(29 days)
Not Found
Not Found
No
The description focuses on mechanical dilation and material properties, with no mention of AI/ML terms or functions.
Yes
The device is described as dilating tissue surrounding cardiac leads, indwelling catheters, and foreign objects, which implies it is used to treat or manage a condition, thereby fitting the definition of a therapeutic device.
No
The device description and intended use clearly state that it is for mechanical dilation of tissue, not for diagnosis.
No
The device description clearly states it is a physical device made of polypropylene and stainless steel, including a dilator, tip, and handle. It is a mechanical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects." This is a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device is a "polypropylene dilator with a semi-threaded stainless steel tip" used to "dilate tissue." This describes a mechanical tool used for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to physically modify tissue within the body during a procedure.
N/A
Intended Use / Indications for Use
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Product codes
DRE
Device Description
The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.
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
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Buckling Test --1. 1
-
- Binding Test
- Bond strength (Connector/gun) 3.
-
- Pull Testing (tip)
-
- Handle Cycling Test
-
- Device Performance
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Dilator Sheath.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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510(k) Summary
Submitted by:
MAY 1 0 11 26
Jim Ferguson Quality Systems Manager Cook Vascular, Incorporated 1186 Montgomery Lane Vandergrift, Pa 15690 724-845-8621, XT 2227 April 10, 2006
Device:
| Trade name: | Cook Vascular EVOLUTION Mechanical Dilator Sheath
Set |
|--------------------------|--------------------------------------------------------------------|
| Proposed Classification: | Dilator, Vessel, for Percutaneous Catheterization
870.1310, DRE |
Predicate Devices:
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is similar in terms of intended use, materials of construction and technology characteristics to predicate devices reviewed as devices for dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
Device Description:
The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
This device will be manufactured to specified process controls and a Quality Assurance program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Vascular. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indication for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
· Cook Vascular, Inc. • Special 510(k) Premarket Submission • EVOLUTION Rotary Dilator System • Confidential • ರಿ
1
Test Data:
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set was subjected to the flowing tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Buckling Test --1. 1
-
- Binding Test
- Bond strength (Connector/gun) 3.
-
- Pull Testing (tip)
-
- Handle Cycling Test
-
- Device Performance
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Dilator Sheath.
· Cook Vascular, Inc. · Special 510(k) Premarket Submission · EVOLUTION Rotary Dilator System · Confidential · 10
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2006
Cook Vascular, Inc. c/o Mr. Jim Ferguson, Jr. Quality Systems Manager 1186 Montgomery Lane Vandergrift, Pennsylvania 15690
Re: K061000
Trade/Device Name: EVOLUTION Mechanical Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: April 10, 2006 Received: April 11, 2006
Dear Mr. Ferguson:
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, 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 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.
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
3
Page 2 - Mr. Jim Ferguson, Jr.
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 (240) 276-0115. 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 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,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
06/000
Device Name:
EVOLUTION Mechanical Dilator Sheath Set
Indications for Use:
.
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K061000 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801 Subpart D) | OR | Over-The-Counter Use
(Per 21 CFR 810 Subpart C) |
| ------------------------------------------------ | ---- | ---------------------------------------------------- |
|---|
· Cook Vascular, Inc. · Special 510(k) Premarket Submission · Evolution Rotary Dilator System · Confidential ·