(73 days)
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No
The document describes a physical medical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to dilate arteries and treat obstructive lesions, directly impacting the physiological function to alleviate medical conditions.
No
This device, a PTA balloon catheter, is described as intended to dilate arteries and treat obstructive lesions, indicating a therapeutic rather than a diagnostic purpose. It is used for intervention, not for identifying a disease or condition.
No
The device description clearly details a physical balloon catheter with lumens, radiopaque markers, and a balloon, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description and intended use of the Opta LP PTA balloon catheter clearly indicate it is a device used inside the body for a therapeutic procedure (dilating arteries and fistulae). It is a physical device used to treat a condition, not to analyze a biological sample.
The device is an interventional medical device used for angioplasty.
N/A
Intended Use / Indications for Use
The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Opta LP PTA Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Cordis Opta LP PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.
The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub.
The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Stenoral, ilio-femoral, popliteal infra popliteal and renal arteries; iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries; native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K971448'. The characters are written in a simple, clear style, making them easily readable.
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SUMMARY OF SAFETY EFFECTIVENESS
" 3 1997 . || ||
I. General Provisions
PTA Balloon Catheter Common or Usual Name:
Opta LP™ PTA Balloon Catheter Proprietary Name:
II. Name of Predicate Devices
- Cordis Opta5 PTA Balloon Catheter
- Cordis PowerFlex PTA Balloon Catheter
- Cordis Small Vessel PTA Balloon Catheter
- Cordis Savvy PTA Balloon Catheter
- Meditech UltraThin Balloon Catheter
III. Classification
Class II
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Cordis Opta LP PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.
The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub.
The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.
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VI. Biocompatibility
All materials used in the Opta LP PTA balloon catheter are biocompatible.
VII. Summary of Substantial Equivalence
The Cordis Opta LP PTA balloon catheter and the referenced Cordis Opta5 PTA balloon catheter, Cordis PowerFlex PTA balloon catheter, Cordis Small Vessel PTA balloon catheter, Cordis Savvy PTA balloon catheter and Meditech UltraThin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol, with "DEPARTMENT OF HEALTH & HUMAN" on the left side and "SERVICES - USA" on the top right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mirjam Barboza, M.D. Manager, Requlatory Affairs and Clinical Research Cordis Corporation P.O. Box 025700. - -----------------------------------------------------------------------------------------------------------------------------------------------------------
K971448 Re : Cordis Opta™ LP PTA Balloon Catheter Regulatory Class: II (two) Product Code: LIT Dated: April 18, 1997 Received: April 21, 1997
Dear Dr. Barboza:
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 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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 witro. ... diagnostic devices); please contact the Office of Compliance at '' '' ' (301) 594-4648. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Cordis Opta LPTM PTA Balloon Catheter
Indications for Use:
The Opta LP PTA Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Tara t. Rh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ------
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