(182 days)
Not Found
No
The summary describes a mechanical embolic coil system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature" for the "management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature," indicating a direct therapeutic action on a medical condition.
No
The device is described as an "Embolic System" intended to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" for "interventional radiologic management". This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states it consists of an implantable coil, introducer, and stylet, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or block the rate of blood flow in vessels of the peripheral vasculature" and for the "interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an "implantable coil housed in an introducer" used to "deploy the coil from the introducer into a delivery catheter." This is a physical device used for a medical procedure within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the HydroCoil® Embolic System does not involve the analysis of such specimens.
Therefore, the HydroCoil® Embolic System is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
Product codes
KRD
Device Description
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. Both the delivery catheter and guidewire are not included in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional radiologic management
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)
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is equivalent in performance to the predicate devices.
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 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).
0
Section 2 - 510(k) Summary
(1) Company Information
MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 349-1360 www.microvention.com
(2) Contact Information
Vincent Cutarelli Telephone: (949) 951-0505 Fax: (949) 349-1360 E-mail: vinc@microvention.com
(3) Device Name
| Classification Name: | Device, Embolization, Arterial |
|---|---|
| Trade/Proprietary Name: | HydroCoil ® Embolic System (HES) |
| AZUR TM Peripheral HydroCoil ® Endovascular Embolization Coil System - Pushable 18 and 35 | |
| Common/Usual Name: | Embolization Coil |
| Classification | Class II |
(4) Device Description
.
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. Both the delivery catheter and guidewire are not included in the system.
JAN
1 2000
1
(5) Indications for Use
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
(6) Name of Predicate or Legally Marketed Device
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent to the Cordis Vascular Occlusion System that was determined to be substantially equivalent on March 24, 1999 (reference K983483), the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a Modified Detachment System that was determined to be substantially equivalent on June 28, 2005 (reference K050954) and the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (18) Coils that was determined to be substantially equivalent on October 22, 2003 (reference K032590)..
(7) Technological Characteristics and Substantial Equivalence
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices.
(8) Performance Data Summary
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is equivalent in performance to the predicate devices.
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 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 fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
JAN 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention Inc. c/o Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance 75 Columbia, Suite A Aliso Viejo, CA 92656
Re: K071939
HydroCoil® Embolization System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 30, 2007 Received: November 2, 2007
Dear Mr. Cutarelli:
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 - Mr. Vincent Cutarelli
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 (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 Biometric's (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.
Duna R. Vuchner
( ) Bram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number: __K071939
Device Name: HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils
Indications for Use: The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE):
Duana R. Lechner
(Division Sign-Off)
Division of Cardiac
(1978) Sign-Oli)
Division of Cardiovascular Devices
510(k) Number_k © 7 193 9
Prescription Use: __X (Per 21 CFR 801.109)