The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES are 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 HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment.

AI/ML Overview

This document describes the HydroCoil Embolic System (HES), specifically the HydroFrame® 10 for neurovascular and peripheral vascular embolization.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the nature of the "Result" column, which uniformly states "All test samples passed testing", "Non-toxic", "No sensitizer response", "Non-irritant", "Non-hemolytic", "No adverse effect on coagulation time", "Non-pyrogenic", and "Negative response for mutagenicity". The specific quantitative thresholds for "passing" are not explicitly stated in this summary but would be detailed in the full test reports (e.g., PDH-HFRM-ATP for visual inspection).

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Bench Testing	Meets established performance requirements for the test	All test samples passed testing
Visual Inspection	Coils inspect per device drawing (PDH-HFRM-ATP)	All test samples passed testing
Dimensional Measurement	Coil's secondary wire diameter inspectable using a microscope	All test samples passed testing
Simulated Use	Performs as expected in an in-vitro cerebrovascular benchtop model	All test samples passed testing
Reposition Time	Gel performs as expected when device is repositioned	All test samples passed testing
Advancement/Retraction Force	Maximum force for advancement/retraction meets specifications	All test samples passed testing
Expanded Gel Diameter	Expanded diameter of hydrogel (post hydration) meets specifications	All test samples passed testing
Spring Constant	Spring constant force (maximum force to break monofilament) meets specifications	All test samples passed testing
Weld Tensile	Coil/coupler weld tensile strength meets specifications	All test samples passed testing
Biocompatibility (HydroFrame 10 Implant & Delivery Pusher)
Cytotoxicity (MEM Elution Test)	Non-toxic	Non-toxic
Cytotoxicity (ISO Cell Culture Agar Overlay)	Non-toxic	Non-toxic
Sensitization (Guinea Pig Max.)	No sensitizer response	No sensitizer response
Irritation (Intracutaneous React.)	Non-irritant	Non-irritant
Hemocompatibility (Hemolysis)	Non-hemolytic	Non-hemolytic
Hemocompatibility (Prothrombin Time)	No adverse effect on coagulation time	No adverse effect on coagulation time
Systemic Toxicity (IV injection)	Non-toxic	Non-toxic
Systemic Toxicity (Rabbit Pyrogen Test)	Non-pyrogenic	Non-pyrogenic
Genetic Toxicology (Ames Test)	Negative response for mutagenicity	Negative response for mutagenicity
Implantation (7-day muscle)	Non-irritant	Non-irritant
Implantation (13-week intramuscular)	Non-irritant	Non-irritant
Implantation (26-week intramuscular)	Non-irritant	Non-irritant

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

Sample Size: The document repeatedly states "All test samples passed testing" but does not specify the precise number of samples used for each test. This information would typically be found in the detailed test protocols or reports referenced (e.g., PDH-HFRM-ATP).
Data Provenance: The tests performed are pre-clinical bench and biocompatibility laboratory tests. The country of origin of the data is not explicitly stated, but the company, MicroVention, Inc., is based in Tustin, California, USA, suggesting the testing was likely conducted in the USA or by labs compliant with US regulatory standards. Since these are in-vitro and animal tests, they are inherently prospective as they are specifically conducted for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This document describes technical and biological tests, not studies requiring expert human interpretation of medical images or conditions to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists, pathologists) does not apply here. The "ground truth" for these tests is established by the predefined pass/fail criteria and objective quantitative measurements of the device's physical and biological performance against established standards (e.g., ISO 10993 series for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes among multiple human reviewers for clinical endpoints or image interpretation. The tests described are objective performance and biocompatibility assays with predefined pass/fail criteria.

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

No MRMC comparative effectiveness study was mentioned or performed. The document focuses on demonstrating substantial equivalence through technical and biocompatibility performance data, not through human reader performance with or without AI assistance.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. The HydroCoil Embolic System is a physical medical device (coils for embolization), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant. The performance evaluated is the device's physical and biological function.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

Quantitative Bench Test Specifications: Predefined engineering and performance specifications for physical characteristics like dimensions, forces, and material properties.
Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological response to medical devices. These standards define the acceptable biological reactions (e.g., non-toxic, non-irritant).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical medical device.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of medical device.

Summary

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Image /page/0/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 image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2016

MicroVention, Inc. Ms. Sapna Singh, MS. RAC Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K161367

Trade/Device Name: HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: July 28, 2016 Received: August 4, 2016

Dear Ms. Singh:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161367

Device Name HydroCoil® Embolic System (HES)

Indications for Use (Describe)

The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES are 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 yenous embolizations in the peripheral vasculature.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This 510(k) summary for the HydroCoil® Embolic System (HES) - HydroFrame® 10 is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.

