(26 days)
The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
The IVS Introducer Set consists of a 7 French Introducer Sheath and a Dilator with or without a 0.38" (0.97mm) 'J' tip Guidewire.
This submission does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary for the IVS Introducer Set, Model 1003-7, indicating its substantial equivalence to a predicate device (Model 1003-6).
The relevant sections state:
- "Testing: The IVS Introducer Set is tested in vitro and in clinical model systems. The modifications to the device do not affect the safety or effectiveness of the device for the intended use."
This statement confirms that some testing was performed, but it lacks specific details about:
- What acceptance criteria were used.
- The results of the tests.
- The methodology of the "clinical model systems."
- Any statistical analysis or sample sizes.
- An AI/Software component that would involve ground truth, expert review, or training/test sets.
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JUN 1 6 2003
This 510(k) summary of safety and effectiveness information is being submitted in
accordance with the requirements of 21 C. F.R. § 807.92.
| Submitted by: | Susan Turner, Ph.D.Director, Regulatory Affairs & Quality AssuranceIntegrated Vascular Systems, Inc.743 N. Pastoria Ave.Sunnyvale, CA 94085Telephone: (408) 328-9090Fax: (408) 328-9099 | |
|---|---|---|
| Date prepared: | May 20, 2003 | |
| Device name: | IVS Introducer Set, Model 1003-7 | |
| Common name: | Catheter introducer, vessel dilator for percutaneous catheterization,catheter guide wire | |
| Classification names: | Regulation # and Product Code | Classification Name |
| 21 C.F.R. § 870.1340DYB | Catheter introducer | |
| 21 C.F.R. § 870.1310DYB | Vessel dilator for percutaneouscatheterization | |
| 21 C.F.R. § 870.1330DYB | Catheter guide wire | |
| Predicate devices: | IVS Introducer Set, Model 1003-6, K030723 | |
| Device description: | The IVS Introducer Set consists of a 7 French Introducer Sheath and aDilator with or without a 0.38" (0.97mm) 'J' tip Guidewire. | |
| Indication for Use: | The IVS Introducer Set is indicated for use in procedures requiringpercutaneous introduction of intravascular devices. | |
| Technological characteristics: | The Model 1003-7 Introducer Set has the same technologiccharacteristics as the Model 1003-6 (K030723) device. | |
| Testing: | The IVS Introducer Set is tested in vitro and in clinical model systems.The modifications to the device do not affect the safety or effectivenessof the device for the intended use. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
JUN 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integrated Vascular System, Inc. Susan Turner, Ph.D. Director, Regulatory Affairs and Quality Assurance 743 North Pastoria Avenue Sunnyvale, CA 94085
Re: K031583
Trade/Device Name: IVS Introducer Set, Model 1003-7 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DYB Dated: May 20, 2003 Received: May 21, 2003
Dear Ms. Turner:
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.
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
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Page 2 - Susan Turner, Ph.D.
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
M
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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Indications For Use Statement
1031583 510(k) Number (if known)
IVS Introducer Set, Model 1003-7J and Model 1003-7 Device Name
Indications For Use The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | L031583 |
| Prescription Use(Per 21 CFR § 801.109) | OR Over-The-Counter Use |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).