(252 days)
Not Found
No
The summary describes a physical embolization coil and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for embolization in the peripheral vasculature, which is a medical procedure to treat conditions like vascular malformations or bleeding, thus making it a therapeutic device.
No
The device is described as an embolization coil used for therapeutic purposes (occluding blood vessels), not for diagnosing conditions.
No
The device description clearly states it is a physical coil and delivery system made of wire and fibers, 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 "arterial and venous embolization in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is a physical implant (embolization coil) used to achieve this blockage.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health or condition. This device does not perform any such analysis.
Therefore, the MReye Flipper Detachable Embolization Coils are a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The MReye® Flipper® Detachable Embolization Coil and Delivery System consists of a fibered detachable embolization coil and a delivery system. The MReye Flipper Detachable Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.035 inch. Upon exiting from the catheter, the embolization coil forms a secondary curl in vasculature, ranging from 3 to 8 mm.
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
Prescription Use
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
MRI Testing verifies that the implant will be labeled as MR Conditional 0 with the applicable parameters described in the Instructions for Use.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
Cook Incorporated Nozomi Yagi Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K150964
Trade/Device Name: MReye Flipper Detachable Embolization Coil and Delivery System 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 (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.
1
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150964
Device Name
MReye® Flipper® Detachable Embolization Coil and Delivery System
Indications for Use (Describe)
MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters, and the word "MEDICAL" is in smaller letters below it. There is a registered trademark symbol next to the word COOK.
510(k) SUMMARY
K150964
As required by 21 CFR §807.92 Date Prepared: October 19, 2015
I. SUBMITTER
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | David Lehr, RAC |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x102309 |
| Contact Fax Number: | (812) 332-0281 |
II. DEVICE
Trade Name:
Common Name: Classification Name: Panel: Regulation: Product Code
MReye® Flipper® Detachable Embolization Coil and Delivery System Embolization coil Vascular embolization device Cardiovascular 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 Flipper® Detachable Embolization Coil (K063619).
IV.DEVICE DESCRIPTION
The MReye® Flipper® Detachable Embolization Coil and Delivery System consists of a fibered detachable embolization coil and a delivery system. The MReye Flipper Detachable Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.035 inch. Upon exiting from the catheter, the embolization coil forms a secondary curl in vasculature, ranging from 3 to 8 mm.
V. INDICATIONS FOR USE
MReye Flipper Detachable Embolization Coils are used for arterial and venous embolization in the peripheral vasculature. The indication for use is identical to the predicate device.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modification included in this submission does not include any new technological characteristics. The MReye® Flipper® Detachable Embolization Coil and Delivery System is comparable to the predicate device. Specifically, the MReye® Flipper® Detachable Embolization Coil and Delivery System is identical to the predicate device in terms of intended use, principle of operation, materials of construction, and basic technological characteristics.
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 0 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.