(90 days)
No
The summary describes a mechanical embolization coil and delivery system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for arterial and venous embolization, which involves occluding blood vessels to treat conditions like aneurysms or bleeding. This is a therapeutic intervention aimed at treating medical conditions.
No
The device is an embolization coil used for therapeutic purposes (arterial and venous embolization), not for diagnostic imaging or analysis.
No
The device description clearly outlines physical components (embolization coils, delivery wire, handle) made of materials like stainless steel and synthetic fibers, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolization in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The description details a physical device (coils and a delivery wire) used for a physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is used to directly treat a condition within 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 is used for arterial and venous embolization for the peripheral vasculature. This device is used in conjunction with the Flipper Detachable Coil Delivery Wire. The detachable coil delivery system provides safe delivery of embolization coils where the size of embolization coil is difficult to predetermine. A handle facilitates manipulation and provides safe and easy detachment of embolization coils. This device is provided sterile and is intended for one-time use.
The Flipper™ Detachable Embolization Coil consists of the embolization coils and the delivery wire. The embolization coils are manufactured using stainless steel wire with synthetic fibers. The delivery wire is manufactured using stainless steel with TFE coating. The device will be available in the following sizes and is compatible with catheters of 80 and 110 cm lengths.
| Delivery Wire Diameter | 0.035" |
|---|---|
| Extended Embolus Diameter | 0.035" |
| Coil Length | 3cm, 4cm, 5cm, 6cm, 8cm, 10cm, |
| 12cm | |
| Coil Embolus Diameter | 3mm, 5mm, 6.5mm, 8mm |
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)
The following tests have been performed to evaluate the ability of the Flipper Detachable Embolization Coil to perform in accordance with the requirements of the design plan.
-
In-Vitro Performance Test: Loading, Passage and Deployment
-
Tensile Test: Coil Thread/Delivery System.
-
- Tensile Test: Torque Wire to Braid Solder
The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature.
- Tensile Test: Torque Wire to Braid Solder
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K940189, K901337, K983483, K951256
Reference Device(s)
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
JAN 1 1 2000
178
Safety and Effectiveness Information
| Submitted By: | Karen Bradburn |
|---|---|
| Regulatory Affairs Coordinator | |
| COOK INCORPORATED | |
| 925 South Curry Pike | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| (812) 339-2235 |
Device:
Flipper™ Detachable Embolization Coil Device, Embolization, Arterial (79KRD) 21 C.F.R. Part 870.3300
Predicate Devices
The Flipper™ Detachable Embolization C s of intended use, materials of construction and technological charact edicate devices reviewed: Embolization Coil Positioner Set, Hilal Embolization Vascular Occlusion System, Guglielmi Detachable Coil and Fibered Platinuit
Device Description
The Flipper™ Detachable Embolization Coil is used for arterial and venous embolization for the peripheral vasculature. This device is used in conjunction with the Flipper Detachable Coil Delivery Wire. The detachable coil delivery system provides safe delivery of embolization coils where the size of embolization coil is difficult to predetermine. A handle facilitates manipulation and provides safe and easy detachment of embolization coils. This device is provided sterile and is intended for one-time use.
The Flipper™ Detachable Embolization Coil consists of the embolization coils and the delivery wire. The embolization coils are manufactured using stainless steel wire with synthetic fibers. The delivery wire is manufactured using stainless steel with TFE coating. The device will be available in the following sizes and is compatible with catheters of 80 and 110 cm lengths.
| Delivery Wire Diameter | 0.035" |
|---|---|
| Extended Embolus Diameter | 0.035" |
| Coil Length | 3cm, 4cm, 5cm, 6cm, 8cm, 10cm, |
| 12cm | |
| Coil Embolus Diameter | 3mm, 5mm, 6.5mm, 8mm |
1
Substantial Equivalence
The Flipper™ Detachable Embolization Coil is similar to many devices already in commercial distribution for arterial and venous embolization. These devices include an Embolization Coil Positioner Set (Cook Incorporated), Hilal Embolization Microcoils (Cook Incorporated), the Vascular Occlusion System (Cordis Endovascular Systems Inc.), the Guglielmi Detachable Coil (Target Therapeutics) and a Fibered Platinum Coil (Target Therapeutics). All devices are introduced via the percutaneous method of entry using a catheter or microcatheter introducer.
