(256 days)
no reference device was used in this submission.
No
The summary describes a physical medical device (embolization coils) and its materials, dimensions, and intended use. There is no mention of software, algorithms, image processing, or AI/ML terms. The performance study focuses on MRI compatibility, not algorithmic performance.
Question: Is this device a therapeutic device?
Yes
The device is described as "embolization coils" intended for "embolization procedures", which is a therapeutic intervention to block blood flow.
No
The device, MReye Embolization Coils, is described as being used in embolization procedures to block vessels, which is a therapeutic function, not a diagnostic one. Its purpose is to physically occlude vessels, as indicated by "peripheral arterial and venous vessel embolization procedures" and "forms a secondary curl diameter" upon deployment. While it is "MR Conditional" and its MRI compatibility is tested, this refers to its safety during imaging, not its function as an imaging or diagnostic tool.
No
The device description explicitly states the device is constructed from coiled Inconel wire and synthetic fibers, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "peripheral arterial and venous vessel embolization procedures." This describes a therapeutic procedure performed within the patient's body to block blood vessels.
- Device Description: The device is a physical coil designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or treatment decisions. This device does not perform any such analysis of specimens.
The device is an implantable medical device used for a therapeutic intervention.
N/A
Intended Use / Indications for Use
MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The MReye Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.025 to 0.038 inches, and the extended embolus lengths range from 1 to 20 cm. Upon exiting from the cartridge and the catheter. the coil forms a secondary curl diameter ranging from 0 (straight) to 45 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial and venous vessel
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)
MRI Testing - MRI testing verifies that the implant will be labeled as "MR Conditional" with the applicable parameters described in the Instructions for Use.
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.
no reference device was used in this submission.
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
§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated Nozomi Yagi Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K150931
Trade/Device Name: MReye® Embolization Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 19, 2015 Received: October 20, 2015
Dear Nozomi Yagi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150931
Device Name MReye® Embolization Coils
Indications for Use (Describe)
MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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10.0 510(k) SUMMARY
K150931
As required by 21 CFR §807.92 Date Prepared: April 3, 2015
I. SUBMITTER
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Nozomi Yagi |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 ext. 104511 |
| Contact Fax Number: | (812) 332-0281 |
II. DEVICE
Trade Name: Common Name: Classification Name: Regulation: Product Code
MReye® Embolization Coils Vascular Embolization Device Device, Vascular, For Promoting Embolization 21 CFR §870.3300 KRD
III. PREDICATE DEVICE
The device subject of this submission is believed to warrant a determination of substantial equivalence to the predicate device, the Cook MReye Embolization Coils (K090624). This predicate has never been subject to a design-related recall, and no reference device was used in this submission.
IV. DEVICE DESCRIPTION
The MReye Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.025 to 0.038 inches, and the extended embolus lengths range from 1 to 20 cm. Upon exiting from the cartridge and the catheter. the coil forms a secondary curl diameter ranging from 0 (straight) to 45 mm.
V. INDICATIONS FOR USE
MReye Embolization Coils are intended for use in peripheral arterial and venous vessel embolization procedures.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modification included in this submission expands the using existing technology and does not include any new technological characteristics. The MReye® Embolization Coils are comparable to the predicate device. Specifically, the MReye® Embolization Coils are identical in terms of intended use, principles of operation, materials of construction, and basic technological characteristics to the predicate device.
In addition to product expansion, a revision to the MRI labeling to update MR Conditional language has been included in this submission. The modifications are adequately supported by testing.
VII. PERFORMANCE DATA
The following test was performed to determine the appropriate Magnetic Resonance Imaging information for the proposed device:
- . MRI Testing - MRI testing verifies that the implant will be labeled as "MR Conditional" with the applicable parameters described in the Instructions for Use.
VIII. CONCLUSIONS
The result of the testing provides reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements of its intended use. The proposed device also does not raise new questions of safety or effectiveness as compared to the predicate device and thus is substantially equivalent to the predicate device.