(187 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the embolization coils. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended for arterial and venous embolization, which is a therapeutic procedure to block blood flow in specific vessels to treat various conditions.
No
The device is described as an embolization coil intended for arterial and venous embolization, which is a therapeutic procedure to block blood vessels, not to diagnose a condition.
No
The device description clearly states it is a physical medical device made of coiled platinum wire with nylon fibers, intended for embolization. It is delivered by microcatheters and includes a loading cartridge and stylet. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "arterial and venous embolization in the peripheral vasculature." This describes a therapeutic procedure performed within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical coil designed to be delivered into blood vessels. This is consistent with a therapeutic embolization device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Hilal Embolization MicroCoils™ are a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Hilal Embolization MicroCoils™ are intended for arterial and venous embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
Hilal Embolization MicroCoils™ are manufactured from coiled platinum wire with equidistantly spaced nylon fibers and are available in straight, single-curl, and multiple-curl configurations. The Hilal coils are designed to be delivered by microcatheters with a minimum end hole diameter of 0.018 inch. The extended embolus lengths of the finished device range from 0.5 to 6.0 centimeters. The coiled embolus diameters range from 2 to 10 millimeters. The Hilal coils are loaded in a straight configuration into a loading cartridge. A loading stylet is also provided for loading this coil into the delivery catheter.
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 subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters.
- 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.
- Animal Testing – An acute performance study was performed in a porcine model on straight and single curl Hilal coils, showing no evidence of arterial damage or coil migration. The predetermined acceptance criteria were met.
Other testing was leveraged from the 510(k) submission for Nester® and Tornado® Embolization Coils (K153778). 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
Cook Incorporated Mr. David Lehr Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-0489
Re: K160219
Trade/Device Name: Hilal Embolization MicroCoils™ Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 23, 2016 Received: June 24, 2016
Dear Mr. 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 vours
sincerely yours,
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) K160219
Device Name Hilal Embolization MicroCoils™
Indications for Use (Describe)
The Hilal Embolization MicroCoils™ 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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2.0 510(k) SUMMARY
As required by 21 CFR §807.92 Date Prepared: August 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: | Hilal Embolization MicroCoilsTM |
|---|---|
| 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), which has never been subject to a design-related recall.
IV. DEVICE DESCRIPTION
Hilal Embolization MicroCoils™ are manufactured from coiled platinum wire with equidistantly spaced nylon fibers and are available in straight, single-curl, and multiplecurl configurations. The Hilal coils are designed to be delivered by microcatheters with a minimum end hole diameter of 0.018 inch. The extended embolus lengths of the finished device range from 0.5 to 6.0 centimeters. The coiled embolus diameters range from 2 to 10 millimeters. The Hilal coils are loaded in a straight configuration into a loading cartridge. A loading stylet is also provided for loading this coil into the delivery catheter.
V. INDICATIONS FOR USE
The Hilal Embolization MicroCoils™ 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 device, the Hilal Embolization MicroCoils™, 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 device is a pushable embolization coil (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 Hilal coils (intended for delivery through catheters with end hole sizes of 0.018 through 0.025 inch) have straight, singlecurl, and multiple-curl shapes and are available in lengths ranging from 0.5 to 6 cm and in diameters ranging from 2 to 10 mm. Additionally, the subject device, like the predicate device, is labeled as MR Conditional. However, there are differences in the MR scanning conditions to reflect the testing performed on the subject device. Based on the comparison of the design, intended use, materials, fundamental technology, and principle of operation, the subject device is considered to be substantially equivalent to the currently marketed predicate device.
VII. PERFORMANCE DATA
The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters.
- . 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.
- . Animal Testing – An acute performance study was performed in a porcine model on straight and single curl Hilal coils, showing no evidence of arterial damage or coil migration. The predetermined acceptance criteria were met.
K160219
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Cook Incorporated - Traditional 510(k) Hilal Embolization MicroCoilsTM August 1, 2016
Other testing was leveraged from the 510(k) submission for Nester® and Tornado® Embolization Coils (K153778). 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.
VIII. CONCLUSIONS
The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device. This supports a determination of substantial equivalence.