(90 days)
Not Found
Not Found
No
The summary describes a standard balloon catheter for angioplasty and explicitly states it is similar to commercially available PTA catheters. There is no mention of AI, ML, image processing, or any data-driven analysis capabilities.
Yes
The device is intended for balloon dilatation of lesions in peripheral arteries and treatment of obstructive lesions, which are therapeutic interventions.
No
The device is described as a PTA Catheter intended for "balloon dilatation of lesions" and to "treat obstructive lesions," which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is a "PTA Catheter," which is a physical medical device used for balloon dilatation. There is no mention of software as the primary or sole component.
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 the body.
- Device Description and Intended Use: The description clearly states that the Cordis PTA Catheters are used for balloon dilatation of lesions in peripheral arteries and arteriovenous dialysis fistulae. This is a procedure performed inside the body to physically open up narrowed blood vessels.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with IVDs.
Therefore, based on the provided information, the Cordis PTA Catheter is a therapeutic device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral), 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)
All appropriate biocompatibility tests were successfully performed on Cordis Corporation's Savy PTA Catheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K971010
June 18, 1997
PREMARKET NOTIFICATION 510(k) Cordis Corporation Savyy PTA Catheters March 19, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions: l.
Common Name:
Percutaneous Transluminal Angioplasty Catheters
Savy PTA Catheters Proprietary Name:
Name of Predicate Devices: 11.
- Savyy PTA Catheters Trade Name: 1. Cordis Corporation Manufacturer:
- Opta 5 PTA Catheters 2. Trade Name: Cordis Corporation Manufacturer:
- Ultra Thin PTA Catheter 3. Trade Name: Meditech Manufacturer:
111. Classification:
Class II
Performance Standards: IV.
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:
Savvy PTA Catheters are designed for dilating stenotic atherosclerotic lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
VI. Blocompatibility
All appropriate biocompatibility tests were successfully performed on Cordis Corporation's Savy PTA Catheters.
VII. Summary of Substantial Equivalence:
Savyy PTA Catheters are substantially equivalent to the predicate devices. Savy PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.
000013
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 1997
Ms. Jodi Lynn Greenizen Requlatory and Clinical Affairs Associate Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700
Re: K971010 Cordis Savvy PTA Catheter Regulatory Class: II (two) Product Code: LIT Dated: March 17, 1997 Received: March 20, 1997
Dear Ms. Greenizen:
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, Druq, 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, qood 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 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 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.
2
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) 594-4648. 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. Callahon
Thomas J. Callahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION 510(K) Cordis Corporation Savvy PTA Catheters
INDICATIONS FOR USE
510(k) Number: . . . . K971010 . . . . . . . .
Cordis Savvy PTA Balloon Catheter Device Name:
Indications for Use: The Cordis PTA Catheters are intended for balloon dilatation of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral, and 华 ilio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Tim Ah
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 971010 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over - The Counter Use_