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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not describe, nor does it require for a 510(k) submission, the specific information requested about acceptance criteria, a study proving device performance against such criteria, sample sizes, ground truth establishment, or clinical effectiveness studies in the format typically associated with a new device approval.

Instead, the submission focuses on comparing the new device to a predicate device (HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) Coils (K070656)) to establish substantial equivalence based on material, design, and intended use. The performance attributes mentioned would typically refer to bench testing or animal studies demonstrating similar functional characteristics, rather than human clinical trials with performance metrics for an AI/algorithm-driven device.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's an attempt to address the request based on the available information, noting where information is not present:

Acceptance Criteria and Study for K080666: HydroSoft® and HydroSoft Plus Embolization Coil Systems

This 510(k) submission establishes substantial equivalence for the HydroSoft® and HydroSoft Plus Embolization Coil Systems to a predicate device (HydroCoil® Embolic System, K070656). The evaluation does not involve acceptance criteria or a study design in the context of an AI/algorithm-driven device's performance against clinical metrics. Instead, it relies on demonstrating similar technical and performance attributes to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Substantial Equivalence	Device is similar in materials of construction to the predicate device.	The HydroSoft and HydroSoft Plus Embolization Coils Systems are similar in materials of construction to the predicate HydroCoil device.
Substantial Equivalence	Device is similar in intended use to the predicate device.	The HydroSoft and HydroSoft Plus Embolization Coils Systems are similar in intended use to the predicate HydroCoil device.
Technical Attributes	(Not explicitly stated as numerical criteria, but implied to be equivalent or improved)	"technical and performance attributes" are similar and are available in larger secondary diameters and longer lengths to suit physician needs.
Performance Attributes	(Not explicitly stated as numerical criteria, but implied to be equivalent or improved)	"technical and performance attributes" are similar and are available in larger secondary diameters and longer lengths to suit physician needs.

Missing Information: The document does not provide specific quantitative acceptance criteria or detailed numerical performance metrics for the device, as it is focused on establishing substantial equivalence based on similarities to a predicate device, not on proving de novo clinical efficacy against predefined thresholds.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not applicable or not specified. A clinical "test set" in the context of a new AI algorithm's performance is not part of this 510(k) submission for an embolization coil.
Data Provenance: Not applicable or not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable or not specified. Ground truth establishment by experts for a test set is relevant for AI/diagnostic algorithms, not for physical medical devices in a 510(k) substantial equivalence submission.
Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is typically conducted for diagnostic devices (e.g., imaging software) to assess reader performance with and without AI assistance. This document describes a physical neurovascular embolization coil.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: No. This is not an AI/algorithm device.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of an AI/algorithm device. For this physical device, the "ground truth" for demonstrating substantial equivalence lies in comparing its material composition, design, and intended use against the legally marketed predicate device, and ensuring that any differences do not raise new questions of safety or effectiveness. This is implicitly established through engineering specifications, material testing, and a comparison of intended uses.

8. Sample Size for the Training Set

Sample Size (Training Set): Not applicable or not specified. There is no AI algorithm being trained.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment (Training Set): Not applicable.

Summary

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K080666

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, 882.5950Class II, 870.3300
Submitted By:	MicroVention, Inc.75 Columbia, Suite AAliso Viejo, CA 92656
Contact:	Kevin E. Daly
PredicateDevices:	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:

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.

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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

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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

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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:

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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004

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).