(18 days)
Not Found
No
The document describes a standard balloon catheter for angioplasty and does not mention any AI or ML components or functionalities.
Yes
The device is described as dilating stenoses and treating fistulae, which are therapeutic actions aimed at improving a patient's health condition.
No
The device description clearly states its purpose is to "dilate stenoses" and for "treatment," which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical catheter with a balloon, shaft, marker bands, and a flushing needle, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to dilate stenoses in blood vessels and arteriovenous fistulae. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter, designed for mechanical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and.for the treatment of stenoses of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. The dilatation section of the balloon has two radiopaque marker bands that indicate the balloon dimensions and aid in balloon placement. This catheter configuration has two proximal shaft marker bands at 90 cm and 100 cm from the distal tip to indicate the relative position of the catheter to the distal end of the guiding catheter. An additional band aids in locating the exit location of the guide wire. A flushing needle is packaged with the catheter as an accessory for flushing, and is for single use as indicated in the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The safety and effectiveness of the subject Cordis AMIIA PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification tests and analyses. All materials used in this modified device have been tested according to ISO 10993-Part 1 and were found biocompatible.
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.
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
FDA Special 510(k) Notification
Koso645
Cordis AMIIA .014" PTA Balloon Catheter
Attachment B:
510(k) Summary of Safety and Effectiveness
| Submitter & Contact person: | Cordis Europa, N.V., a Johnson & Johnson Company
Harm Hovinga,
Oosteinde 8
NL-9300 LJ Roden,
The Netherlands
Tel: +31 (5050) 22479
Fax: +31 (5050) 22456
e-mail: hhovinga@crdnl.jnj.com |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 11, 2005 |
| Trade Name | Cordis AMIIA™ Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification Name & Device Classification | |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Classification: | Class II |
| FDA Classification Panel: | Cardiovascular |
| Product Code: | LIT |
| Predicate Device(s) | The predicate devices in this submission are the Cordis AVIATOR (510(k) #K013581) and the Cordis M3 PTA Balloon Catheters (510(k) #K003920,
which have been determined substantial equivalent on November 28, 2001 and June 15, 2001 respectively. |
1
FDA Special 510(k) Notification Cordis AMIIA .014" PTA Balloon Catheter The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. Device The Cordis I Info I I T I causs indicate the dilatation section of the balloon description I wo facilopaque marker bands the balloon dimensions are indicated on the and ald in banoon pracements eter configuration has two proximal shaft nub 1D band. The 112 cm cm from the distal tip to indicate the relative markers at 90 cm and 100 on fistal end of the guiding catheter. An additional position of the catheror to the dist. exit and aids in locating the exit location of the guide wire. the guide wire.
A flushing needle is packaged with the catheter as an accessory for flushing A husining necure is packaged with use as indicated in the Instructions for Use The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, Intended Use The Cordils AMILA I Pre catalogin fra popliteal and renal arteries and for the temoral, ino-remoral; popilious of native or synthetic arteriovenous dialysis fistulae. The safety and effectiveness of the subject Cordis AMIIA PTA Balloon Safety and The Safety and Criocavonstrated via data collected from non-clinical design Performance Calletel has been demonstrated 11 materials used in this modified device have Data vertification tests and analyses. 1993-Part 1 and were found biocompatible. In summary, the subject Cordis AMIIA PTA Catheter is, in our opinion, Substantial In summal y, the subject Cordis devices with respect to intended Equivalence substantial equivalent to the prechedle O, sterility and operating principles.
2
FDA Special 510(k) Notification
Cordis AMIIA .014" PTA Balloon Catheter
A statement of substantial equivalence to another product is required by Substantial 21 CFR 807.87 and relates only to whether the present product can be Equivalence marketed without prior reclassification or clinical approval. Statement The present submission is therefore not related to the coverage of any I he present submission serpreted as an admission or used as evidence in patcht and is not to not lawsuit. As the commissioner of the FDA stated: a patcht mirringement in equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The lawraily markees a t intended to have any bearing whatsoever on the deter inmation is not infringement suits." 42 Federal Register 42, 50 et seq. (1977).
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2005
Cordis Europa N.V. c/o Mr. Harm Hovinga Senior Regulatory Affairs Associate Oosteinde 8, 9301 LJ Postbus 38, 9500 AA Roden The Netherlands
Re: K050645
AMIIA .014" PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: March 11, 2005 Received: March 14, 2005
Dear Mr. Hovinga:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device 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 encrosals) it the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, are except and entitle provisions of the Federal Food, Drug, devices mat nave occh receasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provision gractice, 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 If your device is chassified (over as a virols. Existing major regulations affecting your device can may oc subject to sach address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous ocements concerning your device in the Federal Register.
4
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 or any i 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. production 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
APPENDIX A:
Indications for Use
K050645 510(k) Number (if known):
Cordis AMIA PTA Catheter Device Name:
Indications For Use:
The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and.for the treatment of lomoral, popilisal, mostive 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)
Blumena
Sign-Off) Division of Cardiovascular Devices 510(k) Number Kosovati
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