(191 days)
Not Found
Not Found
No
The summary describes a mechanical clip closure system and does not mention any AI or ML components or functions.
Yes
The device is described as aiding "healing in minimally invasive procedures" by achieving hemostatic closure of puncture sites, which is a therapeutic function.
No
Explanation: The device is intended for hemostatic closure of puncture sites, which is a therapeutic rather than a diagnostic function. It is used to aid healing, not to diagnose a condition.
No
The device description explicitly states it consists of an extravascular implantable nitinol clip and an Introducer Sheath, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The IVS Clip Closure System is a physical device used to mechanically close vascular puncture sites. It is an implantable device that directly interacts with the patient's tissue.
- Intended Use: The intended use is to achieve hemostatic closure of puncture sites to aid healing in minimally invasive procedures. This is a therapeutic and procedural function, not a diagnostic one based on analyzing biological samples.
The description clearly indicates a surgical/procedural device used in vivo (within the living body), not a test performed in vitro (in a lab setting on samples).
N/A
Intended Use / Indications for Use
The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.
Product codes (comma separated list FDA assigned to the subject device)
FZP, DYB
Device Description
The IVS Clip Closure System consists of an extravascular implantable nitinol clip mounted on an Introducer Sheath. A clip applier acts to release the clip into vascular tissue where it closes vascular puncture wounds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular puncture sites
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 Clip Closure System has been tested in vitro, in vivo and in human model systems. Test results show that the device is safe and effective for the intended use. All components which contact the fluid path or tissue are biocompatible in accordance with ISO Standard 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Angiolink EVS™ Vascular Closure System.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K020879 page 1/2
Integrated Vascular Systems, Inc.
SEP 2 5 2002
510(k) Summary
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: | July 2, 2002 | |
| Device name: | IVS Clip Closure System | |
| Common name: | Clip, clip applier, catheter introducer | |
| Classification names: | Regulation # and
Product Code | Classification Name |
| | 21 C.F.R. § 878.4300
FZP | Implantable clip |
| | 21 C.F.R. § 870.1340
DYB | Catheter introducer |
| Predicate devices: | The IVS Clip Closure System is substantially equivalent to
the Angiolink EVS™ Vascular Closure System. | |
| Device description: | The IVS Clip Closure System consists of an extravascular
implantable nitinol clip mounted on an Introducer Sheath.
A clip applier acts to release the clip into vascular tissue
where it closes vascular puncture wounds. | |
| Indication for Use: | The IVS Clip Closure System is intended for use to
approximate vascular tissue for achieving hemostatic
closure of puncture sites to aid healing in minimally
invasive procedures under direct or endoscopic
visualization. | |
| Technological
characteristics: | The subject and predicate devices have the same intended
use and principles of operation. Both systems stabilize the
site, guide and center on the wound and deliver a clip/staple
to the wound site for tissue approximation and immediate
mechanical extravascular closure. The IVS systems uses a
nitinol clip; the EVS system uses a titanium staple. The clip
applier and stapler are both manually operated although the
mechanisms are different. Performance testing of the IVS
system demonstrates that there are no new issues of safety
or effectiveness associated with this difference.
The IVS implantable clip is mounted on an Introducer
Sheath. The sheath is a standard 6 French sheath and
performance testing demonstrates that there are no new
issues of safety or effectiveness associated with the presence
of the clip/clip carrier assembly on the catheter introducer. | |
| Testing: | The IVS Clip Closure System has been tested in vitro, in
vivo and in human model systems. Test results show that
the device is safe and effective for the intended use. All
components which contact the fluid path or tissue are
biocompatible in accordance with ISO Standard 10993. | |
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KOZO879 page 2/2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with a design that suggests flowing hair or fabric.
MAR 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Susan Turner, Ph.D. Director, Regulatory Affairs & Quality Assurance Integrated Vascular Systems, Inc. 743 North Pastoria Avenue Sunnyvale, California 94085
Re: K020879
Trade/Device Name: IVS Clip Closure System, Model 1002 and IVS Introducer Set Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: July 2, 2002 Received: July 2, 2002
Dear Dr. Turner:
This letter corrects our substantially equivalent letter of September 25, 2002 regarding the IVS Clip Closure System, which failed to include the IVS Introducer Set.
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 (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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Susan Turner, Ph.D.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Muriam C. Provost
to Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
K 020879 Response to FDA request for additional information July 2, 2002
Indications For Use Statement Revised July 2, 2002
K020879 510(k) Number (if known)
The IVS Clip Closure System. Device Name
Indications For Use The IVS Clip Closure System is intended for use to approximate vascular tissue for achieving hemostatic closure of puncture sites to aid healing in minimally invasive procedures under direct or endoscopic visualization.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use Prescription Use (Per 21 CFR § 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number _
CONFIDENTIAL Information of Integrated Vascular Systems, Inc.
3