The EMBA Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.

Device Description

The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.

AI/ML Overview

This document describes the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED). The information provided focuses on the device's substantial equivalence to predicate devices rather than a detailed study proving it meets specific quantitative acceptance criteria for performance metrics in a clinical setting.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for performance metrics (e.g., specific thresholds for occlusion rates, migration rates, etc.) that the device was evaluated against in a clinical study. Instead, it lists various comparative performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests focused on design and functional characteristics to show that technological differences do not raise new safety or effectiveness concerns.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical/Physical
Kink Radius	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit in "Comparative performance testing was conducted to demonstrate that the technological differences... do not raise concerns of substantial equivalence").
Trackability	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit).
Partial Deployment &	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit).
Retraction
Deployment Accuracy	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit).
Chronic Outward Force	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit).
Embolic Device Length &	Within specified design ranges and comparable to predicate devices.	Conducted; passed (implicit). Device dimensions are provided in the DEVICE DESCRIPTION section (e.g., 10mm diameter, 20mm length).
Diameter
Foreshortening	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns.	Conducted; passed (implicit).
Contrast Flow	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., allows for adequate visualization).	Conducted; passed (implicit).
Migration Resistance	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., device stays in intended location).	Conducted; passed (implicit).
Occlusion Effectiveness	Demonstrates performance comparable to predicate devices and does not introduce new safety concerns (e.g., obstructs blood flow as intended).	Conducted; passed (implicit). The fundamental purpose of the device is to obstruct or reduce blood flow.
Corrosion	Demonstrates biocompatibility and structural integrity.	Conducted; passed (implicit).
Fatigue Testing	Demonstrates durability and structural integrity over time.	Conducted; passed (implicit).
Delivery System Integrity	Demonstrates safe and effective delivery of the device.	Conducted; passed (implicit).
Biocompatibility	Biocompatible in accordance with ISO 10993.	"The subject device... passed appropriate ISO 10993 testing to demonstrate biocompatibility."
Sterility	Terminally sterilized by ethylene oxide (EtO).	"All of the devices are terminally sterilized by ethylene oxide (EtO)."
MR Compatibility	Safe for use in an MR environment.	Conducted; passed (implicit).
Shelf Life	Maintains performance and sterility over its stated shelf life.	Conducted; passed (implicit).
Clinical Safety &	Demonstrated safety and effectiveness endpoints.	"Human Use Clinical Testing has been conducted on the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) (n=51) to evaluate safety and effectiveness endpoints." (No specific metrics or results are provided in this summary, just that it was evaluated.)
Effectiveness (Human Use)

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

Sample Size: Human Use Clinical Testing was conducted on n=51.
Data Provenance: The document does not specify the country of origin. The study appears to be a prospective human use clinical study, although full details are not provided in this summary.

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

The document does not mention the number of experts used to establish ground truth for the clinical test set or their specific qualifications. It only states that human use clinical testing was conducted to evaluate "safety and effectiveness endpoints," implying clinical assessment by medical professionals.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used for the clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this was not an MRMC comparative effectiveness study. The text discusses comparative performance testing against predicate devices, but this refers to bench testing and animal testing, and for the human use study, it was to evaluate safety and effectiveness endpoints of the EMBA device itself, not to compare human readers with and without AI assistance. The device is a physical medical implant, not an AI diagnostic tool.

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

This question is not applicable as the EMBA™ HOURGLASS™ Peripheral Embolization Device is a physical medical device, not a software algorithm. Its "standalone" performance would typically refer to its mechanical and functional performance in in-vitro or animal models, which was indeed performed as "comparative performance testing."

7. The Type of Ground Truth Used:

For the human use clinical testing, the "ground truth" would implicitly be clinical outcomes data assessed by medical professionals, related to the safety and effectiveness of the device's embolization. For the non-clinical performance tests (Kink Radius, Trackability, Migration Resistance, Occlusion Effectiveness, etc.), the "ground truth" was established by engineering and scientific measurements against predefined specifications or comparison with predicate device performance.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical medical implant, not an AI algorithm that requires a "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

Summary

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510(k) Summary

Date Prepared:	July 31, 2017
510(k) SPONSOR:	EMBA Medical Limited3451 Commerce ParkwayMiramar, FL 33025Phone Number: 954-874-1016

EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) TRADE NAME:

COMMON NAME: Vascular Embolization Device

Product	Regulation andDescription	Product Code	Device	Device Class
PeripheralEmbolizationDevice (PED)	21 CFR870.3300VascularEmbolizationDevice	KRD	VascularEmbolizationDevice	II

PREDICATE DEVICES:

Reverse Medical® MVP® Micro Vascular Plug System (K141313) Amplatzer® Vascular Plug 4 (K113658)

DEVICE DESCRIPTION:

The configuration of the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) is listed below.

