(105 days)
Not Found
Not Found
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, indicating a therapeutic purpose.
No
The device description indicates that the AMPHIRION DEEP catheter is a therapeutic device used to dilate stenoses. It does not mention any function for diagnosing conditions.
No
The device description clearly details a physical catheter with an inflatable balloon, lumens, marker bands, and a hydrophilic coating. This is a hardware device, not software.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is a physical device used within the body to dilate blood vessels. It is used for a therapeutic procedure (angioplasty) and does not analyze samples taken from the body.
The description clearly indicates it's an interventional device used directly on anatomical structures within the patient.
N/A
Intended Use / Indications for Use
The AMPHIRION™ DEEP 0.014" OTW PTA BALLOON 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 AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. 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 is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.
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, and for the treatment of obstructive lesions of 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
In-vitro testing was conducted to demonstrate the safety and effectiveness of the AMPHIRION DEEP catheter. This testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions and guidewire and introducer compatibility.
Key Metrics
Not Found
Predicate Device(s)
Boston Scientific SYMMETRYTM Small Vessel Balloon Dilatation Catheter, Cordis AVIATORTM Peripheral Dilatation Catheter
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
K04262 y
510(k) Summary AMPHIRION™ DEEP 0.014" OTW PTA BALLOON 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
(Manufacturer) | Invatec Innovative Technologies, s.r.l.
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 |
| Submitter | ev3 Inc.
4600 Nathan Lane North
Plymouth, MN 55442
Tel: (763) 398 7000
Fax: (763) 398 7200 |
| Contact Person | Mike Winegar
Tel: (763) 398-7225
Fax: (763) 398-7200
E-mail: mwinegar@ev3.net |
| Date Prepared | September 24th, 2004 |
| Device Trade Name | AMPHIRIONTM DEEP 0.014" OTW PTA BALLOON CATHETER |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class II
Product Code: LIT |
| Classification Panel | Cardiovascular |
| Predicate Devices | Boston Scientific SYMMETRYTM Small Vessel Balloon Dilatation
Catheter
Cordis AVIATORTM Peripheral Dilatation Catheter |
| Intended Use | The AMPHIRIONTM DEEP 0.014" OTW PTA BALLOON
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 AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. 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 is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm. |
| Biocompatibility | All material used in the AMPHIRION DEEP catheter are biocompatible, based on test results. |
| Performance Data | In-vitro testing was conducted to demonstrate the safety and effectiveness of the AMPHIRION DEEP catheter. This testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions and guidewire and introducer compatibility. |
| Summary of Substantial
Equivalence | The AMPHIRION DEEP catheter is similar to the predicates with respect to intended use and with respect to physical characteristics, such as catheter and balloon dimensions and catheter design and materials. The AMPHIRION DEEP catheter is therefore substantially equivalent to the predicate devices. Mechanical and biocompatibility testing data is indicative of the safety and effectiveness of the AMPHIRION DEEP catheter. Therefore, based on its own performance characteristics and the technological similarities, the AMPHIRION DEEP catheter is expected to perform similar to the predicate devices and other comparable, currently marketed PTA catheters. |
| Conclusion | The AMPHIRION DEEP catheter is substantially equivalent to the predicate devices and other currently marketed PTA catheters. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping chevrons or swooshes, creating a sense of movement or flow.
JAN 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ev3 Inc. c/o Mr. Mike Winegar Vice President, International Regulatory Affairs 4600 Nathan Lane North Plymouth, MN 55442
Re: K042624 Trade Name: AMPHIRION DEEP PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: September 24, 2004 Received: September 27, 2004
Dear Mr. Winegar:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 rotty premeined is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatis and the Medical Device American so to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the dis devices that have been icclassified in accercance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval one You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market the device, experients for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is crassified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller a Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of concerning your device in the Federal Register.
3
Page 2 – Mr. Mike Winegar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession requirements of the Act
that FDA has made a determination that your device complies with other matt that FDA has made a determination that your active federal agencies. You must of any Federal statutes and regulations annualines but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good if applicable, the electronic Iorni in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050. product fadiation control provisions (Decleons De Levice as described in your Section 5 10(k) I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket nothication. The PDA maing of backers on the said 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 If you desire specific arvice for your as 1100 % 276-0120. Also, please note the regulation entitled, p Colliact the Office of Complians as (21 trip Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Oolisanter : 16www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Danna R. Victines
Bram D. Zuckerman, M.D. ﮐﮯ Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: KC)42624
Device Name: AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
Indications For Use:
The AMPHIRION™ DEEP 0.014" OTW PTA Balloon 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
(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)
Muna R. Vochner
(Division Sign-Off)
ovision of Cardiovascular Devices
510(k) Number_KO
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