(140 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the embolization coils, with no mention of AI or ML.
Yes
The device is described as an "Embolization Coil" intended for "arterial and venous embolization," which is a therapeutic intervention to block blood flow.
No
Explanation: The device, Embolization Coils, is described as intended for "arterial and venous embolization," which means it is used to block blood vessels. This is a therapeutic action, not a diagnostic one. The performance studies also focus on physical properties and biocompatibility, not on detecting or identifying medical conditions.
No
The device description explicitly states the device is constructed from coiled platinum wire and synthetic fibers, which are physical components, not software. The performance studies also detail testing on physical characteristics like tensile strength and biocompatibility.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Nester® and Tornado® Embolization Coils are intended for "arterial and venous embolization in the peripheral vasculature." This involves physically blocking blood vessels within the body.
- Lack of In Vitro Testing: The description of the device, its use, and the performance studies do not mention any testing of samples taken from the body. The performance studies focus on the physical properties of the coils, their delivery, and their interaction with the body (biocompatibility, animal testing).
Therefore, based on the provided information, the Nester® and Tornado® Embolization Coils are implantable medical devices used for therapeutic purposes within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Nester® and Tornado® Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The Nester® and Tornado® Embolization Coils are constructed from coiled platinum wire and synthetic fibers. The wire forms primary coil diameters that can be delivered through catheters with end hole diameters of 0.018, 0.035, and 0.038 inch. For the Nester® Embolization Coils, the extended embolus lengths range from 3 to 20 cm, and upon deployment the coiled embolus diameters range from 2 to 20 mm. For the Tornado Embolization Coils, the extended embolus lengths range from 2 to 14.2 cm, and upon deployment the coiled embolus tapering diameters range from 3/2 to 10/5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial and venous embolization in the 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
Performance (bench, MRI, and animal) and biocompatibility testing was conducted:
- Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility, and Pyrogenicity tests were performed on the implantable embolization coils. Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Hemocompatibility tests were performed on the device's loading stylet and loading cartridge. All tests results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible.
- Wire Tensile Testing: Testing shows the raw wire has a peak load value greater than or equal to the minimum tensile strength requirements. The predetermined acceptance criteria were met.
- Coil Tensile Testing: Testing characterized the embolization coils' uniaxial tensile strength.
- Rotations to Failure Testing: Testing characterized the embolization coils' torque strength.
- Delivery Friction Testing: Testing shows that the embolization coils fully deploy into the portion of the target artery in an anatomical model. The predetermined acceptance criteria were met.
- Delivery Fatigue Testing: Testing shows that the embolization coils do not have any visual defect after delivery. The predetermined acceptance criteria were met.
- Fiber Security Testing: Testing shows that an entire fiber is not released from the coils during simulated delivery conditions. The predetermined acceptance criteria were met.
- MRI Testing: MRI compatibility was assessed by evaluating magnetic field interactions (displacement force and torque), artifact, and RF-induced heating in accordance with FDA guidance titled, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.
- Animal Testing: One-month, three-month, and six-month safety evaluations in swine were performed on platinum embolization coils. Testing shows that the target arteries do not indicate a substantially adverse biological response. The predetermined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Cook Retracta® Detachable Embolization Coil (K123712/K151676)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Cook Incorporated David Lehr, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K153778
Trade/Device Name: Nester® and Tornado® Embolization Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: May 11, 2016 Received: May 12, 2016
Dear David Lehr:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
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) K153778
Device Name
Nester® and Tornado® Embolization Coils
Indications for Use (Describe)
The Nester® and Tornado® Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 812.339.2235 TOLLEREE: 800.457.4500 WWW.COOKMEDICAL.COM
Image /page/3/Picture/2 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, with a registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in white, set against a red background. The red background is a rectangle that extends slightly beyond the width of the word "COOK".
