(19 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (a balloon catheter) and does not mention 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" fields are explicitly marked as "Not Found".
Yes
The device is described as dilating stenoses and treating obstructive lesions, which are therapeutic actions aimed at improving a patient's condition.
No
The device is a therapeutic device (balloon catheter) used for dilating stenoses and deploying stents, not for diagnosing medical conditions.
No
The device description clearly identifies it as a "PTA Balloon Catheter," which is a physical medical device used for dilatation and stent deployment, not a software-only product.
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. These tests are performed outside of the body.
- Device Function: The Maxi DS PTA Balloon Catheter is a device used inside the body to physically dilate blood vessels and deploy stents. It is an interventional device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly describes a therapeutic procedure (dilating stenoses, treating obstructive lesions, deploying stents) performed directly on the patient's anatomy.
Therefore, based on the provided information, the Maxi DS PTA Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Maxi DS PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system.
The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system.
Product codes
LIT
Device Description
The Maxi DS PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system.
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, biliary system.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cordis Opta5 PTA Balloon Catheter, Cordis Maxi LD PTA Balloon 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
Attachment 4
Summary of Safety and Effectiveness JUN 15 1999 Trade Name: Cordis Maxi DS PTA Balloon Catheter General Provisions Common/Classification Name: Peripheral Transluminal Angioplasty Balloon Catheter Name of Cordis Opta5 PTA Balloon Catheter Cordis Maxi LD PTA Balloon Catheter Predicate Devices Class II. Classification Performance standards have not been established by the FDA under section 514 of Performance the Food, Drug and Cosmetic Act. Standards The Maxi DS PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, Intended Use femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the and Device treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Description In addition, certain sizes of the Maxi DS catheters are also indicated for deployment of Palmaz balloon expandable stents for the biliary system. Biocompatibility All materials used in the Maxi DS PTA Balloon Catheters are biocompatible. Summary of The Maxi DS catheters are substantially equivalent to the previously cleared Opta5 and Maxi LD catheters. Substantial Equivalence
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three wavy lines that resemble a person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
JUN 15 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ariel MacTavish, RAC Sr. Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami Lakes, FL 33014
Re: K991811 Cordis Maxi DS PTA Balloon Catheter Trade Name: Requlatory Class: II Product Code: LIT Dated: May 26, 1999 Received: May 27, 1999
Dear Ms. MacTavish:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices
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Page 2 - Ariel MacTavish, RAC
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Maxi DS PTA balloon Catheter |
| Indications for Use | The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K991811 | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use _____ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ---------------------------------------------------------------------------- |