(123 days)
No
The summary describes a physical medical device (embolization coils and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as an "Embolization Coil System" intended for the "endovascular embolization of intracranial aneurysms and other neurovascular abnormalities" and for "vascular occlusion of blood vessels". These actions are direct medical interventions to treat and permanently obstruct blood flow to abnormalities, classifying it as a therapeutic device.
No
This device is an embolization coil system used for "endovascular embolization" and "vascular occlusion of blood vessels," which are therapeutic procedures aimed at treating abnormalities by obstructing blood flow. It does not perform diagnostic functions.
No
The device description explicitly states it is a "platinum embolization coil with an inner hydrogel core, and a V-TrakTM Delivery Pusher," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a device used for embolization, which is a procedure performed inside the body to block blood vessels. It involves physically inserting coils into the vascular system.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient.
Therefore, based on the provided information, the HydroSoft and HydroSoft Plus Embolization Coil Systems are not IVDs. They are interventional medical devices used for therapeutic procedures.
N/A
Intended Use / Indications for Use
The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The HydroSoft and HydroSoft Plus Embolization Coils Systems also are intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
Product codes
HCG
Device Description
The HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are platinum embolization coils with an inner hydrogel core, and a V-TrakTM Delivery Pusher.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms), neurovascular system, 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)
Not Found
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
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).
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510(k) Summary
JUL 11 2008
| Trade Name: | HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-
HC-HS (10) Coils |
|-----------------------|----------------------------------------------------------------------------------------------|
| Generic Name: | Artificial Embolization Device |
| Classification: | Class II, 882.5950
Class II, 870.3300 |
| Submitted By: | MicroVention, Inc.
75 Columbia, Suite A
Aliso Viejo, CA 92656 |
| Contact: | Kevin E. Daly |
| Predicate
Devices: | HydroCoil® Embolic System with (HES) with the HES-HC-HS (10)
Coils (K070656) |
Device Description:
The HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are platinum embolization coils with an inner hydrogel core, and a V-TrakTM Delivery Pusher.
Indications for Use:
The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The HydroSoft and HydroSoft Plus Embolization Coils Systems also are intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
Comparison to Predicate Device:
The HydroSoft and HydroSoft Plus Embolization Coils Systems are similar in materials of construction and intended use to the predicate HydroCoil device, but are available in larger secondary diameters and longer lengths to suite the needs of the physician.
Summary:
Based upon the technical and performance attributes of the HydroSoft and HydroSoft Plus Embolization Coils Systems, these devices are substantially equivalent to the cited predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention, Inc. % Mr. Kevin E. Daly Vice President, Regulatory Affairs and Quality Assurancc 75 Columbia, Suite A Aliso Viejo, California 92656
JUL 11 2008
Re: K080666
Trade/Device Name: HydroSoft® Plus Embolization Coil Systems with HES-HE-HS (10) Coil Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: June 6, 2008 Received: June 9, 2008
Dear Mr. Daly:
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.
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
2
Page 2 - Mr. Kevin E. Daly
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
1080666
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils
Indications for Use:
The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The HydroSoft and HydroSoft Plus Embolization Coils Systems also are intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General, Restorative, and Neurological Devices |
| 510(k) Number | 1080666 |
|---|---|
| --------------- | --------- |
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