(15 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical embolization coil, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is used for arterial and venous embolization, a medical procedure to block blood flow, which is a therapeutic intervention.
No
This device is an embolization coil used for therapeutic purposes (occluding blood vessels), not for diagnosing conditions.
No
The device description clearly describes a physical medical device (embolization coil) made of Inconel with specific dimensions and features, intended for physical implantation in the peripheral vasculature. It also details physical testing performed on the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Flipper® Detachable Embolization Coil is a device that is introduced into the body (specifically, the peripheral vasculature) to physically block blood flow (embolization). It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is for "arterial and venous embolization," which is a treatment procedure, not a diagnostic test.
The information provided clearly describes a device used for a therapeutic intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Used for arterial and venous embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 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 when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.
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
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)
Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil . (Inconel) meets applicable design and performance requirements.
- Coil Deformation Testing ■
- Wire Tensile Strength 트
- Delivery Friction Testing 트
- 피 Fiber Pull-Out Testing
- Detachment Reliability Testing
- Magnetic Resonance (MR) Testing ■
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
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
Special 510(k): Device Modification Flipper Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006
KO63619 2. Lot2
510(k) SUMMARY
| Submitted By: | Lisa Webb, MBA, RAC
Regulatory Affairs Manager
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402
(812) 339-2235 x 2643
December 4, 2006 |
| --------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
DEC 2 0 2006
Device:
| Trade Name: | Flipper® Detachable Embolization Coil (Inconel) |
|---|---|
| Proposed Classification Name: | Device, Vascular, Embolization |
| 21 CFR 870.3300, KRD | |
| Indications for Use: | Used for arterial and venous embolization in the peripheral |
| vasculature. |
Predicate Devices:
The Flipper® Detachable Embolization Coil (Inconel) is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Flipper® Detachable Embolization Coil (stainless steel) and MReye® Embolization Coil.
Device Description:
The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 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 when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.
Substantial Equivalence:
Cook Incorporated currently markets the Flipper® Detachable Embolization Coil (stainless steel—K993455) and the MReye® Embolization Coil (K052834), to which the Flipper® Detachable Embolization Coil (Inconel) is substantially equivalent. The similar indications for use, materials of construction, and technological characteristics of the Flipper® Detachable Embolization Coil (Inconel) as compared to the predicate devices support a determination of substantial equivalence.
1
Special 510(k): Device Modification Flipper® Detachable Embolization Coils (Inconel) COOK INCORPORATED 04 December 2006
-063619
Test Data:
Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil . (Inconel) meets applicable design and performance requirements.
- Coil Deformation Testing ■
- Wire Tensile Strength 트
- Delivery Friction Testing 트
- 피 Fiber Pull-Out Testing
- Detachment Reliability Testing
- Magnetic Resonance (MR) Testing ■
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine, and its presence in the logo signifies the department's role in promoting and protecting the health of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Cook, Incorporated c/o Lisa Webb, MBA, RAC Regulatory Affairs Manager P.O. Box 489 Bloomington, IN 47402-0489
Re: K063619
Trade/Device Name: Flipper® Detachable Embolization Coil Regulation Number: 21 CFR 870.3300 Regulation Name: Embolectomy Coil Regulatory Class: II (two) Product Code: KRD Dated: December 4, 2006 Received: December 5, 2006
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, 7 rug, 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, UDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. 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 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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Blymmimor for
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): | K063619 |
|---|---|
| Device Name: | Flipper ® Detachable Embolization Coil (Inconel) |
| Indications for Use: | Used for arterial and venous embolization in the peripheral |
| vasculature. |
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 Devices (a561) 510(k) Number