(76 days)
Not Found
No
The device description and intended use are purely mechanical, describing a balloon catheter for dilation. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
The device is intended to dilate stenoses in various arteries and for the treatment of obstructive lesions, which are therapeutic actions aimed at treating a medical condition.
No
This device is a dilatation catheter used to open stenoses (narrowings) in blood vessels and fistulae. It is a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, lumens, and a hydrophilic coating, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The EverCross 0.035" OTW PTA Dilatation Catheter is a device used inside the body to physically dilate blood vessels and fistulae. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed within the body to treat blockages, not to analyze samples.
- Device Description: The description details a catheter with a balloon for inflation within a vessel, which is consistent with an interventional procedure, not an in vitro test.
Therefore, based on the provided information, the EverCross 0.035" OTW PTA Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The EverCross .035" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The EverCross Peripheral Dilatation Catheter is an over the wire (OTW) 0.035" dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip to aid in crossing tight stenoses. The distal catheter, proximal to the balloon, is covered with a hydrophilic coating. The catheter manifold includes two lumens. The lumen marked "THRU" is the central lumen of the catheter which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.035 inches. The lumen, marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, peripheral vasculature
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.
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.
K053116, K062809, K072947, K072283
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for EV3, a robotics kit. Above the logo are some handwritten characters that are difficult to decipher. The EV3 logo consists of three black circles arranged in a triangular formation, with the letters "ev3" in a stylized font below the circles. The "3" has a registered trademark symbol next to it.
NOV 20 2008
510(k) Summary
EverCross™ .035" OTW PTA Dilatation Catheter
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R § 807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | cv3 Inc.
9600 54th Ave. N
Plymouth, MN 55442
Tel: 763-398-7000
Fax: 763-398-7200 |
| Contact Person | David Worrell, MS, RAC
Director, Regulatory Affairs |
| Date Prepared | September 3rd, 2008 |
| Device Trade Name | EverCrossTM .035" OTW PTA Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 800.1250,
Product Code LIT |
| Classification Panel | Cardiovascular |
| Predicate Devices | Sterling OTW PTA Balloon Dilatation Catheter (K053116), Admiral
Xtreme PTA Balloon Catheter OTW .035 (K062809), Savvy Long and
Sleek PTA Catheter (K072947), and Dorado PTA Balloon Dilatation
Catheter (K072283). |
| Intended use | The EverCross .035" OTW PTA Dilatation Catheter is intended to
dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive
lesions of native or synthetic arteriovenous dialysis fistulae. This
device is also indicated for stent post-dilatation in the peripheral
vasculature. |
| Device Description | The EverCross Peripheral Dilatation Catheter is an over the wire
(OTW) 0.035" dual lumen catheter with a distally mounted semi-
compliant inflatable balloon and an atraumatic, tapered tip to aid in
crossing tight stenoses. The distal catheter, proximal to the balloon, is
covered with a hydrophilic coating. The catheter manifold includes
two lumens. The lumen marked "THRU" is the central lumen of the |
| | catheter which terminates at the distal tip. This lumen is used to pass
the catheter over a guidewire with a maximum outer diameter of 0.035
inches. The lumen, marked "BALLOON" is used to inflate and
deflate the dilatation balloon with a solution of contrast medium and
saline. The balloon has two radiopaque markers for positioning the
balloon relative to the stenosis. |
| Performance data | Bench testing and biocompatibility testing were performed to support
a determination of substantial equivalence. Results from this testing
provide assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. |
| Summary of Substantial
Equivalence | The EverCross .035" OTW PTA Dilatation Catheter has the following
similarities to the predicate devices:
• Similar fundamental scientific technology (all predicates)
• Similar operating principle (all predicates)
• Similar balloon lengths (Savvy Long and Sleek K072947)
• Similar rated burst pressures (Dorado K072283). |
| Conclusion | Based on the similar indications for use, technological characteristics
and performance testing, ev3 believes the EverCross .035" OTW PTA
Dilatation Catheter is substantially equivalent to the Sterling OTW
PTA Balloon Dilatation Catheter (K053116), the Admiral Xtreme
PTA Balloon Catheter (K062809), the Savvy Long and Sleek PTA
Catheters (K072947) and the Dorado PTA Balloon Dilatation Catheter
(K072283). |
ev3 Corporate World Headquarters / Peripheral Vascular ● 9600 54th Avenue North ● Plymouth, MN 55442 ● PH +1 763 398 7000 ev3 Europe SAS • ¡06/108 rue La Boetie • 75008 Paris, France • PH +33 156 88 59 10 Page 1 of 2 ev3 Neurovascular • 9775 Toledo Way • Irvine, CA 92618 • PH +1 949 837 3700 FoxHollow Technologies ● 740 Bay Road ● Redwood City, CA 94063 ● PH +1 650 421 8400
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is rendered in black, and the text is also in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2008
ev3 Inc. c/o Mr. David Worrell 4600 Nathan Lane North Plymouth, MN 55442-2920
Re: K082579
EverCross 0.035" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (2) Product Code: DQY Dated: November 12, 2008 Received: November 13, 2008
Dear Mr. Worrell:
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 dcvices 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.
3
Pagc 2 - Mr. David Worrell
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 Fedcral 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) promarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, plcase contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
una R. Volmer
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Indications for Use Statement
K082579 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EverCross™ .035" OTW PTA Dilatation Catheter
Indications for Use:
The EverCross 0.035" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. 2) Thell remmer
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko82579