Reference Number	Embolic DeviceDiameter(mm)	Embolic DeviceLength(mm)	Embolic DeviceMaximum CoveredLength(mm)
PEP-001	10	20	10

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INDICATIONS FOR USE:

CONTRAINDICATIONS

The device should not be implanted in vessels < 6 mm due to risk of vessel perforation or device fracture.

The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels due to risk of device fracture.

BASIS FOR SUBSTANTIAL EQUIVALENCE:

The EMBA" HOURGLASS" Peripheral Embolization Device (PED) and the predicate devices, Reverse Medical® MVP® Micro Vascular Plug System and Amplatzer® Vascular Plug 4 are intended for embolization/obstruction of blood flow in the peripheral vasculature - arterial and venous. Compared to the predicate devices, the subject device is not indicated for use in blood vessels < 6 mm or subject to repetitive motion: however, these differences do not introduce a new intended use. Additionally, the combination of device labeling and totality of data support that the EMBA Hourglass does not raise new questions of safety and effectiveness.

The operating principle of the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) and the predicate devices, Reverse Medical® MVP® Micro Vascular Plug System, and Amplatzer® Vascular Plug 4 are equivalent. All the devices are delivered through a Delivery System that is introduced into the vasculature using standard techniques. The Delivery System is advanced to the site of interest by the physician using fluoroscopic guidance. Once in position, the Embolic Device is delivered by manipulating the Delivery System to mechanically release the Embolic Device. The Amplatzer® Vascular Plug 4 and Reverse Medical® MVP® Micro Vascular Plug System are mounted on a pusher and tracked through a guide catheter to the desired location. The EMBA™ HOURGLASS™ Peripheral Embolization Device is mounted on a pusher, inside an outer body, which is tracked to the desired location. The Amplatzer® Vascular Plug 4 and Reverse Medical® MVP® Micro Vascular Plug System are deployed by rotating the delivery wire to unscrew the proximal end of the embolic device from the wire. The EMBA™ HOURGLASS™ Peripheral Embolization Device is released by retracting the outer body until the embolic device is exposed, thus allowing the proximal portion of the device to expand, releasing the device from the interlock mechanism. Although there are technological differences in the delivery system and modes of detachment, these differences do not raise any different questions of safety and effectiveness. All of the Embolic Devices consist of a self-expanding material which, when deployed, expand to obstruct the blood flow in the vessel thus triggering the clotting cascade.

The EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) and the predicate devices, Reverse Medical® MVP® Micro Vascular Plug System, and Amplatzer® Vascular Plug 4 have similar technological characteristics and materials of construction. The Reverse Medical® MVP® Micro Vascular Plug System Embolic Device is laser cut nitinol in an oblong shape tapering at each end. The device includes a polymer covering. The Amplatzer® Vascular Plug 4 is a braided wire construction in a multi-lobed shape. The EMBA" HOURGLASS"

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Peripheral Embolization Device (PED) is a laser cut nitinol in a multi-lobed or hourglass shape including a polymer covering. These characteristics are present in the other predicate devices. Design features of the embolic device of the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) and the predicate devices are very similar and are considered substantially equivalent: Delivery System length, system compatibility, Embolic Device shape, and Embolic Device size, Embolic Device materials of construction, and indicated vessel sizes. Although there are slight technological differences in the embolic device designs, these differences do not raise any different questions of safety and effectiveness.

The subject device, EMBA™ HOURGLASS™ Peripheral Embolization Device (PED), passed appropriate ISO 10993 testing to demonstrate biocompatibility.

The subject device, EMBA™ HOURGLASS™ Peripheral Embolization Device (PED), and the cited predicate devices are provided packaged sterile and all of the devices are terminally sterilized by ethylene oxide (EtO).

Comparative performance testing was conducted to demonstrate that the technological differences the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) and the predicate devices do not raise concerns of substantial equivalence. Testing was conducted in accordance with the FDA guidance document of "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices." Testing conducted consisted of Kink Radius, Trackability, Partial Deployment and Retraction, Deployment Accuracy, Chronic Outward Force, Embolic Device Length and Diameter, Foreshortening, Contrast Flow, Migration Resistance, Occlusion Effectiveness, MR Compatibility, Corrosion, Fatigue Testing, Delivery System Integrity. Shelf Life, and Animal Testing.

Human Use Clinical Testing has been conducted on the EMBA™ HOURGLASS™ Peripheral Embolization Device (PED) (n=51) to evaluate safety and effectiveness endpoints.

CONCLUSIONS:

Review of the in-vitro and in-vivo performance testing as well as the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, EMBA™ HOURGLASS™ Peripheral Embolization Device (PED), is substantially equivalent to the cited predicate devices, Reverse Medical® MVP® Micro Vascular Plug System (K141313) and Amplatzer® Vascular Plug 4 (K113658). Any differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

EMBA Medical Limited % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K171845

Trade/Device Name: EMBA Hourglass Peripheral Embolization Device Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: June 20, 2017 Received: June 20, 2017

Dear Randy Prebula:

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 device

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related 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.

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 vours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).