The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

The HES is also 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 embolizations in the peripheral vasculature.

Device Description

The HydroCoil® Embolic System (HES) is based on electrical coil detachment. The HES consist of an implantable coil attached to a delivery system called a V-TRAK™ Delivery Pusher. The Delivery Pusher is a variable stiffness, stainless steel and tapered mandrel. Two silver electrical leads run along the outside of the mandrel from the proximal to the distal end. Platinum and stainless steel wires are wound around the distal end of the mandrel to form the electrical heater and provide kink-resistance. Two outer layers of PET tubing cover the distal end of the pusher assembly. A layer of polyimide tubing covers the proximal end. The proximal end of the HES coils incorporates a platinum coupler for attachment to the Delivery Pusher. A polyolefin elastomer filament is attached to the proximal end of the coil. This filament runs through the inner lumen of the coil coupler and is attached to the distal end of the Delivery Pusher.

The Delivery Pusher is powered by a hand-held, battery-powered V-GRIP™ Detachment Controller designed specifically for the HES. A gold-plated stainless steel connector at the proximal end of the Delivery Pusher is used to connect it to the Detachment Controller, The Detachment Controller is provided separately. The coil is delivered to treatment site on the Delivery Pusher through standard neuro-interventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the HES into the micro-catheter. Once the coil is deployed, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the Detachment Controller is turned on, the flow of current melts the polyolefin elastomer filament at the coupler/pusher junction resulting in coil detachment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the HydroCoil® Embolic System (HES) and states that performance testing has demonstrated its equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot populate the table or answer most of the questions directly from the provided text.

Here's a summary of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	"Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is equivalent in performance to the predicate devices."

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified in the provided document.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not specified in the provided document. This device is an embolization coil system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is a medical device (embolization coil system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified in the provided document. The performance testing aimed to show equivalence to predicate devices, likely based on engineering performance metrics (e.g., detachment reliability, coil stability, mechanical properties) rather than diagnostic accuracy against a "ground truth" as typically understood in AI/imaging studies.

8. The sample size for the training set

Not applicable as this is a medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable as this is a medical device, not an AI/ML algorithm.

Additional Information from the text:

Device Name: HydroCoil® Embolic System (HES)
Intended Use: Endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae; also for vascular occlusion of blood vessels within the neurovascular system and peripheral vasculature.
Regulatory Status: 510(k) cleared, determined to be "substantially equivalent" to predicate devices.
Nature of Study: Performance testing was conducted to demonstrate equivalence to predicate devices, focusing on operating principle, method of applications for use, design, materials, packaging, and sterilization.

Summary

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K07D656 page

Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 349-1360 www.microvention.com

JUN 1 5 2007

Contact Information (2)

Vincent Cutarelli Telephone: (949) 951-0505 Fax: (949) 349-1360 E-mail: vinc@microvention.com

(3) Device Name

Classification Name:	Device, Artificial Embolization
Trade/Proprietary Name:	HydroCoil® Embolic System (HES)
Common/Usual Name:	Embolization Coil
Classification	Class II

(4) Device Description

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K070656 page 2/2

(5) Indications for Use

(6) Name of Predicate or Legally Marketed Device

The HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is substantially equivalent to the HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils that was determined to be substantially equivalent on December 30, 2003 (reference K033836) and the 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).

(7) Technological Characteristics and Substantial Equivalence

The HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is substantially equivalent in operating principle, method of applications for use, design, materials, packaging and sterilization to the predicate devices.

Performance Data Summary (8)

Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils is equivalent in performance to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MicroVention, Inc % Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance 75 Columbia, Suite A Aliso Viejo, California 92677

JUN 1 5 2007

Re: K070656

Trade/Device Name: HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG, KRD Dated: May 30, 2007 Received: May 31, 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.

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

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Page 2 - Mr. Vincent Cutarelli

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/index20tm1

Sincerely yours,

Fox Po
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and

ROMA DIRECT
6/14.

Radiological Health

Enclosure

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Indications For Use

510(k) Number:

Device Name: HydroCoil® Embolic System (HES) with the HES-HC-HS (10) coils

Indications for Use: The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Concurrence of CDRH, Office of Device Evaluation (ODE):

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L67065

Prescription Use: X (Per 21 CFR 801.109)

Regulation Number and Section

§ 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).