(59 days)
No
The summary describes a physical medical device (an embolization device) and its delivery system. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the physical properties and clinical outcomes of the device itself.
Yes.
The device is intended to obstruct or reduce the rate of blood flow in blood vessels, which is a therapeutic intervention.
No
The device is an embolization device used to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EMBA Peripheral Embolization Device is an implantable device used to physically obstruct or reduce blood flow within the peripheral vasculature. It is used in vivo (within the living body) during a medical procedure.
- Intended Use: The intended use clearly describes a therapeutic intervention within the body, not the analysis of samples taken from the body.
- Device Description: The description details an implantable structure and a delivery system, consistent with a device used for internal procedures.
- Input: The input is fluoroscopic guidance, which is an imaging modality used during in vivo procedures.
Therefore, the EMBA Peripheral Embolization Device falls under the category of an implantable medical device used for therapeutic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
Product codes
KRD
Device Description
The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
The configuration of the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) is listed below.
Reference Number: PEP-001
Embolic Device Diameter (mm): 10
Embolic Device Length (mm): 20
Embolic Device Maximum Covered Length (mm): 10
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic guidance
Anatomical Site
Peripheral vasculature, 6-8mm 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)
Comparative performance testing was conducted to demonstrate that the technological differences the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) and the predicate devices do not raise concerns of substantial equivalence. Testing was conducted in accordance with the FDA guidance document of "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices." Testing conducted consisted of Kink Radius, Trackability, Partial Deployment and Retraction, Deployment Accuracy, Chronic Outward Force, Embolic Device Length and Diameter, Foreshortening, Contrast Flow, Migration Resistance, Occlusion Effectiveness, MR Compatibility, Corrosion, Fatigue Testing, Delivery System Integrity. Shelf Life, and Animal Testing.
Human Use Clinical Testing has been conducted on the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) (n=51) to evaluate safety and effectiveness endpoints.
Review of the in-vitro and in-vivo performance testing as well as the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, EMBA™ HOURGLASS™ Peripheral Embolization Device (PED), is substantially equivalent to the cited predicate devices, Reverse Medical® MVP® Micro Vascular Plug System (K141313) and Amplatzer® Vascular Plug 4 (K113658). Any differences between the subject and predicate devices do not raise different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reverse Medical® MVP® Micro Vascular Plug System (K141313), Amplatzer® Vascular Plug 4 (K113658)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
| Date Prepared: | July 31, 2017 |
|---|---|
| 510(k) SPONSOR: | EMBA Medical Limited |
| 3451 Commerce Parkway | |
| Miramar, FL 33025 | |
| Phone Number: 954-874-1016 | |
EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) TRADE NAME:
COMMON NAME: Vascular Embolization Device
| Product | Regulation and
Description | Product Code | Device | Device Class |
|--------------------------------------------|----------------------------------------------------------|--------------|------------------------------------|--------------|
| Peripheral
Embolization
Device (PED) | 21 CFR
870.3300
Vascular
Embolization
Device | KRD | Vascular
Embolization
Device | II |
PREDICATE DEVICES:
Reverse Medical® MVP® Micro Vascular Plug System (K141313) Amplatzer® Vascular Plug 4 (K113658)
DEVICE DESCRIPTION:
The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
The configuration of the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) is listed below.
| Reference Number | Embolic Device
Diameter
(mm) | Embolic Device
Length
(mm) | Embolic Device
Maximum Covered
Length
(mm) |
|------------------|------------------------------------|----------------------------------|-----------------------------------------------------|
| PEP-001 | 10 | 20 | 10 |
1
INDICATIONS FOR USE:
The EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
CONTRAINDICATIONS
The device should not be implanted in vessels