(90 days)
Not found
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the coil, with no mention of AI or ML.
Yes
The device is intended for the embolization of vascular malformations, which is a therapeutic intervention.
No
Explanation: The device is intended for embolization (treatment) of vascular malformations, not for diagnosing conditions.
No
The device description clearly describes a physical medical device (occlusion coils) and associated hardware (catheters, introducer, adapter). There is no mention of software as the primary component or function.
Based on the provided information, the Berenstein Coil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "embolization of vascular malformations of the neuro vasculature." This describes a therapeutic procedure performed within the patient's body to block blood vessels.
- Device Description: The device is a physical coil designed to be delivered through a catheter into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Berenstein Coil does not perform any such function.
The Berenstein Coil is a therapeutic medical device used for interventional procedures.
N/A
Intended Use / Indications for Use
Berenstein Coils are intended for the embolization of vascular malformations of the 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 separatelv.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
In-vitro, in-vivo, and biocompatibility testing was performed to demonstrate that the Berenstein Coil is as safe, as effective, and performs as well as or better than the predicate device.
Functional bench testing was comprised of: 1) force required to deliver coils through catheters, and 2) coil/catheter compatibility. The results of these tests showed the Berenstein Coil is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Target Therapeutics Platinum Occlusion Coils
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/3 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle with a horizontal line extending from the center to the right, and the word "TARGET" in bold, sans-serif font above the word "THERAPEUTICS" in a smaller, sans-serif font. A horizontal line is placed between the two words.
AUG 15
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 separatelv.
INTENDED USE:
Berenstein Coils are intended for the embolization of vascular malformations of the neuro vasculature.
1
PREDICATE DEVICES:
The Berenstein Coil is substantially equivalent in materials, intended use, performance, and design parameters to Target Therapeutics Platinum Occlusion Coils. It is equivalent in the method of delivery to Cook Embolization Coils. All predicate devices are currently cleared for commercial distribution. The only difference between the Berenstein Coils and the predicates is the outer diameter of the platinum wire. In instances where the technological characteristics are different, it has been demonstrated with invivo and in-vitro testing that there are no new questions raised regarding safety or efficacy of the Berenstein Coil.
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
In-vitro, in-vivo, and biocompatibility testing was performed to demonstrate that the Berenstein Coil is as safe, as effective, and performs as well as or better than the predicate device.
Functional bench testing was comprised of: 1) force required to deliver coils through catheters, and 2) coil/catheter compatibility. The results of these tests showed the Berenstein Coil is substantially equivalent to the predicate device.
(k) Notification K961923 get Therapeutics Berenstein Coil Occlusion Device August 14, 1996