SUBMITTER [807.92(a)(1)]

MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.

Telephone:	(714) 247-8162
Fax:	(714) 247-8014

Contact Person:	Sapna Singh
Email:	sapna.singh@microvention.com
Date Prepared:	May 16, 2016

DEVICE [807.92(a)(2)]

Name of Device:	HydroCoil Embolic System (HES)
Common or Usual Name:	HydroCoils
Classification Name:	Neurovascular Embolization Device
Product Code:	HCG, KRD
Regulatory Class:	Class II
Submission Type:	Special 510(K)
Regulation Number:	21 CFR 882.5950
Reviewing Product Branch:	Division of Neurological and Physical Medicine Devices(Office of Device Evaluation CDRH)

PREDICATE DEVICE [807.92(a)(3)]

HydroFrame® 10 (K090357, K100454 and K103758)

DEVICE DESCRIPTION [807.92(a)(4)]

The HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core.

The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is Page 1 of 6

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attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment.

INDICATIONS FOR USE [807.92(a)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

The Table I compares the technological characteristics of the existing HydroFrame coils (K090357, K100454 and K103758) with the additional models presented in this 510(k) submission. The devices,

Have the same intended use
. Use the same operating principle
Incorporate the same basic coil design ●
Use similar construction and material
Are packaged and sterilized using same material and processes

The line extension of the HydroFrame 10 coils (includes addition of sizes from 1mm to 9 mm secondary wind diameter with lengths from 2 cm to 36 cm) and change in the Stretch Resistance Member Material from Polyethylene Terephthalate (PET) to PET or Polyolefin Elastomer (Engage™) does not change the indications for use of the coils and is not a change to the fundamental scientific technology. The performance data below shows the device will perform as well as the previously marketed device.

Table I: Predicate Device vs Subiect Device Comparison Table

	Existing HydroFrame 10 (Predicate Device,(K090357, K100454 and K103758) )	HydroFrame 10 LineExtension (SubjectDevice)
Intended Use

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Intended UseStatement	The HydroCoil Embolic System (HES) areintended for the endovascular embolization ofintracranial aneurysms and otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae. The HES are alsointended for vascular occlusion of bloodvessels within the neurovascular system topermanently obstruct blood flow to ananeurysm or other vascular malformation andfor arterial and venous embolizations in theperipheral vasculature.	Same
Performance
Function	The coils are used for the endovascularembolization of aneurysms, otherneurovascular abnormalities such asarteriovenous malformations, arteriovenousfistulae and arterial and venous embolizationsin the peripheral neurovasculature.	Same
Anatomical Location	General intravascular use, including the neuroand peripheral vasculature.	Same
	Implantable Embolization Coil		Coil Shape	3D - Spherical	Same	Primary Coil Wire OD	0.00150 inch, .00175 inch, .00200 inch,.00225 inch	Same	Coil Implant Diameter	2 – 12 mm	1 – 9 mm	Coil Restrained Length	2 – 43 cm	2 - 36 cm	Coil Gap	Closed	Same	Delivery pusher length	195 cm	Same	Material	Main Coil Wire	Platinum/Tungsten Alloy (Pt/W: 92/8)	Same	Coil-to-Pusher Coupler	Platinum/Iridium (Pt/Ir: 90/10)	Same	Adhesive	Ultraviolet Curing Adhesive	Same	Implant to PusherFilament	Polyolefin Elastomer	Same	Stretch resistant (SR)	Polyethylene Terephthalate (K103758) orPolyolefin Elastomer (K090357, K100454)	Same	Hydrogel	Hydrophilic Acrylic Copolymer	Same	Other Attributes	Detachment System	Detachment Controller; stand alone, handheld battery operated unit detaches the coilimplant	Same	Catheter compatibility	Compatible with 10-system microcatheters(minimum ID of 0.0165")	Same
	Implantable Embolization Coil
Coil Shape	3D - Spherical	Same
Primary Coil Wire OD	0.00150 inch, .00175 inch, .00200 inch,.00225 inch	Same
Coil Implant Diameter	2 – 12 mm	1 – 9 mm
Coil Restrained Length	2 – 43 cm	2 - 36 cm
Coil Gap	Closed	Same
Delivery pusher length	195 cm	Same
Material
Main Coil Wire	Platinum/Tungsten Alloy (Pt/W: 92/8)	Same
Coil-to-Pusher Coupler	Platinum/Iridium (Pt/Ir: 90/10)	Same
Adhesive	Ultraviolet Curing Adhesive	Same
Implant to PusherFilament	Polyolefin Elastomer	Same
Stretch resistant (SR)	Polyethylene Terephthalate (K103758) orPolyolefin Elastomer (K090357, K100454)	Same
Hydrogel	Hydrophilic Acrylic Copolymer	Same
Other Attributes
Detachment System	Detachment Controller; stand alone, handheld battery operated unit detaches the coilimplant	Same
Catheter compatibility	Compatible with 10-system microcatheters(minimum ID of 0.0165")	Same

