(24 days)
Not Found
No
The 510(k) summary describes a physical medical device (a coil system) and its modification. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests evaluating physical properties.
Yes
The device is intended to reduce or block blood flow in peripheral vasculature for the management of various vascular lesions, which is a therapeutic intervention.
No
Explanation: The device is intended to reduce or block blood flow in vessels and is used for therapeutic interventions (management of arteriovenous malformations, fistulae, aneurysms, and other lesions). There is no mention of it being used to collect or analyze data for diagnostic purposes.
No
The device description clearly states it is an implantable coil system with hardware components (coil, introducer, stylet, guidewire). The modification is the addition of a platinum overcoil, which is also a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" and for "interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature." This describes a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on samples like blood or tissue.
- Device Description: The device is an implantable coil delivered to a treatment site within the body. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
The device is clearly intended for therapeutic embolization within the peripheral vasculature.
N/A
Intended Use / Indications for Use
The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The AZUR PURE Peripheral Coil System, Pushable 18, consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
The subject of this Special 510(k) is the addition of a platinum overcoil to the AZUR PURE Pushable 18 device. The purpose is to improve tracking performance of the coil implant during delivery.
With the exception of the modification to add the platinum overcoil, the modified devices are identical to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral 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)
Pre-Clinical Testing:
Study Type: Design Verification and Validation Bench Test Summary
Sample Size: Not specified
Key Results:
- Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance): All performance ratings shall be ≥ 3. Result: PASS, acceptance criteria met.
- Advancement Force (Measure the force required to advance the coil into the microcatheter):
§ 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
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:
| Trade Name: | AZUR PURE Peripheral Coil System, Pushable 18 | DEC 2 0 2013 |
|---|---|---|
| Generic Name: | Vascular Embolization Device, accessory | |
| Classification and | ||
| Product Code: | Class II, 21 CFR 870.3300 | |
| Product Code KRD | ||
| Date Submitted: | November 22, 2013 | |
| Submitted By: | MicroVention, Inc | |
| 1311 Valencia Avenue | ||
| Tustin, California 92780 | ||
| U.S.A | ||
| Phone: 714-247-8000 | ||
| Contact: | Laraine Pangelina | |
| Sr. Regulatory Affairs Project Manager | ||
| MicroVention, Inc. | ||
| Predicate Device: | AZUR PURE Peripheral Coil System, Pushable 18 (K122543) | |
| Indications for Use: | The AZUR PURE is intended to reduce or block the rate of blood flow in | |
| vessels of the peripheral vasculature. It is intended for use in the | ||
| interventional radiologic management of arteriovenous malformations, | ||
| arteriovenous fistulae, aneurysms, and other lesions of the peripheral | ||
| vasculature. | ||
| Device Description: | The AZUR PURE Peripheral Coil System, Pushable 18, consists of an | |
| implantable coil housed in an introducer. A stainless steel stylet is used to | ||
| deploy the coil from the introducer into a delivery catheter. The coil is | ||
| delivered to the treatment site through the delivery catheter using a | ||
| standard guidewire. |
The subject of this Special 510(k) is the addition of a platinum overcoil to
the AZUR PURE Pushable 18 device. The purpose is to improve tracking
performance of the coil implant during delivery.
With the exception of the modification to add the platinum overcoil, the
modified devices are identical to the cleared predicate devices with regard
to intended use, principal of operation, materials, manufacturing
processes, packaging configuration, and sterilization method. | |
1
Pre-Clinical Testing:
| Design Verification and Validation Bench Test Summary | |||
|---|---|---|---|
| Test / Test Description | Acceptance Criteria | Test & Acceptance | |
| Criteria same as | |||
| predicate device? Y/N | Result | ||
| Simulate Use | |||
| Introduction, Tracking, Deployment, | |||
| Compartmentalizing, Frame Movement, | |||
| Microcatheter movement, Detachment, Overall | |||
| Performance | All performance | ||
| ratings shall be ≥ 3 | Y | PASS, acceptance | |
| criteria met | |||
| Advancement Force | |||
| Measure the force required to advance the coil | |||
| into the microcatheter |