(84 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or image processing. The only information present is a predicate device which is a surgical repair kit, not typically associated with AI/ML.
No
The predicate device is a surgical repair kit, which suggests the device is used for surgical procedures rather than therapeutic purposes.
No
The device record states "Not Found" for "Intended Use / Indications for Use", "Device Description", and all other categories that would indicate its function. The only information available is a predicate device, which is a "Repair Kit", suggesting a non-diagnostic purpose.
No
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device. The only information available is a predicate device which is a physical repair kit, suggesting the subject device might also be hardware-related.
Based on the provided information, it is not possible to determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is "Not Found". This is the primary section that would describe how the device is used and what it is intended to diagnose, monitor, or treat. Without this information, we cannot assess if it involves in vitro examination of specimens from the human body.
- All other relevant sections that might provide clues about the device's function are also "Not Found". This includes the device description, input imaging modality, anatomical site, etc.
The presence of a predicate device (K970341 Bard Davol Repair Kit) suggests it's a medical device, but the predicate device's name (Repair Kit) doesn't inherently indicate an IVD function.
Therefore, with the information provided, we cannot conclude whether this device is an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
Not Found
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
N/A
0
510(k) Summary upon which equivalency is claimed Medtronic PS Medical Repair Kit Summary of Safety and Efficacy
APR 23 1997
The determination of safety and efficacy for the Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit is based upon the predicate Bard Davol Repair Kit. The safety and efficacy of design and indications is based upon years of clinical history with vascular access products fabricated from silicone elastomer. The materials utilized in the Medtronic PS Medical Rivas™ Vascular Catheter Repair Kit have demonstrated clinical in-vivo safety and efficacy.
The Bard Davol Repair Kit has proven safe and effective for repair of the external segment of a vascular catheter.
Vascular access products are not free from failure. Complications associated with the use of the device may be similar to those experienced in any other similar surgical procedure:
Reactions to drugs or anesthetic agents; Electrolyte imbalance: Allergic reaction to materials;
Local and systemic infections are not uncommon with this type of procedure. They are most usually due to organisms that inhabit the skin, particularly Staphylococcus epidermidis.
Based upon the summary above, Medtronic PS Medical determines substantial equivalence and safety and efficacy of the Rivas™ Vascular Catheter Repair Kit based upon the predicate and currently marketed devices.