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) consists of an implantable coil attached to a fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The HES coils are platinum helical coils with an outer layer of a hydrophilic polymer. The polymer material is a cross-linked copolymer of acrylamide and acrylic acid. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heatshrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to the treatment site on the delivery pusher through standard neurointerventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.

AI/ML Overview

Below is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Acceptance Criteria and Device Performance

The provided document describes the HydroCoil® Embolic System (HES), an embolization coil. The core of its acceptance for market entry (510(k) clearance) is based on its substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (HydroCoil® Embolic System - HES)
Substantial Equivalence	Demonstrates equivalence in operating principle, method of application, indications for use, design, materials, packaging, and sterilization to predicate devices.	The modified HydroCoil® Embolic System (HES) is substantially equivalent to the HydroCoil® Embolic System (HES) cleared on October 22, 2003 (K032590) and December 30, 2003 (K033836), and to the Matrix™ Stretch Resistant Detachable Coils cleared on May 14, 2003 (K031168) in these characteristics.
Performance	Performance testing demonstrates equivalence to predicate devices.	"Performance testing has demonstrated that the modified HydroCoil® Embolic System (HES) is equivalent in performance to the predicate devices." (Specific performance metrics are not detailed in the provided text, but the overall conclusion of equivalence is stated.)
Indications for Use	Must align with the indications of the predicate device or be deemed safe and effective for the stated uses.	The HES is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities (e.g., arteriovenous malformations, arteriovenous fistulae), and for vascular occlusion within the neurovascular system and arterial/venous embolizations in the peripheral vasculature. These indications are accepted by the FDA based on substantial equivalence.

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

The provided text does not specify a "test set" in the context of a clinical study with real patient data. The evaluation is based on "performance testing" demonstrating equivalence to predicate devices. This typically refers to

Bench testing: In-vitro mechanical, material, and functional tests.
Animal studies: Pre-clinical evaluations of safety and performance in an animal model, if required.
Comparison to existing clinical data from predicate devices: This is implied by the substantial equivalence claim, rather than new clinical data for this specific modified device.

Therefore, details like country of origin or whether it was retrospective/prospective are not applicable as a separate clinical "test set" for this specific device's clearance is not described. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided as the clearance is based on substantial equivalence and "performance testing," not a clinical study requiring expert ground truth assessment of patient cases.

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

This information is not provided as a clinical test set requiring adjudication is not described.

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:

This is not applicable. The device (HydroCoil® Embolic System) is a medical implant (embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

This is not applicable. The device is an embolization coil, not an algorithm.

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

For the purpose of this 510(k) clearance, the "ground truth" for the device's acceptance is based on:

Established safety and effectiveness of predicate devices: The primary ground truth is that the predicate devices (HydroCoil® Embolic System and Matrix™ Stretch Resistant Detachable Coils) have already been deemed safe and effective and are legally marketed.
Performance testing (bench and potentially animal studies): These tests likely compared the new device's physical properties, mechanical performance, and perhaps immediate biological interactions to specifications or established performance of the predicate devices.

8. The sample size for the training set:

This information is not provided and is not applicable in the context of this device's regulatory submission, as it is not an AI/machine learning product requiring a training set.

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

This information is not provided and is not applicable for the reasons mentioned above.

Summary

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JUL = 7 2004

K041551

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Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 461-3329 www.microvention.com

Contact Information (2)

Vincent Cutarelli Telephone: (949) 768-1184 ext. 105 Fax: (949) 768-0464 E-mail: vinc@microvention.com

Device Name (3)

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

(4) Device Description

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Indications for Use (ર)

Name of Predicate or Legally Marketed Device (6)

The modified HydroCoil® Embolic System (HES) is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590) and December 30, 2003 (reference K033836), and to the Matrix™ Stretch Resistant Detachable Coils that were determined to be substantially equivalent on May 14, 2003 (reference K031168).

Technological Characteristics and Substantial Equivalence (7)

The modified HydroCoil® Embolic System (HES) is equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices.

Performance Data Summary (8)

Performance testing has demonstrated that the modified HydroCoil® Embolic System (HES) is equivalent in performance to the predicate devices.

Koultt

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JUL - 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vincent Cutarelli Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs MicroVention, Inc. 75 Columbia, Suite A Aliso Viejo, California 92656

Re: K041551

Trade/Device Name: HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Embolization coil Regulatory Class: III Product Code: HCG Dated: June 7, 2004 Received: June 9, 2004

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 for association 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 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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Page 2 - Mr. Vincent Cutarelli

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D.
Director Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: HydroCoit® Embolic System (HES)

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.

The HES is also intended for vascular occlusion of blood vessels within the neurovascular THE ITED is and intelling to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

X = AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number K041851

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).