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MRI compatibility	Yes	Same
Method of Supply	Sterile and single use (Gamma Radiation)	Same
Package Configuration	Placed in Introducer Sheath, Dispenser Coil,Pouch, and Shipping Carton	Same

PERFORMANCE DATA [807.92(b)]

Results of the verification and validation testing (Table II) indicate that the product meets established performance requirements, and is substantially equivalent for its intended use.

Table II: Design Verification and Validation Test Summary

Bench Testing	Result
Visual Inspection: Using a microscope, inspect HydroFrame Coilsper device drawing, PDH-HFRM-ATP.	All test samples passed testing.
Dimensional Measurement: Using a microscope, inspectHydroFrame Coil's secondary wire diameter.	All test samples passed testing.
Simulated Use: The test simulate the use of HydroFrame coils in-vitro using a cerebrovascular benchtop model.	All test samples passed testing.
Reposition Time: The test reposition the device within simulateduse bench top model and determine the performance of the gel.	All test samples passed testing.
Advancement/Retraction Force: The test measures the maximumforce required to advance and retract the coil through themicrocatheter after 30 minutes.	All test samples passed testing.
Expanded Gel Diameter: The HydroFrame coils are detached fromthe pusher and the expanded diameter of the hydrogel (posthydration) are measured using a microscope.	All test samples passed testing.
Spring Constant: The spring constant force (determination ofmaximum force to break monofilament) of the coil is measured.	All test samples passed testing.
Weld Tensile: The coil/coupler weld tensile strength is tested andmeasured.	All test samples passed testing.

Biocompatibility Summary – HydroFrame 10 Implant

Biocompatibility	Test Standard	Results
Cytotoxicity
MEM Elution Test	ISO 10993-5	Non-toxic
ISO Cell Culture Agar Overlay	ISO 10993-5	Non-toxic
Sensitization

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Sensitization-Guinea Pig Maximization Test	ISO 10993-10	No sensitizer response
Irritation
ISO Intracutaneous Reactivity EvaluationTest	ISO 10993-10	Non-irritant
Hemocompatibility
Hemolysis	ISO 10993-4	Non-hemolytic
Prothrombin Time Assay - ISO	ISO 10993-4	No adverse effect on coagulation time
Systemic Toxicity
Systemic toxicity(IV injection)	ISO 10993-11	Non-toxic
Rabbit Pyrogen Test (material mediated)	ISO 10993-11	Non-pyrogenic
Genetic Toxicology
Bacteria Reverse Mutation Assay (AmesTest)	ISO 10993-3	Negative response for mutagenicity
Intramuscular Implantation
7-day Muscle Implantation	ISO 10993-6	Non-irritant
13-week Intramuscular Implantation Test	ISO 10993-6	Non-irritant
26-week Intramuscular Implantation Test	ISO 10993-6	Non-irritant

Biocompatibility Summary – V-Trak™ or V-Trak™ Advanced Delivery Pusher

Biocompatibility	Test Standard	Results
Cytotoxity
MEM Elution Test	ISO 10993-5	Non-toxic
ISO Cell Culture Agar Overlay	ISO 10993-5	Non-toxic
Sensitization
Sensitization-Guinea Pig Maximization Test	ISO 10993-10	No sensitizer response
Irritation
ISO Intracutaneous Reactivity EvaluationTest	ISO 10993-10	Non-irritant
Hemocompatibility
Hemolysis	ISO 10993-4	Non-hemolytic
Prothrombin Time Assay - ISO	ISO 10993-4	No adverse effect on coagulation time
Systemic Toxicity
Systemic toxicity (IV injection)	ISO 10993-11	Non-toxic

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Rabbit Pyrogen Test (material mediated)	ISO 10993-11	Non-pyrogenic
-----------------------------------------	--------------	---------------

CONCLUSIONS

Based on the 510(k) summary and information provided herein, we conclude the subject device, HydroFrame 10 in the HES, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate HydroFrame 10, K090357, K100454 and K103758.

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).