(29 days)
Not Found
No
The 510(k) summary describes a standard PTA catheter with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is described as dilating stenoses and treating obstructive lesions, indicating a direct therapeutic action on the body.
No
The device is a percutaneous transluminal angioplasty (PTA) catheter intended to dilate stenoses, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ADMIRAL XTREME™ PTA Catheter is a physical device used to mechanically dilate blood vessels within the body. It is inserted into the body and directly interacts with the anatomical structures.
- Intended Use: The intended use clearly describes a procedure performed inside the body (dilating stenoses in arteries and fistulae).
- Device Description: The description details the physical components of a catheter designed for insertion and manipulation within the vascular system.
The information provided describes an invasive medical device used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The ADMIRAL XTREME™ (PTA) 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.
Product codes
LIT, DQY
Device Description
The ADMIRAL XTREME™ PTA Catheter is an OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It is a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft and balloon cones are hydrophilic coated (balloon excluded). The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 80 and 130cm.
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, arteriovenous dialysis fistulae.
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)
In vitro testing was conducted to demonstrate equivalent performance of the ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty (PTA) Catheter with the predicate device. The testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions, deflation time and guidewire and introducer compatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOG2809 p. 4x(2
510(k) Summary
per of 21 C.F.R § 807.92
| Manufacturer's Name and
Address | Invatec Innovative Technologies
Via Martiri della Libertà, 7
25030 Roncadelle (BS) Italy
Tel: +39 030 258 93 11
Fax: +39 030 258 93 12
www.invatec.com
info@invatec.com
OCT 1 8 2006 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and
Address | ev3 Inc.
4600 Nathan Lane North
Plymouth, MN 55442
Tel: (763) 398 7000
Fax: (763) 398 7200 |
| Contact Person | David Worrell
Manager, Regulatory Affairs
Tel: (763) 398-7344
Fax: (763) 398-7200
e-mail: dworrell@ev3.net |
| Date Prepared | September 18, 2006 |
| Device Trade Name | ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty
(PTA) Catheter |
| Device Common Name | Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation
Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification
Classification Panel | Regulatory Class: Class II |
| | Product Code: LIT
Cardiovascular |
| Predicate Device | SAILOR PLUS™ Percutaneous Transluminal Angioplasty (PTA)
Catheter - K042538, cleared November 8, 2004 |
| Intended use | The ADMIRAL XTREME™ (PTA) 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. |
| Device Description | The ADMIRAL XTREME™ PTA Catheter is an OTW PTA
catheter with a semi-compliant inflatable balloon mounted at the
distal tip. It is a dual lumen catheter with a guidewire lumen and a
balloon inflation lumen. The catheter tapers beneath the balloon
segment to achieve the lowest possible deflated profile. Two
radiopaque marker bands are placed under the balloon segment of
the catheter shaft to provide visual reference points for balloon
positioning within the vessel. The distal catheter shaft and balloon
cones are hydrophilic coated (balloon excluded). The maximum
recommended guidewire diameter is 0.035". The device is available
in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80
and 120mm and catheter lengths of 80 and 130cm. |
| Biocompatibility | All materials used in the ADMIRAL XTREME™ PTA Catheter are |
| Performance data | biocompatible based on biocompatibility testing results.
In vitro testing was conducted to demonstrate equivalent
performance of the ADMIRAL XTREME™ Percutaneous
Transluminal Angioplasty (PTA) Catheter with the predicate device.
The testing included balloon compliance, balloon burst pressure,
balloon fatigue, shaft burst pressure, bond strength, catheter
dimensions, deflation time and guidewire and introducer
compatibility. |
| Summary of Substantial
Equivalence | The ADMIRAL XTREME™ Percutaneous Transluminal
Angioplasty (PTA) Catheter is identical to the predicate device with
respect to intended use, catheter design and balloon dimensions.
The mechanical and biocompatibility testing data met the specified
requirements for the ADMIRAL XTREME™ Percutaneous
Transluminal Angioplasty (PTA) Catheter and are comparable with
the predicate device. |
| Conclusion | Based on the intended use and the technological characteristics, the
ADMIRAL XTREME™ PTA Catheter has been shown to be
substantially equivalent to the SAILOR PLUS™ PTA Catheter
(K0402538, cleared November 8, 2004). |
1
and the comments of the comments of the comments of the comments of
:
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its 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
Invatec Innovative Technologies c/o ev3 Inc. Attn: David Worrell 9600 54th Avenue North Plymouth, MN 55442-2111
OCT 1 8 2006
Re: K062809
Trade/Device Name: ADMIRAL XTREME™ PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 18, 2006 Received: September 19, 2006
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 devices that have been reclassified in accordance with the provisions of the Federal Food, Trug, 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, EDA 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 not the Act
3
Page 2 – Mr. David Worrell
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 (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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Vachner
Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or signature. The symbol is drawn with a thick stroke, giving it a bold appearance. The overall impression is abstract and difficult to interpret without additional context.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Kolo2809
Device Name: ADMIRAL XTREME™ PTA Catheter
Indications for Use:
The ADMIRAL XTREME™ PTA Balloon 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vorhies
Division Sich-Off) Division of Cardiovascular Devices
510/k) Number_K062809
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