(24 days)
No
The summary describes a physical medical device (embolization coil) and its mechanical performance testing. There is no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The device is used for vessel embolization procedures, which aims to occlude blood flow to treat various conditions, thus performing a therapeutic function.
No
The device is used for embolization procedures, which involve blocking blood vessels, not for diagnosing conditions. The performance studies focus on the physical properties and delivery of the device, not on diagnostic accuracy.
No
The device description clearly states it is a physical coil pre-loaded into a cartridge for delivery, indicating it is a hardware medical device. The performance studies also focus on physical properties like deformation, friction, and pull-out.
Based on the provided information, the Cook MReye Embolization Coil is not an IVD (In Vitro Diagnostic) device.
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 body, not a test performed on a sample taken from the body.
- Device Description: The description details a device used to deliver a coil into blood vessels for embolization. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cook MReye Embolization Coil is a therapeutic device used to block blood flow in vessels.
N/A
Intended Use / Indications for Use
The Cook MReye Embolization Coil is used for peripheral arterial and venous vessel embolization procedures.
Product codes
KRD
Device Description
The Cook MReye Embolization Coil is a device used for peripheral arterial and venous vessel embolization procedures. The coil is pre-loaded into a cartridge to facilitate delivery into a microcatheter, which then delivers the coil to the embolization site.
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
The following testing data were presented to demonstrate that the Cook MReye Embolization Coils meet applicable design and performance requirements:
- Coil deformation testing .
- Delivery friction testing
- Embolization fiber pull-out testing
- . Cannula to catheter delivery testing
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
K052834, Cook Stainless Steel Embolization Coils (Pre-amendment)
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
Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009
- 20 -
1090624
510(k) SUMMARY
APR - 2 2009
| Submitted By: Susanne Galin, RAC |
|---|
| Regulatory Affairs Specialist |
| Cook Incorporated |
| 750 Daniels Way, P.O. Box 489 |
| Bloomington, IN 47402 |
| (812) 339-2235 x 2296 |
| February 20, 2009 |
Device:
| Trade Name: | Cook MReye Embolization Coils |
|---|---|
| Proposed Classification Name: | Vascular embolization device |
| 21 CFR §870.3300, Product Code KRD | |
| Indications for Use: | The Cook MReye Embolization Coil is used for peripheral |
| arterial and venous vessel embolization procedures. | |
| Predicate Devices: | Cook MReye Embolization Coils (K052834) |
| Cook Stainless Steel Embolization Coils (Pre-amendment) |
Device Description:
The Cook MReye Embolization Coil is a device used for peripheral arterial and venous vessel embolization procedures. The coil is pre-loaded into a cartridge to facilitate delivery into a microcatheter, which then delivers the coil to the embolization site.
1
Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009
Substantial Equivalence:
The identical indications for use, technological characteristics, and similar dimensions of the Cook MReye Embolization Coils as compared to the predicate device supports a determination of substantial equivalence.
Test Data:
The following testing data were presented to demonstrate that the Cook MReye Embolization Coils meet applicable design and performance requirements:
- Coil deformation testing .
- Delivery friction testing ●
- Embolization fiber pull-out testing ●
- . Cannula to catheter delivery testing
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated, Inc. c/o Ms. Susanne Galin, RAC Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
APR - 2 2009
Re: K090624
Cook MReye® Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: March 6, 2009 Received: March 9, 2009
Dear Mr. Galin:
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. Susanne Galin, RAC
Please be advised that FDA's issuance of a substantial equivalence determinátion 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Cook MReye Embolization Coils COOK INCORPORATED 06 March 2009
Indications for Use
510(k) Number (if known):
Device Name:
Cook MReye® Embolization Coil
Indications for Use:
The Cook MReye Embolization Coil is used for peripheral arterial and venous vessel embolization procedures.
Prescription Use _ XX (Per 21 CFR 801.109)
OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular | |
| 510(k) number | K090621 |
-Company Confidential-