(355 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical function of a physical dilator and do not mention any computational or data-driven components.
Yes
The device is intended to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures, which directly addresses a physiological condition (narrowed vessels) to facilitate medical interventions. This falls under the definition of a therapeutic device.
No
The primary purpose of the device is to enlarge or calibrate a vessel, which is a therapeutic or interventional procedure, not a diagnostic one. While it can "measure the caliber via the tip of the vessel," this measurement is secondary to its dilating function and is part of a procedure to modify the vessel, not simply to identify a condition or disease.
No
The device description explicitly states it is a "catheter with smooth stainless steel tip(s)," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical catheter used to mechanically enlarge a vessel lumen. This is a surgical/interventional tool, not a diagnostic test kit or instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic/interventional tool used directly on the patient's vascular system.
N/A
Intended Use / Indications for Use
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.
Product codes (comma separated list FDA assigned to the subject device)
870.4475 (Surgical Vessel) Vascular Dilator
Device Description
The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure.
The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained physician
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)
Comparison of EVI's Vascular Dilator to Cook's Dotter Dilator performance characteristics indicate that they are substantially equivalent. Comparison of EVI's Vascular Dilator and Pilling Weck's Amato Dilator physical characteristics indicates that they are substantially equivalent.
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.
Not Found
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
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
DEC 1 1998
Endo Vascular Instruments Inc.'s Peripheral Vascular Dilator Premarket Notification Summary Of Data
Submitter: 1.
Tom Kelly
.
.
·
:
.
.
:
- Director of Engineering
- EndoVascular Instruments. Inc.
- 2501 SE Columbia Way, Suite 150
- Vancouver, Washington 98661-8038
- Tel: (360) 750-1150
- Fax: (360) 750-1101
ri Device Name
2.1 Classification:
Common/Usual Name: 2.2
Proprietary Name: 2.3
Panel 70, Class II, 870,4475 (Surgical Vessel) Vascular Dilator Peripheral Vascular Dilator
3. Predicate Device:
3.1 Cook, Inc.'s Dotter Transluminal Dilator
- 3,2 Pilling Weck's Amato Dilators
4. Intended Use:
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel
Device Description: ડ્
The vascular dilator is a catheter with smooth stainless steel tip(s) that enlarges the lumen of the artery and/or measures the caliber via the tip of the vessel. Access is either percutaneous (interventional through a sheath) or cut down (surgical, through an ateriotomy) procedure.
The vascular dilator is used over a guidewire and has tip(s) of increasing size to enlarge the lumen with each repeated pass or to measure the vessel size. Only an appropriately trained physician using sterile techniques uses the sterile device.
Substantial Equivalency Comparisons: 6.
EVI's Peripheral Vascular Dilator is substantially equivalent to Cook, Inc, 's Dotter Transluminal Dilator and Pilling Weck's Amato Dilators, which are preamendment device.
6.1 Comparison of Physical Characteristics:
A comparison of physical characteristics of EVI's Peripheral Vascular Dilator to Pilling Weck's Amato Dilator indicates that they are substantially equivalent in materials;
1
EndoVascular Instruments Inc.'s Peripheral Vascular Dilator Premarket Notification Summary Of Data
construction; diametor and length dimensions, and configuration. The strength of the Vascular Dilator's joints and connections is equal to or greater than the Amato dilator.
Comparison of Physical Characteristics: 6.2
EVI's Vascular Dilator is substantially equivalent to Cook Inc. 's Dottering Set in intended use. Both dilators are used to dilate atheromas and to calibrate vessels. Results of tests indicated that the Vascular Dilator effectively enlarged the vessels and posed no new safety or efficacy issue in any of the tests.
7. Conclusions:
Comparison of EVI's Vascular Dilator to Cook's Dotter Dilator performance characteristics indicate that they are substantially equivalent. Comparison of EVI's Vascular Dilator and Pilling Weck's Amato Dilator physical characteristics indicates that they are substantially equivalent.
2
Food and Drug Administration Rockville MD 20857
1 1998 DEC
Mr. Tom Kelly Director of Engineering EndoVascular Intruments, Inc. 2501 SE Columbia Way, Suite 150 Vancouver, WA 98661-8038
Re: K974617 Peripheral Vascular Dilator Trade Name: Requlatory Class: II DRE Product Code: Dated: November 6, 1998 Received: November 9, 1998
Dear Mr. Kelly:
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, Druq, 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 Requlations, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
3
Page 2 - Mr. Tom Kelly
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 requlations.
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,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Unknown
| 510(k) Number (if known): | |
|---|---|
| Peripheral Vascular Dilator | |
| Device Name: | |
| Indications For Use: |
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.
A.D. Dettloff
(Division Sign-Off)
TJ Callahan
Division of Cardiovascular, Respiratory, and Neurological Devices Kill 510(k) Number_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use