(28 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to dilate stenoses in various arteries and treat obstructive lesions, which are therapeutic interventions.
No
Explanation: The device is a balloon dilatation catheter used for treatment (dilating stenoses), not for diagnosis.
No
The device description clearly outlines a physical catheter with a balloon, shaft, and hub, indicating it is a hardware medical 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 clearly describes a device used within the body to physically dilate blood vessels and fistulae. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical catheter with a balloon, designed for insertion into the vascular system. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LIT, DQY
Device Description
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm.
Modified Device Description:
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.
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, native or synthetic 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)
Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria. Verification testing included catheter and balloon dimensional testing, minimum balloon burst strength (RBP), balloon compliance, balloon inflation and deflation time, balloon fatigue, tensile strength, flexibility and kink test, torque strength, balloon preparation, catheter body burst pressure, guidewire compatibility, introducer sheath compatibility, radiopacity, coating lubricity and coating durability.
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
APR 3 0 2010
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
Applicant:
Invatec S.p.A. Via Martiri della Libertá, 7 25030 Roncadelle (Brescia) Italy Peter Muster PhD, VP QA & RA Invatec S.p.A. Tel: +39 030 258 93 11 Fax: +39 030 258 93 12 Email: Peter.Muster@invatec.com
Contact Person:
Invatec Inc., US Emrick Blvd. 3101, Suite 113 Bethlehem, PA 18020 Tel: (610) 625-1429 Fax: (610) 625-1436 Email: john.clay@invatec-us.com
John Clay, Director, RA&QA
April 1, 2010 Date Prepared:
Device Information
| Trade Name: | ADMIRAL XTREMET™ PTA Balloon Dilatation Cathete |
|---|---|
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Regulation Name: | Percutaneous Catheter |
Predicate Device
Invatec ADMIRAL XTREME™ PTA Catheter (K062809)
Device Description
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is
1
provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm.
Modified Device Description
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.
Indication 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.
Technological Characteristics
The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter has the same or similar design, materials and fundamental technology as the previously cleared ADMIRAL XTREME™ PTA Catheter. This modification provides the user with longer balloon lengths to be used in the peripheral arteries.
Performance Testing and Safety
Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria. Verification testing included catheter and balloon dimensional testing, minimum balloon burst strength (RBP), balloon compliance, balloon inflation and deflation time, balloon fatigue, tensile strength, flexibility and kink test, torque strength, balloon preparation, catheter body burst pressure, guidewire compatibility, introducer sheath compatibility, radiopacity, coating lubricity and coating durability.
There are no new materials used in the manufacture of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. Biocompatibility requirements were previously met with the predicate device according to ISO 10993: Biological Evaluation of Medical Devices and the FDA Blue Book Memorandum #G95-1.
Conclusion
Based on the same intended use, similar technological characteristics, and performance characteristics, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird with outstretched wings. The bird is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 3 0 2010
Invatec S.p.A c/o Peter Muster, Ph.D. Vice President, Quality and Regulatory Via Martiri della Liberta, 7 Roncadelle (Brescia), Italy 25030
Re: K100921
Trade/Device Name: ADMIRAL XTREME™ PTA Balloon Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: April 01, 2010 Received: April 02, 2010
Dear Dr. Muster:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
Page 2 – Dr. Peter Muster
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse of 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 or any I edelar state as a requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note and regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. V. hmin
Image /page/3/Picture/7 description: The image shows a handwritten symbol or character. It appears to be a cursive letter, possibly a stylized 'f' or 'h', with a loop at the top and a stroke extending to the right at the bottom. The character is drawn with thick lines, suggesting it was written with a pen or marker.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100921
Device Name: ADMIRAL XTREME™ PTA Balloon Dilatation 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Turner
Page 1 of |
ision of Cardiovascular Devices
510(k) Number_K10092 |