(134 days)
No
The device description focuses on the physical characteristics and delivery method of an embolization coil, with no mention of AI or ML capabilities.
Yes
The device is described as an "occlusion coil" intended for the "embolization of vascular malformations," which is a therapeutic intervention to treat a medical condition.
No
The device is used for embolization (treatment) of vascular malformations, not for diagnosis.
No
The device description clearly describes a physical medical device (occlusion coils) made of radiopaque material, delivered via catheters, and available in different sizes and shapes. It also mentions an adapter, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Berenstein Coil is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "embolization of vascular malformations of the peripheral and neuro vasculature." This describes a therapeutic procedure performed directly on a patient's body to block blood vessels.
- Device Description: The description details a physical coil designed to be delivered into the body through catheters. This is consistent with an implantable or interventional device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The Berenstein Coil's function is to physically block blood vessels within the body.
N/A
Intended Use / Indications for Use
Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.
Product codes
Not Found
Device Description
The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.
The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.
An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
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)
Reference Device(s)
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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
0
EB 26 1997
a. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON:
Laraine Pangelina Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538
DEVICE NAME:
Berenstein Coil , Class III
DEVICE DESCRIPTION:
The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.
The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.
An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.
INTENDED USE:
Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.
PREDICATE DEVICES:
The Berenstein Coil is identical in materials, performance, and design parameters to Target Therapeutics Berenstein Coils, cleared for commercial distribution for neuro vascular indications in K961923 and is similar to other Target Therapeutics occlusion coils cleared for use in the peripheral vasculature including