(37 days)
Not Found
No
The device description focuses on the physical characteristics and materials of the microcoil and delivery system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for "endovascular embolization of intracranial aneurysms," which is a medical treatment.
No
The device is an embolic coil system intended for the endovascular embolization (treatment) of intracranial aneurysms, not for diagnosis.
No
The device description explicitly details physical components like an embolic coil, a Device Positioning Unit (DPU), and platinum alloy wire, indicating it is a hardware device, not software-only.
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 microcoil designed to be delivered into an aneurysm to block blood flow. This is a physical implant used for treatment.
- Lack of Diagnostic Function: 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 used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The Micrus Presidio 18-System Microcoil consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile).
"Cerecyte" Microcoil Systems in the 18-system size received CE Marking in December 7, 2005. This technical file is in application of CE Marking for the "Presidio" 18-sized system. The Presidio 18-System Microcoil 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 spherical shapes and are available in various diameters and lengths:
- Coil lengths range from 30 to 50 centimeters.
- Coil diameters range from 8 to 20 millimeters. .
Micrus Presidio 18-System Microcoils are fabricated from the same diameter platinum alloy wire as used in the Cerecyte 18 system platinum Microcoils, 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 Microcoils are subjected to the same thermal treatments for primary and secondary shaping processes. The addition of Presidio 18-System Microcoil to the Cerecyte 18-System line means these 18-System Microcoils will be identical to the current CE Marked / FDA Cleared Cerecyte 18-System with only a single point of difference (length). The platinum alloy wire will match the diameter of all Micrus Microcoil 18 Systems (Platinum only and Cerecyte). The catalog number for Presidio-18 is PC4.
The 18 System Presidio Microcoils maintain the same design features as all the current Microcoil Systems. Compared with the current design, size 18 Presidio Microcoil Systems have:
- The same intended use
- Connect to the same connecting cables .
- Detach using the same Detachment Control Box. .
It is important to reiterate, the Micrus Presidio-18 MicroCoils are identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
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)
Not Found
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
AUG 25 2006
Safety and Efficacy Summary ll.
Contact Information A.
Patrick Lee Regulatory Affairs Specialist Micrus Endovascular Corporation 821 Fox Lane San Jose, CA 95131
B. Device Name
Micrus MicroCoil System, Presidio-18 Device, Artificial Embolization Regulation Number: 8822.5950 Product Code: HCG Device Class: II
C. Predicate Device(s)
| Number | Description | Clearance Date |
|---|---|---|
| K053160 | Micrus MicroCoil System, Cerecyte-18 | Dec 07, 2005 |
| K012145 | MicroVention MicroPlex Complex 3D | Oct 29, 2001 |
| K002056 | Micrus MicroCoil Delivery System | Jan 11, 2001 |
D. Device Description
The Micrus Presidio 18-System Microcoil consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile).
"Cerecyte" Microcoil Systems in the 18-system size received CE Marking in December 7, 2005. This technical file is in application of CE Marking for the "Presidio" 18-sized system. The Presidio 18-System Microcoil 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 spherical shapes and are available in various diameters and lengths:
- Coil lengths range from 30 to 50 centimeters.
- Coil diameters range from 8 to 20 millimeters. .
Micrus Presidio 18-System Microcoils are fabricated from the same diameter platinum alloy wire as used in the Cerecyte 18 system platinum Microcoils, 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 Microcoils are subjected to the same thermal treatments for primary and secondary shaping processes. The addition of Presidio 18-System Microcoil to the Cerecyte 18-System line means these 18-System
1
Microcoils will be identical to the current CE Marked / FDA Cleared Cerecyte 18-System with only a single point of difference (length). The platinum alloy wire will match the diameter of all Micrus Microcoil 18 Systems (Platinum only and Cerecyte). The catalog number for Presidio-18 is PC4.
The 18 System Presidio Microcoils maintain the same design features as all the current Microcoil Systems. Compared with the current design, size 18 Presidio Microcoil Systems have:
- The same intended use
- Connect to the same connecting cables .
- Detach using the same Detachment Control Box. .
It is important to reiterate, the Micrus Presidio-18 MicroCoils are identical to the current FDA cleared Micrus Cerecyte-18 MicroCoils except for length
E. Intended Use
The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
062036
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2006
Micrus Endovascular Corporation % Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose, California 95131
Re: K062036
Trade/Device Name: Micrus Microcoil system "Presidio-18" Model #s: PC4 Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: July 17, 2006 Received: July 19, 2006
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Patrick Lee
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (24 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation on it Jed. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
farbare melhn
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Kobjo36 510(k) Number (if known): _
Micrus Microcoil system "Presidio-18" Model #s: PC4 Device Name: ____
Indications For Use:
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1
Carbare Brelund for mxm
Division Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K062036