2.0 510(k) SUMMARY
As required by 21 CFR §807.92 Date Prepared: April 1, 2016
I. SUBMITTER
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | David Lehr, RAC |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 ext. 102309 |
| Contact Fax Number: | (812) 332-0281 |
II. DEVICE
| Trade Name: | Nester® and Tornado® Embolization Coils |
|---|---|
| Common Name: | Vascular Embolization Device |
| Classification Name: | Device, Vascular, For Promoting Embolization |
| Regulation/Class: | 21 CFR §870.3300/Class II |
| Product Code | KRD |
III. PREDICATE DEVICE
The device subject of this submission is considered substantially equivalent to the predicate device, the Cook Retracta® Detachable Embolization Coil (K123712/K151676). This predicate has never been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Nester® and Tornado® Embolization Coils are constructed from coiled platinum wire and synthetic fibers. The wire forms primary coil diameters that can be delivered through catheters with end hole diameters of 0.018, 0.035, and 0.038 inch. For the Nester® Embolization Coils, the extended embolus lengths range from 3 to 20 cm, and upon deployment the coiled embolus diameters range from 2 to 20 mm. For the Tornado Embolization Coils, the extended embolus lengths range from 2 to 14.2 cm, and upon deployment the coiled embolus tapering diameters range from 3/2 to 10/5 mm.
V. INDICATIONS FOR USE
The Nester® and Tornado® Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject devices, the Nester® and Tornado® Embolization Coils, and the predicate device, the Retracta® Detachable Embolization Coil (K123712/151676), are substantially equivalent in that these devices have identical intended uses and similar technological characteristics. The predicate device is a combined embolization coil and delivery wire. Its embolization coil (made of platinum wire and nylon fibers) is delivered by a detachment mechanism. The subject devices are pushable embolization coils (also made of platinum wire and nylon fibers) delivered with a wire guide through a delivery catheter. The predicate coils (intended for delivery through catheters with an end hole size of 0.035 inch) have a helical shape, and are available in lengths of 7 cm or 14 cm and diameters ranging from 4 to 20 mm. The subject Nester coils (intended for delivery through catheters with end hole sizes of 0.018, 0.035, and 0.038 inch) also have a helical shape and are available in lengths ranging from 2 to 20 cm and in diameters ranging from 2 to 20 mm. The subject Tornado coils (also intended for delivery through catheters with end hole sizes of 0.018, 0.035, and 0.038 inch) have a tapered vortex (or tornado) shape and are available in lengths ranging from 2.0 to 14.2 cm and tapering diameters ranging from 3/2 to 10/5 mm. Additionally, the subject devices, like the predicate device, are labeled as MR Conditional. However, there are differences in the MR scanning conditions to reflect the testing performed on the subject devices. Based on the comparison of the design, intended use, materials, fundamental technology, and principle of operation, the subject devices are considered to be substantially equivalent to the currently marketed predicate device.
VII. PERFORMANCE DATA
The subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance (bench, MRI, and animal) and biocompatibility testing was conducted in accordance with applicable FDA guidance documents to confirm the reliable performance of critical device characteristics.
- . Biocompatibility Testing - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility, and Pyrogenicity tests were performed on the implantable embolization coils. Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Hemocompatibility tests were performed on the device's
5
loading stylet and loading cartridge. All tests results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible.
- . Wire Tensile Testing - Testing shows the raw wire has a peak load value greater than or equal to the minimum tensile strength requirements. The predetermined acceptance criteria were met.
- . Coil Tensile Testing - Testing characterized the embolization coils' uniaxial tensile strength.
- . Rotations to Failure Testing - Testing characterized the embolization coils' torque strength.
- . Delivery Friction Testing - Testing shows that the embolization coils fully deploy into the portion of the target artery in an anatomical model. The predetermined acceptance criteria were met.
- . Delivery Fatigue Testing – Testing shows that the embolization coils do not have any visual defect after delivery. The predetermined acceptance criteria were met.
- Fiber Security Testing Testing shows that an entire fiber is not released from the . coils during simulated delivery conditions. The predetermined acceptance criteria were met.
- MRI Testing MRI compatibility was assessed by evaluating magnetic field . interactions (displacement force and torque), artifact, and RF-induced heating in accordance with FDA guidance titled, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.
- . Animal Testing - One-month, three-month, and six-month safety evaluations in swine were performed on platinum embolization coils. Testing shows that the target arteries do not indicate a substantially adverse biological response. The predetermined acceptance criteria were met.
VIII. CONCLUSIONS
The data included in this submission indicate that the subject devices do not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.