(48 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of an embolization coil, with no mention of AI or ML technologies.
Yes
The device is used for vessel embolization procedures, which aims to block blood flow to treat conditions like aneurysms or hemorrhages, thus providing a therapeutic effect.
No
The device is described as an "embolization coil" used for "embolization procedures," which are therapeutic interventions to block blood vessels, not to diagnose conditions.
No
The device description clearly states it is a physical embolization coil made of Inconel with specific dimensions and shapes, intended for physical insertion into vessels. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for peripheral arterial and venous vessel embolization procedures." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The description details a physical implantable device (a coil) used for a surgical/interventional procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or treatment decisions. This device does not perform any such function.
Therefore, the MReye® Embolization Coil is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Used for peripheral arterial and venous vessel embolization procedures.
Product codes
KRD
Device Description
The MReye® Embolization Coil is supplied sterile and is intended for one time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has wire diameters of 0.025, 0.035, and 0.038 inches. It is available in curled and straight shapes. The emboli size range is 0 mm (straight) to 15 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved by a wire guide (sold separately) pushing the coil out of the catheter.
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)
The MReye® Embolization Coil was subjected to the following tests to ensure reliable design and performance under the specified testing parameters.
- Delivery Friction Testing ■
- I Coil Connection Testing
- . Coil Deformation Testing
- Wire Tensile Strength
- L Fiber Pull Out Testing
- 을 Magnetic Resonance (MR) Testing
- 피 Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use in peripheral arterial and venous vessel embolization procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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Traditional 510(k) Submission MReve® Embolization Coil COOK INCORPORATED 5 October 2005
NOV 2 3 2005
510(k) SUMMARY
Submitted By: Lisa Webb, MBA, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2643 4 October 2004
Device: Trade Name: MReye® Embolization Coil
Proposed Classification Name: Arterial Embolization Device
Predicate Devices:
The MReye® Embolization Coil is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Cook Embolization Coil.
Device Description
The MReye® Embolization Coil is supplied sterile and is intended for one time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has wire diameters of 0.025, 0.035, and 0.038 inches. It is available in curled and straight shapes. The emboli size range is 0 mm (straight) to 15 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved by a wire guide (sold separately) pushing the coil out of the catheter.
Substantial Equivalence
Cook currently markets the Cook Embolization Coil which is substantially equivalent to the MReye® Embolization Coil. The similar indications for use and technological characteristics of the MReye® Embolization Coil as compared to the predicate device support a determination of substantial equivalency.
1
Traditional 510(k) Submission MReye® Embolization Coil COOK INCORPORATED 5 October 2005
Test Data
The MReye® Embolization Coil was subjected to the following tests to ensure reliable design and performance under the specified testing parameters.
- Delivery Friction Testing ■
- I Coil Connection Testing
- . Coil Deformation Testing
- Wire Tensile Strength
- L Fiber Pull Out Testing
- 을 Magnetic Resonance (MR) Testing
- 피 Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use in peripheral arterial and venous vessel embolization procedures.
2
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 2005
Cook Incorporated c/o Ms. Lisa Webb Senior Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
Re: K052834 MReye® Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (Two) Product Code: KRD Dated: October 5, 2005 Received: October 6, 2005
Dear Ms. Webb:
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.
3
Page 2 - Ms. Lisa Webb
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 or any I 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. 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 (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duina R. Viihner
Image /page/3/Picture/5 description: The image shows the text "Bram D. Zuckerman, M.D. Director". The text is left-aligned and in a simple, sans-serif font. The text is likely a name and title, possibly indicating a person's name, credentials, and position within an organization.
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Submission MReye® Embolization Coil COOK INCORPORATED 5 October 2005
Indications for Use
510(k) Number (if known): __ Ko 52834
Device Name:
MReye® Embolization Coil
Indications for Use:
Used for peripheral arterial and venous vessel embolization procedures.
Prescription Use XX (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use_ (21 CRF 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
me Munica
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko