(32 days)
Not Found
Not Found
No
The device description and intended use focus solely on the mechanical function of a balloon catheter for dilating stenoses. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as a "PTA Balloon Catheter" intended to "dilate stenoses" and treat "obstructive lesions" in various arteries and fistulae, indicating a direct therapeutic action on the body.
No
This device, a balloon catheter, is described as being "intended to dilate stenoses" and "for the treatment of obstructive lesions," which are therapeutic actions, not diagnostic ones. It is used to perform a medical procedure, not to identify or assess a condition.
No
The device description clearly details a physical catheter with lumens, a balloon, and radiopaque markers, indicating it is a hardware medical device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter clearly indicate it is a device used within the body (in vivo) to physically dilate blood vessels and fistulae. It is a therapeutic device, not a diagnostic one that analyzes samples.
The information provided focuses on the physical characteristics and function of the catheter for a medical procedure, not on analyzing biological samples for diagnostic purposes.
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 (comma separated list FDA assigned to the subject device)
DQY
Device Description
The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" 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 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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 is hydrophilic coated.
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)
Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the 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.
Not Found
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
NOV - 4 2005
Premarket Notification (510(k)) Summary
| 510(k) Number: | K052791 |
|---|---|
| Product Name: | AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter |
| Common Name: | Peripheral Transluminal Angioplasty Catheter |
| Class: | Class II, 21 CFR Sec 870.1250, Product Code DQY |
| Submitter's Name: | ev3 Inc. |
| 4600 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Official Contact: | Stephanie K. Isgrigg Robinson |
| Regulatory Affairs Specialist | |
| Telephone: 763-398-7036 | |
| Summary Preparation Date: | September 30, 2005 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
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.
The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" 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 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. 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 is hydrophilic coated.
The modified device is substantially equivalent* to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use.
- This document uses the term "substantial equivalence" as intended in 21 CFR 807.87. and not as defined in Title 35 of the US Code.
ﺮ
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ev3 Inc. c/o Ms. Stephanie K. Isgrigg Robinson Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442
Re: K052791
Trade Name: AMPHIRION DEEP PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2005 Received: October 03, 2005
Dear Ms. Isgrigg Robinson:
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.
NOV - 4 2005
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.
2
Page 2 - Ms. Stephanie K. Isgrigg Robinson
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 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 vr (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
iener R. bochner
Image /page/2/Picture/5 description: The image contains a signature on the left and the letters 'E' and 'I' on the right. The signature appears to be a stylized combination of curved and angular lines. The letters 'E' and 'I' are in a simple, sans-serif font and are positioned next to the signature.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Kos279 )
AMPHIRION DEEP™ Peripheral Transluminal Angioplasty (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 X (Part 21 CFR 801 Subpart D)
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)
DRung R. Vachner
AND/OR
J
Division Sign-Off) Division ... Cardiovascular Devices
510(K) Number_K6527 41
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