(27 days)
Not Found
No
The summary describes a standard medical device (introducer set) with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is an introducer set, which facilitates the percutaneous introduction of other intravascular devices, but it does not inherently treat a disease or condition itself.
No
The device is described as an "Introducer Set" used for the percutaneous introduction of intravascular devices, which is an interventional or procedural purpose, not a diagnostic one. There is no mention of it being used to identify or characterize a disease, condition, or physiological state.
No
The device description explicitly lists physical components (Introducer Sheath, Dilator, Guidewire), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in procedures requiring percutaneous introduction of intravascular devices." This describes a device used in vivo (within the body) to facilitate the insertion of other devices into blood vessels.
- Device Description: The components (introducer sheath, dilator, guidewire) are all tools used for accessing and navigating within the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for use inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.
Product codes
DYB
Device Description
The IVS Introducer Set consists of a 6 French Introducer Sheath, a Dilator and a 0.38" (0.97mm) 'J' tip Guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Assurance
Integrated Vascular Systems, Inc.
743 N. Pastoria Ave.
Sunnyvale, CA 94085
Telephone: (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 Product
Code | Classification Name |
| | 21 C.F.R. § 870.1340
DYB | Catheter introducer |
| | 21 C.F.R. § 870.1310
DYB | Vessel dilator for percutaneous
catheterization |
| | 21 C.F.R. § 870.1330
DYB | 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, a
Dilator and a 0.38" (0.97mm) 'J' tip Guidewire | |
| Indication for Use: | The IVS Introducer Set is indicated for use in procedures requiring
percutaneous introduction of intravascular devices. | |
| Technological characteristics: | The Model 1003 Introducer Set has the same technologic characteristics
as the Model 1001 (K020879) device. | |
| Testing: | 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. | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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.
2
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
3
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 _