(87 days)
Not Found
No
The summary describes a standard PTA catheter and explicitly states it is similar to commercially available devices, with no mention of AI/ML or related concepts.
Yes
The device is described as a "PTA Catheter" for dilating stenotic lesions and treating obstructive lesions in arteries and fistulae, which are therapeutic interventions.
No
Explanation: The device is a PTA Catheter designed for dilating stenotic lesions and treating obstructive lesions, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states "Jupiter PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters," indicating a physical catheter device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a therapeutic procedure (dilating stenotic lesions and treating obstructive lesions) within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description refers to a "PTA Catheter," which is a medical device used in interventional procedures, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Jupiter PTA Catheter is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Jupiter PTA Catheters are designed for dilating stenotic lesions in peripheral arteries (renal, popliteal, infra popliteal, femoral, and illio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
Not Found
Device Description
Jupiter PTA Catheters are designed for dilating stenotic lesions in peripheral arteries (renal, popliteal, infra popliteal, femoral, and illio 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 (renal, popliteal, infra popliteal, femoral, and illio 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
000048
APR 24 1997
PREMARKET NOTIFICATION 510(k) Cordis Corporation Juniter PTA Catheters January 24, 1997
Attachment 1 SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions: l,
Common Name:
Percutaneous Transluminal Angioplasty Catheters
Jupiter PTA Catheters Proprietary Name:
Name of Predicate Devices: 9.
- Juniter PTA Catheters Trade Name: a. Manufacturer: Cordis Corporation
- Trade Name: Opta 5 PTA Catheters b. Cordis Corporation Manufacturer:
ﻤﺴ
- Ultra Thin PTA Balloon Catheter Trade Name: C. Manufacturer: Medi Tech'
111. 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.
Intended Use and Device Description: V.
Jupiter PTA Catheters are designed for dilating stenotic lesions in peripheral arteries (renal, popliteal, infra popliteal, femoral, and illio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
1 A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA has stated"... A determination of substantial equivalence under the Federal Food. Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without ore-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits" 42 Fed. Reg. 42, 520 et seq. (1977).
1
PREMARKET NOTIFICATION 510(k) Cordia Corporation Jupiter PTA Catheters January 24, 1997
Blocompatibility VI.
Since no new materials are being introduced in this submission, no additional biocompatibility testing was performed. All appropriate biocompatibility tests were successfully performed on Cordis Corporation's Jupiter PTA Catheters. Biocompatibility test results can be found in K955886. Biocompatibility testing was performed in compliance with ISO Standard 10993.
Summary of Substantial Equivalence: VII.
Jupiter PTA Catheters are substantially equivalent to the predicate devices. Jupiter PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.