed inside the patient's body, not on analyzing samples taken from 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 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 codes

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. The 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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K994358, K042338, K031864, K061171

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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

1

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.

2

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular fashion around the eagle.

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.

3

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