(23 days)
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No
The description focuses on the physical characteristics and performance of a medical device (microcoil system) for embolization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "embolic coil" intended for "endovascular embolization of intracranial aneurysms," which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as an embolic coil system intended for the treatment (embolization) of intracranial aneurysms, not for diagnosis.
No
The device description clearly outlines physical components like an embolic coil, a Device Positioning Unit (DPU), and mentions compatibility with microcatheters. The performance studies also focus on physical properties like stiffness, friction, tensile strength, and durability of these physical components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular embolization of intracranial aneurysms." This is a therapeutic procedure performed within the body to treat a medical condition.
- Device Description: The device is a physical implant (microcoil) delivered via a system for placement within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a therapeutic implant used for treatment.
N/A
Intended Use / Indications for Use
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Modified Microcoil System, "Cerecyte-18" is intended for endovascular embolization of intracranial aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The Micrus Modified MicroCoil 18-System (Cerecyte) consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).
The predicate Cerecyte MicroCoil Systems in the 10-system size received FDA Clearance in February 2004. This application is for the 18-sized Cerecyte Microcoil System. The Cerecyte 18-System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in helical and spherical shapes and are available in various diameters/lengths:
- Coil lengths range from 4 to 30 centimeters. .
- Coil diameters range from 2 to 20 millimeters. .
Micrus Cerecyte MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The only difference between the Cerecyte 18 System and 10 System is size. Both contain PGA suture as their stretch resistant member. Both contain exactly the same PGA strand, i.e., the amount of PGA suture material is identical. Micrus does not insert a larger strand of suture in the 18 system coils.
The 18 System Cerecyte MicroCoils maintain the same design features as all the current MicroCoil Systems. Compared with the current design, size 18 Cerecyte MicroCoil Systems have:
- The same intended use .
. - Connect to the same connecting cables ●
- Detach using the same Detachment Control Box. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial aneurysms
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies were performed specifically on the Cerecyte-18 Microcoil System to ensure the design did not affect safety or function.
Coil Stiffness/Softness for Cerecyte-18 MicroCoils V0544: Characteristic: Stiffness limits for the Cerecyte-18 MicroCoil Systems. Test data: The Cerecyte-18 MicroCoils met the stiffness specifications. Result: Substantially equivalent.
Friction in the Microcatheter (Delivery Force) V0542: Characteristic: Average push force must be substantially equivalent to predicates. Test data: The Modified MicroCoil had average push forces that are comparable to those of the predicate. Result: Substantially equivalent.
Tensile Strength V0547: Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant Cerecyte-10 predicate. Test data: Tensile strength meets desired strength criteria. Result: Substantially equivalent to the stretch resistant predicate.
Durability (Reliability after Fatigue) V0543: Characteristic: Withstand deployment and retraction 6 times in a tortuous anatomy. Test data: No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria. Result: Substantially equivalent.
Sterilization Validation V0394 for Cerecyte 10-System: Characteristic: Minimum Sterility Assurance Level of 10-6. Test data: Cerecyte-10 was validated under V0394. Due to the significant similarities (in materials used, manufacturing processes, product weight & density, and packaging) between the 10 & 18 Systems, V0394 will serve as validation for the 18-system Cerecyte. Result: Substantially equivalent.
MRI Compatibility of Implant: No change was made which would impact MRI compatibility. Result: Substantially equivalent.
Package Integrity V0399 for Cerecyte 10 System: Characteristic: Demonstrate package integrity per ISO 11607. Test: No change was made to packaging. Reference Cerecyte 10 test result V0399. Result: Substantially equivalent.
Ship/Transit V0400 for Cerecyte 10 System: Characteristic: Successfully withstand domestic and international distribution environment. Test: Does successfully withstand domestic and international distribution environment. No change was made to packaging or product materials. Reference Cerecyte 10 test result. Result: Substantially equivalent.
This functional testing demonstrates the substantially equivalent performance of the Micrus Cerecyte-18 MicroCoil System with the 2 predicate devices: (1) Micrus MicroCoil Delivery System, and (2) Micrus Cerecyte-10 MicroCoil System. All test results are included in "Section 2.2, Verification/Validation."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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/1 description: The image shows the text "K053160 1/8" in a handwritten style. The text is written in black ink on a white background. The numbers and letters are slightly uneven and have a rough texture, indicating that they were written by hand.
