(27 days)
The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
The IVS Introducer Set consists of a 6 French Introducer Sheath, a Dilator and a 0.38" (0.97mm) 'J' tip Guidewire
The provided text is a 510(k) summary for the IVS Introducer Set, Model 1003. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study with specific acceptance criteria and performance metrics for a novel medical device like AI algorithms.
Therefore, I cannot provide the requested information about acceptance criteria and study results because the submitted document does not contain this type of data. The 510(k) summary is for a device seeking clearance based on substantial equivalence, not a new device requiring performance studies against defined acceptance criteria in the manner an AI device would.
Here's a breakdown of why this information isn't present in the provided text:
- Type of Device: The IVS Introducer Set is a physical medical device (catheter introducer, dilator, guidewire), not an AI/software device.
- Regulatory Pathway: The 510(k) pathway for this device relies on demonstrating "substantial equivalence" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. This is different from the rigorous performance studies often required for novel AI devices.
- Testing Information: The document states, "The IVS Introducer Set has been tested in vitro and in clinical model systems. Test results show that the modifications to the device do not affect the safety or effectiveness of the device for the intended use." This is a very high-level statement and does not provide specific acceptance criteria, performance metrics, sample sizes, or details about ground truth and experts as would be expected for an AI device study.
If you can provide a document describing a performance study for an AI device, I would be happy to complete the requested table and information.
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APR - 3 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) 328-9090 | |
|---|---|---|
| Fax: (408) 328-9099 | ||
| Date prepared: | March 5, 2003 | |
| Device name: | IVS Introducer Set, Model 1003 | |
| Common name: | Catheter introducer, vessel dilator for percutaneous catheterization,catheter guide wire | |
| Classification names: | Regulation # and ProductCode | 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 1001, K020789, K021004, K964814 | |
| Device description: | The IVS Introducer Set consists of a 6 French Introducer Sheath, aDilator and 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 Introducer Set has the same technologic characteristicsas the Model 1001 (K020879) device. | |
| Testing: | The IVS Introducer Set has been tested in vitro and in clinical modelsystems. Test results show that the modifications to the device do notaffect the safety or effectiveness of the device for the intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2003
Integrated Vascular Systems, Inc. c/o Susan Turner, Ph.D. 743 N. Pastoria Avenue Sunnyvale, CA 94085
Re: K030723
IVS Introducer Set, Model 1003 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 6, 2003 Received: March 7, 2003
Dear Dr. 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. Iisting 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 - Susan Turner, Ph.D.
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 (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,
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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Integrated Vascular Systems, Inc. Special 510(k) IVS Introducer Set, Model 1003
Indications For Use Statement
510(k) Number (if known)
Device Name
IVS Introducer Set, Model 1003
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)
Prescription Use X
(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).