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 dc-airing and coil detachment. The HES prominer 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 junetion 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

The provided document is a 510(k) premarket notification for the HydroCoil® Embolic System (HES). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria based on detailed performance studies with clinical outcomes in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving it, sample sizes for test/training sets, expert consensus details, or MRMC studies.

Instead, it states the following:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the document. The document states that "Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils is equivalent in performance to the predicate devices." However, it does not provide specific acceptance criteria or the numerical results of this performance testing.

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

This information is not present in the document.

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

This information is not present in the document.

4. Adjudication method for the test set:

This information is not present in the document.

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

This information is not present in the document. The device in question is an embolization coil, not an AI-assisted diagnostic tool.

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

This information is not present in the document. The device is an embolization coil, not an algorithm.

7. The type of ground truth used:

This information is not present in the document.

8. The sample size for the training set:

This information is not present in the document.

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

This information is not present in the document.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, indications for use, design, materials, packaging, and sterilization. It does not provide the detailed performance study data, acceptance criteria, or ground truth establishment methods typically found in clinical trials or AI algorithm validation studies.

Summary

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DEC 3 0 2003

Dafe 1 of

Section 2 - Summary of Safety and Effectiveness

Company Information (1)

MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 768-1184 Fax: (949) 768-0464 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

Device Description (4)

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Indications for Use (5)

Name of Predicate or Legally Marketed Device (6)

The HydroCoil® Embolic System (HES) with the HES-HC-S (10) coils is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590), the GDC-10 Stretch Resistant Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993415) and the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993418).

Technological Characteristics and Substantial Equivalence (7)

The HydroCoil® Embolic System (HES) with the HES-HC-S (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-S (10) coils is equivalent in performance to the predicate devices.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2003

Mr. Vincent Cutarelli Vice President, Regulatory Affairs Quality Assurance and Clinical Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656

Re: K033836

Trade/Device Name: HydroCoil® Embolic System (HES) with the HES-HC-S (10) Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: December 9, 2003 Received: December 11, 2003

Dear Mr. Cutarclli:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stared in the 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 I va may, therefore, mans 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 11 your de hee to such additional controls. Existing major regulations affecting your device can may or die Jeen 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 mcan I reaso be ac mode a determination that your device complics with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must of any I catal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct el K Fart 6077, atoomig (21 OS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 premainer noticate 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/cdrb/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

Enclosure

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K035832

Indications for Use

510(k) Number (if known): K033836

Device Name: HydroCoil® Embolic System (HES) with the HES-HC-S (10) Coils

Indications For Use: The HydroCoil® Embolic System (HES) is intended for the mulcations For USC." The Tryalio aneurysms and other neurovascular chuovasoular Umbolization of increations and arteriovenous fistulae.

The HES is also intended for vascular occlusion of blood vessels within the The HEO is aloo intended formanently obstruct blood flow to an aneurysm or other vascular cystem and for arterial and venous embolizations in the peripheral vasculature.

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

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

All ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) Division of General, Restorative and Neurological Devices

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Number K033836

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).