Section 1.4: Cerecyte-18, 510(k) Summary
Contact Information: 1.4.1
| Name: | Margaret Webber, Director, Regulatory & Clinical Affairs |
|---|---|
| Address: | Micrus Endovascular Corporation |
| 610 Palomar Ave. | |
| Sunnyvale, CA 94085 | |
| Telephone: | 408-830-5900, ext. 108 |
| Date: | Nov. 28, 2005 |
Device Information 1.4.2
Micrus Modified MicroCoil, "Cerecyte" 18-System Device Name: Common Name: Device, Artificial Embolization Classification: Class II
Predicate Devices Identification 1.4.3
K033813, Micrus Modified Microcoil 10-System "Cerecyte" K002056, Micrus Microcoil Delivery System (10 and 18 sizes)
Device Description 1.4.4
The Micrus Modified MicroCoil 18-System (Cerecyte) consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).
The predicate Cerecyte MicroCoil Systems in the 10-system size received FDA Clearance in February 2004. This application is for the 18-sized Cerecyte Microcoil System. The Cerecyte 18-System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in helical and spherical shapes and are available in various diameters/lengths:
- Coil lengths range from 4 to 30 centimeters. .
- Coil diameters range from 2 to 20 millimeters. .
Micrus Cerecyte MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The only difference between the Cerecyte 18 System and 10 System is size. Both contain PGA suture as their stretch resistant member. Both contain exactly the same PGA strand, i.e., the amount of PGA suture material is identical. Micrus does not insert a larger strand of suture in the 18 system coils.
The 18 System Cerecyte MicroCoils maintain the same design features as all the current MicroCoil Systems. Compared with the current design, size 18 Cerecyte MicroCoil Systems have:
-
The same intended use .
. -
Connect to the same connecting cables ●
-
Detach using the same Detachment Control Box. .
1
KOS3160
Image /page/1/Figure/1 description: This image shows the Micrus Modified MicroCoil System, Cerecyte, which is available in 10 and 18 system sizes. The image shows the different parts of the system, including the DPU, detachment fiber, coil, PGA suture, and PGA ball tip. The Cerecyte MicroCoil Systems (in 10 and 18 System sizes) have a PGA ball tip and a PGA suture that extends to the detachment zone.
Cerecyte 18-System coils size ranges are:
- Helical Cerecyte (CHE) ranges from 2 -- 20 mm in diameter and from 4 -. 30 cm in length.
- Spherical Cerecyte (CSP) ranges from 2 20 mm in diameter and 2.7 -. 30 cm in length.
Indications for Use 1.4.5
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Contraindications
None.
Required Accessory Products
The Micrus MicroCoil Systems require two other components for the Micrus MicroCoil Delivery System to operate:
1.Detachment Control Box (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
2.Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 meters) long.
Accessories, which are an Integral Part of the Sales Unit:
The Micrus MicroCoil System is packaged with an introducer in place. This introducer allows introduction of the MicroCoil into the microcatheter used by the clinician.
2
Accessories (Not Part of the Sales Unit, not supplied by Micrus Endovascular Corporation)
- Guiding Catheter (generally, 5-7F) .
- Infusion microcatheter with 2 tip markers located 3cm apart .
- Guide wire compatible with the microcatheter ●
- Continuous Saline Flush Set-Ups with pressure bags, one of which . is a flush for the guiding catheter and one the other a flush for the microcatheter.
- Rotating Haemostatic Valves (2) .
- 3-Way Stopcock .
- 1-Way Valve .
- IV Pole .
- Femoral Sheath .
Comparison to Predicate 1.4.5
Intracranial aneurysms can form for a variety of reasons, and the consequences of aneurysm formation and/or rupture can be dire for the patient. Treatment of intracranial aneurysms involves the segregation of the sac from the blood supply of the parent artery. This prevents the aneurysm from growing in size, from rupturing or from re-rupturing. Treatments currently include the application of an aneurysm clip to the base of the aneurysm using open surgical procedures (craniotomy). Alternatively, the aneurysm may be embolically closed or occluded using minimally invasive delivery of embolic coils. Embolic coils are generally made of a biocompatible metal, such as stainless steel, tungsten or platinum. Dacron, nylon, or silk fibers may be incorporated into the design to enhance thrombosis. The coils come in a variety of widths, lengths, softness, and shapes and are delivered by small catheters ("microcatheters"). Multiple coils are placed into the aneurysm to completely fill the sac and prevent continued inflow of blood. The embolic coils cause stagnation of blood within the aneurysm resulting in platelet aggregation, which leads to the development of scar tissue. This prevents the continuing enlargement of the aneurysm and the potential fro rupture or re-rupture.
