(90 days)
Berenstein Coils are intended for the embolization of vascular malformations of the neuro vasculature.
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.
The provided text describes a medical device (Berenstein Coil) and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria as typically understood in the context of AI/ML or diagnostic device performance.
The document is a 510(k) summary for a Class III medical device (Berenstein Coil). It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than establishing specific diagnostic performance metrics (like sensitivity, specificity, AUC) against a defined ground truth.
Therefore, I cannot provide a response based on your requested structure, as the necessary information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, or training set details is not present in the provided text.
The "Testing in Support of Substantial Equivalence Determination" section describes:
- In-vitro, in-vivo, and biocompatibility testing: These are general categories of testing to ensure safety and effectiveness comparable to predicate devices.
- Functional bench testing:
- Force required to deliver coils through catheters.
- Coil/catheter compatibility.
These are engineering/design validation tests, not clinical performance metrics against a ground truth.
In summary, the provided text does not contain the type of study data (e.g., diagnostic accuracy metrics against a ground truth, reader study results) that your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic devices would typically require.
{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
§ 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).