(87 days)
Not Found
No
The summary describes a physical embolic device (PVA particles) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used for "vascular occlusion of blood vessels" and "presurgical devascularization" of "arteriovenous malformations and neoplastic lesions," which are medical treatments.
No
The device description states its use for vascular occlusion and presurgical devascularization, which are therapeutic interventions, not diagnostic processes.
No
The device description and intended use clearly indicate a physical product (PVA particles) used for vascular occlusion, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "vascular occlusion of blood vessels within the neurovascular systems." This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This process happens in vitro (outside the body).
The description of the TRUFILL PVA particles and their intended use aligns with a device used for a therapeutic intervention within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable.
Product codes (comma separated list FDA assigned to the subject device)
84HCG
Device Description
TRUFILL PVA Particles
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular systems, blood vessels
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.
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
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
PREMARKET NOTIFICATION 510 (K) Cordis Endovascular Systems, Inc. Truffil PVA Particles Modification - September 13, 1996
( 1.5
SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Provisions
19:21
03/19/91
Common or Usual Name: Proprietary Name:
03058248610
Artificial Embolization Device TruFill™ PVA Particles
II. Name of Predicate Devices
TruFill PVA Particles manufactured by Cordis Endovascular Systems, Inc (CES) 510(k) No. K951314, concurred on 8/8/95
Contour PVA manufactured by Interventional Therapeutics Corporation 510 (k) No. K944354, concurred 12/13/94
III. Classification
Class III. Artificial Embolization Device, 84HCG, CFR 882.5950
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.
TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable.
Biocompatibility VL.
All appropriate biocompatibility tests were successfully performed on the TruFill PVA Particles.
Summary of Substantial Equivalence VII.
The TruFill PVA are similar in their basic design, construction, indication for use and performance characteristics to other commercially available poly vinyl alcohol particles.