INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
Device Facts
| Record ID | K992668 |
|---|---|
| Device Name | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) |
| Applicant | Innerdyne, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | May 26, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Intended Use
The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use: Percutaneous vascular access.
Device Story
REVAS is a radially expanding vascular access system used during minimally invasive surgery. Device consists of an expandable sleeve assembly and a dilator/sheath assembly with an integral hemostasis valve. Operation: sleeve is inserted over a guidewire into a vessel; sleeve is radially compressed for insertion and expands to accommodate the dilator/sheath. This process dilates surrounding tissue. Once dilated, the dilator is removed, leaving the sleeve and sheath in place to provide a sealed port for instrument passage. System allows for initial placement of a small-diameter sheath, which can be removed and replaced with a larger-diameter dilator/sheath through the same sleeve to create a larger port. Used by clinicians in a surgical setting to facilitate instrument access to the vasculature. Benefits include temporary, sealed percutaneous access.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on design, material, and functional similarity to legally marketed predicate devices.
Technological Characteristics
System comprises an expandable sleeve, tapered dilator, and sheath with integral hemostasis valve. Materials are medical grade, assembled via adhesives, welds, and mechanical interlocks. Operates via mechanical radial expansion of the sleeve to accommodate dilators. No energy source or software components.
Indications for Use
Indicated for percutaneous vascular access in patients requiring minimally invasive surgery for temporary passage of instruments into the vasculature (arterial or venous). Contraindicated for use in the presence of vascular grafts at the access site.
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Predicate Devices
- InnerDyne, Inc., REVAS products (K992668)
Related Devices
- K972684 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM · Innerdyne, Inc. · Oct 10, 1997
- K980578 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) · Innerdyne, Inc. · Sep 11, 1998
- K990854 — INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE · Innerdyne, Inc. · Aug 2, 1999
- K160254 — GORE DrySeal Flex Introducer Sheath · W. L. Gore & Associates, Inc. · May 12, 2016
- K990493 — INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE · Innerdyne, Inc. · May 18, 1999
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for InnerDyne, Inc. The words "InnerDyne" are in a bold, black font, with a registered trademark symbol after the word "Dyne". The word "Inc." is to the right of "InnerDyne" and is outlined in black.
## SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
Submitter: InnerDyne, Inc. 5060 Amelia Earhart Dr Salt Lake City, Utah (801)-350-3600
Date Prepared: August 6, 1999
Contact: Rick Gaykowski Corporate Vice President, Regulatory Affairs and Quality Assurance
Classification Name: Percutaneous Introducer Common/Usual Name: Percutaneous Introducer With Sheath Trade/Proprietary Name: InnerDyne, Inc., Radially Expanding Vascular Access System (REVAS™)
The REVAS product consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected vessel over a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments.
This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the lumion the sleeve while leaving the sleeve inserted in the vessel. A larger dirmeter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments.
The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.
The subject InnerDyne, Inc., REVAS product is substantially equivalent to predicate
{1}------------------------------------------------
InnerDyne, Inc., REVAS products. The subject REVAS device is similar to the referenced predicate in size, function, product dimensions and indications for use.
The REVAS product is intended for use during minimally invasive surgery for temporary percutaneous vascular access for passage of instruments into the vasculature. The device is configured to be used for arterial or venous access.
The basic design principles for the subject InnerDyne, Inc., REVAS product and the predicate REVAS devices are similar, and remain essentially unchanged from information provided to the Agency. The product configuration, composition, and utilized materials are similar in each of the products. The principles of operation for the subject InnerDyne, Inc., REVAS product and the predicate REVAS devices are similar. That is, each of these products employs a similar insertion technique, indications for use, contraindications for use, warnings and precautions. The subject device has an incorporated contraindication against use in the presence of vascular grafts at the access site.
From the foregoing, we conclude that the subject REVAS product is as safe and effective as currently marketed devices for the stated indications.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The background is plain white, providing a stark contrast to the black text.
Image /page/2/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
MAY 2 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rick Gaykowski Vice President, RA/QA InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, UT 84116
K992668 Re: Trade Name: REVAS™ Radially Expanding Vascular Access System Regulatory Class: II (two) Product Code: 74 DYB Dated: April 25, 2000 Received: April 26, 2000
Dear Mr. Gaykowski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Mr. Rick Gaykowski
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Buim E. Hansenym
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
510(k) Number (if known):
Device Name: InnerDyne, Inc., Radially Expanding Vascular Access System (REVAS™)
Indications for Use: The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use:
> Percutaneous vascular access. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suinn E. Hanson
Divi and N 510k) N
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
