(48 days)
Used for peripheral arterial and venous vessel embolization procedures.
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.
This document describes a 510(k) premarket notification for the MReye® Embolization Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance criteria through clinical studies or detailed algorithm evaluations.
Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies assessing AI/ML device performance or clinical effectiveness studies for novel devices, is not present in this 510(k) submission.
Here's an explanation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with specified quantitative thresholds for performance metrics. Instead, it lists the types of tests performed to ensure reliable design and performance, and generally states that the results provide "reasonable assurance" of conformance.
| Test Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Delivery Friction Testing | (Implied: Acceptable friction for deployment) | Not specified beyond "subjected to tests" |
| Coil Connection Testing | (Implied: Secure connection) | Not specified beyond "subjected to tests" |
| Coil Deformation Testing | (Implied: Maintains shape as intended) | Not specified beyond "subjected to tests" |
| Wire Tensile Strength | (Implied: Sufficient strength to avoid breakage) | Not specified beyond "subjected to tests" |
| Fiber Pull Out Testing | (Implied: Fibers remain securely attached) | Not specified beyond "subjected to tests" |
| Magnetic Resonance (MR) Testing | (Implied: MR compatibility/safety) | Not specified beyond "subjected to tests" |
| Biocompatibility Testing | (Implied: Biocompatible) | Not specified beyond "subjected to tests" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for a medical device (embolization coil), not an AI/ML diagnostic or prognostic algorithm that uses test sets with patient data. The "tests" mentioned are engineering and material compatibility tests, not clinical studies with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is relevant for studies where human expert review establishes a "ground truth" for comparison, typically in AI/ML performance evaluations or clinical trials. This 510(k) focuses on the physical and material characteristics of the coil.
4. Adjudication Method
Not applicable for the same reasons as points 2 and 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. This type of study is designed to assess how human readers' performance changes with AI assistance, which is not applicable to a physical medical device like an embolization coil.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study evaluating an algorithm's performance was not performed. This device is a physical embolization coil, not a software algorithm.
7. Type of Ground Truth Used
Not applicable. The "ground truth" concept (e.g., pathology, outcomes data, expert consensus) is typically used in the context of diagnostic or prognostic evaluations, often involving imaging or other patient data. The tests performed for this device relate to its physical and material properties.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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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.
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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.
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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.
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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
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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
§ 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).