The Embolization Coil Positioner Set was reviewed as substantially equivalent under D.C. K940189 and is indicated for arterial and venous embolization. The device is constructed of stainless steel and synthetic fiber with a coil wire diameter of 0.018 to 0.038 inches. The coils are available in straight or curled shapes with an emboli size range of 2 to 20 mm. A push-button release mechanism is the method of deployment.
Hilal Embolization Microcoils were reviewed bstantially equivalent under D.C. K901337 and are indicated for the embolization of tiovenous malformations and other vascular lesions of the brain, spinal cord and spine. The is constructed of platinum and synthetic fiber with a coil wire diameter of 0.018 in theses. The coils are available in straight and curled shapes with an emboli size range of 3 to 10 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter.
The Vascular Occlusion System was reviewed as substantially equivalent under D.C. K983483 and may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. It is intended for the interventional radiologic management of arteriovenous malformation, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord and spine. The device is constructed of platinum and synthetic fiber with a coil wire diameter of 0.014 inches. The coils are available in straight. "C", flat spiral and complex shapes with an emboli size range of 2 to 10 mm. Deployment is achieved by a wire guide which pushes the coils out of the microcatheter.
The Guglielmi Detachable Coil was reviewed as substantially equivalent under D.C. K951256. K960705 and K962503 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and arterial venous embolizations in the peripheral vasculature. The device is constructed of platinum with a coil wire diameter of 0.010 to 0.018 inches. The coils are available in a helical shape with an emboli size range of 2 to 20 mm. The coils are deployed by electrolytic detachment from the wire guide.
The Fibered Platinum coil was reviewed as substantially equivalent under D.C. K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is constructed of platinum and synthetic fiber with a coil wire diameter of 0.010 to 0.035 inches. The coils are available in the following shapes: straight, C-shaped, helical and complex helical. The emboli size range is 2 to 30 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter.
2
The Flipper™ Detachable Embolization Coil will be indicated for arterial and venous embolization for the peripheral vasculature. The delivery wire will be constructed of stainless steel with a diameter of 0.035 inches. The stainless steel coils with synthetic fiber will be available in curled shapes with an coil embolus diameter range of 3 to 8 mm. The coil is deployed when interlocking threads between the coils and the delivery wire are unscrewed.
Performance Data
The following tests have been performed to evaluate the ability of the Flipper Detachable Embolization Coil to perform in accordance with the requirements of the design plan.
-
In-Vitro Performance Test: Loading, Passage and Deployment
-
Tensile Test: Coil Thread/Delivery System.
-
- Tensile Test: Torque Wire to Braid Solder
The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature.
- Tensile Test: Torque Wire to Braid Solder
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines that suggest the head and wings.
JAN 1 1 2000
Ms. Karen Bradburn Regulatory Affairs Coordinator Cook, Inc. P.O. Box 489 Bloomington, In 47402
Re: K993455 Flipper™ Detachable Embolization Coil Regulatory Class: III Product Code: KRD Dated: October 12, 1999 Received: October 13, 1999
Dear Ms. Bradburn:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
4
Page 2 - Ms. Karen Bradburn
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Acting Director Division of Cardiovascular Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
5
510(k) Premarket Notification Flipper™ Detachable Embolization Coil COOK INCORPORATED
| 510(k) Number (if known): | K 993455 |
|---|---|
| --------------------------- | ---------- |
Flipper™ Detachable Embolization Coil Device Name:
Used for arterial and venous embolization in the peripheral vasculature. Indications for Use:
Bree R. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 99345 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Division Sign 1111 Division of .. manager a spillators and Neurolog Compar 510(k) Number