The intent of endovascular treatment of intracranial aneurysms using embolic coils is to pack the lumen of the aneurysm with the coils, thereby eliminating the influx of fresh blood into the lumen. The existing blood and soft clot trapped within the lumen of the aneurysm begins to solidify, ultimately becoming hardened clot and scar tissue. With treatment of the aneurysm lumen (from aneurysm dome to neck) a blood flow pathway is reestablished down the lumen of the parent artery, and the weakened wall of the aneurysm is totally isolated from arterial pressures. Reendothelialization occurs on the surface of the scar tissue, and the pretreatment vortical flow is changed back to normal, laminar flow within the parent artery.
3
cranial aneurysms
oth, bare, platinum
4/
Micrus MicroCoil Systems have been used to treat intracranial aneurysms Micrus May 2000. MicroCoils are available in both bare platinum implants and stretch resistant implants containing either absorbable suture (PGA) or non-absorbable suture (polypropylene). Micrus MicroCoils are (1 Gr ) or mon abbere 10 and 18 sizes and in spherical and helical shapes in a variety of lengths and diameters.
Clinical data regarding MicroCoils (and other intracranial coil implants) have been presented in previous 510k submissions to FDA as each new coil family member was introduced. The Cerecyte MicroCoil 18-System is an addition to the Cerecyte 10-System coil line. Below are Bystein 15 an addition equivalence of Cerecyte-18 to the ecomparison tables to and predicate Micrus (10 &18 sized bare platinum helical and spherical) MicroCoil Systems.
4
ne Design Comparison Table and Functional Comparison Table Mow the Corecyte-18 Modified MicroColis are designed
identical manner as the current family of CE Marked MicroCoil
| Design
| Feature | Micrus Platinum 18-System Predicate | Micrus Cerecyte-10 System Predicate | Micrus Cerecyte-18 System |
|---|---|---|---|
| Implant | |||
| Material | |||
| Composition | Platinum Tungsten Alloy Wire. | ||
| No suture. | Platinum Tungsten Alloy Wire. | ||
| Absorbable PGA suture. | Same as Cerecyte 10 System predicate | ||
| Diameter | Implant available in up to 20 mm diameter | Implant available in up to 10 mm diameter | Same as Platinum 18 System predicate |
| Implant | |||
| length | Implant available in up to 30 cm lengths | Implant available in up to 15 cm lengths | Same as Platinum 18 System predicate |
| Device | |||
| Positioning | |||
| Unit (DPU) | Stainless steel hypotube (proximal), stainless steel braid (mid), and polymer (distal) sheathing for 2 conduction wires and distal resistive heating coil. | Stainless steel hypotube (proximal), stainless steel braid (mid), and polymer (distal) sheathing for 2 conduction wires and distal resistive heating coil. | Same as predicates. |
| Connecting | |||
| Cable | |||
| compatibility | Single cable with proprietary connectors to fit only the Micrus Detachment Control Box and the Micrus MicroCoil System. | Single cable with proprietary connectors to fit only the Micrus Detachment Control Box and the Micrus MicroCoil System. | Same as predicates. |
| Detachment | |||
| technique | Shear polyethylene fiber with a loop of resistively heated coil. | Shear polyethylene fiber with a loop of resistively heated coil. | Same as predicates. |
| Packaging | Packaged in plastic loop, enclosed in foil pouch | Packaged in plastic loop, enclosed in foil pouch | Packaged in plastic loop, enclosed in foil pouch |
| Instructions | |||
| for Use | Uses a single IFU for the entire MicroCoil family | Uses a single IFU for the entire MicroCoil family | Same as predicates |
| Microcatheter | |||
| compatibility | Compatible with 2-tip marker microcatheters: | ||
| • 10 system uses 10 & 14 catheters | |||
| • 18 system uses 14 & 18 catheters | Compatible with 2-tip marker microcatheters: | ||
| • 10 system uses 10 & 14 catheters | Compatible with 2-tip marker microcatheters: | ||
| • 18 system uses 14 & 18 catheters | |||
| Sterilization | E-Beam | E-Beam | E-Beam |
T